(29 days)
The Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) for use in electrosurgery and is designed for the following:
Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.
Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.
Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
Incorporate thermocouples for temperature feedback.
Provide for local delivery of fluid.
This RITA® Model 90 device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy out from the trocar tip. The RITA Model 90 device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible hypodermic tubing at the distal end of probe trocar insulation: fixed clear polymer shrink tubing handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through a Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: Five temperature sensors at the periphery of the array depth indicators: Incremental 1-cm marks denote needle penetration depth.
The sponsor, RITA Medical Systems, Inc., conducted a study to verify that the Model 90 Electrosurgical Probe met its specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Performance: (Specific criteria not detailed in the provided text, but implied by "battery of electrical... testing") | The devices met the specifications. |
| Mechanical Performance: (Specific criteria not detailed in the provided text, but implied by "battery of... mechanical testing") | The devices met the specifications. |
| Biocompatibility: (Specific criteria not detailed in the provided text, but implied by "battery of... biocompatibility testing") | The materials did not elicit toxicological responses. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the electrical, mechanical, and biocompatibility testing. It only mentions that the "Model 90 devices were subjected to a battery" of tests, implying multiple devices were tested. The data provenance is not specified, but it's likely to be internal testing conducted by the manufacturer, RITA Medical Systems, Inc., given the context of a 510(k) summary. It would be considered retrospective testing as it occurred prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The testing appears to be objective performance testing against predefined engineering specifications rather than expert-derived ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The testing described is performance-based against specifications, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The study focuses on the device's technical specifications and safety (biocompatibility) rather than comparing its effectiveness in a clinical setting with or without human assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an electrosurgical probe, which is a physical medical instrument, not an algorithm or an AI-powered system that would have standalone performance or human-in-the-loop evaluation.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing was derived from the engineering specifications for electrical and mechanical performance, and toxicological standards for biocompatibility. These are objective, pre-defined criteria that the device had to meet.
8. The Sample Size for the Training Set:
Not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical electrosurgical probe.
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SEP 1 0 1999
K992693 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 8.0
| GeneralProvisions | Trade Name: Model 90 Electrosurgical ProbeCommon/Classification Name: Electrosurgical cutting and coagulation accessory |
|---|---|
| Name ofPredicate | RITA Medical Systems Inc. - Model 70 Electrosurgical Probe |
| Classification | Class II |
| PerformanceStandards | Performance standards have not been established by the FDA under section 514 ofthe Food, Drug and Cosmetic Act. |
| Intended Use | The Model 90 Electrosurgical Probe is designed to supply energy (generated by theRITA Medical Systems' Electrosurgical Generator) for use in electrosurgery and isdesigned for the following: |
| Incorporation of multiple needles on each probe minimizing the number ofinvasive accesses necessary to achieve desired lesions. Provide a minimally invasive laparoscopic, percutaneous, or intraoperativeaccess to the targeted tissue. Deliver radiofrequency energy in a controlled fashion to create coagulativenecrotic lesions. Incorporate thermocouples for temperature feedback. Provide for local delivery of fluid. | |
| DeviceDescription | This RITA® Model 90 device is available in 15 cm and 25 cm lengths for a varietyof medical applications. The secondary electrodes deploy out from the trocartip. The RITA Model 90 device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible hypodermic tubing at the distal end of probe trocar insulation: fixed clear polymer shrink tubing handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through a Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: Five temperature sensors at the periphery of the arraydepth indicators: Incremental 1-cm marks denote needle penetration depth. |
| PerformanceData | The Model 90 devices were subjected to a battery of electrical, mechanical, andbiocompatibility testing to verify that the devices met the specifications. Thedevices met the specifications and the materials did not elicit toxicologicalresponses. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1999
Ms. Erin Dignan Director, Regulatory Affairs RITA Medical Systems, Inc. 967 North Shoreline Boulevard Mountain View, California 94043
Re: K992693 Trade Name: RITA Model 90 Electrosurgical Accessory Regulatory Class: II Product Code: GEI Dated: August 10, 1999 Received: August 12, 1999
Dear Ms. Dignan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Erin Dignan
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INTENDED USE 3.0
| Indications for Use Statement | |
|---|---|
| 510(K) Number(if known) | K 992693 |
| Device Name | Model 90 Electrosurgical Probe |
| The Model 90 Electrosurgical Probe is designed to supply energy (generatedby the RITA Medical Systems' electrosurgical generator) for use inelectrosurgery and is designed for the following: | |
| Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions. | |
| Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue. | |
| Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions. | |
| Incorporate thermocouples for temperature feedback. | |
| Provide for local delivery of fluid. | |
| PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off)Division of General Restorative Devices | |
| 510(k) Number: K992693 | |
| (per 21 CFR 801.109) | Prescription Use V OR Over the Counter Use ______ |
ﻨﻴﻮ
§ 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.