(79 days)
Not Found
No
The document describes a wound dressing with a "gel formula" and an "intelligent film" for moisture management and barrier properties. There is no mention of AI, ML, image processing, or any data-driven algorithms. The term "intelligent" in this context refers to the material's physical properties, not computational intelligence.
No
The device is a wound dressing used for the management of various wounds, not a device that provides therapy for diseases or conditions.
No.
The device is described as a wound dressing, designed for the management and healing of wounds by absorbing exudate and providing a protective barrier. Its function is therapeutic, not diagnostic.
No
The device description clearly describes a physical wound dressing made of hydrocolloid material, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a wound dressing for managing various types of wounds. This is a topical application for wound care, not a test performed on samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The description details the physical properties and function of a wound dressing (absorbing exudate, providing a barrier). This aligns with a medical device for wound management, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a medical device for wound care, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
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
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): 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.
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
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, Limited
Road Three, Winsford Industrial Estate
Cheshire 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 Wound
Dressing. |
| Common or Usual Name: | I lydrocollold Wound Dressings |
| Classification: | Wound Dressings, currently unclassified by FDA. |
| Description: | 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 |
| Intended Use: | 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 |
| Substantial Equivalence: | Substantial equivalence was provided in 510(k)
K971126. |
| Testing Summary: | 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. |
1
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:
-
- 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. 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
2
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
3
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