US FDA finalizes 510(k) exemptions for some Class I and II medical devices

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has finalized plans to exempt some “well understood” Class I and II medical devices from 510(k) premarket notification requirements, according to new guidance from the agency.

The final guidance states that until the FDA issues a final rule regarding such exemptions, the regulator will not enforce 510(k) compliance for qualifying devices. Examples of Class I, II and unclassified devices targeted for exemption include the following:

• Anesthesiology devices: powered algesimeters (BSI), nitrogen diozide analyzers (MRQ), portable air compressors (BTI)
• Cardiovascular devices: lung sound monitors (OCR), oscillometers (DRZ), trocars (DRC)
• Dental devices: pulp testers (EAT), dental irrigating syringes (EIB), fluid-filled teething rings (KKO)
• Ear, nose and throat devices: inserted hearing detectors (EWD), electroglottographs (KLX), master hearing aids (KHL)
• Gastroenterology-urology devices: hemorrhoid cushions (LRL), colostomy rods (EZP), esophageal ligators (MND)
• General and plastic surgery devices: talking first aid kits (OVR), ophthalmic patient drapes (HMT), incandescent surgical lamps (GBC)
• General hospital and personal use devices: medical support stockings (DWL), conductive patient restraints (BRT), ultraviolet medical water purifiers (KMG)
• Neurological devices: ataxiagraphs (GWW), ventricular cannulae (HCD), shunt system implantation instruments (GYK)
• Obstetrical and gynecological devices: proceptive fertility diagnostic devices (LHD), cervical drains (HFL), liquid crystal thermographic systems (LHM)
• Ophthalmic devices: photorefractors (MMF), AC-powered euthyscopes (HMK), battery-powered corneal burrs (HOG)
• Physical medicine devices: spine curvature monitors (LZW), powered reflex hammers (IKO), paraffin baths (IMC)

Again, the FDA has selected these devices for exemption from 510(k) premarket notification requirements because the agency considers these products well understood in terms of safety and effectiveness. Other regulatory requirements, however, will still have to be met in order for these devices to be sold legally in the US. Applicable requirements include 21 CFR Part 807 on registration and listing; 21 CFR Part 820 on FDA Quality System Regulations; 21 CFR Part 801 on labeling; and 21 CFR Part 803 on reporting.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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MassDevice.com +3 | The top 3 medtech stories for July 2, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. Alcon wins CE Mark for AcrySof IQ PanOptix trifocal lens

Alcon said last month that it won CE Mark approval in the European Union for its AcrySof IQ PanOptix trifocal intraocular lens.

The lens is indicated for use in patients undergoing cataract surgery who need treatment for near, intermediate, and distance vision needs with a single lens, the Switzerland-based company said. Read more

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2. Cambridge Robotics startup aims at Intuitive Surgical

U.K.-based startup Cambridge Medical Robotics said it is tilting at a growing robotic surgery market and taking aim at market leader Intuitive Surgical, according to an interview with Business Weekly.

The startup said it is developing a “next-generation universal robotic system for minimal access – or keyhole – surgery,” and aims to make it more affordable by broadening the range of procedures that can be performed robotically. Read more

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1. B. Braun picks up German dialysis firm

B. Braun Medical said that its Avitum AG dialyis subsidiary acquired Lauer Membran Wassertechnik, which makes the Aquaboss water treatment system, for an undisclosed amount.

“This latest global acquisition will allow us to expand and grow our business as a full-system supplier of dialysis products and services in the U.S.,” vice president Sam Amory, said in prepared remarks. “We are proud to offer the revolutionary Aquaboss in-center water treatment system to our valued customers.” Read more

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Hansen Medical wins 510(k) for Magellan 10Fr catheter

Hansen Medical (NSDQ:HNSN) said yesterday it won FDA 510(k) clearance for its Magellan 10Fr robotic catheter with indications for use in the peripheral vasculature.

The Mountain View, Calif.-based company’s robotic catheter is designed to navigate the peripheral vasculature and provide a conduit for the placement of therapeutic devices, Hansen Medical said. The catheter operates as part of Hansen’s Magellan robotic system.

The Magellan robotic system is a platform that drives Magellan robotic catheters and guide wires during minimally invasive, endovascular procedures, the company said.

“We have been eagerly anticipating having access to the Magellan 10Fr robotic catheter. Our team has found significant clinical value in the Magellan system to predictably navigate tortuous vascular anatomy and provide a stable platform during treatment. The 10Fr catheter, with its larger inner lumen, will enable us to broaden our use of Magellan to include many additional procedures in which the delivery of stents, balloons or other devices requires a 7Fr catheter inner lumen,” Dr. Fred Weaver of the Keck Hospital of the University of Southern California said in a press release.

“We are excited to introduce the Magellan 10Fr robotic catheter to our customers in the United States. We believe that robotic technology offers the potential to transform how endovascular treatment is performed, by bringing enhanced control and predictability to procedures, and by addressing serious occupational hazards faced by physicians and their teams in the delivery of patient care. With this new catheter, we expect that many more patients will now be able to benefit from procedures with the Magellan Robotic System,” CEO Cary Vance said in prepared remarks.

Hansen won CE Mark approval for the catheter in April, and has been used in procedures in Australia, Germany and the U.K. since its approval, the company said.

In April, Hansen also said it won CE Mark approval in the European Union for a new, larger version of its Magellan robot-assisted surgery platform for use in treating peripheral artery disease.

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Lantheus closes $66.7m IPO

Lantheus Medical Imaging said today it closed its $65 million initial public offering after exercising an over-allotment option that netted an estimated $66.7 million in proceeds.

The North Billerica, Mass.-based company said it floated 12.3 million shares of stock at $6.00 per share, with 1.4 million shares being sold through an over-allotment option.

Credit Suisse Securities, Jefferies, RBC Capital Markets and Wells Fargo Securities were book-runners for the offering, with Robert W. Baird & Co acting as co-manager, the company said. Lantheus has listed on the NASDAQ global market under the trading symbol “LNTH.”

The offering met what Lantheus said they expected in June, seeking $65 million with 10.8 million shares floated at $6.00 per share, with an extra 1.4 million available through an underwriters over-allotment option.

Last month, Lantheus said it hoped to bring in $75 million with the offering. The company said it planned to float nearly 7.9 million shares at a price range of $8.50 to $10.50, with an underwriter’s option for an over-allotment worth another 1.2 million shares.

Last year the company said it planned to price the offering at $12 to $15 per share, for a range of $111.1 million to $138.9 million. At the midpoint of that range, Lantheus would have commanded a fully diluted market capitalization of $370 million. But the company tabled the proposed flotation in July.

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Integra LifeSciences closes SeaSpine spinout

SeaSpine Holdings (NSDQ:SPNE) closed its spinout from Integra LifeSciences (NSDQ:IART) and began trading today on the NASDAQ exchange.

Plainsboro, N.J.-based Integra revealed its plan to shed the spine business last November, saying it planned for SeaSpine to become a stand-alone, publicly traded company to focus on its surgical solutions, orthopedics and tissue technology businesses.

Integra acquired Vista, Calif.-based SeaSpine for $89 million in 2011, doubling its distribution footprint and customer base in the U.S. spine market. SeaSpine co-founder and former CEO Kirt Stephenson is in line to be named chairman of the company’s latest iteration.

“We believe that an independent SeaSpine will focus its investments on research and development and sales and marketing to drive faster growth. Similarly, the separation will result in faster growth for the remaining Integra businesses, Specialty Surgical Solutions and Orthopedics and Tissue Technologies,” Integra president & CEO Peter Arduini said in April.

“Today marks a meaningful milestone for SeaSpine, as we reposition the company for innovation and growth,” president & CEO Keith Valentine said in prepared remarks. “We are well positioned in the spine market with a leading orthobiologics platform, a robust R&D pipeline with several novel product launches expected this calendar year, and a strong balance sheet with $47 million of cash and no debt post-spin to fund growth initiatives. We are confident in our ability to deliver long-term growth and value creation to our shareholders as an independent company.”

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FDA adds medication adherence indication to Proteus Digital Health’s pill sensor

Proteus Digital Health today said the FDA expanded the indications for use for its sensor-enabled pill technology, claiming it as the only FDA-approved device designed to measure medication adherence.

“We are delighted that our collaborative work with the FDA continues to enable positive progress,” co-founder & chief medical officer Dr. George Savage said in prepared remarks. “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings.”

Redwood Shores, Calif.-based Proteus said its ingestible sensor logs actual intake time as a quantifiable event, communicating with an adhesive patch worn on the torso.

A year ago Proteus drummed up a $172 million Series G round. Although the company didn’t provide details on that funding, previous backers include Medtronic (NYSE:MDT), Novartis (NYSE:NVS), Kaiser Permanente and others.

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Konica Minolta buys Brazilian X-ray maker Sawae

Konica Minolta (TYO:4902) said today it acquired Brazilian X-ray system equipment manufacturer Sawae through its Konica Minolta Healthcare do Brazil division.

The Tokyo, Japan-based company said it made the acquisition to address an increasing amount of aging X-ray and medical systems in the 200-million person Brazilian market.

After acquiring Sawae, Konica Minolta will be able to utilize the Brazilian company’s name brand and sales network in the expanding market, the company said.

Konica Minolta said it would also grow its digital radiography and computed radiography businesses in Brazil after the acquisition. Konica Minolta moved into Brazil in April this year, establishing its Brazilian arm in Sao Paulo.

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