(84 days)
Not Found
No
The 510(k) summary describes a biological wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the management of wounds and provides an environment that supports wound healing, which aligns with the definition of a therapeutic device.
No
The device, Porcine Dermal Xenograft, is described as an acellular, sterile, porcine dermal xenograft intended for managing and treating wounds by providing an environment that supports healing. It does not perform any diagnostic function.
No
The device description clearly states it is a "Porcine Dermal Xenograft," which is a physical biological material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description states it's an acellular, sterile, porcine dermal xenograft for use in treating topical wounds. This is a material applied to the body for healing purposes.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. IVDs are designed for this purpose.
The device is a wound dressing/graft, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.
Product codes
KGN
Device Description
Porcine Dermal Xenograft is an acellular, sterile, porcine dermal xenograft for use in treatment of topical wounds. The product is available in several sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K113866 page 1/2
MAR 2 3 2012
SUMMARY OF SAFETY AND EFFECTIVENESS 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.
16.1 SUBMITTER INFORMATION
Brennen Medical, LLC
Original Pre-market 510(k) Notification
| a. Company Name: | Brennen Medical, LLC |
|---|---|
| b. Company Address: | 1290 Hammond Road |
| St. Paul, MN 55110 | |
| c. Company Phone: | |
| Company Facsimile: | (651) 429-7413 |
| (651) 429-8020 | |
| d. Contact Person: | Kenneth B. Herland |
| V.P. Regulatory Affairs/QA | |
| e. Date Summary Prepared: | December 28, 2011 |
DEVICE IDENTIFICATION 16.2.
- a. Trade/Proprietary Name:
- b. Regulation Number :
- C. Regulation Name :
- ದೆ. Device Class :
- Product Code : e.
Porcine Dermal Xenograft (TBD) N/A Porcine Dermal Xenograft Unclassified KGN
16.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Brennen Medical | Porcine Surgical Mesh | K111436 | 10/12/2011 |
| Lifecell's | LTM Wound Dressing | K082103 | 10/08/2008 |
| TEI Biosciences | PriMatrix | K083440 | 12/12/2008 |
16.4 DEVICE DESCRIPTION
Porcine Dermal Xenograft is an acellular, sterile, porcine dermal xenograft for use in treatment of topical wounds. The product is available in several sizes.
1
K113866 page 2/2
Brennen Medical, LLC Original Pre-market 510(k) Notification
SUBSTANTIAL EQUIVALENCE 16.5
Porcine Dermal Xenograft is substantially equivalent to TEI's PriMatrix and Lifecells ATM Wound Dressing along with Brennen's Porcine Surgical Mesh. Porcine Dermal Xenograft 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
Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.
16.7 TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are identical to the predicate devices (Porcine Surgical Mesh, PriMatrix and LTM Wound Dressing). The ISO 10993-1 required Biocompatibility testing was conducted on the product. 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 16.8
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 Xenograft IS that the device performs as intended and substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Brennen Medical, LLC % Mr. Kenneth Herland VP Regulatory Affairs/QA 1290 Hammond Road Saint Paul, Minnesota 55110
Re: K113866
Trade/Device Name: Porcine Dermal Xenograft Regulatory Class: Unclassified Product Code: KGN Dated: February 13, 2012 Received: February 14, 2012
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
MAR 2 3 2012
3
Page 2 - Mr. Kenneth Herland
forth in the quality systems (OS) 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.fda.gov/AboutFDA/CentersOffices/CDRHVCDRHOffices/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/MedicalDevices/Safety/ReportaProblem/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.
For Dpt
Mark N. Melkerson/DSO (110)
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Brennen Medical, LLC Original Pre-market 510(k) Notification
INDICATION FOR USE
510(k) Number:
Device Name: Porcine Dermal Xenograft
Indications for Use: Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Division Sign-Off) | Daniel Rone for Mxy |
| Division of Surgical, Orthopedic, and Restorative Devices |
CONFIDENTIAL
Page 23 of 156
| §10(k) Number | K113866 |
|---|---|
| --------------- | --------- |