(49 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of the bovine pericardium strips, with no mention of AI or ML.
No
The device is described as reinforcing staple lines during surgical resections of the lung and bronchus, which is an adjunctive surgical aid rather than a direct therapeutic intervention for a disease or condition.
No
The device is described as reinforcing staple lines during surgical resections of the lung and bronchus, indicating it is an surgical adjunct rather than a device used for diagnosis.
No
The device description clearly states it is made of dehydrated bovine pericardium strips and a hydrogel, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a physical material (dehydrated bovine pericardium strips) intended to be implanted during surgical procedures (lung and bronchus resections) to reinforce staple lines. It is used in vivo (within the body) during surgery, not in vitro (in a lab setting) on a sample.
The information provided about the device's function, materials, and intended use all point to it being a surgical implant or adjunct, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
Dehydrated bovine pericardium strips cross-linked with glutaraldehyde. Affixed to the stapler forks with PSD Gel, a hydrogel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung and bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
animal implants, indicate that the product performs in a manner equivalent to our current product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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