(89 days)
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
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.
The provided text is related to a 510(k) submission for "Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings." This document is a regulatory submission for medical devices, specifically seeking clearance to market a device based on its substantial equivalence to a legally marketed predicate device.
Key Observation:
The document does not describe a study that proves the device meets specific acceptance criteria. Instead, it outlines the regulatory review process for a 510(k) submission. In a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as the predicate. This is typically achieved by comparing the new device's technological characteristics, indications for use, and performance data (if available and relevant for equivalence) to the predicate device. It does not generally involve a new clinical study with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) submission would for novel devices.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on:
- Device Description: Hydrocolloid and Intelligent Hydrocolloid Wound Dressings.
- Intended Use: Management of various wounds (dermal ulcers, superficial wounds, burns, donor sites, post-operative wounds, protective dressings).
- Comparison to a Predicate Device: Duoderm CGF / Extra Thin Hydrocolloid Dressings manufactured by Convatec, highlighting similarities in composition, surface, indications for use, transparency, self-adhesiveness, and sterilization method.
- Safety Assertions: Biocompatibility testing completed.
- Regulatory Clearance: A letter from the FDA determining substantial equivalence, along with limitations on labeling claims.
To directly answer your request based on the provided text, while acknowledging the absence of a detailed study report:
Acceptance Criteria and Device Performance Study (Not Applicable as a standalone study report is not provided)
The provided document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics. The implicit "acceptance criteria" for a 510(k) submission is that the device is as safe and effective as the predicate device.
1. A table of acceptance criteria and the reported device performance
Since no specific acceptance criteria for a new study are outlined, and no new performance data comparing against such criteria is presented, this table cannot be created from the text. The document does, however, provide a comparative table between the applicant's device and the predicate device, showing their similar characteristics:
| Characteristics | Innovative Technologies | Convatec (Predicate Device) |
|---|---|---|
| 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, partial-full thickness wounds, trauma wounds, dermal lesions | 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 |
| Sterilization Method | Gamma Irradiation (in accordance with ANSI/AAMI/ISO11137-1995 and AAMI TIR8-1991 for dosimetric release with a sterility assurance level of 10^-6^) | Gamma Irradiation |
| Biocompatibility | Successfully completed per ISO/Tripartite guidelines (cytotoxicity, acute systemic toxicity, skin irritation, sensitization) | (Implicitly assumed to be met given its status as a legally marketed predicate; not explicitly detailed for the predicate in this document) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical "test set" in the context of a new study designed to meet specific performance criteria. The evaluation is based on a comparison to a predicate device and existing regulatory standards (e.g., for sterilization and biocompatibility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment for a test set is described as part of a clinical performance study. The expertise cited is related to quality assurance and regulatory affairs (Priscilla Whitehead, Director of QA/RA for Innovative Technologies).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a wound dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to "human readers improving with AI" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established regulatory approval and safety profile of the legally marketed predicate device (Duoderm CGF / Extra Thin Hydrocolloid Dressings by Convatec), combined with the Innovative Technologies' device meeting relevant standards for sterilization and biocompatibility.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or diagnostic algorithm device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set.
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JUN 2 4 1997
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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), donorsites, post operative wounds,protective dressings | Dermal ulcers, superficial wounds,burns (1st & 2nd degree), donorsites, 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
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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.
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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
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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)
Rond There Winstend hichestrial Estane, Wirstend, Cheshire (W") 4PD C.K. 11 000 1000 80 000 East 11 GD 1606 86 3600 Reveached in Empland 2007-15-
N/A