GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING

K963175 · Glycar, Inc. · FTM · Sep 23, 1996 · General, Plastic Surgery

Device Facts

Record IDK963175
Device NameGLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
ApplicantGlycar, Inc.
Product CodeFTM · General, Plastic Surgery
Decision DateSep 23, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.3300
Device ClassClass 2
AttributesTherapeutic

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 intra-abdominal 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 Story

Glycar Tissue Repair Patch consists of glutaraldehyde-treated bovine pericardium; used for soft tissue repair, reinforcement, and reconstruction. Device provides durable patch for surgical applications including hernia repair, pelvic floor reconstruction, and staple bolsters. Implanted by surgeons in clinical settings. Material is strong, pliable, and biocompatible. Proprietary anti-inflammation treatment (XX) applied during manufacturing. Sterilized via formaldehyde and propylene oxide to SAL 10^-6. Sourced from BSE-certified cattle in South Africa. Device functions as a mechanical scaffold for tissue repair.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including pyrogenicity testing and breaking strength comparisons to the predicate device.

Technological Characteristics

Material: Glutaraldehyde-treated bovine pericardium. Form factor: Tissue patch/strip. Sterilization: Formaldehyde and propylene oxide (SAL 10^-6). Manufacturing includes proprietary anti-inflammation treatment (XX).

Indications for Use

Indicated for repair, replacement, or reinforcement of natural soft tissue, including hernia repair (inguinal, paracolostomy, ventral, paraumbilical, scrotal, femoral, diaphragm, thoracic, abdominal wall), pericardial closures, urethral slings, pelvic floor reconstruction, rectal and vaginal prolapse repair, and use as suture/staple bolsters or pledgets.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} 510 (K) SUMMARY - GLYCAR TISSUE REPAIR PATCH K963175 GLYCAR # 510(K) SUMMARY SEP 23 1996 ## 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 ## 4. F.D.A. Device Classification Class II Device ## 5. 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. ## 6. Product Description a) Candidate Device Composition The Glycar Tissue Repair Patches are made of the same material as the predicate device, the Peri-Guard™ Aug.7, 1996 {1} 510 (K) SUMMARY - GLYCAR TISSUE REPAIR PATCH GLYCAR tissue patches, which are made from glutaraldehyde-treated 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 anti-inflammation 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. Aug.7, 1996 ii {2} 510 (K) SUMMARY - GLYCAR TISSUE REPAIR PATCH GLYCAR 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 intra-abdominal 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 Aug.7, 1996 iii {3} 510 (K) SUMMARY - GLYCAR TISSUE REPAIR PATCH 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 formaldehyde and propylene oxide under environmental control in a class 100 Clean Room environment. 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 glutaraldehyde-treated bovine pericardium in that they are: i) manufactured from the same material, glutaraldehyde-treated 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 Aug.7, 1996 iv {4} 510 (K) SUMMARY - GLYCAR TISSUE REPAIR PATCHI GLYCAR 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*. Aug.7, 1996
Innolitics
510(k) Summary
Decision Summary
Classification Order
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