(324 days)
Not Found
Not Found
No
The provided 510(k) summary describes a wound dressing and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes.
The device is indicated for the management and treatment of various types of wounds, including ulcers and burns, which are conditions that require therapeutic intervention.
No
Explanation: The device is a wound dressing indicated for the management of various types of wounds, not for diagnosis. It is used for treatment and protection, not for identifying the nature or cause of a disease or condition.
No
The 510(k) summary describes a wound dressing, which is a physical medical device, not software.
Based on the provided information, the device, Puracol® Plus Ag MicroScaffold™ Wound Dressing, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for the management of various types of wounds. This is a topical application for treating the wound itself, not for testing or analyzing samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Performing tests in a laboratory setting
The device is a wound dressing, which falls under the category of medical devices used for wound care and management.
N/A
Intended Use / Indications for Use
Puracol® Plus Ag MicroScaffold™ Wound Dressing is indicated for the management of:
- Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- First and second degree burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Trauma wounds healing by secondary intention
- Dehisced wounds
- Surgical wounds
- Dehisced surgical wounds
These dressings may be cut to size and may be layered for the management of deep wounds.
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.)
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.
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).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2008
Medline Industries, Inc. % Mr. Matt Clausen One Medline Place Mundelein, Illinois 60060
Re: K071552
Trade/Device Name: Puracol Plus Ag Collagen Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 17, 2008 Received: April 18, 2008
Dear Mr. Clausen:
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 - Mr. Matt Clausen
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: Puracol® Plus Ag MicroScaffold™ Wound Dressing
Indications for Use:
Puracol® Plus Ag MicroScaffold™ Wound Dressing is indicated for the management of:
- Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- First and second degree burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Trauma wounds healing by secondary intention
- Dehisced wounds
- Surgical wounds
- Dehisced surgical wounds
These dressings may be cut to size and may be layered for the management of deep wounds.
PRECAUTIONS:
Puracol® Plus Ag wound dressings are suitable for use under compression therapy with healthcare professional supervision. Wounds with diagnosed infection may be managed with Puracol® Plus Ag dressings only when the causes of infection are being treated in parallel by medical professionals. The dressing is not intended for the treatment of infected wounds, and cannot be considered to be a substitute for proper management of infections.
CONTRAINDICATIONS:
Puracol® Plus Ag cannot be used on patients who are allergic to collagen or silver. Product use should be discontinued should signs of sensitization occur. The product is not indicated for the treatment of third degree burns.
Prescription Use XX (Per 21 CFR 801.109)
Nel RPl
(Division Sign-Off) formem
Division of Generar, Restorative,
and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS ANOTHER PAGE IF NEEDED) 11552 Concurrence of CDRH, Office of Device Evaluation (ODE)