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.

AI/ML Overview

Due to the nature of the device (a medicated wound gel), the provided documents (K020540) do not contain information about acceptance criteria and studies in the context of device performance as one would expect for an AI/software device. Instead, the "study" described is related to biocompatibility and a comparison to a predicate device for substantial equivalence.

Therefore, I cannot directly provide the requested table and detailed information as it pertains to AI/software performance criteria. However, I can extract the relevant information regarding the safety and equivalence arguments made for this specific product.

Here's a breakdown of what the document does provide, structured to address your points as much as possible within the context of a physical medical device submission for substantial equivalence:

Device: Regenecare™ Wound Gel (Medicated Hydrogel Wound and Burn Dressing)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are related to safety and substantial equivalence to a predicate device, rather than quantitative performance metrics like sensitivity/specificity for AI.

Acceptance Criteria Category	Reported Device "Performance" (Evidence from Study)
Biocompatibility	- Demonstrated by Primary Dermal Irritation Test in Rabbits - Demonstrated by Sensitization Test in Guinea Pigs - Demonstrated by In Vitro Cytotoxicity Test
Safety (Lidocaine)	- Pre-established through long history of over-the-counter use of topical lidocaine (up to 4%). - Conclusion: Addition of 2% lidocaine to the original formulation does not raise new biocompatibility issues.
Substantial Equivalence	- Similar in composition to MPM Regenecare™ Wound Gel (K992074). - Identical in function to MPM Regenecare™ Wound Gel (K992074). - Identical in intended use to MPM Regenecare™ Wound Gel (K992074) and other legally marketed hydrogel wound dressing products. - Conclusion: Safe and effective for intended use, performs at least as well as legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility Tests: The document mentions "rabbits" and "guinea pigs" for animal testing, and "in vitro" for cytotoxicity. Specific sample sizes (e.g., number of animals, number of replicates) are not provided in this summary.
Safety of Lidocaine: This relies on the general historical use of lidocaine, not a specific "test set" in this submission.
Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory/animal study results and a comparison to existing market data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not applicable here. The "ground truth" for biocompatibility is whether the biological response meets accepted safety standards, determined by standard laboratory protocols and expert interpretation of those results. The primary "experts" involved would be toxicologists and regulatory reviewers.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader interpretation or clinical endpoints requiring adjudication in the context of an AI device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical wound gel, not an AI or software device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical wound gel, not an AI or software device.

7. The Type of Ground Truth Used

Biocompatibility: Laboratory test results (irritation, sensitization, cytotoxicity) against established physiological endpoints and safety thresholds.
Safety of Lidocaine: Historical clinical use and accepted pharmacological profiles.
Substantial Equivalence: Comparison of device characteristics (composition, function, intended use) to an already cleared (predicate) device.

8. The Sample Size for the Training Set

Not applicable as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not applicable as this is not an AI/ML device.

Summary of the "Study" (Biocompatibility & Comparison to Predicate):

The "study" or evidence presented for K020540 relates entirely to establishing the safety and substantial equivalence of the Regenecare™ Wound Gel, particularly with the addition of 2% lidocaine, to an already approved predicate device (MPM Regenecare™ Wound Gel; K992074).

Biocompatibility: The original predicate device's biocompatibility was established through:
- A primary dermal irritation test in rabbits.
- A sensitization test in guinea pigs.
- An in vitro cytotoxicity test.
Lidocaine Safety: The submission leverages the well-established long history of over-the-counter use for topical lidocaine (up to 4%) to argue that the 2% concentration does not introduce new biocompatibility issues.
Substantial Equivalence Argument: The new device (Regenecare™ Wound Gel with lidocaine) is stated to be similar in composition and identical in function and intended use to the predicate device. This comparison forms the basis for demonstrating that the new device is "safe and effective for its intended use, and performs at least as well as legally marketed predicate devices."

In essence, for this traditional medical device, the "acceptance criteria" were that the device be biocompatible and substantially equivalent in safety and efficacy to a previously cleared device, a benchmark they met by referring to prior testing and established safety profiles.

Summary

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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

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.

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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.

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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

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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)

Regulation Number and Section

N/A