The Primaeva Medical Miratone System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

Device Description

The Primaeva Medical Miratone System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface; a reusable cooler controller; cooler handpiece/applicator; a reusable reusable a electrode insertion device/applicator; and a single patient use, disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.

AI/ML Overview

The provided text describes the Primaeva Medical Miratone System and its 510(k) premarket notification. However, it does not contain specific acceptance criteria for device performance or a detailed study proving the device meets those criteria.

The document states:

"Clinical performance testing demonstrated the Primaeva Medical Miratone System to be safe and effective in the percutaneous treatment of facial wrinkles." This is a general statement of an outcome, not a presentation of acceptance criteria or performance metrics.
"In summary, the results of non-clinical mechanical, electrical and functional bench and/or animal testing, and clinical performance testing have demonstrated that the Primaeva Medical Miratone System meets established design specifications; functions as intended; and is considered to be substantially equivalent to the above noted predicate devices." Again, this is a summary statement without specific data or criteria.

Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text. The document confirms a clinical study was done, but it doesn't offer the details you've requested.

Here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	"Safe and effective in the percutaneous treatment of facial wrinkles."
Not specified in the document	"Meets established design specifications"
Not specified in the document	"Functions as intended"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The device manufacturer, Primaeva Medical, Inc., is based in Pleasanton, CA, USA, which might suggest the study was conducted in the US, but this is not explicitly stated for the clinical performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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

This device is an electrosurgical unit, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable. The document does not mention any AI component.

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

This is an electrosurgical medical device; the concept of a "standalone algorithm" is not applicable here. Studies would focus on the device's physical performance, safety, and effectiveness in treating conditions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For "percutaneous treatment of facial wrinkles," the ground truth likely involves clinical assessment of wrinkle reduction, possibly using standardized photographic scales or other objective measures, alongside patient satisfaction and safety outcomes. However, the specific type of ground truth used is not specified in the document.

8. The sample size for the training set

Not applicable as this is a medical device for treatment, not an AI model requiring a training set in the typical sense. The "training set" for physical devices would rather refer to engineering and clinical validation data.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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Primaeva Medical, Inc.

510(k) Premarket Notification

SEP - 1 2009

Page 1 of ②

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510(k) Summary - ___________ K082391

This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807.92.

Submitter:

Primaeva Medical, Inc. 4160 Hacienda Drive, Suite 100 Pleasanton, CA 94588 USA Telephone: (925) 621-6100 Fax: (925) 621-6101

Contact Person:

Bankim Mehta President & CEO Telephone: (925) 621-6110

Date Prepared:

August 24, 2009

Trade Name:

Primaeva Medical Miratone System

Common Name:

Electrosurgical unit and accessories

Classification:

Class II per 21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories

GEI Product Code:

Predicate Devices: Primaeva Medical Finesse System - K072261 Primaeva Medical System - K080145

Device Description: The Primaeva Medical Miratone System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface; a reusable cooler controller;

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Primaeva Medical, Inc.

cooler handpiece/applicator; a reusable reusable a electrode insertion device/applicator; and a single patient use, disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.

Intended Use:

The Primaeva Medical Miratone System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

Technological Characteristics Comparison:

The Primaeva Medical Miratone System with indications for the percutaneous treatment of facial wrinkles is identical to the predicate Primaeva Medical System noted above.

The Primaeva Medical Miratone System with indications for the percutaneous treatment of facial wrinkles is considered to be substantially equivalent in terms of the target population, energy source, principles of operation, etc., to the above noted predicate devices.

Performance Data:

Non-clinical testing of the Primaeva Medical Miratone System included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench and/or animal testing. Clinical performance testing demonstrated the Primaeva Medical Miratone System to be safe and effective in the percutaneous treatment of facial wrinkles.

Summary:

In summary, the results of non-clinical mechanical, electrical and functional bench and/or animal testing, and clinical performance testing have demonstrated that the Primaeva Medical Miratone System meets established design specifications; functions as intended; and is considered to be substantially equivalent to the above noted predicate devices.

End of section -

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is black, and the text is also black.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP - 1 2009

Primāeva Medical, Inc. % Mr. Brian Grigsby Vice President, QA & RA 4160 Hacienda Drive, Suite 100 Pleasanton, California 94588

Re: K082391

Trade/Device Name: Primaeva Medical Miratone System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 30, 2009 Received: July 2, 2009

Dear Mr. Grigsby:

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 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 may 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Brian Grigsby

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. Mark N. Melker

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Primaeva Medical, Inc.

Indications for Use

: K082391 510(k) Number (if known):

Primaeva Medical Miratone System Device Name:

Indications for Use:

The Primaeva Medical Miratone System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Page 1 of 1

End of section -

CONFIDENTIAL

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.