(48 days)
Not Found
No
The 510(k) summary describes a topical emulsion for wound care and does not mention any AI or ML components or functionalities.
No.
BariRep is intended to manage minor skin injuries and is available over-the-counter, indicating it's not a therapeutic device. Its description as an emulsion for topical application further supports this.
No
The "Intended Use / Indications for Use" states that BariRep is "to manage minor burns, minor abrasions, minor cuts and minor lacerations," indicating it is a therapeutic or treatment device rather than a diagnostic one. Diagnostic devices are used to identify or determine a disease or condition.
No
The device description clearly states it is a "non-sterile, semi-viscous emulsion intended for topical application," indicating it is a physical product, not software.
Based on the provided information, BariRep is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: BariRep is intended for the topical management of minor burns, abrasions, cuts, and lacerations. This is a direct application to the body for therapeutic purposes.
- Device Description: It's a semi-viscous emulsion for topical application. This describes a product applied to the skin.
- Lack of IVD Characteristics: The description does not mention any testing of samples (like blood, urine, tissue) outside of the body to diagnose, monitor, or determine the state of health.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. BariRep's function is to directly treat the affected area on the body.
N/A
Intended Use / Indications for Use
BariRep's intended use is to manage minor burns, minor abrasions, minor cuts and minor lacerations.
Product codes
FRO
Device Description
BariRep is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for over-the-counter use. The product is formulated as an oil-inwater emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of BariRep is composed of glyceride, squalane, lecithin, and fatty acids.
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
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)
Non-Clinical Performance Data
N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K100839
page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Gorbec Pharmaceutical Services Inc. The logo features the word "Gorbec" in large, bold, white letters against a black background. Above and around the letters are chemical structure diagrams, suggesting a connection to the pharmaceutical industry. Below the word "Gorbec" is the text "PHARMACEUTICAL SERVICES INC." in a smaller font size.
2445 South Alston Ave Durham, NC 27713 (919) 281-4080 Phone (919) 281-4070 Facsimile
MAY 1 1 2010
510(k) Summary
Submitter of the Application
Name: Address: River's Edge Pharmaceuticals, LLC 5400 Laurel Springs Pkwy Building 500 Suwanne, GA 30024
Phone: (770) 886-3417 Fax: (770) 886-3917
Contact for the Application
Company:
Gorbec Pharmaceutical Services, Inc. 2445 S. Alston Ave Durham, NC 27713
| Contact Name: | Matthew Popp |
|---|---|
| Phone: | (919) 281-4080 |
| Fax: | (919) 281-4077 |
| Email: | matthewpopp@gorbec.com |
Date of Summary
12 March 2010
Trade Name
BariRep
Common name
Hydrogel wound dressing
Device Classification
21 CFR 878.4022 "Dressing, Wound, Hydrogel" Class I Non-Exempt, NAE.
1
K100839
page 20f2
Image /page/1/Picture/1 description: The image shows the logo for "Gorbac Pharmaceutical Services Inc." The word "Gorbac" is in large, bold, white letters, with chemical structures in the background. Below "Gorbac" is the text "Pharmaceutical Services Inc." in smaller letters. The logo is set against a black background.
2445 South Alstor Durham. NC 27713 919) 281-4080 Phone 919) 281-4070 Facsimile
Substantial Equivalence / Predicate Device
Gorbec Pharmaceutical Services Inc. believes that this submission for BariRep is substantially equivalent to the currently approved device, cleared under K083721, approved 08 January 2009.
Device Description and Design
BariRep is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for over-the-counter use. The product is formulated as an oil-inwater emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of BariRep is composed of glyceride, squalane, lecithin, and fatty acids.
Intended Use of the Device
BariRep's intended use is to manage minor burns, minor abrasions, minor cuts and minor lacerations.
Technological Comparison to Predicate Device
The device is identical in formulation, specifications and performance characteristics. It is being presented for over-the-counter use.
Non-Clinical Performance Data
N/A
Conclusion
The product's ingredients and performance characteristics have remained unchanged and are therefore, identical to the predicate. Tests and performance data are not applicable as the product remains safe, effective and substantially equivalent to the predicate. Over the counter use will not result in any increased risk to the patient.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its wings and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Gorbec Pharmaceutical Services, Inc. % Sandra R. Kircus, Ph.D. Regulatory Affairs Specialist 24458 South Alston Avenue Durham, North Carolina 27713
MAY 1 1 2010
Re: K100839
Trade/Device Name: BariRep Product Code: FRO Dated: March 15, 2010 Received: March 24, 2010
Dear Dr. Kircus:
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.
3
Page 2 - Sandra R. Kircus, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___K100839
Device Name: _________________________________________________________________________________________________________________________________________________________________ BariRep
Indications for Use:
BariRep's intended use is to manage minor burns, minor abrasions, minor cuts and minor lacerations.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dainl Krome for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K100839