(191 days)
Not Found
No
The summary describes a wound dressing made of ovine collagen and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is intended for use in the treatment of various wounds, which falls under the definition of a therapeutic device designed to cure, mitigate, treat, or prevent a disease or condition.
No
The device is described as a wound dressing for the treatment of wounds, not for diagnosing them.
No
The device description clearly states it is a wound dressing primarily composed of ovine collagen and supplied as a physical sheet, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Endoform™ Dermal Template is for the treatment of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a wound dressing composed of collagen, applied directly to the wound. This is consistent with a topical treatment, not a device used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Endoform™ Dermal Template's function is to aid in the healing of wounds, which is a treatment process.
N/A
Intended Use / Indications for Use
The Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds:
- partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- tunneled/undermined wounds
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery; podiatric, wound dehiscence)
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- draining wounds
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Endoform™ Dermal Template is a wound dressing primarily composed of ovine collagen and is supplied as a sterile intact, perforated or meshed sheet ranging in size from 9cm2 to 400cm2.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Endoform™ Dermal Template has been subjected to extensive non-clinical testing to assess the biocompatibility and the performance of the device. Endoform™ Dermal Template was shown to be safe and effective as a wound dressing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061711, K973170, K993948, K021637, K071425, K014129, K021792
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
JAN 8 1 2010
510(k) Summary for the Mesynthes Limited, Endoform™ Dermal Template
1. SUBMITTER/510(K) HOLDER
Mesynthes Ltd 69 Gracefield Road Lower Hutt Wellington New Zealand 5010
Contact Person Brian Ward Telephone: (+64 4) 931-3275
Date Prepared: July 10, 2009
2. DEVICE NAME
Proprietary Name: Endoform™ Dermal Template Common/Usual Name: Endoform™ Classification Name: Collagen Wound Dressing
3. PREDICATE DEVICES
- 피 OaSIS® Wound Matrix (Cook Biotech) (K061711, K973170, K993948)
- 트 UBM Lyophilized Wound Dressing (MatriStem™) (ACell) (K021637)
- . Unite Biomatrix™ (Pegasus Biologics) (K071425)
- . Promogran® Matrix Wound Dressing (Johnson and Johnson) (K014129)
- 트 IntegraTM Wound Matrix (Integra Life Sciences) (K021792)
4. DEVICE DESCRIPTION
Endoform™ Dermal Template is a wound dressing primarily composed of ovine collagen and is supplied as a sterile intact, perforated or meshed sheet ranging in size from 9cm2 to 400cm2.
1
K092096 page 2/2
5. INTENDED USE
Endoform™ is supplied sterile and is intended for single use in the treatment of the following wounds:
- · partial and full-thickness wounds
- · pressure ulcers
- · venous ulcers
- · diabetic ulcers
- · chronic vascular ulcers
- · tunneled/undermined wounds
- · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery; podiatric, wound dehiscence)
- · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- · draining wounds
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Endoform™ Dermal Template is substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use,
7. PERFORMANCE TESTING
The Endoform™ Dermal Template has been subjected to extensive non-clinical testing to assess the biocompatibility and the performance of the device. Endoform™ Dermal Template was shown to be safe and effective as a wound dressing.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
JAN 2 1 2010
Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Room W-066-0609 Silver Spring, MD 20993-0002
Mesynthes Limited % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760
Re: K092096
Trade/Device Name: Endoform™ Dermal Template Regulatory Class: Unclassified Product Code: KGN Dated: December 21, 2009 Received: December 22, 2009
Dear Ms. McNamara-Cullinane:
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 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
3
Page 2 - Ms. Mary McNamara-Cullinane, RAC
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.fda.gov/AboutFDA/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
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
510(k) Number (if known):
Device Name: Endoform™ Dermal Template
Indications for Use:
The Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds:
- � partial and full-thickness wounds
- . pressure ulcers
- venous ulcers
- . diabetic ulcers
- . chronic vascular ulcers
- tunneled/undermined wounds .
- . surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- . trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- draining wounds �
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause kamxm
(Division Sign Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K092096