(117 days)
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Not Found
No
The 510(k) summary describes a collagen wound dressing, a passive medical device, and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality.
Yes.
The device is used for the management and healing of various types of wounds, including ulcers and burns, which are therapeutic applications.
No
Explanation: The document indicates the device is a wound dressing used for the management and healing of various types of wounds, not for diagnosing conditions.
No
The device description clearly identifies the device as a "Collagen Wound Dressing," which 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 describes the device as a wound dressing for managing various types of wounds. This is a topical application for treating the wound itself, not for diagnosing a condition or analyzing a sample from the body in vitro (outside the body).
- Device Description: The description simply states "Medline Collagen Wound Dressing," which aligns with a physical dressing applied to a wound.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests in vitro
Therefore, the Medline Collagen Wound Dressing is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Medline's Collagen Wound Dressing is indicated for the management of wounds including:
- Full thickness and partial thickness wounds .
- Pressure ulcers .
- Venous ulcers .
- Ulcers caused by mixed vascular etiologies .
- Diabetic ulcers ●
- Partial and full thickness burns ●
- Donor sites and other bleeding surface wounds .
- Abrasions .
- Traumatic wounds healing by secondary intention .
- Dehisced surgical incisions .
These dressings may be cut to size and may be layered for the management of deep wounds.
Product codes
KGN
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
Over-the-Counter Use
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its wing. The text "U.S. Department of Health and Human Services" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 19 2006
Medline Industries, Inc. % Ms. Lara N. Simmons Corporate Director, Regulatory Affairs One Medline Place Mundelein, Illinois 60060-4486
Re: K060456
Trade/Device Name: Medline Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: April 21, 2006 Received: April 24, 2006
Dear Ms. Simmons:
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. 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
1
Page 2 - Ms. Lara N. Simmons
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,
Hulun Lerner as
Mark N. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KOLOUSZ
Page
510(k) Number (if known):
Device Name: Medline Collagen Wound Dressing Indications for Use:
Medline's Collagen Wound Dressing is indicated for the management of wounds including:
- Full thickness and partial thickness wounds .
- Pressure ulcers .
- Venous ulcers .
- Ulcers caused by mixed vascular etiologies .
- Diabetic ulcers ●
- Partial and full thickness burns ●
- Donor sites and other bleeding surface wounds .
- Abrasions .
- Traumatic wounds healing by secondary intention .
- Dehisced surgical incisions .
These dressings may be cut to size and may be layered for the management of deep wounds.
PRECAUTIONS:
Collagen Wound Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. Collagen Wound dressing may be used under compression therapy with healthcare professional supervision.
CONTRAINDICATOINS:
Collagen Wound Dressing is not intended for use on wounds with active vasculitis or on patients with a known sensitivity to collagen.
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use_ XX
Helene Lemer
(Division Sign-Off)
(PLEASE DO NOT WRITE BLOEW TH
Concurrence of CDRH, Office
510(k) Number K060456