(189 days)
ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including:
- pressure ulcers .
- venous ulcers .
- diabetic ulcers ●
- first and second-degree burns ●
- . donor sites
- surgical wounds ●
ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging.
ACTISORB* Silver 220 Antimicrobial Binding Dressing is a sterile primary wound dressing, comprised of activated charcoal cloth, impregnated with silver, within a spun bonded nylon envelope. Within the dressing, there is 220mg silver per 100g activated charcoal cloth equating to 33ug of silver per square centimeter of cloth.
1. Acceptance Criteria and Reported Device Performance:
The provided document describes the ACTISORB Silver 220 Antimicrobial Binding Dressing* as a wound dressing. The acceptance criteria and device performance are not explicitly presented in a table format with specific quantitative metrics in the provided text.
However, the "Device Description" and "Indications for Use" sections imply general performance characteristics against which the device is implicitly accepted:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy: Effective barrier to bacterial penetration. | "ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration..." "The binding properties of the dressing trap bacteria, bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds..." |
| Odor Adsorption: Adsorbs offending odor from wounds. | "...and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor." |
| Biocompatibility/Safety: Non-toxic, non-irritating, non-sensitizing, non-cytotoxic. | "Biocompatibility studies have demonstrated ACTISORB* Silver 220 Antimicrobial Binding Dressing to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text (K022483 510(k) summary) does not contain information about a specific "test set" in the context of clinical studies for diagnostic device performance. This submission is for a wound dressing, and the focus is on substantial equivalence to existing predicate devices based on its physical properties and intended use. The "biocompatibility studies" are mentioned, but details on sample size, design, or data provenance (country, retrospective/prospective) are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to the provided document. The submission is for a wound dressing, which typically relies on pre-clinical testing (e.g., in-vitro antimicrobial efficacy, biocompatibility) and clinical experience with similar devices, rather than a "ground truth" established by experts for a diagnostic output.
4. Adjudication Method for the Test Set:
This information is not applicable to the provided document for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The provided 510(k) summary does not mention or describe a multi-reader multi-case comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human readers interpret results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This is a medical device (wound dressing), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant or applicable.
7. The Type of Ground Truth Used:
As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic studies is not directly applicable here. The evidence for the device's performance appears to be based on:
- In-vitro testing: Implied by the statement "ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor..." and "Biocompatibility studies have demonstrated..."
- Clinical experience/literature: Supporting the indications for use in various wound types, likely drawing from evidence related to silver and charcoal dressings.
- Substantial equivalence: The primary "proof" for regulatory clearance is establishing substantial equivalence to legally marketed predicate devices with similar materials and intended use.
8. The Sample Size for the Training Set:
This information is not applicable as this is not an AI/algorithm-based device that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as this is not an AI/algorithm-based device that would require a "training set."
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SECTION 2: 510(k) SUMMARY
ACTISORB* Silver 220 Antimicrobial Binding Dressing
| Submitter's Name and Address | Johnson & Johnson Medical LimitedGargraveSKIPTONNorth YorkshireBD23 3RXUnited Kingdom |
|---|---|
| Contact Person | Patricia Flood.Senior Project Manager, Regulatory AffairsJohnson & Johnson Wound Management Worldwidea Division of Ethicon, Inc.Route 22 West P.O. Box 151Somerville, NJ 08876 |
| Telephone: 908-218-2893Facsimile: 908-218-2595e-mail: pflood@ethus.jnj.com | |
| Name of Medical Device | Classification Name: Dressing, WoundCommon/Usual Name: Antimicrobial Wound DressingProprietary Name: ACTISORB* Silver 220 Antimicrobial Binding Dressing |
| Substantial Equivalence | ACTISORB* Silver 220 Antimicrobial Binding Dressing is substantially equivalent to:ACTISORB* Plus Activated Charcoal Dressing with Silver (K892851) manufactured by Johnson & Johnson Medical Ltd., Gargrave, SKIPTON, BD23 3RX, United KingdomACTICOAT Calcium Alginate Dressing (K002896) manufactured by Westaim Biomedical Inc, One Hampton Road, Suite 320, Exeter, NH 03833 |
ACTISORB* Silver 220 Antimicrobial Binding Dressing Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc.
26/7/02
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Antimicrobial wound dressings are currently unclassified by Device Classification United States Food and Drug Administration's Center for Devices and Radiological Health. ACTISORB* Silver 220 Antimicrobial Binding Dressing is a Device Description sterile primary wound dressing, comprised of activated charcoal cloth, impregnated with silver, within a spun bonded nylon envelope. Within the dressing, there is 220mg silver per 100g activated charcoal cloth equating to 33ug of silver per square centimeter of cloth. ACTISORB* Silver 220 Antimicrobial Binding Dressing provides Indications for Use an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacteria, bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including: pressure ulcers ■ ■ venous ulcers 트 diabetic ulcers . first and second-degree burns 마 donor sites l surgical wounds ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging. Biocompatibility studies have demonstrated ACTISORB* Silver Safety 220 Antimicrobial Binding Dressing to be non-toxic, nonirritating, non-sensitizing, and non-cytotoxic.
ACTISORB* Silver 220 Antimicrobial Binding Dressing Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc.
26/7/02
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
FEB 0 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Johnson & Johnson Medical Limited c/o Ms. Patricia Flood Senior Project Manager, Regulatory Affairs Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, New Jersey 08876
Re: K022483
Trade Name: Actisorb* Silver 220 Antimicrobial Binding Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 25, 2002 Received: November 26, 2002
Dear Ms. Flood:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
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Page 2 - Ms. Patricia Flood
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
(41 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) Number (if known):_
Device Name: ACTISORB* Silver 220 Antimicrobial Binding Dressing
Indications for Use:
ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including:
- pressure ulcers .
- venous ulcers .
- diabetic ulcers ●
- first and second-degree burns ●
- . donor sites
- surgical wounds ●
ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Federal Law restricts, this device to sale by or on the order of a physician (or properly licensed practitioner).
Miriam C. Provost
tive
ACTISORB* Silver 220 Antimicrobial Binding Dressing Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc.
26/7/02
N/A