(378 days)
Not Found
No
The summary describes a radiofrequency energy delivery system for dermatological procedures and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the percutaneous treatment of facial wrinkles, which is a therapeutic intervention.
No
The device is described as being used for "electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles," which refers to therapeutic and surgical procedures involving energy delivery, not diagnostic assessment of a condition.
No
The device description explicitly lists multiple hardware components: a reusable RF generator, a reusable cooler controller, a cooler handpiece/applicator, a reusable electrode insertion device/applicator, and a single patient use, disposable electrode cartridge. This indicates it is a hardware-based medical device with associated software for control and operation.
Based on the provided information, the Primaeva Medical Miratone System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles." This describes a device used directly on a patient's body for treatment, not for testing samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The components described (RF generator, cooler controller, handpieces, electrode cartridge) are consistent with a device used for delivering energy to tissue for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the Primaeva Medical Miratone System is a therapeutic device used for surgical and dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GEI
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 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.
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)
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.
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
§ 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.
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Primaeva Medical, Inc.
510(k) Premarket Notification
SEP - 1 2009
Page 1 of ②
ﺔ ﺍﻟ
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;
1
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 -
2
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
3
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