(87 days)
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery: Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Porcine Dermal Matrix is a prescription, sterile, pyrogen free, single use, porcine skin that has both the epidermal and subdermal sides removed. The product is available in several sizes.
The provided text is a 510(k) summary for the Porcine Dermal Matrix Surgical Mesh. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device might.
Therefore, many of the requested points cannot be answered from the provided text, as the information is not typically included in a 510(k) summary for a Class II device like a surgical mesh.
Here's an attempt to answer based only on the provided text, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: - Intended use - Mode of action - Design - Does not raise new issues of safety or effectiveness | Substantially equivalent to DermMatrix, Permacol/Pelvicol, and SurgiMend surgical meshes. - Equivalent in intended use, mode of action, and design. - Introduction does not raise any new issues of safety or effectiveness. - Biocompatibility testing per ISO 10993-1 demonstrated device is "safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices." |
| Performance as Intended | "Test evaluations of Porcine Dermal Matrix show that the device performs as intended." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "biocompatibility testing" and "bench testing" but does not provide details on the sample sizes used for these tests.
- Data Provenance: Not specified, beyond general "biocompatibility testing conducted per ISO 10993-1, bench testing and numerous clinical experiences." No country of origin is mentioned, nor is it explicitly stated if the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The study design does not appear to involve human readers or ground truth established by experts in the context of diagnostic performance. The evaluation is based on material properties and biological compatibility.
4. Adjudication method for the test set
- Not applicable/not provided. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation (e.g., radiology reads), which is not the nature of the evidence presented for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC comparative effectiveness study was not done, as this is a surgical mesh with a focus on material properties and biological integration, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical product (surgical mesh), not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for this device's substantial equivalence and safety/effectiveness relies on biocompatibility testing results (per ISO 10993-1) and bench testing results for its material properties and performance. It also relies on the established safety and effectiveness profile of the predicate devices with which it demonstrates equivalence. No pathology or outcomes data is explicitly detailed as "ground truth" for the current device's performance, but rather for the predicate devices and generally accepted biocompatibility standards.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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K081272
pg 1 of 2
2008
SUMMARY OF SAFETY AND EFFECTIVEN SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 16.1
| a. | Company Name: | Brennen Medical, LLC |
|---|---|---|
| b. | Company Address: | 1290 Hammond RoadSt. Paul, MN 55110 |
| c. | Company Phone:Company Facsimile: | (651) 429-7413(651) 429-8020 |
| d. | Contact Person: | Kenneth B. HerlandV.P. Regulatory Affairs/QA |
| e. | Date Summary Prepared: | July 28, 2008 |
DEVICE IDENTIFICATION 16.2.
| a. Trade/Proprietary Name: | Porcine Dermal Matrix (TBD) |
|---|---|
| b. Regulation Number : | 21 CFR 878.3300 |
| c. Regulation Name : | Surgical Mesh |
| d. Device Class : | II |
| e. Product Code : | FTM |
IDENTIFICATION OF PREDICATE DEVICES 16.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Advanced Uroscience | Porcine Surgical Mesh | K993459 | 11/05/1999 |
| Brennen Medical | Porcine Surgical Mesh | K030460 | 03/07/2003 |
| Brennen Medical | DermMatrix | K021160 | 06/12/2002 |
| Tissue Sciences Labs | Permacol/Pelvicol | K013625 | 01/17/2002 |
| TEI Biosciences | SurgiMend | K071807 | 08/06/2007 |
DEVICE DESCRIPTION 16.4
Porcine Dermal Matrix is a prescription, sterile, pyrogen free, single use, porcine skin
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K081272
pg 202
that has both the epidermal and subdermal sides removed. The product is available in several sizes.
SUBSTANTIAL EQUIVALENCE 16.5
Porcine Dermal Matrix is substantially equivalent to DermMatrix, Permacol/Pelvicol, and SurgiMend surgical meshes. Porcine Dermal Matrix is equivalent in intended use, mode of action, and design to the predicate devices. The introduction of this product does not raise any new issues of safety or effectiveness.
16.6 INTENDED USE
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. Specifically indicated for: Plastic and reconstructive surgery; Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons.
TECHNOLOGICAL CHARACTERISTICS 16.7
The technological characteristics are identical to the predicate devices (Porcine Surgical Mesh and DermMatrix). Biocompatability testing conducted per ISO 10993-1, bench testing and numerous clinical experiences have demonstrated that the device is safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices.
16.8 CONCLUSIONS
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. Test evaluations of Porcine Dermal Matrix show that the device performs as intended and substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Brennen Medical, LLC % Mr. Kenneth B. Herland VP Regulatory Affairs/QA 1290 Hammond Road Saint Paul, Minnesota 55110
JUL 3 1 2008
Re: K081272
Trade/Device Name: Porcine Dermal Matrix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 1, 2008 Received: May 5, 2008
Dear Mr. Herland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kenneth B. Herland
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH) s) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mullison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K081272
Device Name: Porcine Dermal Matrix Surgical Mesh
Indications for Use:
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery: Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Mark X Melkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K08172
Prescription Use Over-The-Counter Use (X) AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of (Posted November 13, 2003)
§ 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.