(77 days)
Not Found
No
The 510(k) summary describes a physical wound dressing with antimicrobial properties and a cold pack, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The primary purpose of the device is wound management and acting as a barrier to microbial colonization, not for treating a disease or condition itself.
No
The device is described as a postoperative wound dressing and its intended use is for the management of post-surgical wounds. There is no indication that it is used to diagnose a medical condition.
No
The device description clearly lists physical components such as elastic straps, bandages, dressing, foam islands, and a reusable cold pack, indicating it is a physical medical device, not software-only.
Based on the provided information, the Arthrex ProWick™ Postoperative Wound Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of post-surgical wounds and acting as a barrier to microbial colonization within the dressing. This is a topical application for wound care, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a wound dressing with various components for wound management and antimicrobial properties. It does not describe a device used to analyze biological samples.
- 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
Therefore, the Arthrex ProWick™ Postoperative Wound Dressing falls under the category of a wound care device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the silver component present in the dressing may act as a barrier to colonization of E coli, S aureus, A. niger, C. albicans, and P. aeruginosa within the dressing.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Arthrex ProWick™ device is a post-surgical antimicrobial wound dressing containing a variety of elements such as elastic straps, waterproof bandages, dressing, foam islands infused with a silver based antimicrobial agent, and a reusable cold pack, sold sterile.
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.
K033900, K050726, K062559, and K062212
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
K07 2378
pagel gl
510(k) Summary
NOV 0 9 2007
| 510(k) Number: | K072378 |
|---|---|
| Date: | 8/21/2007 |
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse |
| Trade Name: | Arthrex ProWick™ |
Trade Name: Arthrex ProVVick Wound dressing Common Name: Classification: wound dressing Product Code: FRO Predicate Devices: K033900, K050726, K062559, and K062212
Description:
The Arthrex ProWick™ device is a post-surgical antimicrobial wound dressing containing a variety of elements such as elastic straps, waterproof bandages, dressing, foam islands infused with a silver based antimicrobial agent, and a reusable cold pack, sold sterile.
Indications for Use:
The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the silver component present in the dressing may act as a barrier to colonization of E coll, S aureus, A. niger, C. albicans, and P. aeruginosa within the dressing.
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex ProWick TM and the predicate devices with similar indications and technological characteristics do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices.
1
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the edge. In the center of the seal is a stylized image of an eagle or bird with its wings spread, depicted with thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K072378
Trade/Device Name: Arthrex ProWick™ Regulatory Class: Unclassified Product Code: FRO Dated: October 3, 2007 Received: October 22, 2007
Dear Ms. Waterhouse:
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.
2
Page 2 - Ms. Ann Waterhouse, RAC
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
3
Indication for Use Form 3.
510(k) Number: K072378
Device Name: Arthrex ProWick™
Indications for Use:
The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the silver component present in the dressing may act as a barrier to colonization of E coll, S aureus, A. niger, C. albicans, and P. aeruginosa within the dressing.
Prescription Use AND/OR Over-The-Counter Use (Per 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)
Page 1 of
(Division Sign-Off) Division of General, Restora and Neurological Devices
510(k) Number_6223378
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