(461 days)
Not Found
No
The device description and supporting information focus solely on the properties and application of Manuka honey as a wound dressing, with no mention of AI or ML technologies.
Yes.
The device is intended for the management of various wounds, including diabetic foot ulcers, leg ulcers, pressure ulcers, burns, and surgical wounds, which are therapeutic applications.
No
The device description clearly states it is a "wound care dressing" and its intended use is for "management" of various wounds by providing a sterile honey dressing. There is no indication of it being used for diagnosis, only treatment.
No
The device description clearly states it is a "wound care dressing" and a "squeeze tube for one-time use," indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and dressing of various types of wounds and skin conditions. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a wound care dressing made of Manuka honey. This is a topical application for treatment, not a test performed on a sample from the body to diagnose a condition.
- No mention of diagnostic testing: There is no indication that this device is used to analyze samples (like blood, urine, tissue, etc.) to provide information about a patient's health status or to diagnose a disease.
- Anatomical Site: The anatomical sites listed are external wounds and skin areas, which are treated directly by the dressing. IVDs typically involve analyzing internal samples or bodily fluids.
In summary, the Activon Tube ™ Sterile 100% Manuka Honey is a wound care product intended for therapeutic use, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
OTC: For minor wounds, minor ulcerations, minor burns, minor abraded skin, and minor irritated areas.
Professional: Intended in the management of:
- 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; ●
- grafted and donor sites and traumatic and surgical wounds. ●
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Activon Tube ™ Sterile 100% Manuka Honey is a wound care dressing for use in moist wound management. The Activon Tube TM Sterile 100% Manuka Honey is offered as a 0.99 oz (2.8 g) twist off cap squeeze tube for one-time use .
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)
Biocompatibility testing (cytotoxicity, sensitization and irritation) performed with Activon Tube ™ Sterile 100% Manuka Honey demonstrates that the dressing is safe for its intended use. The performed testing was conducted according to ISO guidelines.
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.
K102478, K092689, K083334, K081584, K080315
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
K10114
Page 1 of 2
510(k) Summary
15
1. Submitter's Name and Address
JUL 2 6 2011
Advancis Medical Sidings Road, Lowmoor Industrial Estate Kirby in Ashfield Nottinghamshire. NG17 7JZ
| Contact Person: | Toni Miller PhD
LEC Associates LLC
26 Chestnut Ridge Rd #12
Montvale NJ 07645
201 615 1212
Fax: 1.201.825.0978
Email: tfmiller@lecassociates.com |
| ----------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8 November 2010 Date Prepared
2. Device Name
| Trade Name: | Activon Tube ™ Sterile 100% Manuka Honey |
|---|---|
| Common: | Dressing, Wound |
| Classification Name: | Dressing, Wound |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
3. Predicate Devices
Activon Tube ™ Sterile 100% Manuka Honey is substantially equivalent to the following Manuka Honey wound dressings:
| OTC Elasto-Gel Manuka Honey Wound Dressing | K102478 |
|---|---|
| Manukapli Wound Dressing | K092689 |
| Elasto-Gel Manuka Honey Wound Dressing | K083334 |
| Derma Sciences OTC Medihoney Dressings With | |
| Active Manuka Honey | K081584 |
| Medihoney Active Manuka ( Leptospermum ) | |
| 100% Honey dispensed from a tube | K080315 |
1
K101114
Page 2 of 2
4. Device Description
Activon Tube ™ Sterile 100% Manuka Honey is a wound care dressing for use in moist wound management. The Activon Tube TM Sterile 100% Manuka Honey is offered as a 0.99 oz (2.8 g) twist off cap squeeze tube for one-time use .
5. Statement of Intended Use
Activon Tube ™ Sterile 100% Manuka Honey for Over-the-Counter is intended for the management of normal skin and minor wounds, minor ulcerations, minor burns, minor abraded skin, and minor irritated areas. Under the supervision of a health care professional, Activon Tube TM Sterile 100% Manuka Honey may be used for the management of diabetic foot and leg 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, grafted and donor sites, and traumatic and surgical wounds.
Activon Tube ™ Sterile 100% Manuka Honey may be applied directly to the wound to fill the wound cavities or to a primary dressing.
6. Technological Characteristics and Substantial Equivalence
Activon Tube ™ Sterile 100% Manuka Honey is essentially and substantially identical to the predicate devices in their use of Manuka Honey for moist wound management. Medihoney Active Manuka (Leptospermum)100% Honey (K080315) is sterilized by gamma radiation and dispenses Manuka honey from a tube, essentially identically in technology and indications to Activon Tube ™ Sterile 100% Manuka Honev. The additional predicate devices (K102478, K092689, K083334, K081584) are substantially identical to Activon Tube ™ Sterile 100% Manuka Honey in their use of active Manuka Honey for wound management, but the honey is either presented in a hydrocolloid/gel sheet or part of an absorbent wound dressing.
7. Assessment of Performance Data and Safety
Biocompatibility testing (cytotoxicity, sensitization and irritation) performed with Activon Tube ™ Sterile 100% Manuka Honey demonstrates that the dressing is safe for its intended use. The performed testing was conducted according to ISO guidelines.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The bird is composed of three thick, curved lines that suggest movement or flight. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advancis Medical % LEC Associates, LLC Toni Miller, PhD 26 Chestnut Ridge Road, #12 Montvale, New Jersey 07645
Re: K101114
Trade/Device Name: Activon Tube® Regulatory Class: Unclassified Product Code: FRO Dated: July 11, 2011 Received: July 31, 2011
JUL 26 2011
Dear Dr. Miller:
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 - Toni Miller, PhD
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/ycm115809.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,
FOR Pete D. Rummmo
Mark N. Melkerson
mph
Director Division of Surgical, Orthoped and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K101114
Indications for Use Statement
Activon Tube® Device Name:
Indications for use:
OTC: For minor wounds, minor ulcerations, minor burns, minor abraded skin, and minor irritated areas.
Professional: Intended in the management of:
- 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; ●
- grafted and 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 801 Subpart C)
(PLEAS DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kacne for MKM
Division Sign Off
Division S Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101114
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K101114