(147 days)
Not Found
No
The summary describes a traditional wound dressing with an antibiotic hydrogel and a polymeric film. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a wound dressing that helps manage wounds and prevent bacterial contamination, which is a supportive rather than a therapeutic function.
No
The device is a wound dressing with an antibiotic hydrogel, used for managing partial and full-thickness wounds. Its purpose is therapeutic (wound management and prevention of bacterial contamination), not diagnostic.
No
The device description clearly states it is a wound dressing composed of physical materials (hydrogel, polymeric film) and contains an antibiotic mixture, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the management of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound dressing with an antibiotic hydrogel. This is a topical treatment, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, the CardioTech Antibiotic Hydrogel Wound Dressing is a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full- thickness wounds. They may be used on the following wounds:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Blisters
Superficial burns
Abrasions and lacerations
Donor sites"
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
"CardioTech Antibiotic Hydrogel Wound Dressings are semi-occlusive, and absorptive. The wound contact surface is composed of an antibiotic containing hydrogel. The OTC antibiotic mixture used consists of the following components: Neomycin Sulfate, 3.5mg, Bacitracin Zinc 500 Units and Polymyxin B Sulfate, 10,000 Units. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. A second outer layer consists of a polymeric film."
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)
Not Found
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
510(k) CardioTech Antibiotic Hydrogel Wound Dressing CardioTech International, Inc.
DEC 3 0 2002
510(k) Summary
CardioTech Antibiotic Hydrogel Wound Dressing
| Submitters Details: | CardioTech International, Inc.
78-E, Olympia Avenue,
Woburn, MA 01801-2057
Tel: (781) 933-4772
Fax: (781) 933-3933 | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Contact Person: | Michael Szycher, Ph.D.
Chairman and CEO
CardioTech International, Inc.
Tel: (781) 933-4772
Fax: (781) 933-3933 | |
| Name of Device: | Classification Name: Dressing, Wound
Common Name: Dressing
Proprietary Name: CardioTech Antibiotic Hydrogel Wound Dressing
Device Classification: Unclassified. | |
| Substantial Equivalence: | CardioTech Antibiotic Hydrogel Wound Dressings are substantially equivalent
to MEDIMAC Bandages (Enquay Pharmaceutical Associates, K930457) and
Adhesive Bandage with Antibiotic (Johnson & Johnson, K943314). | |
| Description: | CardioTech Antibiotic Hydrogel Wound Dressings are semi-occlusive,
and absorptive. The wound contact surface is composed of an antibiotic
containing hydrogel. The OTC antibiotic mixture used consists of the
following components: Neomycin Sulfate, 3.5mg, Bacitracin Zinc 500 Units
and Polymyxin B Sulfate, 10,000 Units. The antibiotic mixture is present to
help prevent bacterial contamination of the dressing. A second outer layer
consists of a polymeric film. | |
| Indications for Use: | CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the
management of partial and full- thickness wounds. They may be used on the
following wounds: | |
| | Venous stasis ulcers
Diabetic ulcers
Pressure sores
Blisters | Superficial burns
Abrasions and lacerations
Donor sites |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Public Health Service .
DEC 30 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CardioTech International, Inc Andrew M. Reed. Ph.D. 12106 West 75" Lane Arvada, Colorado 80005-5306
Re: K022584
Trade/Device Name: CardioTech Antibiotic Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: October 31. 2002 Received: November. 7, 2002
Dear Dr. Reed:
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.
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 mav 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
2
Dr. Andrew M. Reed
quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (01) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) CardioTech Antibiotic Hydrogel Wound Dressing CardioTech International, Inc.
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(k) Number:
K022584 CardioTech International, Inc.
Device Name:
CardioTech Antibiotic Hydrogel Wound Dressing
Indications for Use:
Cardio Tech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and fullthickness wounds. They may be used on the following wounds:
Venous stasis ulcers Diabetic ulcers Pressure sores Blisters
Superficial burns Abrasions and lacerations Donor sites
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Miriam C. Provost
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
of Gene i Restorative umlavical +26 ices
Kc22584
(Optional Formal 1-2-96)