(74 days)
Not Found
No
The device description is a simple hydrogel, and there are no mentions of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
Yes
The device is a hydrogel wound dressing intended for the local management of various types of wounds, including partial- and full-thickness wounds, ulcers, surgical wounds, and burns, which are all conditions requiring therapeutic intervention.
No
The device, a hydrogel wound dressing, is intended for the management and treatment of wounds, not for diagnosis. Its purpose is therapeutic, and the provided information does not mention any diagnostic capabilities.
No
The device description explicitly states "Hydrogel," indicating a physical, non-software component. The performance studies also focus on the physical properties and biological interactions of the hydrogel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the management of various types of wounds and burns. 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 device is a hydrogel, which is a type of wound dressing. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on safety, biocompatibility, and preservative effectiveness, which are relevant for a therapeutic device applied to the body. They do not involve diagnostic performance metrics like sensitivity, specificity, etc.
Therefore, this device is a therapeutic medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
Hydrogel
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
Use under the supervision of health care professionals
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)
The safety and preservative effectiveness of Woun'Dres® are substantiated by the sensitization, biotoxicological and challenge tests conducted on this device as listed below:
| Test | Results |
|---|---|
| Acute Dermal Toxicity Study | Not Considered Toxic |
| Primary Skin Irritation Test | Is not considered a primary Irritant |
| Delayed Contact Sensitization Study | No evidence of causing delayed contact sensitization. |
| Cytotoxicity Agarose overlay | Nontoxic |
| Hemolysis Test (In Vitro) | Nonhemolytic |
| USP 23 Anti-microbial Preservatives-Effectiveness | Meets USP 23 Requirements |
| Bioburden | Pass |
| Drop Ship Test | No leakage or damage to tubes occurred. |
| Latex Gloves Product Compatibility | No changes imparted to Woun'Dres from the gloves and no change in strength of the gloves was observed. |
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
4 1999
JUN
Coloplast 510(k) -Woun'Dres® Collagen Hydrogel Wound Dressing
510(k) SUMMARY
-
- DATE PREPARED June 4, 1999
- SUBMITTER Coloplast Corporation Skin Care Division 1940 Commerce Drive North Mankato, MN 56003
- CONTACT PERSON Harvey M. Arbit, Pharm.D., M.B.A. Vice President Research and Development
-
- NAME OF THE MEDICAL DEVICE Classification Name: Dressing, Wound and Burn, Hydrogel Common/Usual Name: Collagen Hydrogel Wound Dressing
Proprietary Name: Woun'Dres®
-
- DEVICE CLASSIFICATION Regulatory Class: Not Classified Product Code: MGQ SU (80)
STATEMENT OF SUBSTANTIAL EQUIVALENCE દ.
Woun'Dres® is substantially equivalent to Carrasyn Hydrogel Wound Dressing which obtained marketing approval under 510(k) K894541 and DuoDerm Hydroactive Gel which obtained marketing approval under 510(k) K925993. Carrasyn Hydrogel Wound Dressing was found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976.
1
Coloplast 510(k) —Woun'Dres® Collagen Hydrogel Wound Dressing
INDICATIONS FOR USE 7.
May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
PHYSICAL DESCRIPTION 8. Hydrogel
BIOCOMPATIBILITY 9.
The safety and preservative effectiveness of Woun'Dres® are substantiated by the sensitization, biotoxicological and challenge tests conducted on this device as listed below:
| Test | Results |
|---|---|
| Acute Dermal Toxicity Study | Not Considered Toxic |
| Primary Skin Irritation Test | Is not considered a primary Irritant |
| Delayed Contact Sensitization Study | No evidence of causing delayed |
| contact sensitization. | |
| Cytotoxicity Agarose overlay | Nontoxic |
| Hemolysis Test (In Vitro) | Nonhemolytic |
| USP 23 Anti-microbial | |
| Preservatives-Effectiveness | Meets USP 23 Requirements |
| Bioburden | Pass |
| Drop Ship Test | No leakage or damage to tubes |
| occurred. | |
| Latex Gloves Product Compatibility | No changes imparted to Woun'Dres |
| from the gloves and no change in | |
| strength of the gloves was observed. |
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, resembling a caduceus or a symbol of health and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 4 1999
Harvey M. Arbit, PharmD, MBA Vice President, Research and Development Coloplast Corporation 1940 Commerce Drive P.O. Box 8300 North Mankato, Minnesota 56003
Re: K991202 Trade Name: Woun'Dres Regulatory Class: Unclassifed Product Code: MGQ Dated: March 19, 1999 Received: March 22, 1999
Dear Dr. Arbit:
We have reviewed your Section 510(k) 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
3
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number 991202
Device Name: Woun'Dres® Collagen Hydrogel Wound Dressing
Indications for Use:
May be used for superficial wounds and abrasions and ● minor burns. Use under the supervision of health care professionals for the local management of partial- and fullthickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
(Please Do Not Write Below This Line-Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) Or Over-The-Counter Use
Aöallulo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991202