(131 days)
Not Found
No
The device description and supporting information focus on the material composition and physical properties of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is a dressing intended to treat various types of wounds and skin injuries, supporting the healing process and absorbing exudates.
No
The device is a dressing designed to absorb exudates from wounds and protect various sites, which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes a physical dressing made of silver alginate, calcium alginate, and a polyester or polyurethane backing, designed to absorb exudates from wounds. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for treating various types of wounds and protecting surgical sites. These are applications directly on the body for therapeutic or protective purposes.
- Device Description: The device is a wound dressing designed to absorb exudates and provide antimicrobial properties. This is a topical application, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is to manage and treat a wound.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
SilverSite Catheter Dressing containing a slow release anti-microbial silver is intended for use as a hydrophilic wound dressing that is used to absorb exudates and to cover a wound caused by the use of vascular and non-vascular perculaneous medical devices. It may be placed under and around external catheter tubing, and held in place on the wound an/or access device by a transparent gas permeable film harrier dressing, or other protective/retention covering; or it may be used as a stand alone device without a secondary cover.
Professional Indications (Prescription Use):
Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
Device Description
The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound.
The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.
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)
Studies including Cytotoxicity, Sensitization, Irritation or Cutaneous Reactivity Testing, Microbial Growth Suppression, Microbial Sterility Testing, Analysis for Bacterial Contamination, and Antimicrobial Properties have demonstrated and supported safety and efficacy criteria for this device.
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.
Not Found
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
SEP 2 0 2004
510(k) SUMMARY X.
- SUBMITTER'S NAME ﺎ .
- CONTACT PERSON AT ADRI 2.
- DATE THAT 510(k) SUMMARY WAS PREPARED 3.
- NAME OF THE MEDICAL DEVICE (Classification/ Common/ Proprietary) 4.
- LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL న. EQUIVALENCE IS CLAIMED
- DESCRIPTION OF THE DEVICE 6.
- INTENDED USE OF THE DEVICE 7.
- TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE 8. DEVICES
- SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND 9. CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES
T. SUBMITTER'S NAME - START - START - START
ADRI 232 Main Street - Suite 11A Park Forest, IL 60466
Phone: (708)747-3717 Fax: (708)747-3657
2 ... U.S. REGULATORY CONTACT PERSON FOR ADRI
George H. Scherr, Ph.D. ADRI P.O. Box 134 Park Forest, IL 60466
Phone: (708)747-3717 Fax: (708)747-3657
1
KOY1268
DATE THAT 510(k) SUMMARY WAS PREPARED
April 25, 2004
AMIBO BETHBUDD CARD CARDER COM
Classification name
- 4 11. 4
Common / usual name
Dressing, wound and burn, (Surgery, 79 MGP)
Topical Wound Dressing Silver Alginate Foam Dressing
Trade Names: SilverSite™ or Calgitrol™
Proprietary names
EGALLY MARKETED DEVICES TO WHICH SU QUIVALENCE IS CLAIMED
- CALGITROL™ Ag Silver Alginate Foam Dressing (K011618) 】.
- ARGLAES-AB™ Antimicrobial Barrier Film Dressing (K970566) 2.
- ARGLAES-AB™ Antimicrobial Barrier Film Dressing (K990810) 3.
DESCRIPTION OF THE DEVICE
The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound.
The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.
2/3
2
KO41268
INTENDED USE OF THE DEVICE
SilverSite Catheter Dressing containing a slow release anti-microbial silver is intended for use as a hydrophilic wound dressing that is used to absorb exudates and to cover a wound caused by the use of vascular and non-vascular perculaneous medical devices. It may be placed under and around external catheter tubing, and held in place on the wound an/or access device by a transparent gas permeable film harrier dressing, or other protective/retention covering; or it may be used as a stand alone device without a secondary cover.
LOGICAL COMPARISON BETW 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
The predicate devices are:
-
- 510(k) K011618
The device set forth in the instant application is prepared exactly of the same composition as approved in our 510(k) application K011618.
The predicate devices of 510(k) ARGLAES AB (K970566) and 510(k) ARGLAES AB (K990810) provide the same or similar functions, characteristics, and accessories as described herein for the instant device.
Although there are some structural differences between the predicate devices and the instant application device, these differences are minor and raise no new questions of safety or effectiveness.
Y OF PRECLINICAL PERFORMANCE STUL NCLUSIONS FROM PRECLINICAL PERF NODEST
Studies including Cytotoxicity, Sensitization, Irritation or Cutaneous Reactivity Testing, Microbial Growth Suppression, Microbial Sterility Testing, Analysis for Bacterial Contamination, and Antimicrobial Properties have demonstrated and supported safety and efficacy criteria for this device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). 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 caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2004
George H. Scherr, Ph.D. ADRI P.O. Box 134 Park Forest, Illinois 60466
Re: K041268
K041200
Trade/Device Name: CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin
Regulatory Class: Unclassified Product Code: MGQ, FRO Dated: August 23, 2004 Received: August 24, 2004
Dear Dr. Scherr:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 2011 - 11:25 pm accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costieter rear (110.) that be novice, subject to the general controls provisions of the Act. The r ou may, merefore, mainer 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 If your device is clussined (boo acc or ols. Existing major regulations affecting your device can may oc subject to satin atatifical 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 r toase of acrisou may read that your device complies with other requirements of the Act that I Dri has made a avad regulations administered by other Federal agencies. You must or any I catal batates and states and station of be not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Far 607); adoling (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic north in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - George H. Scherr, Ph.D
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket nothication. The PDA miding of backandal office 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 If you desire specific advice for your ac 11-04-4659. Also, please note the regulation entitled, Colliact the Office of Compilance an (Set notification" (21CFR Part 807.97). You may obtain of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
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
5
Indications for Use
510(k) Number (if known): K041268
Device Name: · CALGITROL™ Ag Silver Alginate Fosm and Gel Foam Dressings with or without Maltodextrin
Indications For Use:
Professional Indications (Prescription Use):
Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites
Prescription Use X (Part 21 CFR 801 Subpar( D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE:-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) T
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1. of 1
510(k) Number K041268
EXHIBIT Q