Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.

Device Description

Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.

AI/ML Overview

Here's an analysis of the provided information regarding the GlucaMesh and Glucatex (Polypropylene/Polyester) Mesh, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Technological Characteristics	Similar to Prolene, Mersilene, and Biomesh (constructed of polypropylene and polyester)	"For technical characteristics, the values established for GlucaMesh and Glucatex are similar to those established by Prolene, Mersilene and Biomesh which were constructed of polypropylene and polyester."
Biocompatibility	Biocompatible (implied by substantial equivalence and predicate device characteristics)	"The meshes are biocompatible..."
Material Degradation	Not biodegradable (implied by substantial equivalence and predicate device characteristics)	"...and not biodegradable."
Mechanical Properties (Strength, Durability, Porosity)	Excellent strength, durability, sufficient porosity for tissue ingrowth (implied by substantial equivalence to predicate devices known for these properties)	"The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth."
Intended Use/Indications	Use as a prosthesis in general surgery for abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse.	"This mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse." The FDA letter also confirms the indications for use.
Safety and Effectiveness	Substantially equivalent to predicate devices (Prolene Soft, Mersilene, Biomesh)	"Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device(s) under the Federal Food, Drug and Cosmetic Act."

Study Information (Based on the provided K021835 documentation):

The provided documentation describes a 510(k) Premarket Notification for the GlucaMesh/Glucatex Surgical Mesh. This regulatory pathway primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials for de novo approval.

Here's a breakdown of the study aspects based on the given text:

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size for Test Set: Not applicable (N/A) in the context of a clinical test set. The submission refers to "Sufficient bench testing" and a comparison of technological characteristics to predicate devices. There is no mention of a clinical test set of patients or data in the provided documents.
Data Provenance: The primary data provenance is bench testing and comparison to the known characteristics of predicate devices. There is no mention of a specific country of origin, nor whether any human data (if collected) was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable (N/A). There is no mention of a test set requiring expert ground truth in the provided summary. The substantial equivalence determination is based on a comparison of technical characteristics and intended use to established predicate devices.

4. Adjudication Method for the Test Set:

Not applicable (N/A). No clinical test set or expert adjudication is described in the provided documents.

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. An MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. This type of study is typically associated with AI-driven diagnostic or screening devices, which is not the nature of a surgical mesh.

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

No. This device is a surgical mesh, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established physical and material characteristics, performance, and clinical history of the predicate devices (Prolene Soft, Mersilene, Biomesh), combined with the results of bench testing for the GlucaMesh/Glucatex. The substantial equivalence argument serves as the "truth" for regulatory purposes here.

8. The Sample Size for the Training Set:

Not applicable (N/A). There is no "training set" in the context of an AI/machine learning model for this surgical mesh submission. The development relies on established engineering principles, material science, and comparison to existing devices.

9. How the Ground Truth for the Training Set was Established:

Not applicable (N/A). As there is no training set for an AI model, this question does not apply.

Summary

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K021835

OCT 1 7 2002

Summary of Safety and Effectiveness (As required by 21 CFR 807.92)

Device Name: GlucaMesh and or Glucatex (Polypropylone/Polyester) Mesh.

Predicate Device Name: Prolene Soft (Polypropylene), Mersilene (Polyester ) and Biomesh (polypropylene) mesh.

Device Description Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.

Intended Use This mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse.

Indications Statement This mesh is used for the repair of abdominal wall reinforcements, hernia repairs, eventrations, rectal or genitourinary prolapses.

Technological Characteristics For technical characteristics, the values established for GlucaMesh and Glucatex are similar to those established by Prolene, Mersilenc and Biomesh which were constructed of polypropylenc and polyester.

Performance Data Sufficient bench testing was conducted in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

Conclusions Based on the 510(k) summaries and 510(k) statements (21 ClFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device(s) under the Federal Food, Drug and Cosmetic Act.

Contact	Philip B. Lawin, Ph.D.PresidentBrennen Medical1290 Hammond RoadSt. Paul, MN 55110Contact Telephone Number 651-429-7413
Date	October 8, 2002

Phillip B. Lawin, Ph. D.
President

Date: 10/9/02

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles overlapping each other, creating a sense of depth and unity. The profiles are arranged in a way that suggests movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2002

Brennen Medical, Inc. Phillip B. Lawin, Ph.D. President 1290 Hammond Road St. Paul, Minnesota 55110

Re: K021835

Trade/Device Name: Brennen Medical Surgical Mesh. GlucaMesh/Glucatex Regulation Number: 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: August 8, 2002 Received: August 12, 2002

Dear Dr. Lawin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 – Dr. Phillip B. Lawin

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 021835

Page 1 of 1

510(k) Number (If Known):

Device Name: Brennen Medical GlucaMesh Surgical Mesh

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 (Optional Format 1-2-96)

Atpt Rurle

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.