PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.

Device Description

PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States.

The product consists of a loading unit which includes two (2) buttresses, one for the anvil (ANV) and one for the cartridge (CART) side of the stapler. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch.

PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure.

PSDV-SG is provided sterile and intended for single use. Sterilization occurs via ethylene oxide. The bovine pericardium buttress and acrylic adhesive are intended for permanent implant.

AI/ML Overview

This document is a 510(k) summary for a medical device called PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG). It describes the device, its intended use, comparison to predicate devices, and performance data.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

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

The document lists various assessments for design verification. It doesn't present these as formal "acceptance criteria" with specific pass/fail values in a table, but rather as "assessments" with the general outcome mentioned as "Testing passed the acceptance criteria" for biocompatibility and "demonstrate the performance of the PSDV-SG device is substantially equivalent to the predicate devices" for bench testing.

Based on the text, here's a conceptual table:

Assessment/Criteria Category	Specific Assessment	Reported Device Performance/Outcome
Design Verification (Pre-Clinical Bench Studies)
General Performance	Visual Inspection	Results demonstrate substantial equivalence to predicate devices.
General Performance	Thickness	Results demonstrate substantial equivalence to predicate devices.
General Performance	Functional Testing	Results demonstrate substantial equivalence to predicate devices.
General Performance	Manipulation Testing	Results demonstrate substantial equivalence to predicate devices.
Material Safety	Chemical residuals	Results demonstrate substantial equivalence to predicate devices.
Physical Property	Drape	Results demonstrate substantial equivalence to predicate devices.
Material Safety	Heavy Metals	Results demonstrate substantial equivalence to predicate devices.
Material Safety	Endotoxin	Results demonstrate substantial equivalence to predicate devices.
Material Safety	Bioburden	Results demonstrate substantial equivalence to predicate devices.
Sterilization	Sterilant residuals	Results demonstrate substantial equivalence to predicate devices.
Packaging Integrity	Seal strength of packaging seals	Results demonstrate substantial equivalence to predicate devices.
User Interface/Workflow	Preparation time	Results demonstrate substantial equivalence to predicate devices.
User Interface/Workflow	Stackability	Results demonstrate substantial equivalence to predicate devices.
Biocompatibility	Cytotoxicity (ISO 10993-5:2009 L929 elution method)	Passed the acceptance criteria. (Specific criteria are implied by the standard but not detailed in the text).
Shelf Life	Aging Testing	Supports a 6-month shelf life claim. (Ongoing testing to extend).
Sterilization Assurance	Sterilization Cycle Adoption	Per AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization.
Usability/Human Factors	Human Factors Study	Successfully completed demonstrating usability and user comprehension of labeling.
Clinical Feedback	Surgeon Validation	Completed and supports customer satisfaction of PSDV-SG functionality.

2. Sample sizes used for the test set and the data provenance:

Sample Sizes: The document does not specify sample sizes for any of the tests (bench studies, biocompatibility, human factors, or surgeon validation). It broadly mentions "testing" or "studies" without numerical details.
Data Provenance: The document implies that the data was generated by Synovis Life Technologies, Inc. (now Baxter International Inc.) as part of their 510(k) submission. There is no information about the country of origin of the data explicitly stated. The studies are pre-clinical bench studies and validation studies, which are typically conducted in a controlled environment as part of product development, not necessarily from a "retrospective" or "prospective" clinical data sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- For the "Human Factors Study," "user comprehension" was assessed, implying user participants, but not "experts" in the sense of ground truth establishment.
- For the "Surgeon Validation," "surgeons" were involved, but their number and specific qualifications (e.g., years of experience, specialty) are not provided. They were involved in assessing functionality and satisfaction, not necessarily establishing a "ground truth" that would be typical for, say, an AI model's diagnostic accuracy.

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

Not applicable / None specified. The studies described (bench, biocompatibility, human factors, surgeon validation) do not involve subjective interpretation of medical images or data requiring an adjudication method common in diagnostic accuracy studies. They are focused on physical and functional performance, safety, and usability.

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:

No MRMC study was done. This device is a surgical mesh for staple line reinforcement, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.

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

Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI. Standalone performance for an algorithm is not relevant here.

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

Not applicable in the typical sense of diagnostic "ground truth." For this device, "ground truth" relates to the functional performance of the device against engineering specifications, biocompatibility standards, and usability criteria.
- For bench testing, the "ground truth" is likely defined by engineering specifications and comparative performance to predicate devices.
- For biocompatibility, the "ground truth" is defined by the passing criteria of the ISO 10993-5 standard.
- For human factors, "ground truth" is user comprehension and ability to use the device as intended.
- For surgeon validation, "ground truth" is customer satisfaction and functionality assessment by the surgeons.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, no training set for an AI/ML algorithm.

Summary

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December 17, 2019

Synovis Life Technologies, Inc. (Baxter International Inc.) Megan Sajjad Regulatory Affairs Manager 2575 University Ave. W St. Paul, Minnesota 55114

Re: K192615

Trade/Device Name: Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXE Dated: September 20, 2019 Received: September 23, 2019

Dear Ms. Sajjad:

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.

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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 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 medical devices and radiation-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.

Cindy Chowdhury, Ph.D., M.B.A. Acting 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) K192615

Device Name

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

Indications for Use (Describe)

PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY: PERI-STRIPS Dry Staple Line Reinforcement with 5.0 VERITAS Collagen Matrix with SECURE GRIP Technology

I. SUBMITTER

Synovis Life Technologies, Inc. (Synovis) (A subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024

Contact Person: Megan Sajjad, Manager, Regulatory Affairs Tel: 651-796-7410

Date Prepared: September 20, 2019

II. DEVICE

Device Trade Name: PERI-STRIPS Dry with VERITAS Collagen Matrix with SECURE GRIP Technology

Common Name: Staple Line Reinforcement

Classification Name: MESH, SURGICAL; MESH, SURGICAL, COLLAGEN, STAPLE LINE REINFORCEMENT (21 CFR 878.3300)

Product Code: FTM, OXE

III. PREDICATE DEVICES

Primary Predicate:

PERI-STRIPS Dry with VERITAS Collagen Matrix Staple Line Reinforcement, K041669

Additional Predicate:

PERI-STRIPS Dry Circular Staple Line Reinforcement with VERITAS Collagen Matrix, K083039

IV. DEVICE DESCRIPTION

The product consists of a loading unit which includes two (2) buttresses, one for the anvil (ANV) and one for the cartridge (CART) side of the stapler. Each

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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology TRADITIONAL 510K

buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch.

PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure.

See Table 1 for product models and configurations.

Table 1. PSDV-SG Model Numbers and Sizes
Model Number	Size (mm)	Thickness (mm) per Firing	Stapler Compatibility
PSDA60ECH	60	0.45 - 1.26	Ethicon Echelon 60 ENDOPATH StaplerEthicon Echelon FLEX 60 ENDOPATH Stapler
PSDA60ECHTHN	60	0.45 - 0.86	Ethicon Echelon 60 ENDOPATH StaplerEthicon Echelon FLEX 60 ENDOPATH Stapler

PSDV-SG is provided sterile and intended for single use. Sterilization occurs via ethylene oxide. The bovine pericardium buttress and acrylic adhesive are intended for permanent implant.

V. INTENDED USE/INDICATIONS FOR USE

Statement of Intended Use:

PSDV-SG is intended to be used as a staple line buttress.

Indications for Use

PSDV-SG is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.

The Indications for Use for the PSDV-SG product are not identical to the predicate devices, however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. Both the subject and predicate devices have the same intended use for staple line buttressing.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The Peri-Strips Dry with Veritas (PSDV) product family are implantable biologic meshes comprised of non-cross-linked bovine pericardium. PSDV is the Veritas® Collagen Matrix (K002233) tissue that has been dried and cut to specification for use with staplers to provide buttress reinforcement at the staple line. PSDV

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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology TRADITIONAL 510K

allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

PSDV-SG is substantially equivalent to the predicates PERI-STRIPS Dry with VERITAS Collagen Matrix Staple Line Reinforcement (PSDV-L) (K041669) and PERI-STRIPS Dry Circular Staple Line Reinforcement with VERITAS Collagen Matrix (PSDV-C) (K083039) based on having the same fundamental technology and intended use. The PSDV-SG product modifies the current PSDV-L product by replacing the hydrogel accessory component, used for the securement of the PSDV-L tissue buttress to a surgical stapler, with a pre-applied adhesive strip. The pre-applied adhesive strip is protected by a removable liner with pull tab until time of use. The adhesive strip being added is the same material that is used in the current PSDV-C product.

The subject and predicate devices are identical in the following respects:

Same Intended Use (PSDV-L and PSDV-C) ●
Same buttress material (PSDV-L and PSDV-C) ●
Same adhesive material (PSDV-C)
Same tissue dimensions, loading unit and stapler compatibility (PSDV-L ● 60 ECH configuration)
Same packaging materials (PSDV-L) ●
Same method of sterilization (PSDV-L and PSDV-C)

The following technological differences exist between the subject and predicate devices:

o Different mechanism of attachment of the tissue buttress to stapler compared to PSDV-L
Different adhesive coat weight and dimensions compared to PSDV-C ●
Narrowed indications for use compared to the cleared indications for . PSDV-L and PSDV-C

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Pre-Clinical Bench Studies

Design verification of the PSDV-SG device consisted of the following assessments:

Visual Inspection
Thickness ●
Functional Testing ●
Manipulation Testing ●
Chemical residuals ●
Drape

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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology TRADITIONAL 510K

Heavy Metals ●
Endotoxin
Bioburden ●
Sterilant residuals
Seal strength of packaging seals ●
Preparation time
Stackability ●

The results of new bench testing, along with applicable historical testing utilizing PSDV-L or PSDV-C, demonstrate the performance of the PSDV-SG device is substantially equivalent to the predicate devices.

Biocompatibility

All patient contacting materials found in the PSDV-SG device have been previously cleared under Synovis premarket notifications K041669 and K083039. In order to confirm that modifications in the manufacturing process of PSDV-SG have no impact on the biocompatibility of the device, confirmatory cytotoxicity testing was conducted according to ISO 10993-5:2009 L929 elution method. Testing passed the acceptance criteria.

Shelf Life

Synovis has performed aging testing to support a 6 month shelf life claim. Testing at additional timepoints is ongoing and the product shelf life will be extended as stability data justifies.

Sterilization

PSDV-SG will be adopted into the existing sterilization cycle for PSDV-L and PSDV-C per AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization.

Validation Studies

A human factors study was successfully completed demonstrating the usability of the product and user comprehension of the labeling. A surgeon validation was additionally completed and supports customer satisfaction of the PSDV-SG functionality.

VIII. CONCLUSION

PSDV-SG shares the same intended use and technological characteristics as the predicate devices. The physical, functional and performance specifications for the device are substantially equivalent. There are no different questions of safety and effectiveness of PSDV-SG as compared to the predicate devices. Testing supports that PSDV-SG is as safe and effective as the predicate PSDV-L and PSDV-C devices when used according to its labeling.

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.