(208 days)
Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectorny, segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectorny, pneumoreduction, pneumectorny, lobectomies, segmentectomies (segmental resections), wedge resections, bullectornies, blebectomias, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.
Peri-Strips (sleeve and strip) and Peri-Strips Dry are surgical mesh patches derived from bovine pericardium that is cross-linked with glutaraldehyde.
Peri-Strips comes in two configurations: Peri-Strips-sleeve and Peri-Strips-strip. Each unit of Peri-Strips-sleeve is composed of two strips of bovine pericardial tissue. After the final manufacturing step, each strip of pericardium is sewn to a polyolefin strip with polypropylene suture to create a tubular sleeve. The tubular configuration facilitates usage of the product with surgical staplers. The polyolefin strip and sutures are removed after the Peri-Strips-sleeve is secured in place. Peri-Strips-strip is a flat piece of bovine pericardium that is sutured to the stapler by the surgical team.
For Peri-Strips Dry (PSD), the bovine pericardial patch is manufactured in the form of a strip and undergoes an additional manufacturing step of dehydration by vacuum drying. The strip is affixed to the surgical stapler with the aid of a hydrogel (PSD Gel) supplied with the product.
Product may be treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20-25°C, rinsed with deionized (DI) water, and neutralized with citrate solution, followed by a final DI water rinse.
This document is a 510(k) Summary of Safety and Effectiveness for Bio-Vascular, Inc.'s Peri-Strips devices. It is a premarket notification for a medical device seeking substantial equivalence to predicate devices and focuses on expanding the indications for use. As such, it does not contain the level of detail regarding acceptance criteria and specific study results that would typically be found in a clinical trial report or a more extensive study submission.
Here is an analysis based on the provided text, noting where specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device for safety and efficacy. | Bench testing and animal testing show no difference in safety and efficacy between NaOH-treated and non-NaOH-treated tissue. Specifications of NaOH-treated and non-NaOH-treated tissue are identical. Devices are substantially equivalent to predicate devices with regard to safety and efficacy. No new questions of safety and efficacy are raised by the bariatric surgery indication. |
| Performance for proposed expanded indication (bariatric surgery). | Not explicitly detailed in terms of specific performance metrics or thresholds. The statement is that "No new questions of safety and efficacy are raised by the bariatric surgery indication," implying satisfactory performance relative to predicates. |
Missing Information: Specific quantitative acceptance criteria (e.g., minimum burst strength, leak pressure, etc.) are not provided. The "reported device performance" is largely qualitative and comparative to predicate devices.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "bench testing and animal testing" but does not give the number of samples or animals used.
- Data Provenance: Not specified, but given the context of a 510(k) submission, the testing would likely have occurred in a controlled lab or animal research setting. The country of origin is not mentioned. It is prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable or specified. The testing described (bench and animal) would not typically involve human experts establishing ground truth in the way a clinical study with medical image interpretation would. The evaluation of safety and efficacy would be based on scientific and engineering principles.
- Qualifications of Experts: Not applicable or specified.
4. Adjudication Method
- Adjudication Method: Not applicable. The studies described are bench and animal tests, not clinical evaluations requiring adjudication of human expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-assisted diagnostic tool.
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Not applicable. This is a physical medical device (surgical mesh), not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "bench testing" and "animal testing," the ground truth would be based on objective physical measurements and observations (e.g., mechanical properties, biocompatibility, tissue response, healing, absence of adverse events in animal models relative to predicate devices). The document states "Specifications of NaOH-treated and non-NaOH-treated tissue are identical," suggesting that the ground truth for equivalence was based on meeting defined product specifications.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The device is not an AI/ML algorithm that requires a training set. The manufacturing process and design were developed based on established scientific principles and prior versions of the device, rather than a data-driven training process.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device. The design and manufacturing process are based on conventional engineering and biological principles, with "ground truth" being established through quality control, design verification, and validation testing.
§ 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.