(238 days)
Not Found
No
The device description and performance studies focus on the material properties and biological effects of Manuka honey in a wound dressing, with no mention of AI or ML technologies.
Yes
The device is described as a "sterile wound care dressing" intended for "effective wound treatment" for various types of wounds, including diabetic foot ulcers, burns, and surgical wounds, which are therapeutic applications.
No
Explanation: The device description states that Activon Tulle is a "sterile wound care dressing for use in moist wound management" and is "impregnated with 100% Manuka honey for effective wound treatment." Its intended use is for the management of various types of wounds, not for diagnosis. There is no mention of it being used to identify, detect, or characterize a disease or condition.
No
The device description clearly states it is a "sterile wound care dressing" and a "non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey," indicating it is 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 describes the device as a wound care dressing for managing various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a sterile wound care dressing impregnated with honey. This is a physical dressing applied to the body, not a device that analyzes biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Predicate Device: The predicate device is also a wound care dressing, further supporting its classification as a therapeutic device.
Therefore, Activon Tulle is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For minor wounds, ulcerations and burns, abraded skin, and 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
FRO
Device Description
Activon Tulle is a sterile wound care dressing for use in moist wound management. Activon Tulle is offered as 2x2 inch and 4x4 inch non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey for effective wound treatment.
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 Tulle 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)
Medihoney Dressings With Active Manuka Honey - K081584
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
10 11 18
510(k) Summary
1. Submitter's Name and Address
DEC. 1 5 2010
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 |
Date Prepared 26 November 2010
2. Device Name
| Trade Name: | Activon Tulle |
|---|---|
| Common: | Dressing, Wound |
| Classification Name: | Dressing, Wound |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
3. Predicate Devices
Activon Tulle is substantially equivalent to Derma Sciences Medihoney Dressings With Active Manuka Honey -K081584.
4. Device Description
Activon Tulle is a sterile wound care dressing for use in moist wound management. Activon Tulle is offered as 2x2 inch and 4x4 inch non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey for effective wound treatment.
5. Statement of Intended Use
Activon Tulle for Over-the-Counter is intended for the management of normal skin and minor wounds, ulcerations and burns, abraded skin, and irritated areas. Under the
1
supervision of a health care professional. Activon Tulle 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.
6. Technological Characteristics and Substantial Equivalence
Activon Tulle is essentially and substantially equivalent to the predicate devices in its use of Manuka Honey for moist wound management. Both Medihoney Active APIMED Primary Dressing with Active Manuka Honey and Activon Tulle are offered as tulle dressings in the same sizes; sterilized by gamma radiation; and both are offered without adhesive backing. The technological characteristics are also substantially equivalent and both are suitable for use on pressure sores, leg ulcers, superficial wounds and abrasions, 1st and 2nd degree partial thickness burns and post operative wounds. The difference between them is that Activon Tulle is 100% active Manuka honey and does not use calcium alginate that is part of the predicate device.
7. Assessment of Performance Data and Safety
Biocompatibility testing (cytotoxicity, sensitization and irritation) performed with Activon Tulle 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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, possibly representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue 10905 Nett Control Room W-O66-0609 Silver Spring, MD 20993-0002
Calidad Solutions, Inc. % LEC Associates, LLC Toni Miller, PhD 26 Chestnut Ridge Road #12 Montvale, New Jersey 07645
Re: K101118
Trade/Device Name: ActivonTulle® Regulatory Class: Unclassified Product Code: FRO Dated: November 28, 2010 Received: November 30, 2010
DEC 1 5 2010
Dear Dr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate reterenced above and have delemined the article bredicate devices marketed in interstate for use stated in the enclosure) to regally manced to of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug. commerce prior to May 28, 1970, the chacanen and of the Frovisions of the Federal Food. Drug, devices that have been reclassified in accordance who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require and a secreel controls provisions of and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the uctives, saling generals for amual registration, listing of
general controls provisions of the Act include requirements for annual misbranding general controls of the Act the Acceline, and prohibitions against mistranding and devices, good manufacturing practice, into information related to contract liability.
adulteration. Please note: CDRH does not evaluate information related to adulteration. Please note: CDNT does not overaliate in the maint be truthful and not misleading.
warranties. We remind you, however, that device labeling must be truthful
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
If your device is classified (Sec above) and vian elections affecting your device can be
may be subject to additional controls. Existen major regulations affective FDA may may be subject to additional controls. Exismig Mayor of 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, found in the Code of Federal Regulations, This 20, 11:00 Levice in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the started to see and since complies with other requiremen Please be advised that FDA s issuarite of a substitution with other requirements of the Act
that FDA has made a determination that your device with other requires. You must that FDA has made a determination und your divines on the Federal agencies. You must
or any Federal statutes and regulations administered by other Federation and listing or any Federal statutes and regulations administered by other is out of the registration and listing (21
3
Page 2 - Toni Miller, PhD
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
ed to the many of the CDD CCD CCD Collected manufacturing practice requirements as CFR Part 807); labeling (21 CFR Parl 801); pood manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requiremen device-related adverse events) (21 CFR 803), good mana 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 200); 21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please
r (1580) http://www.blogs.com/CDPH/CDPHOffices/ucm 115809 htm for If you desire specific advice for your devices of our offices/ucm ! 1589.htm for the more of Compliance. Also, please go to http://www.tda.gov/AbourLDA/Centers/Griles/Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDBH) s) Offication" (21CFR Part the Center for Devices and Radiongical ricults of any of emarket notification" (21CFR Part
note the regulation entitled, "Misbranding by reference to premarket notification" note the regulation entitled, "Misolanding by reference to premaint of the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office http://www.rad.govetrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general information. on your respected at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
(800) 036-2041 of (301) ical Devices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aling B. Rata
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K101118
Indications for Use Statement
Activon Tulle® Device Name:
Indications for use:
OTC: For minor wounds, ulcerations and burns, abraded skin, and 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) Over-The-Counter Use X ____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
DEC 1 5 2010
(PLEAS DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daind KimefollXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
(D: : S: : C:
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K101118
510(k) Number K101118