RITA STARBURST SDE ELECTROSURGICAL DEVICE by RITA MEDICAL SYSTEMS

The RITA® StarBurst SDE Electrosurgical Device is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue including:
The partial or complete ablation on non-resectable liver lesions and
The palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

Device Description

The RITA StarBurst SDE device is 12-cm in length and can be used for a variety of medical applications. Each secondary electrode deploys out from the side of the trocar through a hole in the wall of the trocar (primary electrode). The RITA device consists of the following components: primary electrode: tubing with a portion exposed as an electrode secondary electrodes: tubing at the distal end of probe trocar insulation: shrink tubing handle: with markings to indicate the amount of secondary electrode deployment from the trocar RF pathway: connection through nine-pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: three temperature sensors in the distal section of the secondary electrodes depth indicators: incremental 1 cm marks denote needle penetration depth

AI/ML Overview

The provided text is a 510(k) Summary for the RITA® StarBurst SDE Electrosurgical Device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on demonstrating equivalence through device description, intended use, and performance data that shows the device meets its own specifications, rather than clinical studies rigorously proving efficacy against specific acceptance criteria for AI/ML devices.

Therefore, much of the requested information regarding AI/ML device study parameters (sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Electrical, mechanical, and functional specifications (exact specifications not detailed in the summary)	"The StarBurst SDE devices were subjected to a battery of electrical, mechanical, and functional testing to verify that the devices met the specifications. The devices met the specifications."

2. Sample size used for the test set and the data provenance:

Not applicable / Not available. This document describes a physical electrosurgical device, not an AI/ML diagnostic or predictive system that uses a "test set" of data in the common AI/ML sense. The "testing" referred to is likely engineering and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not available. Ground truth as understood in AI/ML (e.g., expert consensus on images) is not relevant to the testing described for this electrosurgical device.

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

Not applicable / Not available. Adjudication methods are not relevant to the type of device testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance:

No. This is an electrosurgical device, not an AI-assisted diagnostic or treatment planning tool that would involve human readers.

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

Not applicable. This device is an electrosurgical tool and not an AI algorithm. Its performance is inherent to its design and function when operated by a human, not a standalone algorithmic output.

7. The type of ground truth used:

For the "performance data" section, the "ground truth" would be the engineering and design specifications for the device. The testing verified that the device's electrical, mechanical, and functional properties conformed to these pre-defined specifications.

8. The sample size for the training set:

Not applicable / Not available. This device does not involve a "training set" in the context of machine learning.

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

Not applicable / Not available. (See point 8).

Summary of the Study:

The "study" referenced in the document is a pre-market regulatory submission (510(k)) for a physical electrosurgical device. The performance data consists of:

"A battery of electrical, mechanical, and functional testing" conducted on the StarBurst SDE devices.
The objective of this testing was to "verify that the devices met the specifications."
The outcome was that "The devices met the specifications."

This is fundamentally different from the type of studies typically conducted for AI/ML-based medical devices, which focus on diagnostic accuracy, sensitivity, specificity, and comparative effectiveness against human performance using patient data. For this electrosurgical device, the "acceptance criteria" were the internal design and performance specifications, and the "study" was the in-house engineering and bench testing to demonstrate compliance with those specifications.

Summary

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K030967

APR 2 1 2003

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

GeneralProvisions	Trade Name: StarBurst SDE Electrosurgical DeviceCommon/Classification Name: Electrosurgical cutting and coagulation accessory
Name ofPredicate	RITA Medical Systems Inc. - Model 90/StarBurst Electrosurgical Device
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 RITA® StarBurst SDE Electrosurgical Device is designed to supply energy(generated by the RITA Medical Systems' electrosurgical generator) for use inelectrosurgery and is indicated for use in percutaneous, laparoscopic, orintraoperative coagulation and ablation of soft tissue including:The partial or complete ablation on non-resectable liver lesions and The palliation of pain associated with metastatic lesions involving bone inpatients who have failed or are not candidates for standard therapy.
DeviceDescription	The RITA StarBurst SDE device is 12-cm in length and can be used for a variety ofmedical applications. Each secondary electrode deploys out from the side of thetrocar through a hole in the wall of the trocar (primary electrode). The RITA deviceconsists of the following components: primary electrode: tubing with a portion exposed as an electrode secondary electrodes: tubing at the distal end of probe trocar insulation: shrink tubing handle: with markings to indicate the amount of secondary electrode deployment from the trocar RF pathway: connection through nine-pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: three temperature sensors in the distal section of thesecondary electrodes depth indicators: incremental 1 cm marks denote needle penetration depth
PerformanceData	The StarBurst SDE devices were subjected to a battery of electrical, mechanical,and functional testing to verify that the devices met the specifications. The devicesmet the specifications.

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APR 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Erin Mazzone Director, Quality/Regulatory Affairs RITA Medical Systems, Inc. 967 N. Shoreline Boulevard Mountain View, California 94043

Re: K030967

Trade/Device Name: RITA® StarBurst SDE Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 24, 2003 Received: March 26, 2003

Dear Ms. Mazzone:

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 - Ms. Erin Mazzone

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 Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

forCelia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3.0 INTENDED USE

Indications for Use Statement

510(K) Number(if known)	K030967
Device Name	RITA® StarBurst SDE Electrosurgical Device

. The partial or complete ablation on non-resectable liver lesions and
The palliation of pain associated with metastatic lesions involving . bone in patients who have failed or are not candidates for standard therapy.

PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / OR Over the Counter Use __

(per 21 CFR 801.109)

uriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

April 15, 2003

KO30967 510(k) Number -

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.