(79 days)
Innovative Technologies Hydrucolloids & Intelligent Hydrocolloids can be used for the management of wounds including, minor scalds and burns, superficial wounds such as abrasions, lacerations and minor cuts and as a protective dressing for such uses as minor blisters. This wound dressing may also bo used under the care of a health care professional for such wounds as, partial - full thickness wounds i. o. artorial ulcers, venous ulcers and diabetic ulcers, post operative surgical wounds. donor sites. If at any time you are unsure of the above conditions or the type of wound consult a health care professional. Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional
Highly floxible and conformable gol formula dressings, which absorb wound exudate producing a soft, gel mass which allows pasy removal of the dressing roducing the potential for delicate peri- wound tissue damage during dressing changes. Innovative Technologies Intelligent wound dressings utilize an intelligent film which allows moisture to transpire the hydrocolloid whilst providing a barrier to water and bacteria
The provided document is a 510(k) premarket notification for Hydrocolloid and Intelligent Hydrocolloid Wound Dressings. It outlines the device's description, intended use, and indicates substantial equivalence to a previously cleared device. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in a study to prove the device meets acceptance criteria.
The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence. It confirms that "Biocompatability results presented in 510(k) K971126 remain current, no changes to raw materials or components which would require the submission of new toxicity data." This suggests that previous testing for the predicate device K971126 is being leveraged, but the specifics of that testing are not detailed here.
Therefore, I cannot provide the requested information from the given text.
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K 9 8 3303
DEC 9 1998
Attachment 2
Summary of Safety and Efficacy Summary of Innovative Technologies Hydrocolloid and Intelligent Hydrocollold Wound Dressings
| Manufacturer: | Innovativo Technologies, LimitedRoad Three, Winsford Industrial EstateCheshire CW7 3PD, United Kingdom |
|---|---|
| Regulatory Affairs Contact: | Christopher Oakes, Manager |
| Telephone: | 44 1606 863 500 |
| Date Summary Prepared: | December 1st, 1998 |
| Device Trade Name: | Hydrocolloid & Intelligent Hydrocolloid WoundDressing. |
| Common or Usual Name: | I lydrocollold Wound Dressings |
| Classification: | Wound Dressings, currently unclassified by FDA. |
| Description: | Highly floxible and conformable gol formuladressings, which absorb wound exudate producinga soft, gel mass which allows pasy removal of thedressing roducing the potential for delicate peri- wound tissue damage during dressing changes.Innovative Technologies Intelligent wound dressingsutilize an intelligent film which allows moisture totranspire the hydrocolloid whilst providing a barrierto water and bacteria |
| Intended Use: | Innovative Technologies Hydrucolloids & IntelligentHydrocolloids can be used for the management ofwounds including, minor scalds and burns,superficial wounds such as abrasions, lacerationsand minor cuts and as a protective dressing for suchuses as minor blisters. This wound dressing mayalso bo used under the care of a health careprofessional for such wounds as, partial - fullthickness wounds i. o. artorial ulcers, venous ulcersand diabetic ulcers, post operative surgical wounds.donor sites.If at any time you are unsure of the aboveconditions or the type of wound consult a healthcare professional.Discontinue use if any infection of the wound issuspected and seek guidance from a health careprofessional |
| Substantial Equivalence: | Substantial equivalence was provided in 510(k)K971126. |
| Testing Summary: | Biocompatability results presented in 510(k)K971126 remain current, no changes to rawmaterials or components which would require thesubmission of new toxicity data. |
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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.
9 1998 DEC
Christopher Oakes Innovative Technologies Ltd. Road Three Winsford Industrial Estate Winsford, Cheshire CW7 3PD United Kingdom
Re: K983303 Trade Name: Hydrocolloid and Intelligent Hydrocolloid wound dressings Regulatory Class: Unclassified Product Code: MGP Dated: September 17. 1998 Received: September 21, 1998
Dear Mr. Oakes:
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:
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- This device may not be labeled for use on third degree burns.
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- 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. 3. or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
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).
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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Page 2 - Mr. Christopher Oakes
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/3/Picture/2 description: The image contains a sequence of digits and a letter, specifically 'K983303'. The characters are handwritten and have a slightly irregular appearance. The numbers are all single digits, and the letter 'K' is at the beginning of the sequence.
Page 1 of 1
11983303 510(k) Number (if known):
Device name: Innovative Technologies Hydrocolloid & Intelligent Hydrocolloid Wound Dressings
Indications For Use:
Innovative Tcchnologies Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may he used for the management of wounds including:
Minor Scalds and Minor Burns Superticial Wounds such as abrasions, lacerations and minor cuts Protective dressing for uses such as minor blisters
This wound dressing may also be used under the care of a health care professional for such wounds as Partial - full thickness wounds i.e. Atterial Ulcers, Venous ulvers, and diabetic ulcers, post operative surgical wounds and donor sites.
(CLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF:)
I'rescription Use (Per 21 CFR 801.109) OR Over The Counter Use
(Optional Formal 1-2-96)
picolee
(Division Sign-Off) Division of General Restorative 510(k) Number
N/A