K Number
K963967
Device Name
GLYCAR PERICARDIAL PATCH
Manufacturer
Date Cleared
1997-10-31

(394 days)

Product Code
Regulation Number
870.3470
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

No
The summary describes a biological tissue patch and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.

Yes.
The device is intended for "pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair," which are therapeutic interventions.

No
The device description states its intended uses are for pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair. These are therapeutic or reconstructive uses, not diagnostic.

No

The device description explicitly states it is made of glutaraldehyde-treated bovine pericardium, which is a physical material, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device being used in vivo (within the body) for surgical repair and reconstruction of tissues (pericardium, blood vessels, heart). IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The device is a patch made from treated bovine pericardium, designed to be implanted. This is consistent with a surgical implant, not an IVD.
  • Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological samples.

Therefore, the Glycar Pericardial Patch and Glycar Vascular Patch are surgical implants, not IVDs.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DXZ

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.
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.
Glycar glutaraldehyde-treated bovine pericardium has been found to have negative pyrogenicity.
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.
Sterility is maintained by using aseptic fill under Clean Room 100 conditions, during transfer to anti-inflammation treatment and to the final storage medium, 2% propylene oxide in water.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pericardial, peripheral vascular, cardiac, great vessel, hernia and other intra-abdominal soft tissue, lung tissue, gastric, rectal, vaginal, urethral, pelvic floor, diaphragm, thoracic and abdominal wall

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K923657

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K942911, K954665

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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

  1. 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

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

  2. 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.

  1. 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.

1

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.

2

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

3

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.

4

GLYCAR

V

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.

5

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:

6

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

く 0

Enclosure

7

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)