(450 days)
Not Found
No
The device description and performance studies focus solely on the material properties and biological effects of a collagen wound dressing, with no mention of computational analysis, algorithms, or learning processes.
Yes.
The device is intended for the management of wounds, which is a therapeutic purpose aimed at healing or alleviating a medical condition.
No
This device is a wound dressing designed to manage wounds by absorbing fluid and maintaining a moist environment, not to diagnose medical conditions. Its intended use is therapeutic, not diagnostic.
No
The device description clearly states it is a "highly purified porcine Type I, collagen wound dressing," which is a physical material, not software.
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 of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a wound dressing that absorbs wound fluid and maintains a moist environment. This is a physical and biological interaction with the wound, not an in vitro test on a sample.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to detect diseases, conditions, or markers.
- Performance Studies: The performance studies focus on biocompatibility (cytotoxicity, irritation, sensitization), sterility, and stability, which are relevant for a therapeutic device applied to the body, not for an IVD.
In summary, the CollaFirm Collagen Wound Dressing is a therapeutic device intended for wound management, not a diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use
Product codes
KGN
Device Description
CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.
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
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
CollaFirm Collagen Wound Dressing has not been studied in a clinical setting. Non-clinical performance data includes:
- Agar Overlay (direct contact) Cytotoxicity testing indicated a grade 0 . cytotoxic grade.
- ISO Intracutaneous reactivity (Irritation) testing indicates a nono irritant.
- ISO Guinea Pig Maximization Sensitization Test Report indicates the . product is a non-sensitizer.
- Stability has been demonstrated over a three (3) month period and . Room Temperature and accelerated conditions and was found to maintain the products attributes and characteristics.
- . USP Sterility testing has indicated that the product is sterile.
- LAL Chromogenicity testing indicates the product is non-pyrogenic.
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
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GMM
APR 2 1 2013
K120250
510(k) SUMMARY
1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
CollaFirm LLC 7 Deer Park Drive, Suite M-7 Monmouth Junction, New Jersey 08852
Telephone No.: 732-823-1051 Facsimile No .:
Contact Person: Surendra Batra Ph.D. E-Mail: surendra@collafirm.com
Date Prepared: April 17, 2013
2. Name of Device and Name/Address of Sponsor
CollaFirma Collagen Wound Dressing
CollaFirm LLC 7 Deer Park Drive, Suite M-7 Monmouth Junction, New Jersey 08852
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- Common or Usual Name: Collagen Wound Dressing
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- Classification: Dressing, Wound, Collagen Regulatory Class: Unclassified Product Code: KGN
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- Description: CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.
1
Image /page/1/Picture/0 description: The image shows a black and white drawing of a spiral shape. The spiral starts with a circular shape on the left side and gradually extends to the right. The spiral is decorated with a pattern of diagonal lines, creating a visually interesting design. The drawing is simple and abstract, with no background or other elements.
K120250
6. Predicate Devices
- Medifil Particles K910944 , BioCore Medical Technologies,Inc. O
- CollaTek Power K012990 BioCore Medical Technologies,Inc. O
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- Intended Use/Indication for Use: CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use
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- Amino Acid Analysis: Amino Acid Analysis for CollaFirm collagen was performed by HPLC and was compared with Medfil II collagen particles. The amino acid composition (18 amino acids each) of CollaFirm collagen and predicate device Medfil II is quite similar on comparison.
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- Technological Characteristics: CollaFirm Collagen Wound Dressing is highly purified porcine collagen which absorbs wound fluid, maintains a moist wound environment and is equivalent to predicate products currently in commercial distribution.
This particular formulation does not affect the intended use or alter the fundamental scientific technology of the device.
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- Substantial Equivalence: The CollaFirm Collagen Wound Dressing is as safe and effective as the predicate devices referenced herein. CollaFirm Collagen Wound Dressing has the same intended uses, technological characteristics, and basic principles of operation as the aforementioned predicate devices and raises no new issues of safety or effectiveness. CollaFirm Collagen Wound Dressing is substantially equivalent to the predicate devices referenced.
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Image /page/2/Picture/0 description: The image shows a stylized drawing of a sperm cell. The sperm cell has a round head on the left side of the image. A long, wavy tail extends from the head to the right side of the image. The tail has alternating dark and light stripes.
K120250
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- Non-Clinical Performance Data: The CollaFirm Collagen Wound Dressing has been evaluated in accordance with Part 10-993 of the International Standard Organization (ISO). Standard tests which include:
- Agar Overlay (direct contact) Cytotoxicity testing indicated a grade 0 . cytotoxic grade.
- ISO Intracutaneous reactivity (Irritation) testing indicates a nono irritant.
- ISO Guinea Pig Maximization Sensitization Test Report indicates the . product is a non-sensitizer.
- Stability has been demonstrated over a three (3) month period and . Room Temperature and accelerated conditions and was found to maintain the products attributes and characteristics.
- . USP Sterility testing has indicated that the product is sterile.
- LAL Chromogenicity testing indicates the product is non-pyrogenic. .
- CollaFirm Collagen Wound Dressing has not been studied in a clinical . setting.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
CollaFirm, LLC % Surendra Batra, Ph.D. 7 Deer Park Drive, Suite M-7 Monmouth, New Jersey 08852
April 21, 2013
Re: K120250
Trade/Device Name: CollaFirma Collagen Wound Dressing · Regulatory Class: Unclassified Product Code: KGN Dated: April 08, 2013 Received: April 10, 2013
Dear Dr. Batra:
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
4
Page 2 - Surendra Batra, Ph.D.
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.
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/Safetv/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CollaFim LLC Phone: 732-823-1051 surendra@collafirm.com
CollaFirm Collagen Wound Dressing This eCopy is an exact duplicate of the paper copy
. "ڊ
K120250/S002
Indications for Use
510(k) Number: K120250
Device Name: CollaFirm Collagen Wound Dressing
Indications for Prescription (Rx) Use:
CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns.
Prescription Use 1 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
JiyoungDang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K120250