(255 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biocompatibility of a hydrogel wound dressing with a topical anesthetic, with no mention of AI or ML technologies.
Yes.
The device is described as a wound dressing intended for "local management of painful skin wounds," including various types of ulcers and burns, which indicates a therapeutic purpose.
No
Explanation: The device is a wound dressing with a topical anesthetic, intended for local management of skin wounds. Its function is therapeutic (healing and pain relief), not diagnostic (identifying or characterizing a condition).
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 therapeutic application directly on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic." This is a topical treatment applied to the wound itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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
Regenecare™ Wound Gel is a viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic intended for use in the local management of painful skin wounds. The product is supplied sterile in plastic tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin wounds
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)
The biocompatibility of the predicate device has been established by a primary dermal irritation test in rabbits, a sensitization test in quinea pigs, and an in vitro cytotoxicity test. Since the safety of topical lidocaine (up to 4%) has been well established through a long history of over-the-counter use, the addition of 2% lidocaine to the original formulation does not raise any new biocompatibility issues.
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
K020540
1 2002 NOV
510 (k) SUMMARY
1. ADMINISTRATIVE
Submitter: MPM Medical, Inc. 2301 Crown Court Irving, Texas 75038 (982) 893-4060
Contact Person: Paul R. Miller
Date of Preparation: February 18, 2002
비. DEVICE NAME
Proprietary Name: Regenecare™ Wound Gel Common Name: Medicated Wound Gel Classification Name: Medicated Hydrogel Wound and Burn Dressing
트 PREDICATE DEVICE
MPM Regenecare™ Wound Gel; K992074 (MPM Medical, Inc.)
IV. DEVICE DESCRIPTION
Regenecare™ Wound Gel is a viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic intended for use in the local management of painful skin wounds. The product is supplied sterile in plastic tubes.
INTENDED USE V.
Locoal management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
The biocompatibility of the predicate device has been established by a primary dermal irritation test in rabbits, a sensitization test in quinea pigs, and an in vitro cytotoxicity test. Since the safety of topical lidocaine (up to 4%) has been well established through a long history of over-the-counter use, the addition of 2% lidocaine to the original formulation does not raise any new biocompatibility issues.
VI. COMPARISON TO PREDICATE DEVICE
Regenecare™ Wound Gel is similar in composition, and identical in function and intended use, to MPM Regenecare™ Wound Gel (MPM Medical) and other legally marketed hydrogel wound dressing products.
Accordingly, MPM Medical concluded that Regenecare™ Wound Gel is safe and effective for its intended use, and performs at least as well as legally marketed predicate devices, such as the MPM Regenecare ™ Wound Gel.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2002
MPM Medical, Inc. Paul R. Miller President 2301 Crown Court Irving, Texas 75038
Re: K020540
Trade/Device Name: Regenecare™ Wound Gel Regulation Name: Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGO Dated: July 30, 2002 Received: August 5, 2002
Dear Mr. Miller:
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 mav 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Mr. Paul R. Miller
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" (21 CFR 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,
Mill-N-Millman
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
3
510(k) Number (if known):
K0205540.
Device Name:
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)
(Division Sign-(
Division of Ger
and Neurologicaces
astorative
510(k) Number K020540
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _
(Optional Format 1-2-96)