(272 days)
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.
Rochal Bioshield Silicone Film is a polymeric solution which forms a protective, polymer film (silicone) when applied to skin. The product is biocompatible and non-stinging. 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.
The provided text describes a 510(k) premarket notification for the Rochal Bioshield Silicone Film. This document is a submission for medical device clearance, not a study report for an AI/ML powered device. Therefore, the information requested about acceptance criteria, specific study design for device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.
The document primarily focuses on demonstrating the substantial equivalence of the Rochal Bioshield Silicone Film to legally marketed predicate devices through comparisons of indications for use, product film appearance, and functions, as well as general performance testing related to biocompatibility and sterility.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison table between the subject device (Rochal Bioshield Silicone Film), a predicate device (KeriCure Advanced Liquid Bandage), and a reference device (No Sting Barrier Film). While it lists features being compared, it does not outline specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML device.
| Feature Being Compared | SUBJECT DEVICE K182733 Rochal® Bioshield Silicone Film | PREDICATE DEVICE K131384 KeriCureTM Advanced Liquid Bandage | REFERENCE DEVICE K955103 No Sting Barrier Film |
|---|---|---|---|
| Indications for Use (Rx) | Intended to cover and protect skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions. | Intended to cover and protect skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions. | Not applicable (OTC only for reference device) |
| Indications for Use (OTC) | Intended to help cover and protect skin from infection in minor cuts, scrapes, burns, irritations and abrasions. | Intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions. | As a film-forming product, that upon application to intact or damaged skin forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction and shear. Intended as a primary barrier against irritation from body fluids. |
| Product Film Appearance | Transparent film barrier | Transparent film barrier | Transparent film barrier |
| Functions | Non-stinging, breathable, water-proof barrier | Breathable, barrier | Non-stinging, water-proof barrier |
Reported Performance (General):
- Biocompatibility: Passed ISO 10993 studies (cytotoxicity, sensitization, irritation, pyrogenicity, implantation, chemical analysis, and toxicological risk assessment).
- Sterility: Gamma sterility verified using USP 71, Sterility Tests.
- Shelf life: Real-time aging study indicates the product is stable and effective for the proposed shelf life.
Missing Information (due to the nature of the document):
- Specific quantitative acceptance criteria for each 'feature being compared'.
- Detailed quantitative performance benchmarks or statistical results from the device's operation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document refers to "biocompatibility studies" and a "real-time aging study," but no details on sample sizes or data provenance are given for these tests. This is not an AI/ML device, so there is no "test set" in that context.
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):
This information is not applicable and not provided. The device is a physical product (liquid bandage), not an AI/ML system that requires expert-established ground truth for performance evaluation in the context of diagnostic or prognostic tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided for the same reasons as point 3.
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:
This information is not applicable and not provided. This is not an AI-assisted device, therefore no MRMC study with human readers assisting with AI would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable and not provided. As a physical product, the "ground truth" for its performance would typically be based on established scientific methods for measuring physical and chemical properties (e.g., film formation, permeability, biological response in specific tests) rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set:
This information is not applicable and not provided. The device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided. The device is not an AI/ML system.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized design. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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
-
- 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 (210) 375-9349 wcoulston@rochalindustries.com
-
- Date of 510(k) Summary Preparation: June 26, 2019
-
- Device Name (Proprietary) Rochal® Bioshield Silicone Film
- ട്. Classification Name Bandage, Liquid
-
- Device Class and Regulation Number Class I, 21 CFR 880.5090
-
- 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:
{4}------------------------------------------------
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.
| FeatureBeingCompared | SUBJECT DEVICEK182733Rochal® BioshieldSilicone Film | PREDICATE DEVICEK131384KeriCureTM AdvancedLiquid Bandage | REFERENCE DEVICEK955103No Sting Barrier Film |
|---|---|---|---|
| Indicationsfor Use | Rx: Rochal®Bioshield SiliconeFilm is intended tocover and protect theskin from infectionin minor cuts,scrapes, burns,irritations andabrasions, as well asclosed surgicalincisions andexcisions.OTC: BioshieldSilicone Film isintended to helpcover and protect theskin from infectionin minor cuts,scrapes, burns,irritations andabrasions. | Rx: KeriCureTMAdvanced LiquidBandage is intended tocover and protect theskin from infection inminor cuts, scrapes,burns, irritations andabrasions, as well asclosed surgical incisionsand excisions.OTC: KeriCureTMAdvanced LiquidBandage is intended tohelp cover and protectthe skin from infectionin minor cuts, scrapes,burns, irritations andabrasions. | OTC: No Sting BarrierFilm is a liquid intendedfor use as a film-forming product, thatupon application tointact or damaged skinforms a long-lastingwaterproof barrier,which acts as aprotective interfacebetween the skin andbodily wastes, fluids,adhesive products, andfriction and shear. It isintended as a primarybarrier against irritationfrom body fluids. |
| ProductFilmAppearance | Transparent filmbarrier | Transparent filmbarrier | Transparent filmbarrier |
| Functions | Non-stinging,breathable, water-proof barrier | Breathable, barrier | Non-stinging, water-proof barrier |
12. Substantial Equivalence Discussion
{5}------------------------------------------------
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.
§ 880.5090 Liquid bandage.
(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.