(89 days)
For Over-the-Counter Use: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; - Partial thickness (second degree) burns; l AND/OR - Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg . ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); - Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; - Surgical wounds that heal by primary intent such as dermatological and surgical = incisions (e.g. orthopedic and vascular); - Traumatic wounds; l - Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; - Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; - Painful wounds; - Infected wounds
AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is a one piece wound dressing comprised of two layers of soft, sterile non-woven material. The non-woven pads are comprised of Hydrofiber™ dressing and ionic silver stitchbonded together with regenerated cellulose fibers and designed to provide additional absorbency and tensile strength properties. 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.
Section 5 of the 510(k) summary for AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber (K121275) states that the safety and effectiveness of the device were demonstrated by literature and clinical data provided in previous 510(k)s, specifically referencing K080383 for AQUACEL™ Ag Hydrofiber™ Dressing. This indicates that the current submission relies on the substantial equivalence to a predicate device rather than presenting new primary study data to meet specific acceptance criteria. Therefore, the detailed information requested in the prompt related to a new study's acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not directly available in the provided text for this specific device (K121275).
Summary of Information from the Provided Text:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated as this submission relies on established equivalence to a predicate device. The performance is implied to be similar to the predicate.
- Sample size used for the test set and the data provenance: Not applicable, as no new test set study data is presented. The submission relies on existing literature and clinical data from the predicate device (K080383).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new test set study data is presented.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no new test set study data is presented.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a wound dressing, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly detailed for this submission, as it refers to "literature and clinical data" from a predicate device. For wound dressings, ground truth would typically relate to clinical outcomes such as healing rates, infection reduction, pain management, and tensile strength.
- The sample size for the training set: Not applicable, as no new training set data for an algorithm is relevant to this wound dressing submission.
- How the ground truth for the training set was established: Not applicable.
Conclusion based on the provided text:
The information indicates that the AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber device (K121275) was cleared based on its substantial equivalence to a previously cleared predicate device, AQUACEL™ Ag Hydrofiber™ Dressing (K080383). The claim is that the updated device is "largely based on the AQUACEL™ Ag Hydrofiber™ technology" and that "the safety and effectiveness... has been demonstrated by the literature and clinical data provided in previous 510(k)s (i.e., K080383)." Therefore, no new primary clinical study data or specific acceptance criteria for a new study are detailed in the provided K121275 summary to address the questions directly. The implicit acceptance criteria are that the new device performs similarly to or better than the predicate in terms of safety and effectiveness for wound management, as supported by existing data and literature.
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510(k) Premarket Notification AQUACEL™ Ag Extra™ Hydrofiber™ Dressing with Silver and Strengthening Fiber
April 25, 2012
JUL 2 5 2012
SECTION 5: 510(K) SUMMARY
Device: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber Applicant: ConvaTec Inc. Contact: Katrina Fiedler Associate Director, US Regulatory Affairs 908-904-2541 Fax: 908-904-2235 Email: katrina.fiedler@convatec.com Date: April 25, 2012 Trade Name: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber Classification Name: Dressing, Wound, Drug Device Class: Unclassified Product Code: FRO
Predicate Device: AQUACEL™ Ag Hydrofiber™ Dressing, K080383
AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is a one piece wound dressing comprised of two layers of soft, sterile non-woven material. The non-woven pads are comprised of Hydrofiber™ dressing and ionic silver stitchbonded together with regenerated cellulose fibers and designed to provide additional absorbency and tensile strength properties. 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 EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions, lacerations, minor cuts, minor scalds and burns. Under the supervision of a healthcare professional, AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; partial thickness (second degree) burns; diabetic foot ulcers, (venous stasis
ConvaTec Inc.
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510(k) Premarket Notification AQUACEL™ Ag Extra™ Hydrofiber™ Dressing with Silver and Strengthening Fiber
April 25, 2012
ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); surgical wounds left to heal by secondary intention such as dehisced surgical incisions; surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g. orthopedic and vascular); traumatic wounds; wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; oncology wounds with exudate, such as fungoids-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; painful wounds and infected wounds.
Since AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is largely based on the AQUACEL™ Ag Hydrofiber™ technology, the safety and effectiveness of AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber has been demonstrated by the literature 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 wounds.
Thus we believe that, AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is substantially equivalent to the previously cleared Hydrofiber™technology based products (reference K080383) and that AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber can be used safely and effectively for the management of wounds.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 25 2012
Convatec. Incorporated % Ms. Katrina Fiedler Associate Director, US Regulatory Affairs 200 Headquarters Park Drive Skillman, New Jersey 08558
Re: K121275
Trade/Device Name: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber Regulatory Class: Unclassified Product Code: FRO Dated: April 25, 2012 Received: April 27, 2012
Dear Ms. Fiedler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Katrina Fiedler
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 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/ucm115809.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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milker
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification AQUACEL™ Ag Extra™ Hydrofiber™ Dressing with Silver and Strengthening Fiber
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not Known
Device Name: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber
For Over-the-Counter Use:
AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for:
- Abrasions -
- Lacerations -
- Minor cuts
- Minor scalds and burns
Under the supervision of a healthcare professional:
AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of:
- Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection;
- Partial thickness (second degree) burns; l
AND/OR
- Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg . ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
- Surgical wounds left to heal by secondary intention such as dehisced surgical incisions;
- Surgical wounds that heal by primary intent such as dermatological and surgical = incisions (e.g. orthopedic and vascular);
- Traumatic wounds; l
- Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
- Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma;
- Painful wounds;
- Infected wounds
x
Prescription Use
Over-The-Counter Use _
(Part 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)
Daniel Kane for MM
Division Sign Off
ConvaTec Inc.
al. Orthopedic. and Restorative Devi
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510(k) Number K12(275
N/A