NEOVEIL® Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. NEOVEIL® Staple Line Reinforcement of staple lines during lung resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

Device Description

NEOVEIL® Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid (PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. 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 PGA material is dyed with D&C Green No.6.

AI/ML Overview

This document is a 510(k) summary for a medical device called NEOVEIL® Staple Line Reinforcement. It outlines a Special 510(k) submission, meaning the device is largely similar to a previously cleared predicate device with minor modifications. As such, the submission focuses on demonstrating substantial equivalence through non-clinical performance testing rather than new extensive clinical studies.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria with numerical targets. Instead, it states that "The performance testing validated that NEOVEIL® Staple Line Reinforcement meets its product specification and performs as intended. Results confirm that the specification requirements for the subject device have been met."

The performance tests conducted include:

Test Name	Reported Device Performance
GUNZE internal test method for stapler insertion and removal forces with NEOVEIL®™	Meets product specification and performs as intended.
GUNZE internal test method for stapler firing force with NEOVEIL®™	Meets product specification and performs as intended.
GUNZE internal test method for staple formation with NEOVEIL®™	Meets product specification and performs as intended.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for each of the internal tests. The testing was described as "simulated usability testing on final finished versions of NEOVEIL®™ using a relevant mechanical stapler." The data provenance is "internal GUNZE test methods," implying the testing was conducted by Gunze Limited. The country of origin for the data is not explicitly stated, but Gunze Limited is based in Japan. The testing described is prospective, as it was conducted to validate the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as the evaluation involved non-clinical performance testing of a physical device, not an AI or diagnostic tool where expert ground truth would be established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable as the evaluation involved non-clinical performance testing of a physical device.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a physical medical device (staple line reinforcement), not an AI diagnostic tool. The "usability" mentioned refers to the device's interaction with a stapler, not human interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone performance study was not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance testing was the product specifications and intended performance as defined by Gunze's internal test methods. The tests verified if the device functioned correctly (e.g., stapler insertion, firing, and staple formation) under simulated conditions.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as above.

Summary

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August 26, 2022

Gunze Limited % Stuart Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K221487

Trade/Device Name: NEOVEIL Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXC Dated: July 27, 2022 Received: July 27, 2022

Dear Stuart Goldman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Deborah Fellhauer Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221487

Device Name NEOVEIL® Staple Line Reinforcement

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Special 510(k) Summary NEOVEIL® Staple Line Reinforcement

1. Submission Sponsor

GUNZE LIMITED Medical Division 46 Natsumegaichi, Aono Ayabe, Kyoto Japan 623-8513 Contact: Mr. Hidenori Nishioka Title: Regulatory Affairs

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Contact: Mr. Stuart R. Goldman Title: Sr. Consultant RA/QA

3. Date Prepared

August 23, 2022

4. Device Identification

Type of 510(k):	Special 510(k)
Trade Name:	NEOVEIL® Staple Line Reinforcement
Product Code:	OXC
Classification Name:	Mesh, Surgical, Absorbable, Staple Line Reinforcement
Regulation Number:	21 CFR 878.3300
Regulation Description:	Surgical Mesh
Device Class:	2
Review Panel:	General & Plastic Surgery

5. Legally Marketed Predicate Device

Trade Name:	NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material
510(k) No.:	K130997
Manufacturer:	GUNZE LIMITED

The predicate device has not been subject to a design related recall.

6. Indications for Use

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reinforcement of staple lines during lung resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

7. Device Description

8. Device Changes

This Special 510(k) is being made by GUNZE to modify one of their existing NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material model devices cleared under K130997. The modification gives that device longer tacking threads to better facilitate its use during certain endoscopic procedures when used with certain stapler guns. A new catalogue number has also been given to this new model. In addition, the trade name of the subject device is also being changed to NEOVEIL® Staple Line Reinforcement to better reflect its intended use.

9. Substantial Equivalence Discussion

Except for the minor differences in the size of the absorbable PGA felt and elastic knit and the length of the PGA tacking threads found in NEOVEIL® Staple Line Reinforcement as described above when compared to those same components found in NEOVELL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material (K130997), the subject device is equivalent to the predicate device in intended use, indications for use, technological characteristics and performance.

10. Non-Clinical Performance Testing

As part of demonstrating substantial equivalence of the subject device to the predicate device, GUNZE conducted side-by-side non-clinical performance testing in the form of a simulated usability testing on final finished versions of NEOVEIL®™ using a relevant mechanical stapler that received FDA 510(k) clearance. The non-clinical performance testing was done to internal GUNZE test methods. The test methods used were selected based on the 510(k) Premarket Notification of the predicate device (K130997). The performance testing validated that NEOVEIL® Staple Line Reinforcement meets its product specification and performs as intended. Results confirm that the specification requirements for the subject device have been met.

. Non-Clinical Performance Testing:
- GUNZE internal test method for stapler insertion and removal forces with NEOVEIL®™
- GUNZE internal test method for stapler firing force with NEOVEIL®™ o
- GUNZE internal test method for staple formation with NEOVEIL®™ o
Usability: ●
- O IEC 62366-1:2015, Application of Usability Engineering to Medical Devices
Risk Analysis: ●

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o ISO 14971:2019, Application of Risk Management to Medical Devices

11. Clinical Performance Data

Not applicable to this submission.

12. Substantial Equivalence Conclusion

NEOVEIL® Staple Line Reinforcement has the same intended use and indications for use as the previously cleared predicate device, NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material. The addition of the new size of the subject device and increase in length of the tacking threads for use with other brands of mechanical staplers has been addressed with non-clinical performance testing to well established GUNZE test methods. The test results and analysis support a determination of substantial equivalence of NEOVEIL® Staple Line Reinforcement to the predicate device in terms of safety, effectiveness and performance.

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.