(43 days)
Not Found
Not Found
No
The summary describes a wound dressing and its properties, with no mention of AI or ML technologies. The term "Intelligent Film" appears to refer to the material properties of the film itself, not a computational intelligence.
Yes
The device is a wound dressing indicated for use on various types of wounds to promote healing, which is a therapeutic purpose.
No
This device is described as a wound dressing intended for wound management, creating a moist environment for healing and acting as a barrier. It does not mention any diagnostic capabilities.
No
The device description clearly indicates it is a physical wound dressing made of film, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the dressings are for application to wounds on the body (minor scalds, burns, abrasions, cuts, pressure sores, surgical wounds, etc.). This is a topical application for wound management.
- Device Description: The description focuses on the physical properties of the dressings (conformable, sterile, semi-occlusive barrier, permeability to moisture vapor and oxygen) and how they create a moist environment for wound healing.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of bodily specimens outside the body.
The text describes a wound dressing, which is a medical device used for the direct treatment and management of wounds on the body.
N/A
Intended Use / Indications for Use
Innovative Technologies Transparent Films & Intelligent Films can be used for partial thickness wounds. They can be used for pressure sores. superficial wounds such as minor cuts. Iacerations and abrasions, minor scalds and burns (18 & 2" degree), donor sites, dermal lesions, trauma wounds and post operative surgical wounds.
Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional.
Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on wounds including:
- . Minor scalds and burns
- Superficial Wounds such as Abrasions, Laccrations, and cuts t
This wound dressing may be also used under the care of a health care professional for such wound as, Pressure sores, post operative surgical wounds, donor sites, trauma wounds and dermal Icsions. And for such uses as a IV site and us a secondary fixation device for other wound care products such as alginates, gels and foams used for diabctic ulccrs.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Innovative Technologies Transparent & Intelligent Film Wound Dressings, are conformable, sterile wound dressings intended to provide a moist environment ideally suited for wound management. In particular for partial thickness wounds.
Innovative Technologies Transparent Film dressings act as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.
The Innovative Technologies Intelligent wound dressings utilize an intelligent film to enhance product performance. The semi occlusive dressing acts as a barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
Attachment 2
JUN 3 0 1998
Summary of Safety and Efficacy Summary of Innovative Technologies Transparent and Intelligent Film Wound Dressings
Manufacturer:
Regulatory Affairs Contact:
Telephone:
Date Summary Prepared:
Device Trade Name:
Common or Usual Name:
Classification:
Description:G
Intended Use:
Innovative Technologies, Limited Road Three, Winsford Industrial Estate Cheshire CW7 3PD, United Kingdom
Christopher Oakes, Manager
44 1606 863 500
May 13, 1998
Transparent Film & Intelligent Film Wound Dressing.
Film Wound Dressings
Wound Dressings, currently unclassified by FDA.
Innovative Technologies Transparent & Intelligent Film Wound Dressings, are conformable, sterile wound dressings intended to provide a moist environment ideally suited for wound management. In particular for partial thickness wounds.
Innovative Technologies Transparent Film dressings act as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.
The Innovative Technologies Intelligent wound dressings utilize an intelligent film to enhance product performance. The semi occlusive dressing acts as a barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.
Innovative Technologies Transparent Films & Intelligent Films can be used for partial thickness wounds. They can be used for pressure sores. superficial wounds such as minor cuts. Iacerations and abrasions, minor scalds and burns (18 & 2" degree), donor sites, dermal lesions, trauma wounds and post operative surgical wounds.
Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, graphic style, with bold lines and a sense of movement. The text is in a sans-serif font and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 1998
Mr. Christopher Oakes Innovative Technologies, Limited Road Three Winsford Industrial Estate Winsford, Cheshire United Kingdom CW7 3PD
Re: K981753 Trade Name: Innovative Technologies' Transparent and Intelligent Film Wound Dressing Regulatory Class: Unclassified Dated: May 13, 1998 Received: May 18, 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, 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). 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.
2
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,
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
Enclosure
3
Page lof I
K981753. 510(k) Number (if known): _
Device name: Innovative Technologies: Transparent Film & Intelligent Film Dressings
Indications For Use:
Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on wounds including:
- . Minor scalds and burns
- Superficial Wounds such as Abrasions, Laccrations, and cuts t
This wound dressing may be also used under the care of a health care professional for such wound as, Pressure sores, post operative surgical wounds, donor sites, trauma wounds and dermal Icsions. And for such uses as a IV site and us a secondary fixation device for other wound care products such as alginates, gels and foams used for diabctic ulccrs.
(PLUASE DO NOT WRITE RELOW THIS LINE. CONTINUE ON ANDTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
| OR Over The Counter Use ✓ | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981753 |
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