(51 days)
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.:
- · Pressure Ulcers
- · Venous Stasis Ulcers
- · Diabetic Ulcers
- · 1* and 2nd Degree Burns
- · Surgical Wounds
- · Trauma Wounds
- · Dermal Lesions (Cuts, abrasions, etc)
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as:
- · Superficial cuts
- · Abrasions
- · Lacerations
- Minor scalds
- Minor bums
- Minor skin irritations
FlexiGel-G Amorphous Hydrogel Wound Dressing, is a clear, non-adherent, amorphous gel provided as a sterile, primary wound dressing.
FlexiGel-G Amorphous Hydrogel Wound Dressing encourages natural debridement through autolysis by gently rehydrating necrotic tissue and is intended to provide a moist healing environment ideally suited for the management of partial to full thickness wounds.
FlexiGel-G Amorphous Hydrogel Wound Dressing is supplied sterile in single use pouches or tubes.
The provided text is a 510(k) premarket notification for the FlexiGel-G Hydrogel Wound Dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics as might be found for novel technologies or higher-risk devices.
Therefore, the document does not contain the direct explicit information requested regarding acceptance criteria and a study proving the device meets them in the format of a typical clinical trial. Instead, it relies on demonstrating similarity to a predicate device and fulfilling regulatory requirements for safety and efficacy based on that comparison.
Here's a breakdown of what can be inferred or explicitly stated from the document, and where the requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Reported Device Performance (FlexiGel-G) | Predicate Device (Intrasite™ Gel) Performance |
|---|---|---|
| Composition | Guar gum, borax, propylene glycol, water | CMC, propylene glycol, water |
| Colour | Clear | Clear |
| Indications For Use | Partial to full thickness wounds e.g.: arterial, diabetic, pressure and venous ulcers, 1st & 2nd degree burns, trauma wounds and dermal lesions (Prescription); Superficial cuts, abrasions, lacerations, minor scalds, minor burns, minor skin irritations (OTC) | Shallow and deep open wounds e.g.: pressure sores, leg ulcers, surgical and malignant wounds, partial thickness burns, scalds, lacerations and grazes. |
| Fluid Donation | 0.22 g/g | 0.18 g/g |
| Fluid Absorption | -0.4 g/g | 0.31 g/g |
| Packaging | Foil pouch / poly tube | Polyethylene bulb applicator |
| Sterility | Steam sterilised; Sterility Assurance Level (SAL) of 10-6 (overkill method per ANSI / AAMI / ISO11134 - 993) | (Not explicitly stated for predicate; assumed to meet similar standards) |
| Biocompatibility | Successfully completed per ISO/Tripartite guidelines (cytotoxicity, haemolysis, acute systemic toxicity, skin irritation and sensitisation) | (Not explicitly stated for predicate; assumed to meet similar standards) |
Explanation of "Acceptance Criteria" here: For a 510(k), the "acceptance criteria" are generally that the new device is substantially equivalent to a legally marketed predicate device. This means it must have the same intended use, the same technological characteristics, or if there are differences, those differences do not raise different questions of safety and effectiveness. The table above highlights the comparative features presented to demonstrate this equivalence. The "performance" is simply the reported characteristics of the device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None stated. The submission relies on laboratory testing (biocompatibility, fluid dynamics) and comparison to a predicate device, not a human-subjects test set in the sense of a clinical trial. The "data" provenance for fluid dynamics and composition would be internal lab testing, likely from the UK.
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. This submission does not involve a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No such test set or adjudication method 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
- No MRMC study was done. This device is a wound dressing, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" equivalent in this context is the established safety and efficacy profile of the predicate device (Intrasite™ Gel) and the demonstration through laboratory testing (biocompatibility, physical properties like fluid donation/absorption) that FlexiGel-G performs similarly and meets recognized safety standards. For sterility, the ground truth is meeting a 10^-6 SAL via an overkill method.
8. The sample size for the training set
- Not applicable. This device is a physical wound dressing; there is no "training set" in the machine learning sense. The "development" and "testing" involved product formulation, manufacturing process validation (like sterilization), and biocompatibility testing.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set. The safety and performance validation methods are described:
- Sterilization: Overkill method to achieve a Sterility Assurance Level (SAL) of 10^-6 per ANSI / AAMI / ISO11134 - 993.
- Biocompatibility: Testing successfully completed per ISO/Tripartite guidelines for cytotoxicity, haemolysis, acute systemic toxicity, skin irritation, and sensitisation.
- Functional Characteristics: Laboratory measurements of fluid donation and absorption, compared to the predicate device.
In summary: The provided document is a 510(k) premarket notification. Its "study" is primarily a comparison to a legally marketed predicate device and demonstration of compliance with relevant safety standards and performance characteristics through laboratory testing, not a clinical trial with human subjects and specific performance metrics in the way a diagnostic AI or novel therapeutic device would require. The "acceptance criteria" revolve around proving substantial equivalence and meeting established international standards for sterility and biocompatibility.
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Innovative Technologies Ltd
K 98009 7
FlexiGel-G Hydrogel Wound Dressing
MAR - 4 1998
Safety & Effectiveness Summary: Classification Name: Common / Usual Name: Contact: Prepared:
KMF Liquid Bandage Hydrogel Wound Dressing Priscilla Whitehead Cox, Director of Regulatory Affairs Thursday, January 8, 1998
FlexiGel-G Amorphous Hydrogel Wound Dressing, is a clear, non-adherent, amorphous gel provided as a sterile, primary wound dressing.
FlexiGel-G Amorphous Hydrogel Wound Dressing encourages natural debridement through autolysis by gently rehydrating necrotic tissue and is intended to provide a moist healing environment ideally suited for the management of partial to full thickness wounds.
FlexiGel-G Amorphous Hydrogel Wound Dressing is supplied sterile in single use pouches or tubes. The packaged product will be steam sterilised in accordance with Sterilisation Of Health Care Products -Requirements For Validation and Routine Control - Industrial Moist Heat Sterilisation, ANSI / AAMI / ISO11134 - 993. Qualification will be based on the overkill method with a sterility assurance level of 10-6.
Biocompatibility testing including cytotoxicity, haemolysis, acute systemic toxicity, skin irritation and sensitisation has been successfully completed per ISO/Tripartite guidelines.
FlexiGel-G Amorphous Hydrogel Wound Dressing is similar in design, composition and function to Intrasite™ Gel manufactured by Smith & Nephew.
| Characteristics | Innovative Technologies | Smith & Nephew |
|---|---|---|
| Composition | Guar gum, borax, propyleneglycol, water | CMC, propylene glycol, water |
| Colour | Clear | Clear |
| Indications For Use | Partial to full thicknesswounds eg: arterial, diabetic,pressure and venous ulcers,1st & 2nd degree burns,trauma wounds and dermallesions | Shallow and deep open woundseg: pressure sores, leg ulcers,surgical and malignant wounds,partial thickness burns, scalds,lacerations and grazes. |
| Fluid Donation | 0.22 g/g | 0.18 g/g |
| Fluid Absorption | -0.4 g/g | 0.31 g/g |
| Packaging | Foil pouch / poly tube | Polyethylene bulb applicator |
COMPARATIVE FEATURES
Innovative Technologies I to
-G Hydrogel Wound O
Image /page/0/Picture/16 description: The image shows a circular logo with text and a geometric shape inside. The text "REGISTERED FIRM" is arranged around the top half of the circle, and the letters "FM" are visible at the bottom, followed by the number "34786". Inside the circle is an inverted triangle or diamond shape. The logo appears to be a certification or registration mark.
ISO 9001
EN 46001
Tarvin Sands Complex Tarvin. Cheshire. CH3 8JF U.K. Tel: 44 (0) 1829 741515 Fax: 44 (0) 1829 740456
510(k) Notification
Road Three, Winsford Industrial Estate, Winsford, Cheshire CW7 3PD U.K. Tel: 44 (0) 1606 86 3500 Fax: 44 (0) 1606 86 3600 Registered in England 2666957
Head Office
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1998
Ms. Priscilla Whitehead Cox Director, Quality Assurance/Regulatory Affairs Innovative Technologies, Limited Road Three, Winsford Industrial Estate Winsford Cheshire CW7 3PD U.K.
Re: K980097
Trade Name: Flexigel-G Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGO Dated: January 8, 1998 Received: January 12, 1998
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 enclosures) 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.
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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
Enclosures
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510(k) Number (if known): K980097
Revised: February 19, 1998
Device name: ElexiGel-G™ Hydrogel Wound Dressing (Prescription)
Judications For Use:
FlexiGcl-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.:
- · Pressure Ulcers
- · Venous Stasis Ulcers
- · Diabetic Ulcers
- · 1* and 2nd Degree Burns
- · Surgical Wounds
- · Trauma Wounds
- · Dermal Lesions (Cuts, abrasions, etc)
(I'LEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K980097 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR Over The Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |
(Optional Format 1-2-96)
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( Optional Format 1-2-96)
510(k) Number (if known): K980097
February 19, 1998
Device name: FlexiGel-G13d Hydrogel Wound Dressing (OTC)
Indications For Use:
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as:
- · Superficial cuts
- · Abrasions
- · Lacerations
- Minor scalds
- Minor bums
.
- Minor skin irritations
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTTIER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K980097 |
| Prescription Use(Per 21 CFR 801.109) | OR Over The Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |
( Optional Format 1-2-96)
N/A