(86 days)
Not Found
No
The summary describes a passive wound dressing and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is a wound dressing used for the local management of various types of wounds, which is a therapeutic function.
No
The device is described as a topical wound dressing for managing superficial wounds, not for diagnosing conditions. Its primary function is therapeutic and protective, not diagnostic.
No
The device description clearly states it is a physical wound dressing consisting of a polyurethane backing sheet and a hydrocolloid layer, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "topical wound dressing" for managing wounds on the body surface. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The description details a physical dressing that interacts with wound exudate, not a test or reagent used to analyze a biological sample.
- Performance Studies: The performance studies focus on the safety of the dressing in contact with the body (cytotoxicity, hemolysis, skin irritation, etc.), not on the accuracy of a diagnostic test.
Therefore, the description aligns with a medical device used for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations.
Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.
Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.
Product codes
MGP
Device Description
ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.
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)
ALGOPLAQUE FILM Extra Thin Hydrolloid Dressing (Algoplaque Film Dressing) has been evaluated through in vitro tests and animal safety studies. All data is consistent in indicating that this product is safe for use as a topical wound dressing. The categories of safety tests and the safety test conclusions are as follows:
- Cytotoxicity - USP Agar Diffusion: Algoplaque Film Dressing met the requirements of the USP
- Cytotoxicity - USP Elution Method: Algoplaque Film Dressing met the requirements of the USP
- Hemolysis Study - In Vitro Procedure: Algoplaque Film Dressing was determined to be nonhemolytic
- Systemic Injection In Mice: Algoplaque Film Dressing passed the systemic injection test in mice.
- Primary Skin Irritation In Rabbits: Algoplaque Film Dressing is not classified as a primary irritant or as a corrosive
- Delayed Contact Hypersensitivity in Guinea Pigs: Algoplaque Film Dressing is not a sensitizer
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
FEB 1 3 1998
510(k) SUMMARY Algoplaque Film Extra Thin Hydrocolloid Dressing K974348
page 1 of 4
510(k) SUMMARY
ALGOPLAQUE FILM Extra Thin Hydrocolloid Dressing (79 MGP)
- SUBMITTER'S NAME 1.
- CONTACT PERSON AT LABORATOIRES URGO 2.
- U.S. REGULATORY AGENT FOR LABORATOIRES URGO 3.
- DATE THAT 510(k) SUMMARY WAS PREPARED 4.
- NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary) ട.
- LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS રે. CLAIMED
- DESCRIPTION OF THE DEVICE 7.
- INTENDED USE OF THE DEVICE 8.
- TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE g. DEVICES
- SUMMARY OF SAFETY STUDIES AND CONCLUSIONS FROM SAFETY STUDIES 10.
- STERILIZATION / STERILITY ASSURANCE LEVEL 11.
| 1. SUBMITTER'S NAME |
|---|
| Laboratoires URGO |
| 42, rue de Longvic |
| 21300 Chenove |
| FRANCE |
Telephone: 011-33-3-80 44 79 67
Fax: 011-33-3-80 44 71 12 |
| 2. CONTACT PERSON AT LABORATOIRES URGO | |
|---|---|
| Sophie Lambert-Fortin | |
| Manager, Regulatory Affairs | |
| Telephone: | 011-33-3-80 44 79 67 |
| Fax: | 011-33-3-80 44 71 12 |
1
| U.S. REGULATORY AGENT FOR LABORATOIRES URGO | |
|---|---|
| Evan Dick, Ph.D. | |
| EGDA | |
| 7527 Westmoreland Avenue | |
| St. Louis, MO 63105 | |
| Telephone: | (314) 721-0112 |
| Fax: | (314) 721-7591 |
4. DATE THAT 510(k) SUMMARY WAS PREPARED
November 19, 1997
| 5. NAME OF THE MEDICAL DEVICE | |
|---|---|
| Classification name | Dressing, wound and burn, occlusive |
| (Surgery 79 MGP) | |
| Common / usual name | Hydrocolloid dressing |
| Proprietary name | ALGOPLAQUE® FILM |
| Extra Thin Hydrocolloid Dressing |
ALGOPLAQUE® FILM Extra Thin Hydrocolloid Dressing will also be distributed under the additional proprietary name SORBEX Thin.
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE I CLAIMED CLAIMED · ALGOPLAQUE Hydrocolloid Dressing (K970518, URGO) · DuoDERM Extra Thin CGF Dressing (K925990, ConvaTec) · Comfeel Ulcer Dressing (K840438, Coloplast)
P.15
2
page 3 of 4
7. SUDESCRIPTION OF THE DEVICE IS CONTRACT
ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.
8. INTENDED USE OF THE DEVICE OF THE DEVICE OF THE BE
Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations.
Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.
Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.
TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES DEVICES
Algoplaque Film Extra Thin Hydrocolloid Dressings, Algoplaque Hydrocolloid Dressings (K970518), DuoDERM Extra Thin CGF Dressings (K925990), and Comfeel Ulcer Dressings (K840438) are all flexible, hydrocolloid wound dressings that consist of a polyurethane backing sheet and a hydrocolloid layer. For all of these devices, the hydrocolloid layer is composed of:
- · natural polymers primarily for absorption
- · synthetic polymers plasticizers, elastomers, tackifiers
- · stabilizers to help maintain the integrity of the final product
Algoplaque Film Extra Thing Hydrocolloid Dressing and the predicate devices are all composed, in similar proportions, of closely related natural polymers, synthetic polymers, and stabilizers.
Algoplaque Film Extra Thin Hydrocolloid Dressings are thinner than, for example, Algoplaque Hydrocolloid Dressings (K970518, URGO) and Comfeel Ulcer Dressings (K840438). Thinner dressings are more flexible and therefore easier to place upon dressing sites that require contouring (e.g., elbows). DuoDERM Extra Thin CGF Dressings (K925990) are also specially thin hydrocolloid dressings.
3
page 4 of 4
SUMMARY OF SAFETY STUDIES AND CONCLUSIONS FROM SAFETY STUDIES ALGOPLAQUE FILM Extra Thin Hydrolloid Dressing (Algoplaque Film Dressing) has been evaluated through in vitro tests and animal safety studies. All data is consistent in indicating that this product is safe for use as a topical wound dressing. The categories of safety tests and the safety test conclusions are as follows: · Cytotoxicity - USP Agar Diffusion · Algoplaque Film Dressing met the requirements of the USP · Cytotoxicity - USP Elution Method · Algoplaque Film Dressing met the requirements of the USP · Hemolysis Study - In Vitro Procedure · Algoplaque Film Dressing was determined to be nonhemolytic · Systemic Injection In Mice · Algoplaque Film Dressing passed the systemic injection test in mice. • Primary Skin Irritation In Rabbits > Algoplaque Film Dressing is not classified as a primary irritant or as a corrosive · Delayed Contact Hypersensitivity in Guinea Pigs
- · Algoplaque Film Dressing is not a sensitizer
- STERILIZATION /STERILITY ASSURANCE LEVEL ( FERIE MARK 1
Algoplaque Film Extra Thin Hydrocolloid Dressing is sterilized using beta-irradiation. The sterility assurance level (S.A.L.) for Algoplaque Film Extra Thin Hydrocolloid Dressing is 1 X 10 as validated according to AAMI protocol / validation criteria.
4
Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Evan G. Dick, Ph.D. E.G. Dick & Associates Representing Laboratoires Urgo S.A. 7527 Westmoreland Avenue St. Louis, Missouri 63105
Re: K974348
ALGOPLAOUE® FILM Extra Thin Hydrocolloid Dressing Regulatory Class: Unclassified Product Code: MGP Dated: November 7, 1997 Received: November 19, 1997
Dear Dr. Dick:
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 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.
5
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,
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
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K974348
ALGOPLAQUE FILM Extra Thin Hydrocolloid Dressing Device Name:
Indications For Use:
Algoplaque Film Extra Thin Hydrocolloid Dressings are intended for the local management of superficial, dry to lightly-exudating wounds, including superficial burns, pressure sores, dermal ulcers, post-operative wounds or suture sites, abrasions and lacerations.
Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.
Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 974348
Prescription Use
(per 21 CFR 01.109)
OR Over-The-Counter Use