NEOVEIL™ is indicated for use in surgical procedures in which soft tissue 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.

Device Description

As packaged, NEOVEIL™ is a suture- and staple-reinforcement product 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 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).

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against acceptance thresholds. Therefore, the concept of "acceptance criteria" as typically applied to performance claims (e.g., specific sensitivity/specificity targets for an AI algorithm) is not present. Instead, the "acceptance criteria" are implied by the comparison of technological characteristics and performance testing against a predicate device.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" in the context of substantial equivalence:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Summary)
Nonwoven polymer surgical mesh structure	100% bioabsorbable polyglycolic acid (PGA) nonwoven material.
Thickness comparable to predicate	Thickness ranges from 0.1 mm to 0.85 mm.
Mesh density comparable to predicate (for non-woven, this means basis weight)	Average basis weight ranges from 35 to 225 (g/m²).
Tensile strength comparable to predicate	Bench tensile strength testing performed.
Suture pullout strength comparable to predicate	Suture pull out strength testing performed.
Tear resistance comparable to predicate	Tear strength testing performed.
Bioabsorbable properties comparable to predicate	Degradation (in vitro tensile strength loss at 1 & 2 weeks) testing performed; Bioabsorbable PGA.
Biocompatibility (as per ISO 10993-1)	All materials evaluated in accordance with ISO 10993-1 and deemed acceptable.
Mechanical properties during use (insertion/removal, firing, staple formation, stiffness) comparable to predicate	Insertion/Removal Forces, Firing Force, Staple Formation, Staple Line Stiffness, Buttress Material Stiffness testing performed.
In vivo performance (free bleed, air leak, burst, staple formation, resorption) comparable to predicate	Free Bleed Evaluation, Air Leak Test, Burst Evaluation, Staple Formation, Resorption testing performed.

Study Details

The provided document describes a bench and in vivo animal testing to demonstrate substantial equivalence, not a study involving human subjects or AI performance. Therefore, many of your requested points related to AI algorithms, human readers, and ground truth in a clinical context are not applicable.

Sample size used for the test set and the data provenance:
- Test set size: Not explicitly stated in terms of number of samples for each test, but general in-vitro and in-vivo testing was performed.
- Data provenance: Not explicitly stated, but it would be from internal lab testing (in vitro) and animal studies (in vivo). No information about country of origin of data is provided beyond the submitting company being from Japan. The studies are prospective in nature (designed to demonstrate equivalence).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a device based on material property testing and animal studies, not expert-adjudicated clinical data to establish diagnostic ground truth. The "ground truth" here is the performance of the predicate device and established engineering/biological benchmarks.
Adjudication method for the test set:
- Not applicable for this type of device submission. Performance is measured against physical and biological parameters, not through expert adjudication of qualitative outcomes.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
The type of ground truth used:
- For in vitro tests: Physical and mechanical property measurements (e.g., tensile strength, thickness, density, stiffness) are compared against the known properties of the predicate device and/or defined engineering standards.
- For in vivo tests: Biological responses and functional performance in animal models (e.g., free bleed, air leak, burst, resorption rates) are compared against observations with the predicate device or accepted physiological norms for successful surgical repair.
The sample size for the training set:
- Not applicable. There is no AI model to train.
How the ground truth for the training set was established:
- Not applicable. There is no AI model to train.

Summary

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K130997 page 1/3

510(k) Summary SUBMITTER: GUNZE LIMITED, Medical Division 46 Natsumegaichi, Aono, Ayabe, Kyoto 623-8513 JAPAN Fax: +81 773 42 8593 Tel: +81 773 42 8035 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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.