PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT

K971048 · Bio-Vascular, Inc. · FTM · May 9, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971048
• Device Name: PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
• Applicant: Bio-Vascular, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectomy, segmentectomies (segmental resections) wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus.

Device Story

Peri-Strips Dry consists of dehydrated bovine pericardium strips cross-linked with glutaraldehyde; used to reinforce staple lines during lung/bronchus resections. Device affixed to surgical stapler forks using PSD Gel (hydrogel). Used in clinical/surgical settings by physicians. Product design based on existing bovine pericardium technology; vacuum-dried and precision-cut. Irradiation sterilization replaces chemical sterilization used in predicate devices. Enhances ease of use for surgeons; provides mechanical reinforcement to staple lines to potentially reduce air leaks or tissue trauma during lung procedures.

Clinical Evidence

Animal implant studies conducted to evaluate performance equivalence to predicate devices. No human clinical trial data provided.

Technological Characteristics

Material: Dehydrated bovine pericardium cross-linked with glutaraldehyde. Attachment: PSD Gel (hydrogel). Sterilization: Irradiation. Form factor: Precision-cut strips. Compatible with subset of existing surgical staplers.

Indications for Use

Indicated for patients undergoing lung and bronchus resections, including pneumonectomy, pneumoreduction, segmentectomies, wedge resections, blebectomies, lobectomies, bullectomies, and bronchial resections.

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

• Peri-Strips - Strips Configuration (K942583)
• Peri-Strips - Sleeve Configuration (K940205)

Submission Summary (Full Text)

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K971048

# SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name & Address: Bio-Vascular, Inc., 2575 University Ave., St. Paul, MN 55114-1024

Contact: Barbara Atzenhoefer, Regulatory Affairs Manager

Date Prepared: March 19, 1997

Common or Usual Name: Peri-Strips Dry - Staple Line Reinforcement

DAY - 9 1997

Device Classification Name: Surgical Patch

Substantial Equivalence: Peri-Strips - Strips Configuration K942583 & Peri-Strips - Sleeve Configuration K940205

Device Description: Dehydrated bovine pericardium strips cross-linked with glutaraldehyde. Affixed to the stapler forks with PSD Gel, a hydrogel.

## Statement of Intended Use:

intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectomy, segmentectomies (segmental resections) wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus.

## Summary/Comparison of Technological Characteristics:

Peri-Strips Dry, Peri-Strips Sleeves and Peri-Strips Strips are derived from the same material, Supple Peri-Guard. The dimensions (length, width, and thickness) of the Peri-Strips Dry pericardium strips fall within the same range as the current Peri-Strips products.

The manufacturing processes for all three Peri-Strips products are the same with the following exceptions:
- there are no tyvek sleeves sutured to the pericardium strips as is done with the Peri-Strips sleeves product
- the tissue is vacuum dried at the end of the process, then precision cut.

The staplers intended for use with the Peri-Strips Dry product are a subset of the current Peri-Strip products.

Peri-Strips Dry is irradiation sterilized, the Peri-Strips products are chemically sterilized.

The current Peri-Strips products are attached to the stapler forks with sutures or the tyvek sleeves. The Peri-Strips Dry product utilizes a hydrogel (PSD Gel) to affix the strips to the stapler forks.

Summary: The basis for the product design is the same, bovine pericardium cross-linked with glutaraldehyde. The greatest differences between the Peri-Strips Dry and our current products is in the how the product is sterilized, packaged and affixed to the stapler forks. Each of these changes were made in an effort to enhance the product and make it easier for the physician to use. Moreover, the testing conducted, including the animal implants, indicate that the product performs in a manner equivalent to our current product.

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