(49 days)
No
The device description and intended use focus on the material properties and physical interaction of the wound dressing with exudate, with no mention of AI or ML. The device is a combination of two existing, non-AI/ML wound dressings.
Yes
The device is a wound dressing used for the management of various types of wounds, which is a therapeutic purpose aimed at facilitating healing.
No
The device is a wound dressing intended for the management of wounds, not for diagnosing medical conditions.
No
The device description clearly describes a physical wound dressing made of alginate and zinc fibers, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing that interacts with wound exudate to create a moist healing environment. This is a physical interaction with the wound itself, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as:
- Pressure Ulcers .
- Arterial Ulcers .. ●
- . Venous Ulcers
- . Diabetic Ulcers
- . l st & 2nd Degree Burns
- Donor Sites .
- . Trauma Wounds
- Dermal Lesions
Product codes
KMF
Device Description
Innovative Technologies' Alginate / Zinc Wound Dressings is a combination of two products with existing 510(k)s: DermagranTM Zinc-Saline Wet Dressing manufactured by Derma Sciences, 510(k) #K913344 and Innovative Technologies' Al-GenTM Calcium Alginate Wound Dressing, 510(k) #K953781. Innovative Technologies' Alginate / Zinc Wound Dressings is a highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The non-woven Alginate / Zinc fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an dispersable, gelatinous, mass providing for a moist healing environment. The gel may easily be rinsed away from the wound, reducing the potential for delicate peri-wound fissue damage during dressing changes.
Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with ANSI/AAMI/ISO11137-1994 Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10-6
Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products.
The Innovative Technologies' Alginate / Zinc Wound Dressings are similar in design, composition and function to Dermagran TM Zinc-Saline Wet Dressing manufactured by Derma Sciences, . . and Innovative Technologies' Al-GenTM Calcium Alginate Wound Dressing, 510(k) #K953781.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
OCT 2 1 1997
Image /page/0/Picture/2 description: The image shows the letter 'T' next to a circular symbol. The symbol contains a cross-like figure inside of it. The bottom half of the circle is shaded with a rough texture, while the top half is mostly white with a curved line separating it from the shaded area.
Innovative Technologies Ltd
Innovative Technologies' Alginate / Zinc Wound Dressing
Safety & Effectiveness Summary: Classification Name: Common / Usual Name: Contact: Prepared:
KMF Liquid Bandage Alginate Wound Dressing Priscilla Whitehead Cox, Director of QA/RA Friday, August 29, 1997 Innovative Technologies' Alginate / Zinc Wound Dressings is a combination of two products with existing 510(k)s: Dermagran™ Zinc-Saline Wet Dressing manufactured by Derma Sciences, 510(k) #K913344 and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing, 510(k) #K953781. Innovative Technologies' Alginate / Zinc Wound Dressings is a highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The non-woven Alginate / Zinc fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an dispersable, gelatinous, mass providing for a moist healing environment. The gel may easily be rinsed away from the wound, reducing the potential for delicate peri-wound fissue damage during dressing changes.
Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with ANSI/AAMI/ISO11137-1994 Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10-6
Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products.
The Innovative Technologies' Alginate / Zinc Wound Dressings are similar in design, composition and function to Dermagran ™ Zinc-Saline Wet Dressing manufactured by Derma Sciences, . . and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing, 510(k) #K953781.
COMPARATIVE FEATURES
| Characteristics
Material | IT Alginate/Zinc
Calcium Alginate / | Dermagran™
Cotton Gauze / | Al-Gen™
Calcium Alginate |
|-----------------------------|----------------------------------------|--------------------------------------------|---------------------------------------|
| Non-Theraputic
Additives | Zinc / B-6 | Zinc / B-6 Saline
Moisturizing Solution | N / A |
| Surface | Needled / nip rolled | Woven / Wet | Needled / nip rolled |
| Integrity | Dispersable | Integral | Dispersable |
| Indications | Moderate to severe | Management of | Moderate to severe |
| | exuding wounds, eg. | venous stasis ulcers, | exuding wounds, eg. |
| | pressure, venous | surgical incisions, | pressure ulcers |
| | diabetic and arterial | pressure sores, | wounds, leg ulcers, |
| | ulcers, donor sites, | minor thermal burns, | abrasions, donor |
| | trauma wounds, | superficial lacerations, | sites, lacerations |
| | dermal lesions and | cuts and abrasions, | incisions, 1st and |
| | incisions, 1st & 2nd | other superficial | 2nd degree burns, |
| | degree burns | injuries | trauma wounds |
| Packaging | Paper / Paper or
Poly / Poly Pouch | Foil /Foil
Pouch | Paper / Paper or
Poly / Poly Pouch |
| Sterilisation Method | Gamma Radiation | Steam | Gamma Radiation |
Head Office
an .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Image /page/1/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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Priscilla Whitehead Cox Director, Quality Assurance/Regulatory Affairs Innovative Technologies, Ltd Road Three, Winsford Industrial Estate Winsford, Cheshire CW7 3PD England
OCT 21 1997
Re: K973283
Innovative Technologies Alginate/Zinc Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: August 29, 1997 Received: September 2, 1997
Dear Ms. Cox:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
2
Page 2 - Ms. Priscilla Whitehead Cox
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
to see fo
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page lof 1
510(k) Number (if known): K973283
Device name: Innovative Technologies' Alginate / Zinc Wound Dressing
Indications For Use:
Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as:
- Pressure Ulcers .
- Arterial Ulcers .. ●
- . Venous Ulcers
- . Diabetic Ulcers
- . l st & 2nd Degree Burns
- Donor Sites .
- . Trauma Wounds
- Dermal Lesions
(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 Devices | |
| 510(k) Number | K973283 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| OR Over The Counter Use |
(Optional Format 1-2-96)