(616 days)
Not Found
Not Found
No
The document describes a wound dressing and does not mention any AI or ML components.
No
The device is a dressing that provides a moist environment for wound healing, it does not directly treat or cure the underlying condition.
No
Explanation: The device is described as an absorbent dressing that provides a moist environment for wound healing. Its intended use is for treating various types of wounds, not for diagnosing medical conditions.
No
The device description clearly identifies it as a "Dressing," which is a physical, hardware-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dressing applied to wounds to promote healing. This is a therapeutic device, not a diagnostic one.
- Device Description: The description identifies it as an "Absorbent Dressing," which is consistent with a wound care product.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, API-MED™ ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily exuding wounds such as:
- diabetic foot ulcers .
- leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
- pressure ulcers / sores (partial and full thickness) .
- 1st and 2nd degree partial thickness burns .
- donor sites, and traumatic and surgical wounds. .
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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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.
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three horizontal lines that curve and converge, resembling a stylized human form or a symbol representing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Derma Sciences Canada, Inc. % Sharmini Atheray, M.Sc. Corporate Director QA/RA 104 Shorting Road Toronto, Ontario MIS 3S4 Canada
JUL 1 2 2007
Re: K053095
Trade/Device Name: Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 29, 2007 Received: March 30, 2007
Dear Ms. Atheray:
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. 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
1
Page 2 - Sharmini Atheray, M.Sc.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K053095
Derma Sciences API-MEDTM Active Manuka Honey Absorbent Device Name: Dressing
Indications for Use:
Under the supervision of a healthcare professional, API-MED™ ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily exuding wounds such as:
- diabetic foot ulcers .
- leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
- pressure ulcers / sores (partial and full thickness) .
- 1st and 2nd degree partial thickness burns .
- donor sites, and traumatic and surgical 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 1053090 |
|---|---|
| --------------- | --------- |