(391 days)
OTC: For minor wounds, minor ulcerations, minor abrasions, minor surgical wounds and minor skin irritations.
IONSIL GEL™ is a moist amorphous hydrophilic silver chloride gel designed to act as a barrier for wounds, as a moist wound dressing. The viscous hydrogel of the device contains silver in the form of silver chloride which acts as a self preservative that inhibits the growth of broad spectrum of micro organisms in the dressing.
The product is available in a 1.5 oz (45 gm) polyethylene heat sealed tube container. The tubes will be packed in a cardboard box.
This document is a 510(k) premarket notification for a medical device called IONSIL GEL™, an unclassified wound hydrogel. The FDA determined it is substantially equivalent to a predicate device.
Here's an analysis of the acceptance criteria and supporting study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the device itself (e.g., specific percentages for effectiveness, sensitivity, or specificity). Instead, it focuses on demonstrating substantial equivalence to a predicate device and safety through biocompatibility and antimicrobial testing.
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate device's intended use. | IONSIL GEL™ is intended for OTC use in the management of normal skin and minor wounds, ulcerations, minor abrasions, minor surgical wounds and minor skin irritations. This is stated to be substantially equivalent to the predicate device's indications. |
| Technological Characteristics | Similar to predicate device; moist wound dressing, silver as self-preservative. | IONSIL GEL™ is a moist amorphous hydrophilic silver chloride gel designed to act as a barrier for wounds. It contains silver in the form of silver chloride as a self-preservative inhibiting microbial growth. This is stated to be substantially equivalent to the predicate device (Acryderm Silver Antimicrobial Wound Gel) in form and function. |
| Biocompatibility | Safe for intended use (non-toxic, non-sensitizing, non-irritating). | Biocompatibility testing (systemic toxicity, cytotoxicity, sensitization and irritation) performed with IONSIL GEL™ demonstrates that the dressing is safe for its intended use. Testing was conducted according to ISO Standards. |
| Antimicrobial Properties | Effectiveness against microorganisms (as a self-preservative). | In vitro antimicrobial testing was assessed by the standard Zone of Inhibition and USP Antimicrobial Effectiveness Test <51> and USP microbial limit test <61>. The results of these tests are not explicitly detailed as numerical values but are presented as evidence supporting the silver's self-preservative function and overall antimicrobial effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance data for the device. The data mentioned relates to laboratory (in vitro) testing for biocompatibility and antimicrobial properties.
- Biocompatibility Testing: The text states "Biocompatibility testing... was conducted according to ISO Standards." This implies a set of standardized samples (e.g., material extracts, cell cultures, animal models) as prescribed by the specific ISO standards, but no sample size for a "test set" is provided in the document.
- Antimicrobial Testing: "In vitro antimicrobial testing was assessed by the standard Zone of Inhibition and USP Antimicrobial Effectiveness Test <51> and USP microbial limit test <61>." Again, the sample sizes for these in vitro tests (e.g., number of bacterial cultures, replicates) are not specified.
- Data Provenance: The studies are laboratory-based (in vitro), not involving human subjects or clinical data in the traditional sense. Therefore, country of origin of data (besides the submitting company's location in India) and retrospective/prospective categories are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes laboratory (in vitro) studies for biocompatibility and antimicrobial efficacy, not a human reader or clinical performance evaluation requiring expert ground truth in the diagnostic sense. The "ground truth" for these tests would be the standardized results and observations of the laboratory assays themselves, interpreted by qualified lab personnel.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There is no human observer adjudication mentioned for these in vitro tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies, either standalone or assisted by AI. The device is a wound hydrogel, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical product (wound hydrogel), not a software algorithm.
7. The Type of Ground Truth Used
For the laboratory studies:
- Biocompatibility: The "ground truth" is established by the defined endpoints and criteria of the ISO standards used (e.g., cellular viability, irritation scores in validated models).
- Antimicrobial Properties: The "ground truth" reflects the measurable outcomes of the USP <51> and <61> tests and Zone of Inhibition assays, such as bacterial growth inhibition zones or reduction in microbial counts according to standardized methodologies.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" for its development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Virchow Biotech PVT LTD % Bruce Gibbins, PhD. 5903 SE Milwaukie Avenue Portland, Oregon 97202
Re: K132326 Trade/Device Name: Ionsil Gel™ Regulatory Class: Unclassified Product Code: FRO Dated: June 28, 2014 Received: July 23, 2014
Dear Dr. Gibbins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number:
Indications for Use Statement
IONSIL GEL™ Device Name:
Indications for use:
OTC: For minor wounds, minor ulcerations, minor abrasions, minor surgical wounds and minor skin irritations.
Prescription Use (Part 21 CFR 801 Subpart D)
And/OR
Over-The-Counter Use __X _____________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEAS DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Concurrence of CDRH, Office of Device Evaluation (ODE)
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CONFIDENTIAL
510(k) Summary
5.1 Submitter's Name and Address
| Contact Person: | VIRCHOW BIOTECH PVT LTDPlot No:318 & 320,3rd Floor, Swamy Ayyapa Co-Op Housing Society Ltd.Madhapur, HyderabadTelanganaIndia-500 081Bruce Gibbins PhD5903 SEMilwaukie AvenuePortland OR 97202Ph No: +1 503 781 7565Email: blgibbins@gmail.com |
|---|---|
| Date Prepared: | 09 Aug 2014 |
| Device Name | |
| Trade Name: | IONSIL GELTM |
| Common: | Wound Hydrogel |
| Classification Name: | Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic |
- Regulatory Class: Unclassified
- Product Code: MGQ
5.3 Predicate Devices
5.2
IONSIL GEL™ is substantially equivalent to SilvaSorb Silver Antimicrobial Wound Gel /or (AKA) AcryDerm Silver Antimicrobial Wound Dressing (K011994).
5.4 Device Description
IONSIL GEL™ is a moist amorphous hydrophilic silver chloride gel designed to act as a barrier for wounds, as a moist wound dressing. The viscous hydrogel of the device contains silver in the form of silver chloride which acts as a self preservative that inhibits the growth of broad spectrum of micro organisms in the dressing.
The product is available in a 1.5 oz (45 gm) polyethylene heat sealed tube container. The tubes will be packed in a cardboard box.
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5.5 Statement of Intended Use
IONSIL GEL™ is intended for OTC use in the management of normal skin and minor wounds, ulcerations, minor abrasions, minor surgical wounds and minor skin irritations.
5.6 Technological Characteristics and Substantial Equivalence
IONSIL GEL™ is essentially and substantially equivalent to the predicate device in its use for moist wound management. Both IONSIL GEL™ and Acryderm Silver Antimicrobial Wound Gel are offered as moist wound dressings in a tube. The technological characteristics of IONSIL GEL™ and Acryderm Silver Antimicrobial Wound Gel are substantially equivalent and both are indicated for use on minor wounds, minor ulcerations, minor surgical wounds, minor abrasions and minor skin irritations.
5.7 Assessment of Performance Data and Safety
Biocompatibility testing (systemic toxicity, cytotoxicity, sensitization and irritation) performed with IONSIL GEL™ demonstrates that the dressing is safe for its intended use. The performed testing was conducted according to ISO Standards. In vitro antimicrobial testing was assessed by the standard Zone of Inhibition and USP Antimicrobial Effectiveness Test <51> and USP microbial limit test <61>
N/A