(166 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 (RF Generator and electrosurgical devices) is designed to create coagulative necrotic lesions in soft tissue, and allow localized delivery of fluid to the lesion. The RF Generator is specifically designed for use with RITA Electrosurgical Devices (Accessories). The RF Generator provides multiple temperature sensors, impedance, and power monitoring to assist the user in delivering the desired energy to the target tissue. The electrosurgical devices consist of monopolar electrosurgical devices that include disposable electrosurgical probes with deployable needle arrays that deliver RF power with temperature and impedance monitoring to ablate predictable volumes of tissue.
The provided text describes the RITA® System, an electrosurgical device, and its intended use and performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria (e.g., target specificity, sensitivity, or similar metrics for a diagnostic device). Instead, it describes a clinical study and its observed outcomes as a measure of effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined in terms of specific performance metrics for this device, which is a therapeutic device for ablation and pain palliation) | Effectiveness for Pain Palliation (Worst Pain): 75% of patients experienced at least a two-point reduction in "worst pain" from baseline to week four. |
| Effectiveness for Pain Palliation (Average Pain): 80% of patients experienced at least a two-point reduction in "average pain" from baseline to week four. | |
| Safety/Morbidity: Low attendant morbidity (no reports of death related to use of the devices). | |
| Adverse Events: Three adverse events potentially related to RF ablation. | |
| (Bench study findings on ablation characteristics/parameters) | Bench studies determined the effect of the bone environment on ablation characteristics and parameters. (Specific quantitative results not provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the total number of patients in the clinical study. It refers to percentages of "patients" (75% and 80%) but not the base number.
- Data Provenance: The study was conducted on "patients with lesions that had metastasized to one or more locations in the skeleton." It is a prospective clinical study assessing safety and effectiveness. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a therapeutic device like this, "ground truth" would typically relate to clinical outcomes rather than expert-derived labels on images.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of pain palliation as an endpoint, "adjudication" in the sense of expert consensus on image interpretation is less relevant. The effectiveness was measured using a "validated instrument for evaluating cancer pain," suggesting a standardized assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not provided. The study described is a clinical study evaluating the device's effectiveness in alleviating pain, not a comparative effectiveness study involving human readers with/without AI assistance. The device itself is an RF ablation system, not an AI diagnostic tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This question is not applicable to the RITA® System as described. It is a physical medical device (RF generator and electrosurgical devices) that requires direct human operation, not a standalone algorithm. The "performance" refers to the device's clinical efficacy and safety when used by a clinician.
7. The Type of Ground Truth Used
The "ground truth" for the effectiveness of the RITA® System's pain palliation indication was based on:
- Outcomes Data: Specifically, patient-reported pain levels assessed using an "instrument validated for evaluating cancer pain."
- Safety Data: Observed adverse events and mortality related to the device's use.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The RITA® System is a physical electrosurgical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "bench studies" mentioned would involve laboratory testing, not a data training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no "training set ground truth" in the context of this device.
In summary, the provided text describes a clinical study demonstrating the RITA® System's effectiveness in pain palliation and its safety profile. However, it does not detail specific, quantitative acceptance criteria in a tabular format, nor does it address aspects related to AI/algorithm performance (like training sets, expert adjudication, or MRMC studies) as the device is a therapeutic electrosurgical system.
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| 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | ||
|---|---|---|
| General | Trade Name: RITA® System | ||||
|---|---|---|---|---|---|
| Provisions | Common/Classification Name: Electrosurgical Radiofrequency Generator andElectrosurgical Devices | ||||
| Name ofMarketed Device | RITA Medical Systems Inc. - RITA® System (K983214, K992693, K993944,K003676) | ||||
| Radionics - Radiofrequency system (K963577, K965182, K980430, K982489) | |||||
| Classification | Class II | ||||
| PerformanceStandards | The FDA under section 514 of the Food, Drug and Cosmetic Act has notestablished performance standards. | ||||
| 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 or complete ablation of 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 pain therapy. | |||||
| DeviceDescription | The RITA System (RF Generator and electrosurgical devices) is designed to createcoagulative necrotic lesions in soft tissue, and allow localized delivery of fluid toThe RF Generator is specifically designed for use with RITAthe lesion.Electrosurgical Devices (Accessories). The RF Generator provides multipletemperature sensors, impedance, and power monitoring to assist the user indelivering the desired energy to the target tissue. The electrosurgical devicesconsist of monopolar electrosurgical devices that include disposable electrosurgicalprobes with deployable needle arrays that deliver RF power with temperature andimpedance monitoring to ablate predictable volumes of tissue. | ||||
| PerformanceData | Bench studies were conducted to determine the effect the bone environment has onablation characteristics and to determine ablation parameters. Clinical studies wereconducted to determine the safety and effectiveness of the RITA System for theablation of painful bone lesions in order to alleviate pain. All of the studies wereconducted on patients with lesions that had metastasized to one or more locationsin the skeleton. The RITA System was used in patients who had failedconventional therapies (e.g., analgesics, radiation therapy). Effectiveness wasmeasured using an instrument validated for evaluating cancer pain. From baselineto week four, 75% and 80% patients experienced at least a two-point reduction isworst pain and average pain respectively. The ablation procedure had lowattendant morbidity (no reports of death related to use of the devices) and threeadverse events potentially related to RF ablation. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 9 2002
Ms. Erin Mazzone RITA Medical Systems, Inc. Director, Regulatory Affairs 967 N. Shoreline Boulevard Mountain View, California 94043
Re: K021329
Trade/Device Name: RITA® System Regulatory Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device And Accessories
Regulatory Class: II Product Code: GEI Dated: July 30, 2002 Received: July 31, 2002
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.
sincerely yours,
Stypt Rwords
Celia 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 Statement
| 510(K) Number (if known) | K021329 |
|---|---|
| Device Name | RITA® System |
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
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
pain therapy.
bone in patients who have failed or are not candidates for standard
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / OR Over the Counter Use ___
(per 21 CFR 801.109)
Stupt Dwork
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.