(349 days)
No
The device description and intended use describe a physical wound dressing with antimicrobial properties, and there is no mention of AI or ML in the provided text.
Yes
The device is intended for the management of exuding wounds and various types of ulcers, which are all conditions requiring therapeutic intervention.
No
Explanation: The device description and intended use clearly state that this is a "primary dressing" for "management of exuding wounds," not for diagnosing conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "sterile primary dressing comprised of freeze-dried composite of 55 % collagen, 44 % ORC, 1 % silver-ORC," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of exuding wounds, which 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 device is a wound dressing comprised of collagen, ORC, and silver-ORC. This is a physical material applied to a wound, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies mentioned are biocompatibility studies, which assess the safety of the material in contact with the body, not its diagnostic accuracy.
In summary, the Collagen-ORC Antimicrobial Matrix is a therapeutic device intended for wound management, not a diagnostic device used for in vitro testing.
N/A
Intended Use / Indications for Use
Collagen-ORC Antimicrobial Matrix is intended for the management of exuding wounds.
Under the supervision of a health care professional, Collagen-ORC Antimicrobial Matrix may be used for the management of:
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- Donor sites and other bleeding surface wounds
- Abrasions
- Traumatic wounds healing by secondary intention
- Dehisced surgical wounds
Collagen-ORC Antimicrobial Matrix may be used under compression therapy with healthcare professional supervision.
Product codes
FRO
Device Description
Collagen-ORC Antimicrobial Matrix is a sterile primary dressing comprised of freeze-dried composite of 55 % collagen, 44 % ORC, 1 % silver-ORC. Silver-ORC contains 25 % w/w ionically bound silver.
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
Under the supervision of a health care professional
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 the Collagen-ORC Antimicrobial Matrix to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROMOGRAN Matrix Wound Dressing (K014129), AQUACEL-Ag with Hydrofiber (K013814)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
OCT 2 1 2004
510(K) SUMMARY
Collagen-ORC Antimicrobial Matrix
| Submitter's Name and
Address: | Johnson & Johnson Medical Ltd.
Gargrave
Skipton
North Yorkshire
BD23 3RX
United Kingdom |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | John D. Paulson, Ph.D.
Vice-President, Regulatory Affairs and Quality
Assurance
Johnson & Johnson Wound Management
A division of Ethicon, Inc.
Telephone: (908) 218-2887
Fax: (908) 218-2734
e-mail: jpaulson@ethus.jnj.com |
| Name of Medical Device | Classification Name: Dressing, Wound
Common/Usual Name: Dressing
Proprietary Name: Collagen-ORC Antimicrobial
Matrix |
| Substantial Equivalence | Collagen-ORC Antimicrobial Matrix is
substantially equivalent to:
PROMOGRAN Matrix Wound Dressing (K014129)
Manufactured by Johnson & Johnson Medical, Ltd.,
Gargrave, SKIPTON, BD23 3RX, United Kingdom
AQUACEL-Ag with Hydrofiber (K013814)
Manufactured by ConvaTec, A Division of E.R.
Squibb and Sons, LLC |
| Device Classification | Currently wound dressings containing animal
derived materials are unclassified by U.S. Food and
Drug Administration's Center for Devices and
Radiological Health |
116
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Page 2 of 2
Device Description
Collagen-ORC Antimicrobial Matrix is a sterile primary dressing comprised of freeze-dried composite of 55 % collagen, 44 % ORC, 1 % silver-ORC. Silver-ORC contains 25 % w/w ionically bound silver.
Indications for Use The Collagen-ORC Antimicrobial Matrix is intended for the management of exuding wounds.
Under the supervision of a health care professional, Collagen-ORC Antimicrobial Matrix may be used for the management of:
- Diabetic ulcers .
- Venous ulcers ●
- . Pressure ulcers
- Ulcers caused by mixed vascular etiologies .
- Full-thickness & partial thickness wounds .
- . Donor sites and other bleeding surface wounds
- Abrasions .
- Traumatic wounds healing by secondary . intention
- . Dehisced surgical wounds
Collagen-ORC Antimicrobial Matrix may be used under compression therapy with healthcare professional supervision.
Safety
Biocompatibility studies have demonstrated the Collagen-ORC Antimicrobial Matrix to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
OCT 2 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
John D. Paulson, Ph.D. Vice President, Regulatory Affairs and Quality Assurance Johnson & Johnson Wound Management Route 22 West P.O. Box 151 Somerville, New Jersey 08876
Re: K033523
Trade/Device Name: Collagen - ORC Antimicrobial Matrix Product Code: FRO Dated: July 22, 2004 Received: July 23, 2004
Dear Dr. Paulson:
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 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 - John D. Paulson, Ph.D.
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 (240) 276-0115. 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,
Muriam 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
4
K033528
Indications for Use
коззё23 510(k) Number (if known):
Collagen-ORC Antimicrobial Matrix Device Name:
Indications For Use:
Collagen-ORC Antimicrobial Matrix is intended for the management of exuding wounds.
Under the supervision of a health care professional, Collagen-ORC Antimicrobial Matrix may be used for the management of:
- Diabetic ulcers ●
- Venous ulcers �
- Pressure ulcers .
- Ulcers caused by mixed vascular etiologies ●
- Full-thickness & partial thickness wounds �
- Donor sites and other bleeding surface wounds �
- Abrasions ◆
- Traumatic wounds healing by secondary intention ●
- Dehisced surgical wounds .
Collagen-ORC Antimicrobial Matrix may be used under compression therapy with healthcare professional supervision.
Prescription Use × (Part 21 CFR 801 Subpart 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)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of _ l ________________________________________________________________________________________________________________________________________________________________
510(k) Number K033523