(134 days)
The Primaeva Medical Finesse System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
The Primaeva Medical Finesse System is comprised of four primary components; an RF Generator with User Interface Software, a Cooling System Hand Piece, a Cooler Controller, and a disposable Electrode Insertion Device with an integrated cable. RF energy is delivered from the RF Generator, through the electrodes, and into the target tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs. The RF Generator, Cooler Controller, and Cooling System Hand Piece are not disposable. Each Electrode Insertion Device is supplied sterile and is for single patient use only and cannot be re-sterilized. The insertion device is a hand-held mechanical device that is used to insert the electrodes, at an acute angle, into the target tissue. The device has ten (10) electrodes arranged in a single row array. The device has a mechanism to deploy and retract the electrodes when actuated by the user. There is a cable with a connector that connects to the RF Generator. The Cooler system comprises a solid state cooling device with a feedback loop to monitor and control temperature. The cooling device is placed on the tissue surface during the treatment cycle. The RF Generator is the energy source for the system. Accessory cables and power cords are also supplied with the system.
There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Primaeva Medical Finesse System, which outlines the device's description, intended use, and comparison to predicate devices for substantial equivalence. It also includes the FDA's clearance letter.
Therefore, I cannot provide the requested table or information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for acceptance criteria.
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K0729261
510(k) Summary
Page 1 of (2)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Name, Address, Phone and Fax Number of Applicant A.
Primaeva Medical, Inc. 42840 Christy Street, Suite 101 Fremont, CA 94538, USA (510) 933-6000 Telephone: (510) 933-6001 Fax:
- B. Contact Person
Bankim Mehta President & CEO Phone: (510) 933-6010 Fax: (510) 933-6001
DEC 2 6 2007
C. Date Prepared
August 8, 2007
D. Device Name
| Trade Name: | Finesse System |
|---|---|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Electrosurgical cutting and coagulation device andaccessories (21 CFR 878.4400 Product Code GFI) |
E. Predicate Devices
The Primaeva Medical Finesse System is substantially equivalent to the Thermage ThermaCool System (K000944 and K003183), ArthroCare Visage Cosmetic Surgery System (K981870), and Radionics Cool-Tip RF System (K984552).
ட் Device Description
The Primaeva Medical Finesse System is comprised of four primary components; an RF Generator with User Interface Software, a Cooling System Hand Piece, a Cooler Controller, and a disposable Electrode Insertion Device with an integrated cable. RF energy is delivered from the RF Generator, through the electrodes, and into the target tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs. The RF Generator, Cooler Controller, and Cooling System Hand Piece are not
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Primaeva Medical, Inc.
disposable. Each Electrode Insertion Device is supplied sterile and is for single patient use only and cannot be re-sterilized.
The insertion device is a hand-held mechanical device that is used to insert the electrodes, at an acute angle, into the target tissue. The device has ten (10) electrodes arranged in a single row array. The device has a mechanism to deploy and retract the electrodes when actuated by the user. There is a cable with a connector that connects to the RF Generator.
The Cooler system comprises a solid state cooling device with a feedback loop to monitor and control temperature. The cooling device is placed on the tissue surface during the treatment cycle.
The RF Generator is the energy source for the system. Accessory cables and power cords are also supplied with the system.
G. Intended Use
The Primaeva Medical Finesse System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
H. Technological Comparison
The technological characteristics and principals of operation of the Finesse System are substantially equivalent to the noted predicate devices.
l. Summary of Pre-Clinical Data
Results of pre-clinical testing demonstrated that the Finesse System is safe and effective for its intended use.
J. Summary of Data
The Finesse System has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. İn addition, pre-clinical testing was conducted to validate the performance of the device and ensure the Finesse System functions as intended and meets design specifications. The comparison and pre-clinical results demonstrate that the device is substantially equivalent to the predicate devices and is safe and effective in its intended use.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, stacked one behind the other.
FEB 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Primaeva Medical, Inc. % Mr. Brian Grigsby VP. QA & RA 42840 Christy Street, Suite 101 Fremont, California 94538
Re: K072261
Trade/Device Name: Finesse System Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 11, 2007 Received: December 13, 2007
Dear Mr. Grigsby:
This letter corrects our substantially equivalent letter of December 26, 2007.
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 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); 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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Primaeva Medical, Inc.
510(k) Notification Finesse System
Indications for Use Statement
510(k) Number (if known): K 072261
Finesse System Device Name:
Indications for Use:
The Primaeva Medical Finesse System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Prescription Use
OR (per 21 CFR 801.109) Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jailare Brienw
- Restorativ Division of G and Neurological Devices
510(k) Number K072261
§ 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.