Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectorny, segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectorny, pneumoreduction, pneumectorny, lobectomies, segmentectomies (segmental resections), wedge resections, bullectornies, blebectomias, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.

Device Description

Peri-Strips (sleeve and strip) and Peri-Strips Dry are surgical mesh patches derived from bovine pericardium that is cross-linked with glutaraldehyde.

Peri-Strips comes in two configurations: Peri-Strips-sleeve and Peri-Strips-strip. Each unit of Peri-Strips-sleeve is composed of two strips of bovine pericardial tissue. After the final manufacturing step, each strip of pericardium is sewn to a polyolefin strip with polypropylene suture to create a tubular sleeve. The tubular configuration facilitates usage of the product with surgical staplers. The polyolefin strip and sutures are removed after the Peri-Strips-sleeve is secured in place. Peri-Strips-strip is a flat piece of bovine pericardium that is sutured to the stapler by the surgical team.

For Peri-Strips Dry (PSD), the bovine pericardial patch is manufactured in the form of a strip and undergoes an additional manufacturing step of dehydration by vacuum drying. The strip is affixed to the surgical stapler with the aid of a hydrogel (PSD Gel) supplied with the product.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for Bio-Vascular, Inc.'s Peri-Strips devices. It is a premarket notification for a medical device seeking substantial equivalence to predicate devices and focuses on expanding the indications for use. As such, it does not contain the level of detail regarding acceptance criteria and specific study results that would typically be found in a clinical trial report or a more extensive study submission.

Here is an analysis based on the provided text, noting where specific information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device for safety and efficacy.	Bench testing and animal testing show no difference in safety and efficacy between NaOH-treated and non-NaOH-treated tissue. Specifications of NaOH-treated and non-NaOH-treated tissue are identical. Devices are substantially equivalent to predicate devices with regard to safety and efficacy. No new questions of safety and efficacy are raised by the bariatric surgery indication.
Performance for proposed expanded indication (bariatric surgery).	Not explicitly detailed in terms of specific performance metrics or thresholds. The statement is that "No new questions of safety and efficacy are raised by the bariatric surgery indication," implying satisfactory performance relative to predicates.

Missing Information: Specific quantitative acceptance criteria (e.g., minimum burst strength, leak pressure, etc.) are not provided. The "reported device performance" is largely qualitative and comparative to predicate devices.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "bench testing and animal testing" but does not give the number of samples or animals used.
Data Provenance: Not specified, but given the context of a 510(k) submission, the testing would likely have occurred in a controlled lab or animal research setting. The country of origin is not mentioned. It is prospective testing conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable or specified. The testing described (bench and animal) would not typically involve human experts establishing ground truth in the way a clinical study with medical image interpretation would. The evaluation of safety and efficacy would be based on scientific and engineering principles.
Qualifications of Experts: Not applicable or specified.

4. Adjudication Method

Adjudication Method: Not applicable. The studies described are bench and animal tests, not clinical evaluations requiring adjudication of human expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-assisted diagnostic tool.
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: Not applicable. This is a physical medical device (surgical mesh), not a software algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For the "bench testing" and "animal testing," the ground truth would be based on objective physical measurements and observations (e.g., mechanical properties, biocompatibility, tissue response, healing, absence of adverse events in animal models relative to predicate devices). The document states "Specifications of NaOH-treated and non-NaOH-treated tissue are identical," suggesting that the ground truth for equivalence was based on meeting defined product specifications.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. The device is not an AI/ML algorithm that requires a training set. The manufacturing process and design were developed based on established scientific principles and prior versions of the device, rather than a data-driven training process.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device. The design and manufacturing process are based on conventional engineering and biological principles, with "ground truth" being established through quality control, design verification, and validation testing.

Summary

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FEB 2 2 2000

2637

Bio-Vascular, Inc.

510(k) Summary of Safety and Effectiveness
Applicant Name and Address:	Bio-Vascular, Inc.2575 University Avenue, Suite 180Saint Paul, Minnesota 55114 USA
Contact:	Mary Kay Kessinger Sobcinski, RN, MHAManager of Clinical AffairsPhone: 651-603-3703FAX: 651-642-9018e-mail: m.sobcinski@biovascular.com
Alternate Contact:	Mary L. FrickDirector of Regulatory Affairs, Clinical Affairs, and QualityAssurancePhone: 651-603-3803FAX: 651-642-9018e-mail: m.frick@biovascular.com
Date Prepared:	February 18, 2000
Trade & Common Names:	Peri-Strips® - Sleeve, Peri-Strips® - Strip and Peri-StripsDry™ (non-NaOH-treated); Peri-Strips® - Sleeve and Peri-Strips® - Strip and Peri-Strips Dry™ (NaOH-treated)
Device Classification Name:	mesh, surgical, polymeric
Substantial Equivalence:	• Peri-Strips® - Sleeve (K983162), Peri-Strips® - Strip(K983162) and Peri-Strips Dry™ (K971048) [non-NaOH-treated];• Peri-Strips® - Sleeve (K983162), Peri-Strips® - Strip(K983162) and Peri-Strips Dry™ (K983162) [NaOH-treated]

Device Descriptions:

Peri-Strips (sleeve and strip) and Peri-Strips Dry are surgical mesh patches derived from bovine pericardium that is cross-linked with glutaraldehyde.

Product may be treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20-25°C, rinsed with deionized (DI) water, and neutralized with citrate solution, followed by a final DI water rinse. Bio-Vascular believes that product subjected to the NaOH treatment performs in a substantially

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equivalent manner to non-NaOH-treated product, and that there is no difference in safety and efficacy between treated and non-treated tissue.

Statement of Intended Use:

The indications for Peri-Strips (sleeve and strip) and Peri-Strips Dry are being expanded to include reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Summary/Comparison of Technological Characteristics:

These products are the same as the predicate devices except for the added indication of bariatric surgery.

The devices are comprised of bovine pericardium crosslinked with glutaraldehyde. They have an extensive clinical history of safe and effective use when used as surgical patches. Bench testing and animal testing show no difference in safety and efficacy between NaOH-treated and non-NaOHtreated tissue. Specifications of r NaOH-treated and non-NaOH-treated tissue are identical.

Safety and Effectiveness Conclusions:

These devices are substantially equivalent to the predicate devices with regard to safety and efficacy. No new questions of safety and efficacy are raised by the bariatric sugery indication.

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Image /page/2/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular pattern around the edge. In the center of the seal is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines.

FEB 2 2 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Kay Kessinger Sobcinski, RN, MHA Manager of Clinical Affairs Bio-Vascular, Inc. 2575 University Avenue, Suite 180 Saint Paul, Minnesota 55114

Re: K992537 Trade Name: Peri-Strips® – Sleeve

Peri-Strips® - Strip Peri-Strips® - Dry Regulatory Class: II

Product Code: FTM Dated: November 23, 1999 Received: November 24, 1999

Dear Ms. Kessinger Sobcinski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Mary Kay Kessinger Sobcinski, RN. MHA

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James F. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if Known):

Image /page/4/Picture/2 description: The image shows a sequence of numbers and letters in a bold, stylized font. The sequence appears to be 'K992537'. The characters are black against a white background, creating a high contrast. There is also a black bar on the left side of the image.

Device Name:

Peri-Strips Dry® Staple Line Reinforcement (NaOH-treated product)

Indications for Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

Over-The-Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K992537

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Image /page/5/Picture/0 description: The image shows the text "Indications for Use" at the top. Below that, the text "510(k) Number (if known):" is on the left, followed by a blacked-out section. To the right of the blacked-out section is the number "K992537" in large, bold font. The number appears to be handwritten.

Device Name:

Peri-Strips Dry® Staple Line Reinforcement (non-NaOH-treated product)

Indications for Use:

Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including: pneumonectorny, pneumoreduction, pneumectornies, (segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

pcalles

General Resto 510(k) Numbe

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Image /page/6/Picture/0 description: This image shows the indications for use of a medical device. The 510(k) number, if known, is K992537. The device name is Bori String Staple Line Reinforcement.

Device Name;

Peri-Strips® Staple Line Reinforcement - Strip Configuration (NaOH-treated product)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

Over-The-Counter Use

bcosell

(Division Sign-Off)
Division of General Restorative Devices K992537
510(k) Number

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Indications for Use

510(k) Number (if Known):

Device Name:

Peri-Strips® Staple Line Reinforcement - Strip Configuration (non-NaOHtreated product)

Indications for Use:

Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectorny, pneumoreduction, pneumectomy, lobectomies, segmentectomies (segmental resections), wedge resections, bullectornies, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hemias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

OR Over-The-Counter Use__

of General Restorative De

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510(k) Number (if known):

Image /page/8/Picture/1 description: The image shows the words "Indications for Use" followed by the number K992537. The words "Indications for Use" are in a smaller font than the number. The number is written in a bold, handwritten font. The image is black and white.

Device Name:

Peri-Strips® Staple Line Reinforcement - Sleeve Configuration (non-NaOHtreated product)

Indications for Use:

Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectorny, pneumoreduction, pneumectorny, lobectomies, segmental resections), wedge resections, bullectomies, bronchlal resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the barlatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incuinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications,

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

alt_text

Over-The-Counter Use

casillas

(Division Sign-Off)
Division of General Restorative Devices K992537
510(k) Number

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Image /page/9/Picture/0 description: The image shows the words "Indications for Use" in the upper left corner. To the right of the words is a large, bold, handwritten number "K99 2537". There is also a black line under the words "Indications for Use".

510(k) Number (if known):

Device Name:

Peri-Strips® Staple Line Reinforcement - Sleeve Configuration (NaOH-treated product)

Indications for Use:

Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectorny, pneumoreduction, pneumectorny, lobectomies, segmentectomies (segmental resections), wedge resections, blebectomies, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple Ilne during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

Over-The-Counter Use

castellanos

eral Restorative Devices

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.