K Number
K963175
Device Name
GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
Manufacturer
Date Cleared
1996-09-23

(40 days)

Product Code
Regulation Number
878.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glycar Inc., Tissue Repair Patch family of products have the same intended uses as the predicate device, the Bio-Vascular Inc., Peri-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-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.
Device Description
The Glycar Tissue 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. 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. The manufacturing process for the Glycar Tissue 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 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 antiinflammation treatment and to the final storage medium, 2% propylene oxide in water. Sizes and shapes will be specific for product line reflecting different indications as appropriate for the use.
More Information

No
The description focuses on the material composition and manufacturing process of a tissue patch made from glutaraldehyde-treated bovine pericardium. There is no mention of AI or ML technology in the intended use, device description, or any other section.

Yes
The device is described as a "Tissue Repair Patch" and "Staple Strip" used for "repair, replacement or reinforcement of natural soft tissue," including hernia repair and various other tissue defects. These uses directly involve treating or mitigating a disease or injury, thus qualifying it as a therapeutic device.

No

Explanation: The device, the Glycar Tissue Repair Patch, is described as a material for repairing or reinforcing soft tissue, such as for hernias or other defects. This indicates a therapeutic or reconstructive function, not a diagnostic one. There is no mention of it being used to detect, identify, or monitor medical conditions.

No

The device is a physical tissue patch made from glutaraldehyde-treated bovine pericardium, not software.

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

Here's why:

  • Intended Use: The intended uses described are for the repair, replacement, or reinforcement of soft tissue within the body (hernias, lung tissue, gastric, rectal, vaginal, urethral, pelvic floor, diaphragm, thoracic and abdominal wall). These are surgical procedures performed on the patient, not tests performed on samples taken from the patient.
  • Device Description: The device is a physical patch made from glutaraldehyde-treated bovine pericardium. It is designed to be implanted or used during surgery.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health, diagnosis, or condition.

Therefore, the Glycar Inc., Tissue Repair Patch family of products are surgical implants/devices, not IVDs.

N/A

Intended Use / Indications for Use

The Glycar Inc., Tissue Repair Patch family of products have the same intended uses as the predicate device, the Bio-Vascular Inc., Peri-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-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.

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

Not Found

Device Description

The Glycar Tissue 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.

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 Tissue 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 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 antiinflammation treatment and to the final storage medium, 2% propylene oxide in water.

Sizes and shapes will be specific for product line reflecting different indications as appropriate for the use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hernia and other intraabdominal soft tissue defect or deficiency repair, lung tissue, gastric, rectal and vaginal prolapse, 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

§ 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.

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GLYCAR

510(K) SUMMARY

  1. Contact Person Dr. Dirk Frater 4537 Belclaire Ave. Dallas, TX 75205 Phone: (214) 526-5412

  2. Regulatory Consultant Bertram Hudson Shotwell & Carr Inc. Suite 100, 3003 LBJ Freeway Dallas, TX 75234

  3. Device Name

  • a) Trade Name
    Glycar Tissue Repair Patch Bio-Patch trademark pending Uro-Sling trademark pending

  • b) Common Name Biological Tissue Patch

    1. F.D.A. Device Classification Class II Device
    1. 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 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 Peri-Guard™ labels, see Figures 3 - 4 in the Addenda under Predicate Device Labeling.

  1. Product Description

a) Candidate Device Composition

The Glycar Tissue Repair Patches are made of the same material as the predicate device, the Peri-Guard™

SEP 2 3 1996

1

tissue patches, which are made from glutaraldehydetreated bovine pericardium.

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 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 Tissue 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 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.

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e) Product Sizes

Sizes and shapes will be specific for product line reflecting different indications as appropriate for the use.

7. Intended Use of Product

a) Candidate Device Intended Use

The Glycar Inc., Tissue Repair Patch family of products have the same intended uses as the predicate device, the Bio-Vascular Inc., Peri-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-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, the repair of abdominal and thoracic wall defects, inguinal, paracolostomy, ventral, paraumbilical, scrotal, femoral

iii

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GLYCAR

and other hernias, urethral slings, reconstruction of pelvic floor. repair of rectal and vaginal prolapse, suture and staple bolsters, pledgets and slings, and other soft tissue repair, reinforcement, and reconstruction without any significant reported patient morbidity or mortality attributed to material failures.

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 Tissue 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 Tissue Repair 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 uses,
  • iii) are sterilized to a minimum assurance against contamination of 10-6 organisms (Sterility Assurance Level, SAL = 10-6), and

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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

i) Implanted Material- Bovine Pericardium

There is no difference in the implanted material used for the GlycarTissue Repair Patches and the predicate device, Bio-Vascular Supple Peri-Guard™. Both devices are manufactured from gluraldehyde-treated bovine pericardium. See Comparison Chart, Chart 1, in Addenda under Substantial Equivalence.

ii) Sterilization Method

There is no difference in the chemical sterilization method used for Glycar Tissue 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.