Rochal Bioshield Silicone Film

K182733 · Rochal Industries, LLC · KMF · Jun 27, 2019 · General Hospital

Device Facts

• Record ID: K182733
• Device Name: Rochal Bioshield Silicone Film
• Applicant: Rochal Industries, LLC
• Product Code: KMF · General Hospital
• Decision Date: Jun 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions. OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

Device Story

Rochal Bioshield Silicone Film is a polymeric solution applied to skin; forms transparent, waterproof, breathable silicone film barrier. Used in clinical or home settings; applied by clinician or patient. Acts as protective interface against infection for minor wounds and closed surgical sites. Benefits include non-stinging application and moisture vapor permeability; supports wound healing by providing protective barrier.

Clinical Evidence

Bench testing only. Biocompatibility studies conducted per ISO 10993 (cytotoxicity, sensitization, irritation, pyrogenicity, implantation, chemical analysis, toxicological risk assessment). Sterility verified per USP 71. Real-time aging studies confirm shelf-life stability.

Technological Characteristics

Polymeric silicone solution; supplied in 28 mL HDPE bottles with pump spray. Forms transparent, waterproof, breathable film. Biocompatible; non-stinging. Sterilized via Gamma radiation.

Indications for Use

Indicated for patients requiring protection of minor cuts, scrapes, burns, irritations, abrasions, and closed surgical incisions/excisions. Suitable for both prescription and over-the-counter use.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• KeriCureTM Advanced Liquid Bandage (K131384)

Reference Devices

• No Sting Barrier Film (K955103)

Submission Summary (Full Text)

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June 27, 2019

Rochal Industries, LLC William Coulston Quality & Regulatory Manager 12000 Network Blvd, Ste B200 San Antonio, Texas 78249

Re: K182733

Trade/Device Name: Rochal Bioshield Silicone Film Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: Class I Product Code: KMF Dated: May 24, 2019 Received: May 28, 2019

Dear Mr. William Coulston:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Cynthia Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182733

Device Name Rochal Bioshield Silicone Film

Indications for Use (Describe)

Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.

OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image contains the logo for Rochal Industries LLC. The logo consists of a stylized sphere made of red and gray bands on the left. To the right of the sphere is the company name, "Rochal" in red, with "INDUSTRIES LLC" in smaller, gray font underneath.

# 510(k) Summary

- 1. Submitter's Name and Address Rochal Industries LLC. 12000 Network Blvd. Ste B200 San Antonio, Texas, 78249
- Submitter's Contact Person 2. William J. Coulston Quality and Regulatory Manager [phone] [e-mail]
- 3. Date of 510(k) Summary Preparation: June 26, 2019
- 4. Device Name (Proprietary) Rochal® Bioshield Silicone Film
- ട്. Classification Name Bandage, Liquid
- 6. Device Class and Regulation Number Class I, 21 CFR 880.5090
- 7. Product Code KMF

#### 8. Predicate and Reference Devices:

K131384 KeriCureTM Advanced Liquid Bandage, KeriCure Inc. (predicate device) K955103 No Sting Barrier Film, 3M Medical Product Group (reference device)

- Description of Device 9.
Rochal Bioshield Silicone Film is a polymeric solution which forms a protective, polymer film (silicone) when applied to skin. The product is biocompatible and nonstinging. The formed silicone film is colorless, transparent, water-proof barrier, which is breathable, possessing good oxygen and moisture vapor permeability.

Rochal® Bioshield Silicone Film will be supplied in a High-Density Polyethylene (HDPE), 28 mL bottles with pump spray cap.

#### 10. Indications for Use

Rochal® Bioshield Silicone Film is intended for prescription (Rx) and over-the-counter (OTC) uses as follows:

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Image /page/4/Picture/0 description: The image shows the logo for Rochal Industries LLC. The logo features a stylized globe made of red and gray ribbons on the left. To the right of the globe is the company name, "Rochal" in large, bold, red letters. Below "Rochal" is the text "INDUSTRIES LLC" in smaller, black letters.

- . Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
- OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

#### Performance Testing 11.

Rochal® Bioshield Silicone Film has been subjected to ISO 10993 biocompatibility studies (cytotoxicity, sensitization, irritation, pyrogenicity, implantation, chemical analysis and toxicological risk assessment) to demonstrate the device is as safe and as effective as its predicate device. The product is Gamma sterility has been verified using USP 71, Sterility Tests. The results of real-time aging study indicate the product is stable and effective for the proposed shelf life.

| Feature<br>Being<br>Compared | SUBJECT DEVICE<br>K182733<br>Rochal® Bioshield<br>Silicone Film | PREDICATE DEVICE<br>K131384<br>KeriCureTM Advanced<br>Liquid Bandage | REFERENCE DEVICE<br>K955103<br>No Sting Barrier Film |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Rx: Rochal®<br>Bioshield Silicone<br>Film is intended to<br>cover and protect the<br>skin from infection<br>in minor cuts,<br>scrapes, burns,<br>irritations and<br>abrasions, as well as<br>closed surgical<br>incisions and<br>excisions.<br><br>OTC: Bioshield<br>Silicone Film is<br>intended to help<br>cover and protect the<br>skin from infection<br>in minor cuts,<br>scrapes, burns,<br>irritations and<br>abrasions. | Rx: KeriCureTM<br>Advanced Liquid<br>Bandage is intended to<br>cover and protect the<br>skin from infection in<br>minor cuts, scrapes,<br>burns, irritations and<br>abrasions, as well as<br>closed surgical incisions<br>and excisions.<br><br>OTC: KeriCureTM<br>Advanced Liquid<br>Bandage is intended to<br>help cover and protect<br>the skin from infection<br>in minor cuts, scrapes,<br>burns, irritations and<br>abrasions. | OTC: No Sting Barrier<br>Film is a liquid intended<br>for use as a film-<br>forming product, that<br>upon application to<br>intact or damaged skin<br>forms a long-lasting<br>waterproof barrier,<br>which acts as a<br>protective interface<br>between the skin and<br>bodily wastes, fluids,<br>adhesive products, and<br>friction and shear. It is<br>intended as a primary<br>barrier against irritation<br>from body fluids. |
| Product<br>Film<br>Appearance | Transparent film<br>barrier | Transparent film<br>barrier | Transparent film<br>barrier |
| Functions | Non-stinging,<br>breathable, water-<br>proof barrier | Breathable, barrier | Non-stinging, water-<br>proof barrier |

#### 12. Substantial Equivalence Discussion

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Image /page/5/Picture/1 description: The image shows the logo for Rochal Industries LLC. The logo consists of a stylized globe made of red and gray stripes on the left, followed by the company name in red, with the words "INDUSTRIES LLC" in smaller letters below. The logo is simple and modern, with a focus on the company name.

As discussed in the 510(k) submission, Rochal® Bioshield Silicone Film has the same indications for use, and similar product form and function as the predicate device, KeriCure Advanced Liquid Bandage (K131384). The product formulation and technology are similar to the reference device, 3M No Sting Barrier Film (K955103). The safety evaluation meets the requirements as detailed by USP Chapter <151> and ISO 10993. The benefit-risk profile of the subject and predicate devices is similar, and any differences do not raise different questions regarding safety or effectiveness.

On the basis of the information presented in this 510(k) submission, Rochal Industries LLC, concludes (a) that Rochal® Bioshield Silicone Film is substantially equivalent to the predicate device, as it has the same intended uses as the predicate device; and (b) demonstrates the device is at least as safe and effective as the legally marketed predicate device.