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 Pericardial 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

The provided text describes a 510(k) submission for the Glycar Pericardial Patch. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not typically for proving a device meets specific acceptance criteria through a study with performance metrics in the same way a PMA (Premarket Approval) would. Therefore, the document does not contain a study that explicitly demonstrates the device meets quantitative acceptance criteria with reported device performance as would be expected for a novel device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the Bio-Vascular Inc. Peri-Guard™ patch. This demonstration relies on comparing material composition, intended use, sterilization methods, and other performance features.

Here's a breakdown of the information requested, based on the provided text, and highlighting where the information is not present due to the nature of a 510(k) submission.

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

As this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily related to matching or exceeding the predicate device's characteristics and performance attributes rather than specific, quantitative clinical outcomes from a new study. The document lists several performance features that need to be "equal to or better than" the predicate device. However, it does not provide a table with specific numerical acceptance criteria and a corresponding quantitative "reported device performance" from a dedicated study.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as stated in the 510(k))
Manufactured from the same material (glutaraldehyde-treated bovine pericardium)	"The Glycar Pericardial Patches are made of the same material as the predicate device... which are made from glutaraldehyde-treated bovine pericardium." "There is no difference in the implanted material used for the Glycar Pericardial Patch ... and the predicate device... Both devices are manufactured from glutaraldehyde-treated bovine pericardial tissue."
Have the same intended use (pericardial closure, among others)	"The Glycar Inc., Pericardial Patch has the same intended use, pericardial closure, as the predicate device..." Indications for Use: "pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair." (Aligned with predicate, which has been used for pericardial closures for over ten years without reported material failure, and other soft tissue repairs)
Sterilized to a minimum assurance against contamination of 10-6 organisms (Sterility Assurance Level, SAL = 10-6)	"The Glycar Pericardial Patches are labeled as sterile. They are sterilized to an SAL of 10-6 organisms."
Other performance features equal to or better than those of the predicate device	Material Attributes: "Glycar's glutaraldehyde-treated pericardium possesses tissue strength equaling that of the predicate device." Pyrogenicity: "Glycar glutaraldehyde-treated bovine pericardium has been found to have negative pyrogenicity." Manufacturing Material (Proprietary XX): "Glycar Inc. has demonstrated no adverse effects on safety or efficacy of the use of this manufacturing material... rather it improves safety by virtue of the anti-inflammation properties it confers to the material."
Bovine Spongiform Encephalopathy (BSE)-free source	"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."

The document mentions "See in Addenda , Chart 1, Comparison Chart, under Substantial Equivalence and Breaking Strength under Supporting Data" and "Pyrogenicity under Supporting Data." This suggests that specific data on breaking strength and pyrogenicity would be provided in the full addenda to demonstrate these "other performance features." However, these specific numerical results are not included in the excerpt provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the excerpt. A 510(k) submission typically relies on existing predicate device data, preclinical bench testing, and sometimes animal studies for substantial equivalence. It does not ordinarily involve a prospective clinical study with a "test set" in the sense of a pivotal trial for a novel device. The "Supporting Data" mentioned for breaking strength and pyrogenicity would likely be from bench tests or animal studies, but the sample sizes, methodology, and provenance are not detailed here.

The source of the bovine pericardium (raw material) is from "government approved abbatoirs in Transvaal, S. Africa," and is certified BSE-free. This refers to the source of the biological material, not clinical data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided in the excerpt. As this is a medical device (tissue patch) for surgical repair, the concept of "ground truth for a test set" established by experts, as seen in AI/diagnostic imaging studies, does not apply. Performance is assessed through material properties, biocompatibility, and manufacturing controls, compared to a predicate. Clinical outcomes, if gathered, would be observed through surgical use over time, not via expert interpretation of a "test set."

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

This information is not applicable and therefore not provided. The device's performance is not being evaluated through expert adjudication of cases, as would be common in diagnostic imaging or clinical trials.

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

There is no mention of an MRMC study. This type of study (comparative effectiveness of human readers with/without AI assistance) is specific to AI-powered diagnostic tools or imaging analysis and is not relevant to a biological tissue patch.

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

This is not applicable and therefore not provided. The Glycar Pericardial Patch is a physical medical device (a tissue patch), not an algorithm or software. Therefore, there is no "standalone performance" of an algorithm without human involvement.

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

Given the nature of the device (a tissue patch), the "ground truth" for demonstrating substantial equivalence primarily relies on:

Material Characterization: Chemical composition (glutaraldehyde-treated bovine pericardium).
Physical Property Testing: Bench testing for tissue strength (e.g., breaking strength).
Biocompatibility Testing: Pyrogenicity tests.
Sterility Assurance: Sterility Assurance Level (SAL) verification.
Predicate Device History: The predicate device's long-standing safe use ("over ten years without reported material failure") serves as critical evidence supporting the safety and effectiveness of the material for the stated intended use.
Manufacturing Process Controls: Adherence to established manufacturing and sterilization protocols.

There is no mention of "expert consensus," "pathology," or specific "outcomes data" from a new clinical study. The FDA's 510(k) approval also explicitly states: "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." This indicates that post-market (or future PMAs) studies would be needed for such specific effectiveness claims, but not for the initial 510(k) clearance based on substantial equivalence.

8. The sample size for the training set

This is not applicable as the Glycar Pericardial Patch is a physical medical device, not an AI model requiring a training set.

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

This is not applicable as there is no training set for this type of device.

Summary

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K963967
Oct. 31, 1999
GLYCAR

510(K) SUMMARY

1, Official 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

3, Device Name

a) Trade Name Glycar Pericardial Patch

alternative trade names possible

b) Common Name Biological Tissue Patch

F.D.A. Device Classification Class III Device - we do not believe PMA is needed
Predicate Device

The predicate device is the Tissue Guard™ product line, including Supple Peri-Guard™ product line (K923657), and is a tissue patch made from (102007), and bovine pericardium. The device is produced by Bio-Vascular Inc., 2670 Patton Rd., St. Paul, MN 55113, (800) 255-4018.

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

Product Description

a) Candidate Device Composition

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

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

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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 device. It provides for a durable repair, replacement or reinforcement of natural soft tissue.

See in Addenda , Chart 1, Comparison Chart, under Substantial Equivalence and Breaking 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 Pericardial 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 strip production, additional tanning of the bovine pericardium, and then cutting of the glutaraldehyde-treated bovine pericardium for the designated strip size, followed by sterilization in formaldehyde, followed then by treatment with Glycar's proprietary anti-inflammation 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 antiinflammation 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

Sizes and shape has not been determined at this time.

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7. Intended Use of Product

a) Candidate Device Intended Use

The Glycar Inc., Pericardial Patch has the same intended use, pericardial closure, as the predicate device, the Bio-Vascular Inc., Peri-Guard™ patch, which is a tissue patch 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 are:

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 additional member of the Glycar Tissue Repair Patch family of products, the Glycar Staple Strip (K954665) was deemed substantially equivalent to the Peri-Strips™ 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.

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 the surgical stapling arm).

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

b) Predicate Device Intended Use

The predicate device, the Peri-Guard™ family of glutaraldehyde-treated bovine pericardium tissue patch has been used for pericardial closures for over ten years without reported material failure; this same material has in addition been used to repair abdominal and thoracic wall defects, inguinal, paracolostomy, ventral, paraumbilical, scrotal, femoral and other hernias, urethral slings, reconstruction of pelvic floor. repair of rectal and vaginal prolapse, suture and staple bolsters, pledgets and

GLYCAR

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GLYCAR

slings, and other soft tissue repair, reinforcement, and simgs, and other soft tissue reported patient morbidity or
reconstruction without any reported par reconstractions attributed to material failures.

8. Sterilization

a) Method

The device is sterilized using exposure to The device is stermiece as stermised ander enviromental
formaldeyhyde and propylene oxide under enviroment. See Cutline formaldeynyde and propyrent on enviroment. See Outline Collurol III a Class 100 Station under Sterilization Information.

b) Sterility Assurance Level

The Glycar Pericardial Patches are labeled as sterile. They are sterilized to an SAL of 10-6 organisms. Sterife. They are sterminerarison Chart, under Substantial See in Addenda , Charly 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) ERCEPHalOpacity)
See Figure 5 in Addenda, Certificate of B.S.E.-free Status

9. Substantial Equivalence

a) Comparison with Predicate Device

The Glycar Pericardial Patches are substantially equivalent to the Peri-Guard™ family of glutaraldehydetreated bovine pericardium in that they are:

i) manufactured from the same material, glutaraldehydetreated bovine pericardium,
ii) have the same intended use,
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 or better than those of the predicate device.

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

b) Technological Differences

i) Implanted Material- Bovine Pericardium

There is no difference in the implanted material There is no diference is no diference and the predicate
used for the Glycar Pericardial Patch davices are used for the Grycar Peri-Guard™. Both devices are device, blo Vascular Times glutaraldehyde-treated bovine manufactured from graturares Chart 1, in Addenda under Substantial Equivalence.

ii) Sterilization Method

There is no difference in the chemical sterilization the predicate device.

the predicate device.
See Supporting Data in Addenda Under Sleeve Configuration

iii) Manufacturing Material

aranactaring in the manufacturing process which i 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 safety of enteres for it improves safety by virtue of the material, tard wit confers to the material. See Proprietary Properties of the only in Addenda under Confidential Information.

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPT. OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

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, 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. 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 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.

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) 594-4648. 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,

Thomas f. Callahan

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

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Enclosure

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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 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kella B. Lempereur

(Division Sign-Off) (Division of Cardiovascular, Respiratory, . an Neuronageat Devices

510(K) Number K963967/K963368

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).