(143 days)
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, quadriceps, or other tendons.
Porcine Dermal Matrix is a prescription, sterile, single use, hydrated, non-crosslinked, r orcine skin that has both the epidermal and subdermal sides removed leaving only the dermis. The product is available in several sizes.
-
Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Biocompatibility per ISO 10993-1 (MEM Elution, Bacterial Mutagenicity, Acute Systemic Injection, Guinea Pig Maximization, Intracutaneous Reactivity, Materials Mediated Rabbit Pyrogen, Eight Week Intramuscular Implant, Thirteen Week Intramuscular Implant, Six-Month Intramuscular Implant) The product met all of the stated requirements of each test. Safety and Effectiveness for Intended Use Demonstrated through bench testing. Substantial Equivalence to Predicate Devices Performance is substantially equivalent to the predicate devices. -
Sample Size for Test Set and Data Provenance:
- The document does not specify a distinct "test set" in the context of an AI/ML device. The testing described is bench testing and biocompatibility testing on the product itself, not a dataset of medical cases.
- Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable to this device's evaluation.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not applicable as the device is a surgical mesh, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for case evaluation.
-
Adjudication Method for the Test Set:
- This information is not applicable for the same reasons above.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-assisted diagnostic tools where human performance is being compared with and without AI assistance. The Porcine Dermal Matrix is a physical surgical mesh.
- Therefore, information on the effect size of human readers improving with AI vs. without AI assistance is not applicable.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone study in the context of an algorithm's performance was not done. The device is a physical product.
-
Type of Ground Truth Used:
- The "ground truth" for this device's evaluation was based on bench testing results (demonstrating mechanical properties and performance) and biocompatibility testing results (demonstrating biological safety according to ISO standards). It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be assessed.
-
Sample Size for the Training Set:
- This information is not applicable. The device is a physical product, not an AI/ML algorithm that undergoes a training phase with a dataset.
-
How the Ground Truth for the Training Set Was Established:
- This information is not applicable for the same reasons as above.
{0}------------------------------------------------
page 1 of 2
OCT 1 4 2011
KII1436
Attachment 8
SUMMARY OF SAFETY AND EFFECTIVENESS
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
| 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: | September 8, 2011 |
DEVICE IDENTIFICATION
| 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
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Brennen Medical | Porcine Surgical Mesh | K081272 | 07/31/2008 |
| Brennen Medical | Porcine Surgical Mesh | K030460 | 03/07/2003 |
DEVICE DESCRIPTION
Porcine Dermal Matrix is a prescription, sterile, single use, hydrated, non-crosslinked, r orcine skin that has both the epidermal and subdermal sides removed leaving only the dermis. The product is available in several sizes.
SUBSTANTIAL EQUIVALENCE
Porcine Dermal Matrix is substantially equivalent to Brennen's Porcine Dermal Matrix Surgical Mesh. Porcine Dermal Matrix is substantially equivalent in intended use, mode of action, and design to the predicate devices. The size and thickness is basically the same as
{1}------------------------------------------------
the predicate on K030460 and the intended use is identical to the Porcine Surgical Mesh on K081272. The introduction of this product does not raise any new issues of safety or effectiveness.
2 of
INTENDED USE
K11436
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, quadriceps, or other tendons.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are identical to the predicate devices (Porcine Surgical Mesh and DermMatrix). The following Biocompatability testing was conducted per ISO 10993-1: ISO MEM Elution Assay, Bacterial Mutagenicity Test, ISO Acute Systemic Injection. ISO Guinea Pig Maximization, ISO Intracutaneous Reactivity Test, Materials Mediated Rabbit Pyrogen, Eight week Intramuscular Implant, Thirteen Week Intramuscular Implant. Six-Month Intramuscular Implant. The product met all of the stated requirements of each test.
Bench testing has demonstrated that the device is safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices.
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of several curved lines that create the shape of the bird's body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Brennen Medical, LLC % Mr. Kenneth B. Herland VP, RA/QA 1290 Hammond Road Saint Paul. Minnesota 55110
OCT 1 4 2011
Re: K111436
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: October 12, 2011 Received: October 13, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
{3}------------------------------------------------
Page 2 - Mr. Kenneth B. Herland
CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.ida.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/McdicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eune Keith
Sor Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
KI11436 510(k) Number (if known):
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.
Prescription Use AND/O Over-The-Counter Use (Part 21 CFR 801 Subpart D) R (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off) Division of Surgical, Orthopedic
Page | of (Posted November 13, 2003)
Brennen Medical, LL50(k) Number
- Porcine Surgical Mesh Special 510(k)
+36
Page 12 of 16
CONFIDENTIAL
§ 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.