(250 days)
No
The document describes a wound dressing with absorbent and antimicrobial properties. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
Explanation: The device is used for the management of wounds and aims to support the body's healing process, which aligns with the definition of a therapeutic device. It also acts as an effective barrier to bacterial penetration to help reduce infection.
No
This device is a wound dressing designed to help manage wounds and reduce infection, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical dressing comprised of materials like hydrocolloid adhesive, polyurethane film, and silver, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds healing by primary intent and as a barrier to bacterial penetration. This is a direct therapeutic application to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a wound dressing with adhesive and a film layer. This is a physical barrier and absorbent material applied externally.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
The device is clearly described as a wound dressing for external application and management of surgical incisions.
N/A
Intended Use / Indications for Use
AQUACEL® Ag Surgical dressing is available under the supervision of a healthcare professional and is indicated for the management of wounds healing by primary intent (e.g., traumatic and elective post-operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.
Under the supervision of a healthcare professional: AQUACEL® Ag Surgical may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
AQUACEL® Ag Surgical Dressing with Silver is a one piece post-operative dressing comprised of an inner (wound contact) non-woven pad which is held in place by two layers of skin-friendly hydrocolloid adhesive and an outer top layer of polyurethane film. The nonskin moraly if your over of and innic silver sitems and ionic silver stitchbonded with nylon and elastane yarn for dressing extensibility (so the ressing will stretch and be eiastane yairi for drossing oxiension (after limb movement the dressing will return to its original shape and size without the application of any additional force to the skin).
The one-piece dressing design provides ease of application and removal and provides a waterproof, bacterial, and viral barrier covering to the wound. The benefits provided by this waterproof, at the clinical need for improved management of surgical wounds which have wound drainage and are at risk of infection.
AQUACEL® Ag Surgical combines the absorbency/retention properties of AQUACEL® Ag AQUACEL Ag Surgical combines the absorbonomics of DuoDERM® Extra Thin adhesive.
AQUACEL® Ag Surgical dressing is a soft, sterile, non-woven pad composed of hydrocolloid fibers. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process.
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
healthcare professional
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)
Since AQUACEL® Ag Surgical dressing is based on the AQUACEL® Ag Hydrofiber" technology, the safety and effectiveness of AQUACEL® Ag Surgical has been demonstrated by the lite and clinical data provided in previous 510(k)s (i.e., K080383). In summary, a careful and thorough review of the literature suggests that Hydrofiber® dressings have been used safely and effectively in clinical trials for the management of-surgical incisions healing with primary intent. All the studies which have been reviewed suggest that, compared to a standard dressing, using a dressing with AQUACEL® leads to less dressing changes.
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.
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.
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
K091034
page 1 of 2
Premarket Notification 510(k) K091034 Response to FDA Request for Additional Information
4
October 16, 2009
Section 5: 510(K) Summary
| Device: | AQUACEL® Ag Surgical |
|---|---|
| Applicant: | ConvaTec Inc. |
| Contact: | Patricia Kearins |
| Manager, US Regulatory Affairs | |
| 908-904-2180 | |
| fax: 908-904-2235 | |
| email: patricia.kearins@convatec.com | |
| Date: | October 16, 2009 |
| Trade Name: | AQUACEL® Ag Surgical |
| Classification Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Predicate Devices: | AQUACEL® Ag Hydrofiber® Dressing, K080383 |
| DuoDERM® Extra Thin Dressing, K891696 | |
| (currently Class 1, 510(k) exempt) |
AQUACEL® Ag Surgical Dressing with Silver is a one piece post-operative dressing comprised of an inner (wound contact) non-woven pad which is held in place by two layers of skin-friendly hydrocolloid adhesive and an outer top layer of polyurethane film. The nonskin moraly if your over of and innic silver sitems and ionic silver stitchbonded with nylon and
elastane yarn for dressing extensibility (so the ressing will stretch and be eiastane yairi for drossing oxiension (after limb movement the dressing will return to its original shape and size without the application of any additional force to the skin).
The one-piece dressing design provides ease of application and removal and provides a waterproof, bacterial, and viral barrier covering to the wound. The benefits provided by this waterproof, at the clinical need for improved management of surgical wounds which have wound drainage and are at risk of infection.
AQUACEL® Ag Surgical combines the absorbency/retention properties of AQUACEL® Ag AQUACEL Ag Surgical combines the absorbonomics of DuoDERM® Extra Thin adhesive.
Page 99
1
K091034
page 2 of 2
Premarket Notification 510(k) K091034 Response to FDA Request for Additional Information
October 16, 2009
AQUACEL® Ag Surgical dressing is a soft, sterile, non-woven pad composed of hydrocolloid fibers. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process.
AQUACEL® Ag Surgical dressing is available under the supervision of a healthcare professional and is indicated for the management of wounds healing by primary intent (e.g., traumatic and elective post-operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.
Since AQUACEL® Ag Surgical dressing is based on the AQUACEL® Ag Hydrofiber" technology,
the safety and effectiveness of AQUACEL® Ag Surgical has been demonstrated by the lite and clinical data provided in previous 510(k)s (i.e., K080383). In summary, a careful and thorough review of the literature suggests that Hydrofiber® dressings have been used safely and effectively in clinical trials for the management of-surgical incisions healing with primary intent. All the studies which have been reviewed suggest that, compared to a standard dressing, using a dressing with AQUACEL® leads to less dressing changes.
Thus we believe that, similar to previously cleared Hydrofiber"-based products (reference
K080383), AQUACEL® Ag Surgical can be used safely and effectively for the management wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
ConvaTec Inc. % Ms. Patricia Kearins Manager, US Regulatory Affairs 200 Headquarters Park Drive Skillman, New Jersey 08558
DEC 1 6 2009
Re: K091034
Trade/Device Name: Aquacel® Ag Surgical Regulatory Class: Unclassified Product Code: FRO Dated: December 02, 2009 Received: December 03, 2009
Dear Ms. Kearins:
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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Patricia Kearins
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification 510(k) K091034 Response to FDA Request for Additional Information
October 16, 2009
Section 4: Indications For Use Statement
510(k) Number: K091034
Device Name: AQUACEL® Ag Surgical
Under the supervision of a healthcare professional:
AQUACEL® Ag Surgical may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Daniel Keane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091034
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