(12 days)
The RITA® System (RF generator and electrosurgical devices) supplies energy 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 of 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 pain therapy.
The RITA System consists of the following components:
RF Generator: Provides RF energy to the Device through the Main Cable.
Disposable Electrode ("the Device"): Consists of a number of deployable electrodes. Some or all are equipped with a thermocouple, depending on the model of the Device. Some Devices are used with saline infusion ("Infusion Devices") and require the use of a pump.
Infusion Pump: When using the RF Generator with the Infusion Devices, an off-the-shelf market-cleared infusion pump or a RITA Pump is used to deliver saline through the Infusion Device during ablation. In the off-the-shelf pump, syringes are connected to the Infusion Device and loaded into the Infusion Pump. In the RITA Pump, a Tubing Kit is connected to the Infusion Device and loaded into the RITA Pump. The RF Generator is connected to the Infusion Pump via an RS-232 cable.
Tubing Kit: The tubing kit is designed to load into the pump head from the front of the pump. On the proximal end of the tubing-set there is a PVC Bag Spike fitting that allows the tubing to be attached to an IV bag. The Bag Spike fitting is attached to a single length of tubing that is connected to a splitter fitting that splits the single tubing into 5 separate tubes. The 5 tubes are held together with clips that allow the tubes to be uniformly loaded into the pump head. The distal end on the tubing-set has 5 female luers to attach to the Infusible devices.
Main Cable: Connects the Device to the RF Generator.
Dispersive Electrode: Provides the return path for the RF energy applied by the Device. Depending on the model, the dispersive electrode may be equipped with thermocouples to measure skin temperature at the dispersive pad. Dispersive pads with temperature sensing capabilities are connected to the RF Generator at the dispersive electrode connection and at the Aux port.
Power Cord: A medical grade line cord that provides AC power to the RF Generator.
Foot Pedal: The Foot Pedal is connected to the front of the RF Generator. The Foot Pedal starts and stops the RF energy delivery when the RF Generator is in "READY" mode.
The provided text is a 510(k) summary for the RITA® System, an electrosurgical device. It describes the device, its intended use, and states that performance data exists, but it does not contain specific acceptance criteria or detailed results from a study proving those criteria are met. Instead, it generally states that the device was subjected to various types of testing.
Therefore, I cannot provide the requested table or answer most of the detailed questions because the information is not present in the provided document.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot create this table. The document states: "The RITA System is subjected to design verification, software validation, ablation performance, and sterilization validation testing." However, it does not specify what the acceptance criteria for these tests were or what the reported performance values were.
2. Sample size used for the test set and the data provenance:
- Cannot be determined from the document. The document mentions "ablation performance" testing but provides no details on the study design, sample size, or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Cannot be determined. This type of information is usually relevant for studies involving human interpretation (e.g., image-based diagnosis). The RITA System is an electrosurgical device, and its performance would likely be assessed through objective measures (e.g., lesion size, temperature, power output) rather than expert ground truth for interpretation. No such expert evaluation is mentioned.
4. Adjudication method for the test set:
- Not applicable / Cannot be determined. As above, adjudication methods are typically used for establishing ground truth from multiple expert opinions, which is not described for this device's performance testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. The RITA System is an electrosurgical device, not an AI-based diagnostic tool that would assist human readers in interpreting data. Therefore, this type of study is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Cannot be determined, and likely not applicable in the context of an "algorithm only" device. The RITA System is a physical device (generator, electrodes, pump) operated by a user. Its performance is inherent to the device's function, not a standalone algorithm. While software validation is mentioned, this refers to the software controlling the device, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be determined. The document only generally refers to "ablation performance" testing without specifying the endpoint measurements or how the "truth" of ablation success was established (e.g., by pathology post-ablation, imaging follow-up, etc.).
8. The sample size for the training set:
- Not applicable / Cannot be determined. Training sets are relevant for machine learning algorithms. The RITA System is a medical device, not an AI model requiring a training set in the conventional sense. "Design verification" and "software validation" might involve internal testing and iteration, but this is distinct from "training data" for an AI.
9. How the ground truth for the training set was established:
- Not applicable / Cannot be determined. (See point 8).
Summary of available information related to performance:
- What was tested: Design verification, software validation, ablation performance, and sterilization validation testing.
- Device Type: Electrosurgical cutting and coagulation device.
- Intended Use: Percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including non-resectable liver lesions and palliation of pain from metastatic bone lesions.
Conclusion:
The provided 510(k) summary states that performance testing was conducted, but it lacks the granular detail needed to answer specific questions about acceptance criteria, study sizes, ground truth establishment, or specific performance metrics. It's a high-level overview for regulatory clearance based on substantial equivalence to a predicate device, not a detailed scientific publication of study results.
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APR 2 8 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
COLL - ----------------------------------------------------------------------------------------------------------------------------
| Applicant | RITA Medical Systems, Inc.967 N. Shoreline Blvd.Mountain View, CA 94043 |
|---|---|
| Contact Person | Darrin Uecker |
| Telephone Number: | (650) 314-3433 |
| Fax Number: | (650) 390-8505 |
| GeneralProvisions | Trade Name: RITA® SystemCommon/Classification Name: Electrosurgical cutting and coagulation device |
| Name ofPredicate | RITA Medical Systems Inc. - RITA System |
| 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® System (RF generator and electrosurgical devices) supplies energy foruse in electrosurgery and is indicated for use in percutaneous, laparoscopic, orintraoperative coagulation and ablation of soft tissue, including the partial orcomplete ablation of non-resectable liver lesions and the palliation of painassociated with metastatic lesions involving bone in patients who have failed or arenot candidates for standard pain therapy. |
| Device | The RITA System consists of the following components: |
| Description | RF Generator: Provides RF energy to the Device through the Main Cable. |
| Disposable Electrode ("the Device"): Consists of a number of deployableelectrodes. Some or all are equipped with a thermocouple, depending on themodel of the Device. Some Devices are used with saline infusion ("InfusionDevices") and require the use of a pump. | |
| Infusion Pump: When using the RF Generator with the Infusion Devices, an off-the-shelf market-cleared infusion pump or a RITA Pump is used to deliver salinethrough the Infusion Device during ablation. In the off-the-shelf pump, syringesare connected to the Infusion Device and loaded into the Infusion Pump. In theRITA Pump, a Tubing Kit is connected to the Infusion Device and loaded into theRITA Pump. The RF Generator is connected to the Infusion Pump via an RS-232cable. | |
| Tubing Kit: The tubing kit is designed to load into the pump head from the frontof the pump. On the proximal end of the tubing-set there is a PVC Bag Spikefitting that allows the tubing to be attached to an IV bag. The Bag Spike fitting isattached to a single length of tubing that is connected to a splitter fitting that splitsthe single tubing into 5 separate tubes. The 5 tubes are held together with clipsthat allow the tubes to be uniformly loaded into the pump head. The distal end onthe tubing-set has 5 female luers to attach to the Infusible devices. | |
| Main Cable: Connects the Device to the RF Generator. |
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Page 2 of 2
Dispersive Electrode: Provides the return path for the RF energy applied by the Device. Depending on the model, the dispersive electrode may be equipped with thermocouples to measure skin temperature at the dispersive pad. Dispersive pads with temperature sensing capabilities are connected to the RF Generator at the dispersive electrode connection and at the Aux port.
Power Cord: A medical grade line cord that provides AC power to the RF Generator.
Foot Pedal: The Foot Pedal is connected to the front of the RF Generator. The Foot Pedal starts and stops the RF energy delivery when the RF Generator is in "READY" mode.
Device Description (cont.)
To use the system, the RF Generator is plugged into the wall outlet via the Power Cord. The electrosurgical device is connected to the RF Generator via the Main Cable. The Dispersive Electrode is placed on the appropriate location of the body and is connected to its port on the RF Generator. If a pump is used, it is connected to scrial port B of the RF Generator. Once the system is successfully powered up, the user can set the parameters of the ablation such as the mode of operation, the ablation time, the target temperature, and the power delivery level. One mode of operation, purge, is used to communicate with an infusion pump to prime the system. There are four modes of operation for RF energy delivery: constant power, constant temperature, infusion mode, and track ablation. In the infusion mode, the RF Generator communicates with the infusion pump to set and adjust the infusion With the electrosurgical device placed in the tissue to be ablated and its rate. electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the RF Generator. If the measured parameters arc outside the acceptable limits, the RF energy delivery and fluid delivery (if in infusion mode) automatically stops and a message appears on the liquid crystal display (LCD). The RF energy delivery and fluid delivery (if in infusion mode) also automatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can also be stopped at any point by pressing the RF on/off switch. Fluid delivery can also be stopped at any point by pressing the pump on/off switch.
Performance Data
The RITA System is subjected to design verification, software validation, ablation performance, and sterilization validation testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'APR 2 8 2004
RITA Medical Systems, Inc. c/o Mr. Morten Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050
Re: K040989
Trade/Device Name: RITA System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Codc: GEI Dated: April 14, 2004 Received: April 16, 2004
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for two stated of to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to they 20, 2011 11:47 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 r ou may a news 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 dctermination 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); labcling (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 Christensen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to organization of substantial equivalence of your device to a legally premaince noticate 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 if you desire specific at (301) 594-4659. 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 other general motimational 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
Colia 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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Indications for Use
510(k) Number (if known): _ K 040989
Device Name:
Indications for Use:
The RITA® System (RF generator and electrosurgical devices) supplies energy 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 of 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 pain therapy.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Page I of I
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_ Ko40989
§ 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.