(37 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is used for electrocoagulation and hemostasis in dermatologic and general surgical procedures, which are therapeutic medical interventions.
No
The device is indicated for "electrocoagulation and hemostasis" in "Dermatologic and General Surgical procedures." These are therapeutic/surgical actions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components: a reusable RF generator, a reusable cooler controller, a reusable cooling system handpiece, a reusable electrode insertion device, and a disposable electrode cartridge. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dermatologic and General Surgical procedures for electrocoagulation and hemostasis." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from a patient.
- Device Description: The device components (RF generator, cooler controller, handpiece, electrode insertion device, electrode cartridge) are designed for delivering energy to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly intended for therapeutic and surgical purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Primaeva Medical System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
The Primaeva Medical Finesse System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
The Primaeva Medical System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface, a reusable cooler controller, a reusable cooling system handpiece, a reusable electrode insertion device and a 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
Prescription Use (Part 21 CFR 801 Subpart D)
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 System with reusable Electrode Insertion Device and disposable Electrode Cartridge included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench and/or animal testing.
In summary, the results of non-clinical mechanical, electrical and functional bench and/or animal testing have demonstrated that the Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge meet established design specifications; function as intended; and are considered to be substantially equivalent to the above noted predicate device.
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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Image /page/0/Picture/0 description: The image shows the word "primaeva" in a stylized font. Above the word is a symbol that looks like two crescent moons stacked on top of each other. The text is slightly blurred, giving it a soft, textured appearance. The overall design is simple and elegant.
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FE3 28
510(k) Summary - K080145
This 510(k) summary of substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92.
A. Name, Address, Phone and Fax Number of Applicant
Primaeva Medical, Inc. 42840 Christy Street, Suite 101 Fremont, CA 94538, USA (510) 933-6000 Telephone: Fax: (510) 933-6001
B. Contact Person
Brian Grigsby Vice President. QA & RA Telephone: (510) 933-6090
C. Date Prepared
February 14, 2007
D. Device Name
Trade Name: Common Name: Classification Name: Primaeva Medical System Electrosurgical Unit and Accessories Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code GEI)
E. Predicate Device
The Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge is substantially equivalent to the Primaeva Medical Finesse System, a legally marketed device (K072261).
F. Device Description
The Primaeva Medical System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface, a reusable cooler controller, a reusable cooling system handpiece, a reusable electrode insertion device and a disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.
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KO80145
G. Intended Use
rimāeva
The Primaeva Medical System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
H. Technological Characteristics Comparison
The Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge is substantially equivalent in terms of intended use, target population, energy source, principles of operation, etc., to the above noted predicate device.
1. Non-Clinical Test Summary
Non-clinical testing of the Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench and/or animal testing.
J. Summary
In summary, the results of non-clinical mechanical, electrical and functional bench and/or animal testing have demonstrated that the Primaeva Medical System with reusable Electrode Insertion Device and disposable Electrode Cartridge meet established design specifications; function as intended; and are considered to be substantially equivalent to the above noted predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 depicted with three lines forming the staff and snakes, giving it a modern and abstract appearance. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2000
Primaeva Medical, Inc. % Mr. Brian Grigsby Vice President, QA & RA 42840 Christy Street, Suite 101 Fremont, California 94538
Re: K080145
Trade/Device Name: Primaeva Medical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 18, 2008 Received: January 30, 2008
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 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 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.
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Page 2 - Mr. Brian Grigsby
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 vours.
Mark M. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KO80145 510(k) Number (if known):
Device Name: Primaeva Medical System
Indications for Use:
The Primaeva Medical Finesse System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Prescription Use × (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)
Much A. Millen
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K080145