(26 days)
Model 90/StarBurst Electrosurgical Device
Not Found
No
The summary does not mention any AI or ML components, and the device description focuses on physical components and basic electrosurgical functions.
Yes
The device is indicated for medical procedures such as coagulation and ablation of soft tissue, including liver lesions and palliation of pain associated with bone metastases, which are therapeutic interventions.
No
The device is designed to supply energy for electrosurgery, specifically for the coagulation and ablation of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including electrodes, tubing, a handle, connectors, and temperature sensors. It is an electrosurgical device that delivers energy, which is a hardware function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The RITA® StarBurst SDE Electrosurgical Device is used to directly apply energy to soft tissue within the body for coagulation and ablation. This is an in vivo procedure.
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's liver and bone, not a laboratory test on a sample.
- Device Description: The description details components designed for insertion into the body (trocar, electrodes, etc.) and delivery of energy, not for analyzing biological samples.
Therefore, the RITA® StarBurst SDE Electrosurgical Device is a surgical device used for therapeutic purposes in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, liver lesions, bone
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RITA Medical Systems Inc. - Model 90/StarBurst Electrosurgical Device
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.
0
APR 2 1 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
| General
Provisions | Trade Name: StarBurst SDE Electrosurgical Device
Common/Classification Name: Electrosurgical cutting and coagulation accessory |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate | RITA Medical Systems Inc. - Model 90/StarBurst Electrosurgical Device |
| Classification | Class II |
| Performance
Standards | Performance standards have not been established by the FDA under section 514 of
the 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 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 |
| Performance
Data | 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. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
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,
2
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
3
3.0 INTENDED USE
Indications for Use Statement
| 510(K) Number
| (if known) | K030967 |
|---|---|
| Device Name | RITA® StarBurst SDE Electrosurgical Device |
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.
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 -