(103 days)
Not Found
No
The summary describes a collagen matrix film for wound management and does not mention any AI or ML components or functionalities.
Yes
The device is described for the management of wounds such as various types of ulcers and burns, indicating a therapeutic purpose to aid in healing and recovery.
No
Explanation: The device description states "CollaGUARD™ is a clear collagen matrix film intended for topical use" and the intended use describes it for "management of wounds", indicating it is a wound dressing or treatment device, not a diagnostic device. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description clearly states that CollaGUARD is a "clear collagen matrix film intended for topical use," indicating it is 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 CollaGUARD is for the "management of wounds" and is a "topical wound dressing." This indicates a therapeutic or wound care application, not a diagnostic one.
- Device Description: The description of CollaGUARD as a "clear collagen matrix film intended for topical use" further supports its role as a wound dressing applied externally.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Predicate Device: The predicate device listed is a "Collagen Topical Wound Dressing," which is consistent with a wound care product, not an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. CollaGUARD does not fit this description.
N/A
Intended Use / Indications for Use
CollaGUARD may be used for the management of wounds such as:
- Pressure ulcers .
- . Venous stasis ulcers
- . Diabetic ulcers
- First and second degree burns .
- Partial and full thickness wounds .
- Superficial injuries .
Product codes (comma separated list FDA assigned to the subject device)
KMF, KGN
Device Description
CollaGUARD™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the word "Innocoll" in a bold, sans-serif font. The word is underlined with a thick, black line. Below the line, the word "Pharmaceuticals" is written in a smaller, sans-serif font.
OCT - 2 2006
pass 1 g 2
IDA Business & Technology Park
Garrycaltie, Athlone
Co. Westmeath, Ireland
Tel: +353 (0)90 6486834
Fax: +353 (0)90 6486835
www.innocoll-pharma.com
510(k) Summary
-
- Date Prepared: August 15, 2005
- Submitter
Innocoll Pharmaceuticals IDA Business and Technology Park Garrycastle Athlone Co. Westmeath Ireland. Tel: +353 (0) 9064 86834 Fax: +353 (0) 9064 86835
Submission Correspondent: Aaron Wyse Director of Quality and Regulatory Affairs
- CollaGUARD™ 3. Proprietary Name:
-
- Common Name: Topical Wound Dressing
-
- Device Classification: Product Code: KMF Classification Name: Dressing Wound Collagen Regulatory Class: Unclassified
6. Statement of Substantial Equivalence:
CollaGUARD™ is substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc.
1
K061746
Page 5 - 2
7. Intended Use
CollaGUARD may be used for the management of wounds such as:
- · Pressure ulcers
- Venous stasis ulcers
- · Diabetic ulcers
- · First and second degree burns
- · Partial and full thickness wounds
- · Superficial injuries
8. Description
CollaGUARD™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.
9. Biocompatibility
CollaGUARD's biocompatibility testing has been completed against the requirements of ISO 10993 -1:2003. CollaGUARD has passed the requirements of all tests and has been shown to be a biocompatible topical wound dressing.
10.Conclusion
CollaGUARD™ is a member of a family of collagen products distributed by Innocoll Pharmaceuticals. The collagen products have an extensive and established history of safety and effectiveness. Collagen has a primary role in all phases of wound healing making it an effective agent for managing wound treatment.
CollaGUARD™ is substantially equivalent to the predicate device delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings, and a wavy line representing its legs. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innocoll Pharmaceuticals % Mr. Aaron Wyse Director of Quality and Regulatory Affairs IDA Business and Technology Park. Garrycastle, Athlone Co. Westmeath, Ireland
OCT - 2 2006
Re: K061746
Trade/Device Name: CollaGuard Regulation Name: Collagen Dressing Regulatory Class: Unclassified Product Code: KGN Dated: August 15, 2006 Received: August 31, 2006
Dear Mr. Wyse:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Mr. Aaron Wyse
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours. Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: CollaGUARD
Indications For Use:
Indications:
CollaGUARD may be used for the management of wounds such as:
- Pressure ulcers .
- . Venous stasis ulcers
- . Diabetic ulcers
- First and second degree burns .
- Partial and full thickness wounds .
- Superficial injuries .
Prescription Use x (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 IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | LC6-1746 |