K Number
K992074
Device Name
MPM REGENECARE WOUND GEL
Manufacturer
Date Cleared
1999-12-23

(188 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
Device Description
MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes. Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.
More Information

Not Found

No
The 510(k) summary describes a hydrogel wound dressing, a physical product, with no mention of software, algorithms, or any technology related to AI or ML.

Yes
The device is described as a "wound dressing intended for use in the local management of skin wounds," which directly addresses therapeutic healing and management of medical conditions.

No
Explanation: The device is described as a "wound dressing" for "local management of skin wounds," indicating a therapeutic rather than diagnostic purpose. It does not mention detection, analysis, or diagnosis of disease.

No

The device description clearly states it is a "viscous hydrogel wound dressing" supplied in "plastic tubes," indicating a physical product, 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 "local management of skin wounds." This describes a topical treatment applied directly to the wound, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The description details a "viscous hydrogel wound dressing." This is a physical dressing applied externally.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information.

IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to manage the wound itself, not to diagnose or analyze a condition based on a sample.

N/A

Intended Use / Indications for Use

Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

Product codes

MGO

Device Description

MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes.
Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin

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)

K952276

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

DEC 2 3 1999

K992074

510 (k) SUMMARY

1. ADMINISTRATIVE

MPM Medical, Inc. Submitter: P.O. Box 151335 Arlington, Texas 76015

Contact Person: Paul Miller

Date of Preparation: October 18, 1999

DEVICE NAME ll.

Proprietary Name: MPM Regenecare™ Wound Gel Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing

111. PREDICATE DEVICE

MPM Hydrogel™ Dressing (MPM Medical, Inc.; K952276)

IV. DEVICE DESCRIPTION

MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes.

Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.

V. INTENDED USE

Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

1

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird, with its wings spread and head facing to the left. The logo is black and white.

DEC 2 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MPM Medical, Inc. c/o Mr. Richard A. Hamer Richard Hamer Associates, Inc. 6401 Meadows West Drive Ft. Worth, Texas 76132

Re: K992074 Trade Name: MPM Regenecare Wound Gel Regulatory Class: Unclassified Product Code: MGO Dated: November 30, 1999 Received: December 7, 1999

Dear Mr. Hamer:

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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

2

Page 2 - Mr. Richard A. Hamer

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,

Neil R.P. Ogden

James E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

K99 2074

of Page 1

510(k) Number (if known):K992074
------------------------------------

Device Name: MPM Regenecare™ Wound Gel

Indications for Use:

Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
NRO for JZD
(Division Sign-Off)
Division of General Restorative Devices
510(k) NumberK 992074
Prescription Use (Per 21 CFR 801.109)XOROver-the-Counter Use
(Optional Format 1-2-96)

Premarket Notification: MPM REGENECARE WOUND GEL