The Glycar Pericardial Patch and Glycar Vascular Patch of the Glycar Tissue Repair Patch line of products are intended for pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.

Device Description

The Glycar Vascular Repair Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium.

AI/ML Overview

Here's an analysis of the provided text regarding the Glycar Vascular Repair Patch's acceptance criteria and substantiating study information:

The provided text is a 510(k) summary for a medical device called the Glycar Vascular Repair Patch. It outlines the device's characteristics and its proposed equivalence to a predicate device. However, it does not contain information about a study designed to prove the device meets specific acceptance criteria in the way a clinical trial or performance study would.

Instead, the submission focuses on demonstrating substantial equivalence to an already approved predicate device, the Bio-Vascular Inc., Vascu-Guard™ peripheral vascular patch (K942010), and other Glycar products (K942911, K954665). The "acceptance criteria" here are effectively the characteristics and performance of the predicate device, which the Glycar product aims to match or be comparable to.

Therefore, many of the requested sections (sample size, experts, adjudication, MRMC, standalone, training set, ground truth for training) are not applicable as the submission is a demonstration of substantial equivalence, not a de novo performance study with acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on Predicate Device Characteristics)	Reported Device Performance (Glycar Vascular Repair Patch)
Material Composition: Glutaraldehyde-treated bovine pericardium (same as predicate).	The Glycar Vascular Repair Patches are manufactured from the same material, glutaraldehyde-treated bovine pericardium.
Intended Uses: Same as predicate device (Vascu-Guard™: repair of carotid, femoral, iliac, profunda, tibial arteries, revision of arterio-venous access shunts). Prior Glycar products (K942911, K954665) had approved uses for hernia, intraabdominal soft tissue defects, surgical stapling of lung tissue, gastric staplings, rectal/vaginal prolapse, urethral sling, reconstruction of pelvic floor, hernias/defects of diaphragm/thoracic/abdominal wall. New specific intended uses include pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.	The Glycar Inc., Vascular Repair Patch has the same intended uses as the predicate device (Vascu-Guard™). The 510(k) summary also refers to previous approvals for Glycar products, broadening the family of intended uses. The final "Indications For Use" statement approved by the FDA includes: "pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair."
Material Attributes (Strength): Possesses tissue strength equaling that of the predicate.	Glycar's glutaraldehyde-treated pericardium possesses tissue strength equaling that of the predicate and provides for a durable repair, replacement or reinforcement of natural soft tissue. (References "Chirol Centere Chart 1, Comparison Chart, under Substantial Scc in Audenaul
Material Attributes (Pyrogenicity): Negative pyrogenicity.	Glycar glutaraldehyde-treated bovine pericardium has been found to have negative pyrogenicity. (References "Chart 1, Comparison Chart, under Substantial Equivalence and Pyrogenicity under Supporting Data" – this specific data is not provided in the excerpt).
Sterility Assurance Level (SAL): Minimum 10^-6 organisms (same as predicate).	The Glycar Vascular Repair Patches are labeled as sterile. They are sterilized to an SAL of 10^-6 organisms. (References "Chart 1, Comparison Chart, under Substantial Equivalence and see Validation of Sterilization Processes under Sterilization Information" – specific validation data not provided in the excerpt).
Sterilization Method: Chemical sterilization method (same as predicate, using formaldehyde and propylene oxide).	No difference in the chemical sterilization method used for Glycar Vascular Repair Patches versus that of the predicate device (formaldehyde and propylene oxide under environmental control in a class 100 Clean Room environment).
BSE Status: Sourced from BSE-free cattle.	Pericardium is obtained from cattle from government approved abattoirs in Transvaal, S. Africa, certified free from B.S.E. (bovine spongiform encephalopathy).
Safety and Efficacy: No adverse effects due to proprietary manufacturing material XX.	Glycar Inc. has demonstrated no adverse effects on safety or efficacy of the use of this manufacturing material. (No specific study data provided in the excerpt to support this, other than the claim itself).

2. Sample size used for the test set and the data provenance

Not Applicable. The submission is a demonstration of substantial equivalence, not a performance study with a "test set" in the context of typical algorithm validation. Performance characteristics (like strength, pyrogenicity, SAL) are asserted to be equivalent to the predicate, likely based on internal testing or existing validation data, but not explicitly as a test set for this 510(k). The mention of internal data like "Supporting Data" and "Validation of Sterilization Processes" suggests data exists but is not elaborated upon in this summary.

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

Not Applicable. See point 2.

4. Adjudication method

Not Applicable. See point 2.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not Applicable. This is a medical device for surgical repair (a patch), not an imaging-based AI diagnostic tool that would typically undergo an MRMC study.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Based on Comparison to Predicate Device Characteristics and Internal Testing Standards. The "ground truth" for this submission are the established performance and safety characteristics of the predicate device (Vascu-Guard™) and the conformity to recognized standards for materials (e.g., glutaraldehyde-treated bovine pericardium), sterilization (10^-6 SAL), and biological safety (pyrogenicity, BSE-free source). These are verified through various internal tests and comparisons referenced in the submission (e.g., "See Comparison Chart, Chart 1, in Addenda under Substantial Equivalence and see Supporting Data").

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. See point 8.

Summary

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510(K) SUMMARY

165566

Oct . 31, 1997

GLYCAR

Contact Person Dr. Dirk Frater 4537 Belclaire Ave. Dallas. TX 75205 Phone: (214) 526-5412
Regulatory Consultant Bertram Hudson Shotwell & Carr Inc. Suite 100, 3003 LBJ Freeway Dallas, TX 75234
Device Name

a) Trade Name
Glycar Tissue Repair Patch Family of products: Glycar Vascular Repair Patch alternative proprietary name possible
b) Common Name Biological Tissue Patch
1. F.D.A. Device Classification Class II Device
1. Predicate Device

The predicate device is the Vascu-Guard™ product (K942010, and is a tissue patch made from glutaraldehyde-treated bovine pericardium. The device is produced by Bio-Vascular Inc., 2670 Patton Rd., St. Paul. MN 55113. (800) 255-4018.

For copies of Vascu-Guard™ labels, see Figures 3 - 4 in the Addenda under Predicate Device Labeling.

Product Description

a) Candidate Device Composition

The Glycar Vascular Repair Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium.

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See Comparison Chart, Chart 1, in Addenda under Substantial Equivalence.

b) Material Attributes

Glutaraldehyde-treated bovine pericardium is a strong, pliable, biocompatible material which is easy to handle surgically.

Glycar's glutaraldehyde-treated pericardium possesses tissue strength equaling that of the predicate possesses trouvides for a durable repair, replacement or reinforcement of natural soft tissue.

I Chirol Centere Chart 1, Comparison Chart, under Substantial Scc in Audenaul | Chaking Strength under Supporting Data

c) Pyrogenicity

Glycar glutaraldehyde-treated bovine pericardium has been found to have negative pyrogenicity. See in Addenda , Chart 1, Comparison Chart, under Substantial Equivalence and Pyrogenicity under Supporting Data.

d) Manufacturing Process

The manufacturing process for the Glycar Vascular Repair Patches involves the harvesting of bovine pericardium, fixation of the pericardium in glutaraldehyde, inspection and cleaning of the pericardium, selection of the pericardium for use in patch production, additional tanning of the bovine pericardium, and then cutting of the glutaraldehyde-treated bovine pericardium for the designated patch size, followed by sterilization in formaldehyde, followed then by treatment with Glycar's proprietary anti-calcification treatment, XX. See in Proprietary Manufacturing Material in Addenda under Confidential Information.

Sterility is maintained by using aseptic fill under Clean Room 100 conditions, during transfer to anticalcification treatment and to the final storage medium, 2% propylene oxide in water.

See Outline of Manufacturing Process in Addenda under Manufacturing Information and Sterilization Information.

e) Product Sizes

Single size at present: 2 x 9 cm.

7. Intended Use of Product

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a) Candidate Device Intended Use

The Glycar Inc., Vascular Repair Patch has the same intended uses as the predicate device, the Bio-Vascular Inc., Vascu-Guard™ family of products, which are all tissue patches made from the same glutaraldehyde-treated bovine pericardium.

Already approved intended uses for the Glycar Tissue Repair Patch family of glutaraldehyde-tanned bovine pericardial tissue patches:

The Glycar Tissue Repair Patch (K942911) was deemed substantially equivalent to the Peri-Guard™ bovine pericardial tissue patch and received approval for U.S. marketing for the intended use of hernia and other intraabdominal soft tissue defect or deficiency repair in December, 1994.

An addition to the Glycar Tissue Repair Patch family of products, the Glycar Staple Strip (K954665) was deemed substantially equivalent to the Peri-StripsTM bovine pericardial surgical staple bolsters and received approval for U.S. marketing for the intended uses of surgical stapling of lung tissue, gastric staplings, rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias or defects of the diaphragm, thoracic and abdominal wall in October, 1995. See under Indication For Use Statement.

The Glycar Staple Strip uses the identical material as the Glycar Tissue Repair Patch with the addition of a synthetic suture material to assist placement of the device on a surgical stapling arm.

See in Addenda , Chart 1, Comparison Chart, under Substantial Equivalence .

b) Predicate Device Intended Use

.The predicate device, the Vascu-Guard™ peripheral vascular patch has been used for repair of carotid arteries during carotid endarterectomy surgery. for repair of femoral, iliac, profunda, tibial arteries and for the revision of arterio-venous access shunts without any significant morbidity or mortality attributed to material failures.

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8. Sterilization

a) Method

The device is sterilized using exposure to formaldeyhyde and propylene oxide under enviromental control in a class 100 Clean Room enviroment. See Outline of Sterilization Method in Addenda under Sterilization Information.

b) Sterility Assurance Level

The Glycar Vascular Repair Patches are labeled as sterile. They are sterilized to an SAL of 10-6 organisms. See in Addenda , Chart 1, Comparison Chart, under Substantial Equivalence and see Validation of Sterilization Processes under Sterilization Information.

c) Bovine Spongiform Encephalopathy

Pericardium used for the raw material for these devices is obtained from cattle from government approved abbatoirs in Transvaal, S. Africa.

The cattle of the Republic of South Africa are certified free from B.S.E. (bovine spongiform encephalopathy) See Figure 5 in Addenda, Certificate of B.S.E.-free Status

9, Substantial Equivalence

a) Comparison with Predicate Device

The Glycar Vascular Repair Patches are substantially equivalent to the Vascu-Guard™ peripheral vascular patches in that they are:

i) manufactured from the same material, glutaraldehydetreated bovine pericardium,
ii) have the same intended uses,
iii) are sterilized to a minimum assurance against contamination of 10-6 organisms (Sterility Assurance Level, SAL = 10-6), and
iv) have other performance features equal to those of the predicate device.

See Comparison Chart, Chart 1, in Addenda under Substantial Equivalence and see Supporting Data

b) Technological Differences

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GLYCAR

i) Implanted Material- Bovine Pericardium

There is no difference in the implanted material used for the Glycar Vascular Repair Patches and the predicate device, Bio-Vascular Vascu-Guard™. Both devices are manufactured from gluraldehyde-treated bovine pericardium. See Comparison Chart, Chart I, in Addenda under Substantial Equivalence.

ii) Sterilization Method

There is no difference in the chemical sterilization method used for Glycar Vascular Repair Patches versus that of the predicate device. See Supporting Data in Addenda Under Sleeve Configuration

iii) Manufacturing Material

One difference in the manufacturing process which Glycar Inc. considers proprietary is the use of the manufacturing material, XX.

Glycar Inc. has demonstrated no adverse effects on safety or efficacy of the use of this manufacturing material. See Proprietary Manufacturing Material in Addenda under Confidential Information.

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Image /page/5/Picture/2 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with its wings spread, and the words "DEPT. OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is a simple, abstract design, and the text is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 1997

Dirk Frater, M.D. Official Contact Glycar Inc. 4504 Beverly Drive Dallas, Texas 75205

K963368 and K963967 Re : Glycar Pericardial Patch and Glycar Vascular Patch Requlatory Class: II Product Code: DXZ Dated: July 30, 1997 Received: August 4, 1997

Dear Dr. Frater:

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, Druq, 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. Please be advised that you may not make any claims about the effectiveness of the anticalcification treatment or durability of the device in any labeling or advertisements for this device until results of human clinical studies are submitted and found to substantiate such claims. You may, however, summarize results of animal studies performed, which should include the number and type of animal(s), location and duration of the implant, controls used, endpoints and results.

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices:

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Page 2 - Dirk Frater, M.D.

General regulation (21 CFR Part 820) and that, through periodic QS oneedi logal 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.

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) Additionally, for questions on the promotion and 594-4648. 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director, Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ 1_of__1__

510(k) Number (if known):_K963967 and K963368

Device Name: Glycar Pericardial Patch and Glycar Vascular Patch

Indications For Use: The Glycar Pericardial Patch and Glycar Vascular Patch of the Indications For Use: The Giycal Fencardian Facer and and of pericardial closure,
Glycar Tissue Repair Patch line of products are intended for pericardial closure, Glycar Tissue Repair Patch line of products are in
peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kille R. Lempicki

(Division Sign-Off) (Division Sign Sirdinvascular, Respiratory, and Neurological Cevices Kg(2

14(k) Number_K 910) 3967

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).