← Product Code FRO · K132326 # IONSIL GEL (K132326) _Virchow Biotech Pvt, Ltd. · FRO · Aug 21, 2014 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K132326 ## Device Facts - **Applicant:** Virchow Biotech Pvt, Ltd. - **Product Code:** FRO - **Decision Date:** Aug 21, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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. ## Device Story Ionsil Gel is a moist amorphous hydrophilic silver chloride gel; functions as a barrier dressing for wound management. Silver chloride acts as a self-preservative to inhibit microbial growth within the dressing. Packaged in 1.5 oz polyethylene tubes. Intended for OTC use by patients or caregivers to maintain a moist wound environment, facilitating healing and protecting minor skin injuries. ## Clinical Evidence Bench testing only. Biocompatibility testing (systemic toxicity, cytotoxicity, sensitization, and irritation) performed per ISO standards. Antimicrobial effectiveness assessed via Zone of Inhibition, USP <51> Antimicrobial Effectiveness Test, and USP <61> microbial limit test. ## Technological Characteristics Amorphous hydrophilic hydrogel containing silver chloride. Packaged in polyethylene heat-sealed tubes. Biocompatibility testing conducted per ISO standards. Antimicrobial properties provided by silver chloride. No software or electronic components. ## Predicate Devices - SilvaSorb Silver Antimicrobial Wound Gel /or (AKA) AcryDerm Silver Antimicrobial Wound Dressing ([K011994](/device/K011994.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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) {3}------------------------------------------------ # CONFIDENTIAL #### 510(k) Summary #### 5.1 Submitter's Name and Address | Contact Person: | VIRCHOW BIOTECH PVT LTD
Plot No:318 & 320,
3rd Floor, Swamy Ayyapa Co-Op Housing Society Ltd.
Madhapur, Hyderabad
Telangana
India-500 081
Bruce Gibbins PhD
5903 SE
Milwaukie Avenue
Portland OR 97202
Ph No: +1 503 781 7565
Email: 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. {4}------------------------------------------------ ## 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> --- **Source:** [https://fda.innolitics.com/device/K132326](https://fda.innolitics.com/device/K132326) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com