(35 days)
Not Found
No
The document describes a standard RF electrosurgical device with temperature feedback and saline infusion, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as "intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures," which describes a therapeutic action.
No
The device is described as an electrosurgical device intended to "coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures" by delivering RF energy. This describes a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a monopolar radiofrequency (RF) device consisting of a variably insulated electrode, electrical cable, and infusion tubing set. These are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures." This describes a therapeutic or surgical intervention performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device that delivers radiofrequency energy to tissue for coagulation. This is a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| | SECTION 3
510(k) Summary | K070101 |
|--------------------|----------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | RITA Medical Systems, Inc | |
| Contact Person: | Kam Leung
Manager of Regulatory Affairs, RFA
46421 Landing Parkway
Fremont 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
1
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.
2
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.
3
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
4
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 _________________________________________________________________________________________________________________________________________________________