(272 days)
No
The device description and performance studies focus on the physical and biological properties of a silicone film, with no mention of AI or ML technologies.
Yes
The device is intended to "cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions," which describes a therapeutic purpose.
No
Explanation: The device is described as a protective film intended to cover and protect skin. There is no mention of it being used to identify or analyze a condition, which are characteristics of a diagnostic device.
No
The device description clearly states it is a "polymeric solution" that forms a "protective, polymer film (silicone)" when applied to the skin, and is supplied in a bottle. This indicates a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is applied to the skin to cover and protect wounds. This is a topical application for wound care, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a polymeric solution that forms a protective film on the skin. This aligns with a topical wound dressing, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, Bioshield Silicone Film falls under the category of a wound dressing or topical protectant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
KMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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) |
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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
-
- 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:
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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
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: Rochal®
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. | Rx: KeriCureTM
Advanced Liquid
Bandage 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: KeriCureTM
Advanced Liquid
Bandage is intended to
help cover and protect
the skin from infection
in minor cuts, scrapes,
burns, irritations and
abrasions. | OTC: No Sting Barrier
Film is a liquid intended
for use 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. It is
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 |
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 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.