K Number
K083007
Device Name
PROWICK
Manufacturer
Date Cleared
2009-04-08

(182 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
The 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.
More Information

Not Found

No
The summary describes a physical wound dressing with antimicrobial properties and a cold pack, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No.
The device is a wound dressing which manages post-surgical wounds and provides an antimicrobial barrier; it does not treat or cure a disease or condition.

No
The "Intended Use / Indications for Use" states that the device "is indicated for the management of post-surgical wounds" and "may act as a barrier to colonization." This describes a therapeutic or preventative function, not a diagnostic one. There is no mention of identifying a condition, disease, or its likelihood.

No

The device description explicitly lists physical components such as elastic straps, waterproof 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:

  • IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
  • The Arthrex ProWick is a wound dressing. Its intended use is for the management of post-surgical wounds and to act as a barrier to microbial colonization within the dressing. It is applied externally to the body.

The description clearly indicates it's a topical wound dressing, not a device used to test biological samples.

N/A

Intended Use / Indications for Use

The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the sliver component present in the management of poss barrier to colonization of E. coli, S. aureus, A. niger, C. albicans, and P. aeruginosa within the dressing.

Product codes

FRO

Device Description

The 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)

K072378

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

Ko8 3007 Page 1 of 2

APR - 8 2009

Arthrex. SPECIAL 510(k): ProWick

Manufacturer/Distributor/SponsorArthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
510(k) ContactSally Foust, RAC
Regulatory Affairs Project Manager
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
Telephone: 239/643.5553, ext. 1251
Fax: 239/598.5508
Email: sfoust@arthrex.com
Trade NameProWick
Common NameWound Dressing
Product Code -Classification
NameFRO
Dressing, Wound, Drug
Predicate DeviceArthrex ProWick, K072378
Device Description and Intended
UseThe 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.
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.
Substantial Equivalence
SummaryThe ProWick device is substantially equivalent to the
predicate ProWick device in which the basic features
and intended uses are the same. Any differences
between the ProWick device and the predicate ProWick
device is considered minor and do not raise questions
concerning safety and effectiveness. Based on the
information submitted, Arthrex, Inc. has determined that
ProWick with two-year shelf-life labeling is
substantially equivalent to the currently marketed
predicate device.

4 510(k) Summary of Safety and Effectiveness

1

K08 3007
page 2 of 2

ArthreX. SPECIAL 510(k): ProWick

5 Introductio

This SPECIAL 510(k) premarket notification is submitted to obtain clearance for the ProWick device with two-year shelf life labeling. This device is being submitted as a modification to K072378, Arthrex ProWick. The ProWick device with two-year shelf life labeling requires the submission of a premarket notification due to this labeling change.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written in a circle around the eagle. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2009

Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K083007

:

Trade/Device Name: ProWick Regulatory Class: Unclassified Product Code: FRO Dated: March 31, 2009 Received: April 3, 2009

Dear Ms. Foust:

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

3

Page 2 - Ms. Sally Foust

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 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.

Mule A Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Arthrex SPECIAL 510(k): ProVVick

Indications for Use

510(k) Number: K082007

Device Name: ProWick

The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the sliver component present in the management of poss barrier to colonization of E. coli, S. aureus, A. niger, C. albicans, and P. aeruginosa within the dressing.

Prescription Use _X_AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) PAGE 1 of 1

Dail Krone for MKM

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083007