(25 days)
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Not Found
No
The provided text describes a wound dressing and does not mention any AI or ML capabilities, image processing, or data analysis typically associated with AI/ML medical devices.
Yes
The device is a wound dressing intended for the management of various types of wounds, including ulcers and burns, which are conditions requiring therapeutic intervention for healing.
No
The device is described as a wound dressing intended for the management of various types of wounds, which is a therapeutic function, not a diagnostic one. It does not mention detection, diagnosis, or assessment of a medical condition.
No
The device description and intended use clearly describe a wound dressing, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a wound dressing for managing various types of wounds. This is a topical application for treating the body directly, not for testing samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
IVDs are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Wound dressings, like the one described, are therapeutic devices applied externally to aid in the healing process.
N/A
Intended Use / Indications for Use
The Collagran wound dressing and Collagran Ag wound dressing are intended to be used for the following conditions: the management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, first and second degree burns, donor and graft sites, abrasions and lacerations, dehisced surgical wounds, traumatic wounds healing by secondary intention
Product codes
FRO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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).
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N/A
0
Image /page/0/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text around the border appears to be "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2006
Covalon Technologies Ltd. c/o Mr. Jacques Lemmetti Executive Chairman 2033 Iverson Lane Waxham, North Carolina 28173
Rc: K060804
Trade/Device Name: Collagran wound dressing, Collagran Ag wound dressing Regulation Number: Unclassified Product Code: FRO Dated: March 23, 2006 Received: March 27. 2006
Dear Mr. Lemmetti
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.
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Page 2 -- Mr. Jacques Lemmetti
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Herbie Simmons
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
| 510(k)
Number
| (if known) | ||
|---|---|---|
| Device Name | Collagran wound dressing | |
| Collagran Ag wound dressing | ||
| Indications | ||
| for Use | The Collagran wound dressing and Collagran Ag wound dressing are | |
| intended to be used for the following conditions: | ||
| the management of full and partial thickness wounds including: | ||
| pressure ulcers,diabetic ulcers,ulcers caused by mixed vascular etiologies,venous ulcers,first and second degree burns,donor and graft sites,abrasions and lacerations,dehisced surgical wounds,traumatic wounds healing by secondary intention | ||
| Prescription Use | AND/OR | Over-The-Counter Use |
| (Part 21 CFR 801 Subpart D) | (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_K 060304________________________________________________________________________________________________________________________________________________________
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