(189 days)
No
The 510(k) summary describes a wound dressing with antimicrobial and odor-binding properties, composed of charcoal cloth and silver. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a wound dressing intended to help reduce infection in various types of wounds, which are therapeutic indications.
No
The device is a wound dressing designed to provide an effective barrier to bacterial penetration, adsorb odor, and potentially reduce infection in wounds. It does not diagnose any condition or disease.
No
The device description clearly states it is a physical wound dressing comprised of cloth, charcoal, and silver, indicating it is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a wound dressing that is applied externally to wounds to provide a barrier, adsorb odor, and potentially reduce infection. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a wound dressing (charcoal cloth, silver, nylon envelope). This aligns with a therapeutic device, not a device used to test samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to treat a wound directly.
N/A
Intended Use / 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.
Product codes
FRO
Device Description
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.
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)
Biocompatibility studies have demonstrated ACTISORB* Silver Safety 220 Antimicrobial Binding Dressing to be non-toxic, nonirritating, non-sensitizing, and non-cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACTISORB* Plus Activated Charcoal Dressing with Silver (K892851), ACTICOAT Calcium Alginate Dressing (K002896)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SECTION 2: 510(k) SUMMARY
ACTISORB* Silver 220 Antimicrobial Binding Dressing
| Submitter's Name and Address | Johnson & Johnson Medical Limited
Gargrave
SKIPTON
North Yorkshire
BD23 3RX
United Kingdom |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | 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, NJ 08876 |
| | Telephone: 908-218-2893
Facsimile: 908-218-2595
e-mail: pflood@ethus.jnj.com |
| Name of Medical Device | Classification Name: Dressing, Wound
Common/Usual Name: Antimicrobial Wound Dressing
Proprietary 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 Kingdom
ACTICOAT 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
1
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
2
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.
3
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
4
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