(14 days)
No
The document describes wound dressings and their intended use, device description, and performance studies. There is no mention of AI or ML technology in the text.
Yes
The device is described as a wound dressing for various types of wounds, including minor abrasions, lacerations, cuts, burns, diabetic foot ulcers, and pressure ulcers, which indicates its use in the treatment or prevention of disease.
No
Explanation: The device is a wound care dressing used for treatment and management of wounds, not for diagnosing conditions.
No
The device description clearly states it is a sterile, single-use wound care dressing, which is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for managing wounds (abrasions, cuts, burns, ulcers, etc.). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound care dressing designed to provide a moist environment for healing. This aligns with a therapeutic device, not a diagnostic one used to examine specimens from the body.
- No mention of diagnostic procedures: The text does not mention any procedures involving the examination of samples (blood, tissue, etc.) to diagnose a condition.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly interact with a wound to promote healing.
N/A
Intended Use / Indications for Use
For over the counter use, MEDIHONEY™ APIMED, PRIMARY and 100% HONEY Dressings with Active Manuka Honey may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns
Under the supervision of a healthcare professional, The Derma Sciences Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney 100% Honey Dressings are indicated for nonexuding to moderately exuding wounds. All of the Medihoney Wound Dressings are intended for the management of the following:
- 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
FRO
Device Description
The Derma Sciences OTC Medihoney Dressings (APIMED, Medihoney Primary and Medihoney 100% Gel) with Active Manuka Honey are designed to provide a moist environment conducive to wound healing and are indicated abrasions, minor burns, minor cuts and minor lacerations.
The Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences OTC Medihoney APIMED Primary Dressings with Active Manuka Honey are offered in several sizes including the following: 2x2, 4x4, % x 12, The OTC Medihoney Primary Dressings with Active Manuka Honey are offered in 1.5" x 2", 2" x 2", 4" x 5", and 2"x3" sizes and are offered both with and without an adhesive backing. The OTC Medihoney 100% Honey Gel Dressings are offered in .5, 1, and 1.5 oz. sizes.
The proposed OTC Medihoney Dressings with Active Manuka Honey are identical in fundamental technology and very similar in indications to the parent API-MED Active Manuka Honey Dressings described in K053095, the Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) and the Medihoney Active Manuka (Leptospermum) 100% Honey The dispensed from a tube pending 510(k) premarket notification (K080315). modifications made to the API-MED, Medihoney Primary and Medihoney 100% Gel Active Manuka Honey Dressings to produce the Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are limited to a slight change in indications and over the counter use. The formulation and function are identical to that described in the original 510(k)'s.
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
Over-the-Counter Use and Prescription Use (under the supervision of a healthcare professional)
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)
Biocompatibility testing performed to support the dressings demonstrates that the Medihoney Primary Dressings with Active Manuka Honey are safe for their intended use. Cytotoxicity, sensitization, irritation and implantation testing was performed successfully using the Derma Sciences Wound Dressings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K053095, K072956, K080315, K991608, K053538, K080010
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K081584
page 1 of 3
510(k) Summary
JUN 1 9 2008
for
Derma Sciences OTC APIMED, Medihoney Primary and Medihoney 100% Honey Dressings with Active Manuka Honey
-
- SPONSOR
Derma Sciences 214 Carnegie Center Suite 100 Princeton, NJ 08540
- SPONSOR
Barry Wolfenson Contact Person: Derma Sciences 214 Carnegie Center, Suite 100 Princeton, NJ 08540 Telephone: 609.514.4744 x1103
June 9, 2008 Date Prepared:
2. DEVICE NAME
Proprietary Name:
Common/Usual Name: Classification Name:
OTC Derma Sciences APIMED, Medihoney Primary, and Medihoney 100% Honey Dressings with Active Manuka Honey Wound Dressing Dressing
3. PREDICATE DEVICES
- API-MED Active Manuka Honey Wound Dressing that was cleared for marketing ♥ in the U.S. (K053095). (now called Medihoney)
- Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a . hydrocolloid sheet (K072956)
- Medihoney Active Manuka (Leptospermum) 100% Honey dispensed from a tube . 510(k) premarket notification (K080315)
- OTC Dermaphylyx Calcium Alginate Wound Dressings (K991608) .
- OTC CuraPharm Phytacare Sodium Alginate Wound Dressing (K053538) .
- OTC NOCC Wound Gel Dressing cleared under K080010 .
1
OTC and Rx Aquacel Ag Wound dressing cleared under K013814. ●
4. DEVICE DESCRIPTION
The Derma Sciences OTC Medihoney Dressings (APIMED, Medihoney Primary and Medihoney 100% Gel) with Active Manuka Honey are designed to provide a moist environment conducive to wound healing and are indicated abrasions, minor burns, minor cuts and minor lacerations.
The Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences OTC Medihoney APIMED Primary Dressings with Active Manuka Honey are offered in several sizes including the following: 2x2, 4x4, % x 12, The OTC Medihoney Primary Dressings with Active Manuka Honey are offered in 1.5" x 2", 2" x 2", 4" x 5", and 2"x3" sizes and are offered both with and without an adhesive backing. The OTC Medihoney 100% Honey Gel Dressings are offered in .5, 1, and 1.5 oz. sizes.
The proposed OTC Medihoney Dressings with Active Manuka Honey are identical in fundamental technology and very similar in indications to the parent API-MED Active Manuka Honey Dressings described in K053095, the Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) and the Medihoney Active Manuka (Leptospermum) 100% Honey The dispensed from a tube pending 510(k) premarket notification (K080315). modifications made to the API-MED, Medihoney Primary and Medihoney 100% Gel Active Manuka Honey Dressings to produce the Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are limited to a slight change in indications and over the counter use. The formulation and function are identical to that described in the original 510(k)'s.
5. INTENDED USE
For over the counter use, MEDIHONEY™ APIMED, PRIMARY and 100% HONEY Dressings with Active Manuka Honey may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns -
Under the supervision of a healthcare professional, The Derma Sciences Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary Wound Dressings are indicated for lightly to moderately
2
Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The top line reads "K 081584", with the characters appearing to be written in a slightly messy, cursive style. The second line reads "page 3 of 3", indicating that this is the third page of a three-page document.
exuding wounds. The Medihoney 100% Honey Dressings are indicated for nonexuding to moderately exuding wounds. All of the Medihoney Wound Dressings are intended for the management of the following:
- 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. ●
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The technological characteristics of the proposed Derma Sciences OTC Medihoney Dressings with Active Manuka Honey and the parent API-MED, Medihoney Primary and Medihoney 100% Active Manuka Honey Wound Dressings are substantially equivalent in that they are the same dressings with the identical technology and formulation. No changes have been made to the physical device or specifications for the proposed OTC Medihoney Wound Dressings.
The modifications made to the API-MED, Medihoney Primary and Medihoney !00% Active Manuka Honey Dressings to produce the Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are limited to a slight change in indications and over the counter use. The proposed OTC Medihoney Wound Dresings are formulated from the exact same composition as the predicate devices described in the predicate API-MED Active Manuka Honey Wound Dressing. (K053095) (now called Medihoney), the Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) and the Medihoney Active Manuka (Leptospermum) 100% Honey Dressing.
7. PERFORMANCE TESTING
Biocompatibility testing performed to support the dressings demonstrates that the Medihoney Primary Dressings with Active Manuka Honey are safe for their intended Cytotoxicity, sensitization, irritation and implantation testing was performed use. successfully using the Derma Sciences Wound Dressings.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 stripes extending from its back, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
Derma Sciences, Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane 49 Plain Street North Attleboro, Massachusetts 02760
Re: K081584
Trade Name: Derma Sciences OTC Medihoney Dressings with Active Manuka Honey Regulatory Class: Unclassified Product Code: FRO Dated: June 5, 2008 Received: June 6, 2008
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 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.
4
Page 2 – Ms. Mary McNamara-Cullinanc
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Milliman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Derma Sciences OTC Medihoney Dressings with Active Device Name: Manuka Honev
Indications for Use:
For over the counter use, MEDIHONEY™ APIMED, PRIMARY and 100% HONEY Dressings with Active Manuka Honey may be used for:
- minor abrasions "
- lacerations ・
- = minor cuts
- minor scalds and burns *
Under the supervision of a healthcare professional, The Derma Sciences Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney 100% Honey Dressings are indicated for nonexuding to moderately exuding wounds. All of the Medihoney Wound Dressings are intended for the management of the following:
- 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 | X |
|---|---|
| (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)
Neil RP. Ogl for mrm
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K091584
Derma Sciences 510(k) June 4, 2008 OTC Medihoney Dressings with Active Manuka Honey