(59 days)
Not Found
No
The 510(k) summary describes a passive wound dressing made of collagen and cellulose. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is intended for the management of exuding wounds such as diabetic ulcers, venous ulcers, and pressure ulcers, which are conditions that require therapeutic intervention.
No.
The device description and intended use indicate it is a wound dressing for managing exuding wounds, not for diagnosing conditions.
No
The device description clearly states it is a "sterile primary dressing comprised of a freeze-dried composite of 55% collagen and 45% oxidised regenerated cellulose," which are physical materials, 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 a wound dressing for managing exuding wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the composition of a wound dressing (collagen and cellulose). This is consistent with a medical device used for wound care, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to aid in wound healing, which falls under the category of a therapeutic medical device.
N/A
Intended Use / Indications for Use
The PROMOGRAN Matrix Wound Dressing is indicated for the management of exuding wounds including:
- Diabetic ulcers .
- Venous ulcers .
- Ulcers caused by mixed vascular etiologies ●
- Full thickness and partial thickness wounds .
- Donor sites and other bleeding surface wounds .
- Abrasions .
- Traumatic wounds healing by secondary intention .
- Dehisced surgical wounds .
Product codes
FRO
Device Description
PROMOGRAN Matrix Wound Dressing is a sterile primary dressing comprised of a freeze-dried composite of 55% collagen and 45% oxidised regenerated cellulose. (Ratios are presented as weight-to-weight).
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
Biocompatibility studies have demonstrated PROMOGRAN Matrix Wound Dressing to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
Key Metrics
Not Found
Predicate Device(s)
FIBRACOL Plus Collagen Dressing with Alginate (K982597)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SECTION 2 – 510(k) SUMMARY
FEB 1 4 2002
PROMOGRAN Matrix Wound Dressing
| Submitter's Name and
Address: | Johnson & Johnson Medical Ltd.
Gargrave
SKIPTON
North Yorkshire
BD23 3RX
United Kingdom |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Sergio Gadaleta, PhD
Senior Project Manager
Johnson & Johnson Wound Management Worldwide
a Division of Ethicon, Inc.
Telephone: 908-218-2893
Facsimile: 908-218-2595
e-mail: sgadalet@ethus.jnj.com |
| Name of Medical Device | Classification Name: Dressing, Wound
Common/Usual Name: Dressing
Proprietary Name: PROMOGRAN Matrix Wound Dressing |
| Substantial Equivalence | PROMOGRAN Matrix Wound Dressing is substantially equivalent to:
FIBRACOL Plus Collagen Dressing with Alginate (K982597)
manufactured by Johnson & Johnson Medical Ltd., Gargrave,
SKIPTON, BD23 3RX, United Kingdom |
| Device Classification | Currently, wound dressings containing animal derived materials are
unclassified by United States Food and Drug Administration's Center
for Devices and Radiological Health |
| Device Description | PROMOGRAN Matrix Wound Dressing is a sterile primary dressing
comprised of a freeze-dried composite of 55% collagen and 45%
oxidised regenerated cellulose. (Ratios are presented as weight-to-
weight). |
1
xc 141.29 p 2/2
Indications for Use
The PROMOGRAN Matrix Wound Dressing is indicated for the management of exuding wounds including:
- Diabetic ulcers .
- Venous ulcers .
- Ulcers caused by mixed vascular etiologies ●
- Full thickness and partial thickness wounds .
- Donor sites and other bleeding surface wounds .
- Abrasions .
- Traumatic wounds healing by secondary intention .
- Dehisced surgical wounds .
Biocompatibility studies have demonstrated PROMOGRAN Matrix Wound Dressing to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
Safety
PROMOGRAM Matrix Wound Dressing Johnson & Johnson Wound Management Worldwide, a Division of Ethicon Inc.
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 stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2002
Johnson & Johnson Medical Ltd. c/o Sergio Gadaleta, Ph.D. Senior Project Manager Johnson & Johnson Wound Management Worldwide Route 22 West P.O. Box 151 Somerville, New Jersey 08876
Re: K014129
Trade/Device Name: PROMOGRAN Regulatory Class: Unclassified Product Code: FRO Dated: December 13, 2001 Received: December 17, 2001
Dear Dr. Gadaleta:
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 for ass barner 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 - Sergio Gadaleta, 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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 (301) 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
for 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): _ K0|4|29
Device Name: PROMOGRAN Matrix Wound Dressing
Indications for Use:
PROMOGRAN Matrix Wound Dressing is intended for the management of exuding wounds including:
- Diabetic ulcers .
- . Venous ulcers
- Pressure ulcers .
- Ulcers caused by mixed vascular etiologies ●
- Full thickness and partial thickness wounds .
- Donor sites and other bleeding surface wounds ●
- Abrasions ●
- Traumatic wounds healing by secondary intention ●
- Dehisced surgical wounds ●
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ________________
Or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K014129 510(k) Number --
PROMOGRAM Matrix Wound Dressing Johnson & Johnson Wound Management Worldwide, a Division of Ethicon Inc.