(49 days)
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
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.
The provided document, K973283, is a 510(k) premarket notification for a medical device (Innovative Technologies' Alginate / Zinc Wound Dressing). This type of submission focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting a full clinical study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance in the way you've outlined (including a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.
The document primarily details:
- Device Description: Innovative Technologies' Alginate / Zinc Wound Dressing is a combination of two existing 510(k) products. It's a sterile, primary wound dressing for moderate to heavily exuding partial to full thickness wounds, forming a gel with wound exudate.
- Predicate Devices: Dermagran™ Zinc-Saline Wet Dressing (K913344) and Innovative Technologies' Al-Gen™ Calcium Alginate Wound Dressing (K953781).
- Comparative Features Table: This table compares the new device with the predicate devices across characteristics like material, non-therapeutic additives, surface, integrity, indications, packaging, and sterilization method. This comparison is the core of demonstrating substantial equivalence, showing that the new device is "similar in design, composition and function" to the predicates.
- Safety and Effectiveness: "Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products." This refers to the predicate devices, implying that the new combination product inherits this safety and effectiveness.
- FDA Determination: The FDA determined the device is substantially equivalent to pre-amendment devices and can be marketed, subject to certain labeling limitations (e.g., not for third-degree burns, no claims of accelerating healing, no long-term dressing claims, not a treatment/cure).
- Indications for Use: The FDA-cleared indications for the Alginate / Zinc Wound Dressing are for the management of moderate to heavily exuding partial to full thickness wounds such as Pressure Ulcers, Arterial Ulcers, Venous Ulcers, Diabetic Ulcers, 1st & 2nd Degree Burns, Donor Sites, Trauma Wounds, and Dermal Lesions.
In summary, this document is a 510(k) notification, which establishes substantial equivalence rather than presenting a performance study against predefined acceptance criteria.
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OCT 2 1 1997
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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
| CharacteristicsMaterial | IT Alginate/ZincCalcium Alginate / | Dermagran™Cotton Gauze / | Al-Gen™Calcium Alginate |
|---|---|---|---|
| Non-TheraputicAdditives | Zinc / B-6 | Zinc / B-6 SalineMoisturizing 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 orPoly / Poly Pouch | Foil /FoilPouch | Paper / Paper orPoly / Poly Pouch |
| Sterilisation Method | Gamma Radiation | Steam | Gamma Radiation |
Head Office
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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).
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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
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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)
§ 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.