(89 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the material properties of the dressing.
Yes
The device is a wound dressing used for the management and healing of various types of wounds, which is a therapeutic function.
No.
Explanation: The device is described as a "wound dressing" intended for the "management of wounds," which involves providing an environment for healing, not diagnosing a medical condition.
No
The device description explicitly states it is a "Hydrocolloid Wound Dressing," which is a physical, sterile dressing and not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that this device is a wound dressing applied to the wound itself, not used to analyze a sample taken from the body.
- The intended use is for wound management. This involves treating the wound directly, not diagnosing a condition based on a sample.
- The device description focuses on the physical properties and function of the dressing. It describes how it interacts with wound exudate and provides a moist healing environment, which are characteristics of a topical wound treatment, not an in vitro diagnostic test.
Therefore, the information provided indicates that this is a medical device used for wound care, not an IVD.
N/A
Intended Use / Indications for Use
Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings, are highly conformable, sterile, primary wound dressings-intended to provide an environment ideally suited for chronic wound management. The dressings are soft conformable hydrocolloid preparations for heavy to light exuding partial-full thickness wounds.
Indications For Use:
Innovalive Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including.
- Partial full thickness wounds, ie artenal, venous, diabetic ulocrs .
- Post-operative surgical wounds
- Donor Eiles
- Trauma Wounds
- Dermal Lesions
- Profective dressing
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
Innovative Technologies' Hydrocolloid Wound Dressings, are highly conformable, sterile, primary wound dressings-intended to provide an environment ideally suited for chronic wound management. The dressings are soft conformable hydrocolloid preparations for heavy to light exuding partial-full thickness wounds.
The hydrocolloid preparations react with wound exudate to form an gelatinous mass providing for a moist healing environment. The dressing may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes.
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°.
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.
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
JUN 2 4 1997
Image /page/0/Picture/1 description: The image contains two symbols. The first symbol is a capital letter 'T' with a horizontal line above it. The second symbol is a cross inside of a circle that is divided into two halves. The bottom half of the circle is filled with a textured pattern.
Innovative Technologies Ltd
Safety & Effectiveness Summary: Classification Name: Common / Usual Name: Contact: Prepared:
Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings KMF Liquid Bandage / 79 MGP Wound & Burn, Occlusive Hydrocolloid Wound Dressing Priscilla Whitehead, Director of QA/RA March 25, 1997 Innovative Technologies' Hydrocolloid Wound Dressings, are highly conformable, sterile, primary wound dressings-intended to provide an environment ideally suited for chronic wound
management. The dressings are soft conformable hydrocolloid preparations for heavy to light exuding partial-full thickness wounds.
The hydrocolloid preparations react with wound exudate to form an gelatinous mass providing for a moist healing environment. The dressing may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes.
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°.
Biocompatibility testing including cytotoxicity, acute systemic toxicity, skin irritation and sensitisation has been successfully completed per ISO/Tripartite guidelines.
The Innovative Technologies' Hydrocolloid and Intelligent Hydrocolloid Wound Dressings are similar in design, composition and function to Duoderm CGF / Extra Thin Hydrocolloid Dressings manufactured by Convatec.
| Characteristics | Innovative Technologies | Convatec |
|---|---|---|
| Composition | Hydrocolloid & polyurethane film / | |
| Hydrocolloid, polyurethane foam & | ||
| polyurethane film | Hydrocolloid & polyurethane film / | |
| Hydrocolloid, polyurethane foam & | ||
| polyurethane film | ||
| Surface | Extruded and laminated | Extruded and laminated |
| Indications For Use | Dermal ulcers, superficial wounds. | |
| burns (1st & 2nd degree), donor | ||
| sites, post operative wounds, | ||
| protective dressings | Dermal ulcers, superficial wounds, | |
| burns (1st & 2nd degree), donor | ||
| sites, post operative wounds, | ||
| protective dressings | ||
| Transparent | Yes | Yes |
| Self adhesive | Yes | Yes |
| Packaging | Blister Pack | Pouch |
| Sterilisation Method | Gamma Irradiation | Gamma Irradiation |
COMPARATIVE FEATURES
Priscilla Whitehead, Director OA/DA
Priscilla Whitehead, Director QA/RA
1
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 stylized eagle with three lines forming its body and head. The words "SERVICES • USA" are arranged in a semi-circle above the eagle. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a semi-circle below the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997
Ms. Priscilla Whitehead Director, Quality Assurance/Regulatory Affairs Innovative Technologies, Ltd. ........................................................................................................... Road Three. Winsford Industrial Estate Winsford. Cheshire CW7 3PD United Kingdom
Re: K971126
Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings Regulatory Class: Unclassified Product Code: MGP Dated: March 25, 1997 Received: March 27, 1997
Dear Ms. Whitehead:
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. 1.
-
- 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 ે.
જોડાય તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આં dressing, or as an artificial (synthetic) skin. - This device may not be labeled as a treatment or a cure for any type of 4. 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
Page 2 - Ms. Priscilla Whitehead
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 vour 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
15:56
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IT
Innovative Technologics I.td
Page I of I
sinck) Number (if known) KQ71] 26
Device Nume: Innovative Technologies Hydrocolloid & Intelligent Hydrocolloid Wound Dicssings
Indications For Use:
Innovalive Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including.
- Partial full thickness wounds, ie artenal, venous, diabetic ulocrs .
- Post-operative surgical wounds
- Donor Eiles
- Trauma Wounds
- Dermal Lesions
- Profective dressing
Ulen W/B
(Division Sian-Off) Division of General Restorative 510(k) Number
(PLEASE DO NOT WRITE BEI.OW THIS LINE. CONTINUE ON ANOTHER PACE IF NEEDED)
( vocurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR Over The Ciminter Use
(Optional Pormal 1-2-96)
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