(49 days)
Not Found
No
The document describes a wound dressing and does not mention any AI or ML capabilities.
Yes
The device is a wound dressing indicated for various types of wounds, aiming to provide a moist healing environment, which is a therapeutic function.
No
The device description clearly states its purpose as "conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds." Its indications for use are therapeutic (healing wounds, fixation), not for diagnosing medical conditions.
No
The device description clearly states it is a "Transparent Film & Intelligent Film Dressings," which are physical wound dressings, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a wound dressing intended for direct application to the skin and wounds. It is used to provide a moist healing environment and for fixation. It does not involve testing samples taken from the body.
The device is a wound care product, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on partial thickness wounds including:
- Pressure sores
- . Superficial burns
- Abrasions
- . Lacerations
- . Post-operative surgical wounds
- . Donor Sites
- . Trauma Wounds
- Dermal Lesions
- IV Sites .
- Fixation device
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
Innovative Technologies' Transparent Film & Intelligent Film Dressings are conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds, eg. pressure sores, abrasions, lacerations, donor sites and superficial burns. The dressings may also be used for IV sites or as secondary fixation devices for products such as alginates, gels and foams used for venous stasis and diabetic ulcers.
Dressings are supplied sterile in single use blister packs. Product is gamma irradiated in accordance with the Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition (ANSI/AAMI/ISO11137-1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification of Method 1 for dosimetric release with a sterility assurance level of 10-6.
Biocompatibility testing including cytotoxicity, acute systemic toxicity, skin irritation and sensitisation has been successfully completed per ISO/Tripartite guidelines.
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
Image /page/0/Picture/1 description: The image contains the letters "IT" on the left side of the image. To the right of the letters is a symbol that looks like a cross with a curved line above it. The cross has a horizontal line at the top, a vertical line in the middle, and a horizontal line at the bottom. The curved line above the cross is dotted.
Innovative Technologies Ltd
| Safety & Effectiveness | Innovative Technologies' Transparent Film and Intelligent Film
Dressings | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------|
| Classification Name: | 79 FRO, Dressing | OCT 22 1997 |
| Common / Usual Name: | Film Wound Dressing | |
| Contact: | Priscilla Whitehead Cox, Director of QA/RA | |
| Prepared: | Monday, September 1, 1997 | |
| Innovative Technologies' Transparent Film & Intelligent Film
Dressings are conformable, sterile wound dressings intended to
provide a moist healing environment for partial thickness wounds,
eg. pressure sores, abrasions, lacerations, donor sites and
superficial burns. The dressings may also be used for IV sites or as
secondary fixation devices for products such as alginates, gels and
foams used for venous stasis and diabetic ulcers. | | |
| Dressings are supplied sterile in single use blister packs. Product is
gamma irradiated in accordance with the Sterilisation Of
Health Care Products - Requirements For Validation and Routine
Control - Radiation Sterilisation, 3rd Edition (ANSI/AAMI/
ISO11137-1995) and Microbiological Methods for Gamma
Sterilisation (AAMI TIR8-1991) for qualification of Method 1 for
dosimetric release with a sterility assurance level of 10-6. | | |
| Biocompatibility testing including cytotoxicity, acute systemic
toxicity, skin irritation and sensitisation has been successfully
completed per ISO/Tripartite guidelines. | | |
| The Innovative Technologies' Film & Intelligent Film Dressings are
similar in design, composition and function to Hydroderm Breathable | | |
Simmar in actigh, Complex #K935796. A table of comparative features may be found below.
| Characteristics | IT Transparent Film | IT Intelligent Film | Hydroderm™ |
|---|---|---|---|
| Composition | Polyurethane film and | ||
| pressure sensitive | |||
| acrylic adhesive | Polyurethane film and | ||
| pressure sensitive acrylic | |||
| adhesive | Polyurethane film and | ||
| pressure sensitive | |||
| acrylic adhesive | |||
| Adhesive Coverage | 100% | Pattern coated 50 + 30% | Pattern Coated 40% |
| MVTR g/m²/24hrs | Trade Name: Innovative Technologies Transparent Film & Intelligent Film Dressings Regulatory Class: Unclassified Product Code: MGP Dated: September 1, 1997 Received: September 3, 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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
2
Page 2 - Ms. Priscilla Whitehead Cox
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.
Aadeep
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
510(k) Number (if known): K973312
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 partial thickness wounds including:
- Pressure sores
- . Superficial burns ~===========================================================================================================================================================
- Abrasions
- . Lacerations
- . Post-operative surgical wounds
- . Donor Sites
- . Trauma Wounds
- Dermal Lesions
- IV Sites .
- Fixation device ●
biotela
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use - 2
OR over the Counter Use -