(166 days)
No
The summary describes a radiofrequency ablation system that uses temperature, impedance, and power monitoring to assist the user. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for 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 bone lesions, which are therapeutic applications.
No
The device description and intended use indicate that the RITA System is used for coagulation and ablation of soft tissue, which is a therapeutic or interventional procedure, not a diagnostic one.
No
The device description explicitly mentions a "RF Generator" and "electrosurgical devices" including "disposable electrosurgical probes with deployable needle arrays," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- RITA System Function: The RITA System is used for ablation of soft tissue within the body (in vivo). It directly applies energy to the target tissue to destroy it.
- Intended Use: The intended use clearly states it's for "percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue." This is a therapeutic procedure performed on the patient, not a diagnostic test on a sample.
- Device Description: The description details a "RF Generator and electrosurgical devices" that "create coagulative necrotic lesions in soft tissue." This is consistent with a surgical or therapeutic device, not a diagnostic one.
The RITA System is a therapeutic device used for treating certain conditions, not for diagnosing them by testing samples.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, non-resectable liver lesions, bone (for metastatic lesions)
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)
Bench studies were conducted to determine the effect the bone environment has on ablation characteristics and to determine ablation parameters. Clinical studies were conducted to determine the safety and effectiveness of the RITA System for the ablation of painful bone lesions in order to alleviate pain. All of the studies were conducted on patients with lesions that had metastasized to one or more locations in the skeleton. The RITA System was used in patients who had failed conventional therapies (e.g., analgesics, radiation therapy). Effectiveness was measured using an instrument validated for evaluating cancer pain. From baseline to week four, 75% and 80% patients experienced at least a two-point reduction is worst pain and average pain respectively. The ablation procedure had low attendant morbidity (no reports of death related to use of the devices) and three adverse events potentially related to RF ablation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
From baseline to week four, 75% and 80% patients experienced at least a two-point reduction is worst pain and average pain respectively.
Predicate Device(s)
K983214, K992693, K993944, K003676, K963577, K965182, K980430, K982489
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.
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:
| 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | ||
|---|---|---|
| General | Trade Name: RITA® System | ||||
|---|---|---|---|---|---|
| Provisions | Common/Classification Name: Electrosurgical Radiofrequency Generator and | ||||
| Electrosurgical Devices | |||||
| Name of | |||||
| Marketed Device | RITA Medical Systems Inc. - RITA® System (K983214, K992693, K993944, | ||||
| K003676) | |||||
| Radionics - Radiofrequency system (K963577, K965182, K980430, K982489) | |||||
| Classification | Class II | ||||
| Performance | |||||
| Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not | ||||
| established performance standards. | |||||
| Intended 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. | |||||
| Device | |||||
| Description | 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 RF Generator is specifically designed for use with RITA | |||||
| the lesion. | |||||
| 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. | |||||
| Performance | |||||
| Data | Bench studies were conducted to determine the effect the bone environment has on | ||||
| ablation characteristics and to determine ablation parameters. Clinical studies were | |||||
| conducted to determine the safety and effectiveness of the RITA System for the | |||||
| ablation of painful bone lesions in order to alleviate pain. All of the studies were | |||||
| conducted on patients with lesions that had metastasized to one or more locations | |||||
| in the skeleton. The RITA System was used in patients who had failed | |||||
| conventional therapies (e.g., analgesics, radiation therapy). Effectiveness was | |||||
| measured using an instrument validated for evaluating cancer pain. From baseline | |||||
| to week four, 75% and 80% patients experienced at least a two-point reduction is | |||||
| worst pain and average pain respectively. The ablation procedure had low | |||||
| attendant morbidity (no reports of death related to use of the devices) and three | |||||
| adverse events potentially related to RF ablation. |
1
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.
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 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
3
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_________________________________________________________________________________________________________________________________________________________________