(35 days)
The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode. The instrument has an attached electrical cable and infusion tubing set which connects the device directly to the RITA Medical 1500X RF generator and the IntelliFlow peristaltic pump respectively. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal saline through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.
The provided text describes a 510(k) summary for the UniBlate Electrosurgical Device. This regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing, rather than establishing clinical efficacy through a detailed study with specific acceptance criteria as one might find for a novel therapeutic device.
Therefore, the requested information regarding "acceptance criteria" based on a study of clinical performance, "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for the training set" is not explicitly available within the provided text.
The document indicates that "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications." However, it does not detail these design specifications as specific quantitative acceptance criteria or report device performance against them in a table format. The primary goal of this 510(k) submission is to show that the device is "substantially equivalent to the predicate device, and meets safety and effectiveness criteria" through these performance tests, which are not described in detail.
Here's what can be extracted and inferred from the text:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document. The text states: "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria." This implies that internal acceptance criteria were met, but they are not listed, nor are specific performance metrics reported against them. The focus is on substantial equivalence to predicate devices (StarBurst XLi and Cool-Tip RF System) in terms of principles of operation, construction, and intended use.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly provided in the document. The text mentions "Performance testing" but does not detail the nature, sample size, or provenance (country of origin, retrospective/prospective) of any clinical or technical test sets used for evaluating the device against its "design specifications."
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/provided. The document describes performance testing for device functionality and design specifications, not a study requiring expert-established ground truth for clinical outcomes or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable/provided. No information on an adjudication method is discussed, as the document focuses on technical performance and substantial equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention an MRMC comparative effectiveness study. The context is a device for tissue coagulation, not a diagnostic imaging device where such studies are common.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The UniBlate device is an electrosurgical device, not an algorithm. The concept of "standalone performance" in this context would relate to the device operating as designed, independent of human intervention in its function, which is implicitly what "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications" refers to. However, this is not detailed as a separate study.
7. Type of Ground Truth Used
Device-specific test parameters/design specifications, implicitly. For an electrosurgical device, "ground truth" for performance testing would typically refer to established engineering and safety standards, as well as the ability to achieve defined tissue coagulation parameters (e.g., lesion size, temperature profiles) in a controlled environment, demonstrating it functions "as intended." However, these specific "ground truths" (e.g., measurements of coagulation zone, power output, temperature feedback accuracy) are not detailed in the summary. The overarching "ground truth" for the 510(k) is substantial equivalence to legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable/provided. This device is hardware and does not involve AI or machine learning that would require a "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable. As above, no training set is discussed or implied.
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| SECTION 3510(k) Summary | K070101 | |
|---|---|---|
| Sponsor: | RITA Medical Systems, Inc | |
| Contact Person: | Kam LeungManager of Regulatory Affairs, RFA46421 Landing ParkwayFremont CA 94538(510) 771-0440 | FEB 14 2007 |
| Summary Prepared: | December 20, 2006 | |
| Trade Name: | UniBlate Electrosurgical Device | |
| Common Name: | Electrosurgical cutting and coagulation device and accessories | |
| Classification: | Class II per 21 CFR 878.4400 | |
| Product Code: | GEI | |
| Predicate Devices: | StarBurst XLi (K010060)Cool-Tip RF System (K984552) |
Intended Use:
The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
Description:
The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode. The instrument has an attached electrical cable and infusion tubing set which connects the device directly to the RITA Medical 1500X RF generator and the IntelliFlow peristaltic pump respectively. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal saline through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.
Technological Differences:
The RITA UniBlate, RITA StarBurst XLi (K010060) and Radionics Cool-Tip (K984552) are monopolar electrodes used to deliver RF energy during open, laparoscopic or percutaneous procedures to ablate and coagulate soft tissue. The UniBlate and StarBurst XLi devices are designed to provide a scaleable coagulation zone. The UniBlate electrode has a single active electrode that can be exposed
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SECTION 3
510(k) Summary
from 1 cm to 3 cm by retracting an insulating sheath. The StarBurst XLi consists of multiple electrodes which are deployed into the tissue from an insulated trocar. The Cool-Tip has a fixed length active electrode, but is available in different sizes. Both the UniBlate and StarBurst XLi allow for local fluid delivery as well as temperature monitoring. The UniBlate Electrosurgical Device is similar to the predicate RITA StarBurst XLi and Radionics Cool-Tip in principles of operation and construction and has the same intended use as the Cool-Tip.
Performance Data:
....
Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services in the USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Underwriters Laboratories, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator 455 East Trimble Road San Jose, California 95131-1230
FEB 1 4 2007
Re: K070101
Trade/Device Name: Uniblate Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 29, 2007 Received: January 30, 2007
Dear Mr. Christensen:
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. Morten Simon Christensen
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 (240) 276-0115 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 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 A. Milken
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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SECTION 2 Indications for Use Statement
Indications for Use Statement
510(K) Number (if known)
Device Name
UniBlate Electrosurgical Device
Indications for Use:
The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
Monk A. Mulkerson
sion Sign : Restorative ion of Ge irologi Numb
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.