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

Q: Who is the manufacturer of PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

Synovis Life Technologies. Inc. (A Subsidiary of Baxter filed the 510(k) submission for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K213125).

Q: What is the FDA product code for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

FTM. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K213125 · Synovis Life Technologies. Inc. (A Subsidiary of Baxter · FTM · Oct 27, 2021 · General, Plastic Surgery

Device Facts

Record ID	K213125
Device Name	PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
Applicant	Synovis Life Technologies. Inc. (A Subsidiary of Baxter
Product Code	FTM · General, Plastic Surgery
Decision Date	Oct 27, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

PSDV-SG is intended to be used as a staple line buttress. PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology 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 Story

Device consists of dehydrated bovine pericardium buttresses with acrylic adhesive; used as surgical staple line reinforcement. Provided in loading units (foam/sheath) for attachment to stapler jaws. Used in OR by surgeons during bariatric, gastric, small bowel, colon, and colorectal procedures. Principle of operation: non-cross-linked collagen matrix allows neo-collagen formation, neovascularization, and host tissue remodeling. Provides mechanical strength at staple line during healing. Single-use, sterile, ETO-sterilized implant.

Clinical Evidence

Bench testing only. Verification and validation included manipulation, functional, dimensional, usability, and shelf-life testing. No clinical data presented.

Technological Characteristics

Implantable biologic mesh; non-cross-linked bovine pericardium (cattle <30 months). Acrylic adhesive. Standard (0.20-0.60mm) and Thin (0.20-0.40mm) configurations. ETO sterilization. Permanent implant per ISO 10993-1.

Indications for Use

Indicated for surgical repair of soft tissue deficiencies requiring staple line reinforcement during bariatric, gastric, small bowel, colon, and colorectal procedures.

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

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K192615)

Reference Devices

VERITAS Collagen Matrix (K002233)
Ethicon Echelon ENDOPATH Staplers (K163454, K160521, K140560)
Medtronic Endo GIA Staplers (K111825)
Intuitive Surgical SureForm Staplers (K173721)

Related Devices

K192615 — Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) · Synovis Life Technologies, Inc. (Baxter International Inc.) · Dec 17, 2019
K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION · Synovis Surgical Innovations · Mar 17, 2004
K083039 — VERITAS COLLAGEN MATRIX (DRY) · Synovis Surgical Innovations · Nov 26, 2008
K170945 — Biodesign Staple Line Reinforcement · Cook Biotech Incorporated · Apr 28, 2017
K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT · Synovis Surgical Innovations · Apr 14, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 27, 2021 Synovis Life Technologies. Inc. (A Subsidiary Of Baxter International Inc.) Megan Sajjad Senior Manager, Regulatory Affairs 2575 University Ave. W St. Paul, Minnesota 55114 Re: K213125 Trade/Device Name: PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXE Dated: September 24, 2021 Received: September 27, 2021 Dear Megan 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. 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 {1}------------------------------------------------ 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 and Part 809); 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 (QS) 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, for Deborah Fellhauer, RN, BSN Assistant Director (acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213125 Device Name PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology Indications for Use (Describe) PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staple line reinforcement is needed. 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) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology #### I. SUBMITTER Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Contact Person: Megan Sajjad, Sr. Manager, Regulatory Affairs Phone: 651-796-7410 Date Prepared: September 24, 2021 #### II. DEVICE | Device Name: | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | |----------------------|-------------------------------------------------------------------------------------------------------| | Common Name: | Staple Line Reinforcement | | Classification Name: | MESH, SURGICAL; MESH, SURGICAL, COLLAGEN, STAPLE LINE REINFORCEMENT | | Regulation Number | 21 CFR 878.3300 | | Product Codes: | FTM, OXE | #### III. PREDICATE DEVICE PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology, K192615. This predicate has not been subject to any market recalls. #### IV. DEVICE DESCRIPTION PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age, originating from the United States. There are two types of PSDV-SG configurations based on the tissue buttress thickness range. The Standard configuration has a tissue buttress thickness range of 0.20-0.60mm. The Thin configuration has a tissue buttress thickness range of 0.20-0.40mm. The product consists of a loading unit which includes two (2) buttresses, one for the anvil and one for the cartridge side of the stapler. The buttresses are held in a foam/sheath configuration for loading of the buttress to the stapler jaws. Each buttress has acrylic adhesive {4}------------------------------------------------ ## PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology SPECIAL 510K 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 is accomplished via ethylene oxide (ETO). The bovine pericardium buttress and acrylic adhesive are considered permanent implants per ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. #### V. INTENDED USE/INDICATIONS FOR USE The Intended Use and Indications for Use remain the same as the predicate device. ### Intended Use: PSDV-SG is intended to be used as a staple line buttress. ### Indications for Use: PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology 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. #### TECHNOLOGICAL CHARACTERISTICS AND COMPARISON WITH VI. THE PREDICATE DEVICE PSDV-SG products are implantable biologic meshes comprised of non-cross-linked bovine pericardium. PSDV-SG 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-SG allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. The technological characteristics and specifications of PSDV-SG have been evaluated against its predicate device to determine equivalence. A summary of the comparison between the predicate and subject devices is provided Table 5-1 below. | Attribute | Predicate Device | Subject Device | |------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------| | Product Name | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | SAME | | 510(k)-holder | Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) | SAME | | 510(k) Number | K192615 | K213125 | | Product Code | FTM, OXE | SAME | | Regulation | 21 CFR 878.3300 | SAME | | Classification | Class II | SAME | | Intended Use | PSDV-SG is intended to be used as a staple line buttress. | SAME | | Indications for Use | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is intended for | SAME | Table 5-1. PSDV-SG Predicate and Subject devices - Comparison Table {5}------------------------------------------------ ## PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology SPECIAL 510K | Attribute | Predicate Device | Subject Device | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | | 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. | | | Tissue | Bovine pericardium procured from cattle under 30 months of age, originating from the United States | SAME | | Components | Tissue strips, adhesive, liner pull tab, loading unit (foam, sheath), ship clip and packaging (inner pouch, outer pouch, labeling and carton) | SAME | | Thickness per Firing (mm) | Standard: 0.45 – 1.26 Thin: 0.45 – 0.86 | SAME | | Principle of Operation | Non-cross-linked collagen tissue technology allows for neo- collagen formation and neovascularization of the implanted device and permits infiltration of the device with host tissue, or remodeling. PSDV-SG is designed to provide strength throughout the healing process, particularly where remodeling with the patient's' own tissue is preferred. | SAME | | Stapler Compatibility | Ethicon Echelon ENDOPATH Staplers (K163454, K160521, K140560) | Medtronic Endo GIA Staplers (K111825) and Intuitive Surgical SureForm Staplers (K173721) | | How Supplied | Single-use Sterile | SAME | | Packaging | Sterile double pouch | SAME | | Sterilization | ETO | SAME | | Shelf-life | 3 years | 1 year with testing to 3 years ongoing | #### VII. PERFORMANCE DATA Testing performed to support the new product models subject of this submission included manipulation, functional, and dimensional testing, as well as usability and shelf-life. Materials evaluation was not necessary as the new models are manufactured and packaged utilizing the same materials and components, from the same suppliers, used with the predicate device. ## VII. CONCLUSION The PSDV-SG product family maintains the same intended use, indications for use, materials, and principles of operation. The line extension introducing new product models does not impact these product characteristics. The differences in size and design are made for stapler compatibility. Verification and validation of the product have been completed using the same test methods as the predicate device, or accepted industry standard methods. No new issues of safety and effectiveness have been identified. The new PSDV-SG models have been found substantially equivalent to the predicate device with respect to intended use, design, materials, principle of operation and overall technological characteristics.