(147 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a wound gel, with no mention of AI or ML technologies.
Yes.
The device is intended for the management of various wounds and injuries, including ulcers, burns, and surgical incisions, which falls under therapeutic use.
No
The device is a wound gel intended for the management and treatment of various types of wounds, burns, and skin irritations. It facilitates a moist environment and autolytic debridement, but it does not analyze or diagnose any medical conditions.
No
The device is a wound gel, which is a physical substance applied to wounds, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and treatment of wounds, burns, and skin irritations. This involves applying the gel directly to the external body surface to promote healing and provide a protective environment.
- Device Description: The description focuses on the physical properties of the gel (moist environment, amorphous gel covering) and its chemical components (water, polymers, preservatives) that contribute to wound care.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVDs are specifically designed for these types of in vitro (outside the body) tests.
The device is a topical wound care product, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions.
Rochal Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.
Product codes
FRO
Device Description
ROCHAL Antimicrobial Wound Gel provides a moist environment to wound surfaces. ROCHAL Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial (PHMB). ROCHAL Antimicrobial Wound Gel:
- Resists microbial colonization within the dressing during shelf storage.
- Provides an amorphous gel covering
- Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement where the body's own enzymes breakdown necrotic tissue.
ROCHAL Antimicrobial Wound Gel contains:
Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Octane-1-2-diol, Polyaminopropyl Biguanide (preservative: PHMB 0.1% w/w) Edetate disodium (EDTA), Edetate trisodium (EDTA)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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
Rochal Antimicrobial Wound Gel has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe and as effective as its predicate device. Additionally, a large-animal, full-thickness wound healing study was conducted to demonstrate safety. USP preservative effectiveness testing demonstrates the chosen preservative is appropriate for a product formulation. The results of real-time aging study indicate the product is stable and maintains performance for the proposed shelf life of six months.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2020
Rochal Industries, LLC William Coulston Ouality & Regulatory Manager 12000 Network Blvd. Ste B200 San Antonio, Texas 78249
Re: K192527
Trade/Device Name: Rochal Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: January 3, 2020 Received: January 6, 2020
Dear 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Kimberlv M. Ferlin. Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192527
Device Name Rochal Antimicrobial Wound Gel
Indications for Use (Describe)
ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions.
Type of Use (Select one or both, as applicable)
X 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."
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Indications for Use
510(k) Number (if known)
Device Name Rochal Antimicrobial Wound Gel
Indications for Use (Describe)
ROCHAL Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
|X | 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."
4
510(k) Summary
-
- Submitter's Name and Address Rochal Industries LLC. 12000 Network Blvd. Ste B200 San Antonio, Texas, 78249
-
- Submitter's Contact Person William J. Coulston Quality & Regulatory Manager (210) 375-9349 ext 125 wcoulston@rochalindustries.com
-
- Date of 510(k) Summary Preparation: 7 February 2020
- Device Name (Proprietary) 4. Rochal Antimicrobial Wound Gel
- ട്. Common Name Wound Dressing
- Classification Name 6. Dressing, Wound, Drug
-
- Device Class Unclassified
-
- Device Code FRO
9. Description of Device
ROCHAL Antimicrobial Wound Gel provides a moist environment to wound surfaces. ROCHAL Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial (PHMB). ROCHAL Antimicrobial Wound Gel:
- Resists microbial colonization within the dressing during shelf storage.
- . Provides an amorphous gel covering
Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement where the body's own enzymes breakdown necrotic tissue.
ROCHAL Antimicrobial Wound Gel contains:
Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Octane-1-2-diol, Polyaminopropyl Biguanide (preservative: PHMB 0.1% w/w) Edetate disodium (EDTA), Edetate trisodium (EDTA)
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10. Intended Use of Device
Rochal Antimicrobial Wound Gel is intended for over-the-counter (OTC) and professional (Rx) use as follows:
- For Over-the-Counter Use: ROCHAL Antimicrobial Wound Gel is intended for . the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.
- . Professional Use: ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions.
These indications are similar to the predicate device.
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11. Legally Marketed Device for substantial equivalence comparison:
| Feature Being
Compared | SUBJECT DEVICE
Rochal Antimicrobial Wound Gel | PREDICATE DEVICE
Prontosan Wound Gel X (K130857) | DISCUSSION |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use (Rx) | Rochal Antimicrobial Wound Gel
is intended for the management of
ulcers (including diabetic foot and
leg ulcers and pressure ulcers),
first and second-degree burns,
partial and full thickness wounds,
large surface area wounds, and
surgical incisions. | K130857: Rx: Prontosan® Wound
Gel X is indicated for the
management of ulcers (including
diabetic foot and leg ulcers and
pressure ulcers), 1st and 2nd degree
burns, partial and full thickness
wounds, large surface area wounds
and surgical incisions. | The same. |
| Indications for
Use (OTC) | ROCHAL Antimicrobial Wound
Gel is intended for the
management of minor skin
scrapes, minor cuts, minor
lacerations, minor burns (1st
degree burns), minor irritations. | K130857: OTC: Prontosan Wound
Gel X is indicated for the
management minor cuts, minor
lacerations, minor burns (1st degree
burns), and abrasions. | Similar – slight rewording but
within the same type and
degree of injury |
| Technology | Clear, colorless gel | Clear, colorless gel | Similar - different formulation
but does not raise different
questions related to safety or
effectiveness. |
| Performance | USP preservative
effectiveness testing | USP , modified Strike
Through Barrier testing | Similar – both use PHMB as a
preservative. |
| Biocompatibility | Biocompatibility Testing: ISO
10993-1, surface device with
prolonged contact (>24hours to 30
days) on breached or compromised | Biocompatibility Testing | The subject device has
demonstrated to be safe for use
as a surface device with
prolonged contact (>24hours to |
| | surfaces | 30 days) on breached or | |
| | | compromised surfaces | |
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12. Performance Testing
Rochal Antimicrobial Wound Gel has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe and as effective as its predicate device. Additionally, a large-animal, full-thickness wound healing study was conducted to demonstrate safety. USP preservative effectiveness testing demonstrates the chosen preservative is appropriate for a product formulation. The results of real-time aging study indicate the product is stable and maintains performance for the proposed shelf life of six months.
13. Substantial Equivalence Conclusion
Rochal Antimicrobial Wound Gel has very similar indications for use, and similar product form and function as the predicate device, Prontosan Wound Gel X (K130857).
On the basis of the information presented in this 510(k) submission, Rochal Industries LLC, concludes (a) that Rochal Antimicrobial Wound Gel is substantially equivalent to the predicate device, as it has the same intended uses as the predicate device; and (b) demonstrates the device is as safe and effective as the legally marketed predicate device.