(49 days)
intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectomy, segmental resections) wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions of lung and bronchus.
Dehydrated bovine pericardium strips cross-linked with glutaraldehyde. Affixed to the stapler forks with PSD Gel, a hydrogel.
This document is a Summary of Safety and Effectiveness for a medical device called "Peri-Strips Dry". It describes the device, its intended use, and compares it to existing products. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.
The provided text is a regulatory submission, likely to the FDA, demonstrating substantial equivalence to previously approved devices. It focuses on:
- Applicant Information: Name, address, contact, date.
- Device Identification: Common name, classification, substantial equivalence to prior devices (K942583 & K940205).
- Device Description: What it's made of (dehydrated bovine pericardium, glutaraldehyde, PSD Gel) and how it's used (affixed to stapler forks).
- Intended Use: Reinforcing staple lines in lung and bronchus resections.
- Summary/Comparison of Technological Characteristics: How "Peri-Strips Dry" is similar to and different from existing "Peri-Strips" products (material, dimensions, manufacturing process, sterilization, attachment method).
- Conclusion: States that the product design basis is the same and testing (including animal implants) indicates equivalent performance to current products.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: The document mentions "testing conducted, including the animal implants, indicate that the product performs in a manner equivalent to our current product" but provides no specific criteria, metrics, or performance data.
- Sample sized used for the test set and the data provenance: No details on animal implant study size, type, or origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it's an animal study, not human expert-based assessment.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the animal implants, it would likely be histological analysis or physical assessment of the staple lines, but this is not specified.
- The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a medical device in the context of a regulatory submission but does not contain the detailed study information (acceptance criteria, performance data, sample sizes, ground truth establishment, etc.) that would typically be found in a clinical study report or a more detailed efficacy/safety study summary.
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SUMMARY OF SAFETY AND EFFECTIVENE
Applicant Name & Address: Bio-Vascular; Inc., 2575 University Ave.,St. Paul, MN 55114-1024
Barbara Atzenhoefer, Regulatory Affairs Manager Contact:
Date Prepared: March 19, 1997
Common or Usual Name: Peri-Strips Dry - Staple Line Reinforcement
Device Classification Name: Surgical Patch
Substantial Equivilance: 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, segmental resections) wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions of lung and bronchus.
Summary/Comparision of Technological Characteristics:
Peri-Strips Dry, Peri-Strips Sleeves and Peri-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.
MAY - 9 1997
§ 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.