(20 days)
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
The Endoform™ Dermal Template is a wound care device comprised of one or two layers of ovine extracellular matrix and is supplied as a sterile perforated or non perforated sheet ranging in size up to 400 cm2.
The provided 510(k) summary for the Endoform™ Dermal Template (K101546) does not contain the detailed information necessary to complete the requested table and answer all questions.
This 510(k) document establishes substantial equivalence to a predicate device (Endoform™ Dermal Template, K092096) based on material composition, device characteristics, and intended use, and a declaration of conformity to design control requirements and a risk assessment. It explicitly states that the predicate device (K092096) "was shown to be safe and effective as a wound care product" after "extensive non-clinical testing to assess the biocompatibility and the performance of the device." However, the current submission (K101546) does not present new clinical or performance data for the device itself.
Therefore, many of the requested details, such as specific acceptance criteria, reported performance values, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not available within this document.
Here's what can be answered based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available in this document. The submission refers to non-clinical testing of the predicate device (K092096) for safety and effectiveness, but does not provide specific acceptance criteria or performance metrics for the K101546 device in this document. | Not Available in this document. The document states that the predicate device (K092096) "was shown to be safe and effective as a wound care product" but provides no quantitative performance metrics. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not available in this document. The submission references non-clinical testing for the predicate device, but no details of a clinical test set for K101546 or its provenance are provided.
- Data Provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not available in this document.
- Qualifications of Experts: Not available in this document.
4. Adjudication method for the test set
- Adjudication Method: Not available in this document.
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
- MRMC Study Done?: No. This device is a Dermal Template, not an AI-assisted diagnostic tool. An MRMC study is not applicable.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study Done?: Not applicable. This device is a wound care product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not available in this document. The document refers to non-clinical testing for the predicate device (K092096) to establish safety and effectiveness, but details of how "ground truth" was established for such testing are not provided.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a medical device for wound care, not a machine learning algorithm.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. This device is a medical device for wound care, not a machine learning algorithm.
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Page 1/2
JUN 2 3 2010
510(k) K101546 Summary . for the 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: June 17, 2010
2. DEVICE NAME
| Proprietary Name: | Endoform™ Dermal Template |
|---|---|
| Common/Usual Name: | Extracellular matrix wound care product |
| Classification: | Unclassified |
3. PREDICATE DEVICES
- Endoform™ Dermal Template (Mesynthes) (K092096) .
4. DEVICE DESCRIPTION
The Endoform™ Dermal Template is a wound care device comprised of one or two layers of ovine extracellular matrix and is supplied as a sterile perforated or non perforated sheet ranging in size up to 400 cm2.
5. INTENDED USE
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
{1}------------------------------------------------
K101546 page 2/2
- 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 substantial equivalence of this device was established based on a declaration of conformity to design control requirements and on an assessment of the effects of the changes to the predicate device based on a risk assessment. As such, the Endoform™ Dermal Template (K101546) is substantially equivalent to the predicate device with respect to material composition, device characteristics and intended use.
7. PERFORMANCE TESTING
The Endoform™ Dermal Template (K092096) has been subjected to extensive non-clinical testing to assess the biocompatibility and the performance of the device. Endoform™ Dermal Template (K092096) was shown to be safe and effective as a wound care product.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 3 2010
Mesynthes % Medical Device Consultants, Inc. Ms. Mary McNamara 49 Plain Street North Attleboro, Massachusetts 02760-4153
Re: K101546 · Trade/Device Name: Endoform™ Dermal Template Product Code: KGN Dated: June 2, 2010 Received: June 3, 2010
Dear Ms. McNamara:
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
{3}------------------------------------------------
Page 2 - Ms. Mary McNamara
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
incerely yours,
Mark N. Melkerson
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K101546 510(k) Number:
Endoform™ Dermal Template Device Name:
Indications for Use:
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)
Daniel Keene for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101546
N/A