NEOVEIL

K130997 · Gunze Limited · OXC · Nov 15, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130997
• Device Name: NEOVEIL
• Applicant: Gunze Limited
• Product Code: OXC · General, Plastic Surgery
• Decision Date: Nov 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NEOVEIL™ is indicated for use in surgical procedures in which soft tissue transection or resection with staple or suture line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

Device Story

NEOVEIL™ is a bioabsorbable, nonwoven surgical material composed of 100% polyglycolic acid (PGA) dyed with D&C Green No.6 for visibility. Provided in two forms: Tube type (pre-formed sleeves for stapler cartridge/anvil) for staple-line reinforcement and Sheet type for suture-line reinforcement. Used by surgeons in open or endoscopic procedures to reinforce tissue transection/resection sites. Tube type includes non-degradable elastic knits (polyurethane/nylon) that are removed after deployment. Material provides mechanical reinforcement to suture/staple lines, potentially reducing leaks or bleeding. Device is purely mechanical; no electrical or software components.

Clinical Evidence

No clinical data. Evidence consists of in vitro bench testing (thickness, mass, density, tensile strength, degradation, suture pullout, tear strength, insertion/removal forces, firing force, staple formation, stiffness) and in vivo testing (free bleed evaluation, air leak test, burst evaluation, staple formation, resorption) conducted in accordance with FDA guidance for surgical mesh.

Technological Characteristics

Material: 100% bioabsorbable polyglycolic acid (PGA) nonwoven. Thickness: 0.1 mm to 0.85 mm. Basis weight: 35 to 225 g/m². Mechanical reinforcement via physical barrier. Not electrically powered. No software. Evaluated per ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for patients undergoing surgical procedures requiring soft tissue transection or resection where suture or staple line reinforcement is necessary, including lung, liver, bronchial, bariatric, colon, colorectal, esophageal, gastric, mesenteric, pancreatic, and small bowel surgeries.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Gore SEAMGUARD Bioabsorbable Staple Line Reinforcement (K043056)
• PARIETEX Composite Ventral Patch (K120506)
• SYMBOTEX Composite Mesh (K131969)
• PERI-STRIPS DRY Staple Line Reinforcement (K040415)

Submission Summary (Full Text)

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### 510(k) Summary SUBMITTER: GUNZE LIMITED, Medical Division 46 Natsumegaichi, Aono, Ayabe, Kyoto 623-8513 JAPAN Fax: [phone] Tel: [phone] Noriyuki Morikawa CONTACT PERSON: Regulatory Affairs November 15, 2013 DATE PREPARED: NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material TRADE/PROPRIETARY NAME: Staple line reinforcement material COMMON/USUAL NAME: CLASSIFICATION NAME: Mesh, Surgical, Polymeric REGULATION: 21 CFR 878.3300 OXC PRODUCT CODE: Gore SEAMGUARD Bioabsorbable Staple Line Reinforcement (K043056), PREDICATE DEVICE(S): PARIETEXTM Composite Ventral Patch (K120506), SYMBOTEXTM Composite Mesh (K131969) PERI-STRIPS DRY Staple Line Reinforcement (K040415) As packaged, NEOVEIL™ is a suture- and staple-reinforcement product DEVICE DESCRIPTION: composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL TM are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous

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fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL™ staple line reinforcement ranges from 0.1 mm to 0.85 mm.

Mesh weave characteristics and pore size are not applicable since NEOVEIL™ is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m²).

NEOVEILTM is indicated for use in surgical procedures in which soft tissue INTENDED USE: transection or resection with suture or staple line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES:

NEOVEIL™ bioabsorbable suture and staple line reinforcement is substantially equivalent to the predicate device, SEAMGUARD bioabsorbable staple line reinforcement (K043056) in terms of design for the following technological characteristics:

- . Nonwoven polyester surgical meshes
- . Thickness
- Mesh density
- . Tensile strength
- Suture pullout strength .
- : Tear resistance

The only difference, however, is that the subject device is polyglycolide whereas the SEAMGUARD predicate device is polyglycolide-trimethylene carbonate. Both are neither electrically powered nor use software to function. Both are mechanically manipulated by the surgeon under direct visual control (for open surgery) or endoscopic control (for endoscopic usage) in placement and use. The subject device is also equivalent to the predicate device, PERI-STRIPS DRY Staple Line Reinforcement (K0404)5), for stiffness and is equivalent to the predicate devices, PARIETEX™ Composite Ventral Patch (K120506) and SYMBOTEXTM Composite Mesh (K131969), for the green dye.

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#### MATERIALS:

All materials of NEOVEIL™ have been evaluated in accordance with ISO 10993-1 and are acceptable.

#### PERFORMANCE DATA:

Testing has been performed in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, including the tests shown in the list below which support the determination of substantial equivalence of NEOVEIL™ to the predicate device.

The list below provides the tests performed in vitro:

- Thickness a.
- Mass b.
- Density C.
- Tensile strength: Bench d.
- Degradation: In vitro tensile strength loss 1 week and 2 weeks e.
- f. Suture pull out strength
- Tear strength 8.
- h. Insertion/Removal Forces
- i. Firing Force
- Staple Formation ું.
- k. Staple Line Stiffness
- l. Buttress Material Stiffness

The list below provides the tests performed in vivo:

- Free Bleed Evaluation a.
- b. Air Leak Test
- Burst Evaluation c.
- Staple Formation d.
- Resorption e.

### CONCLUSION OF

#### SUBSTANTIAL EQUIVALENCE:

The device described in this submission is substantially equivalent to the predicate device due to the provided data and information to support the similarities between the two devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2013

GUNZE LIMITED Nobuva Onishi 46 Natsumegaichi, Aono Ayabe, Kyoto 623-8513 Japan

Re: K130997

Trade/Device Name: NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXC Dated: October 18, 2013 Received: October 25, 2013

Dear Mr. Onishi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Nobuya Onishi

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Jiyoung Dang -S

On behalf of Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

510(k) Number (lfknown): _K130997

Device Name : NEOVEIL™ Tube Type staple line reinforcement material and NEOVEIL™ Sheet Type suture line reinforcement material

Indications For Use:

NEOVEIL™ is indicated for use in surgical procedures in which soft tissue transection or resection with staple or suture line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

Prescription Use __ X (Part21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

## David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130997