(15 days)
The Habib 4X Laparoscopic is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures
The Habib 4X Laparoscopic is a bipolar radiofrequency (RF) device that consists of a handle, an instrument shaft, and an array of four needles at the distal end of the instrument. The instrument has an attached cable which connects the device directly to the RITA Medical 1500X RF generator. The device electrodes are inserted into tissue is coagulated using the RF power. The Habib 4X Laparoscopic is designed for use in laparoscopic surgery and the instrument shaft fits through a standard 10mm laparoscopic port. The handle includes an RF on/off switch which can be operated with either the left or right hand. The Habib 4X Laparoscopic is a single use device.
The provided text does NOT contain information about acceptance criteria, device performance metrics, or a detailed study proving the device meets specific criteria. It is a 510(k) summary for a medical device (Habib 4X Laparoscopic) seeking substantial equivalence to existing predicate devices.
The document states:
- "Performance testing was done to ensure that the Habib 4 X Laparoscopic 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."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, ground truth establishment, or expert qualifications for any specific study.
- Information about MRMC studies, standalone algorithm performance, or training set details.
Therefore, I cannot fulfill the request for a table of acceptance criteria and study details based on the provided text. The document focuses on establishing substantial equivalence based on technological characteristics and intended use compared to predicate devices, rather than presenting a detailed performance study with specific quantitative acceptance criteria.
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SECTION 3 Summary of Safety and Effectiveness Sponsor: RITA Medical Systems, Inc Contact Person: Darrin Uecker CT 1 3 2006 Chief Technology Officer 46421 Landing Parkway Fremont Ca 94538 (510) 771-0440 Summary Prepared: September 5, 2006 Trade Name: Habib 4X Laparoscopic Common Name: Electrosurgical cutting and coagulation device and accessories Classification: Class II per 21 CFR 878.4400 Product Code: GEI Predicate Devices: Habib 4X (K051420) Cool-Tip RF System (K984552)
Intended Use:
The Habib 4X Laparoscopic is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures
Description:
The Habib 4X Laparoscopic is a bipolar radiofrequency (RF) device that consists of a handle, an instrument shaft, and an array of four needles at the distal end of the instrument. The instrument has an attached cable which connects the device directly to the RITA Medical 1500X RF generator. The device electrodes are inserted into tissue is coagulated using the RF power. The Habib 4X Laparoscopic is designed for use in laparoscopic surgery and the instrument shaft fits through a standard 10mm laparoscopic port. The handle includes an RF on/off switch which can be operated with either the left or right hand. The Habib 4X Laparoscopic is a single use device.
Technological Differences:
The RITA Medical Systems, Inc. Habib 4X Laparoscopic has the same technological characteristics as the Habib 4X (K051420). The configuration of the electrodes and the method
| No of the county process and A - A | Comments of the contract of the controlled in American in American and Children and Children and Children |
|---|---|
| Habib 4X Laparoscopic 510(k) | |
| RITA Medical Systems | |
| Eection 3. Summary of Safety and Effectiveness-------------------------------------------------------------------------------------------------------------------------------- |
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SECTION 3 Summary of Safety and Effectiveness
the device uses to coagulate tissues is identical. The differences are primarily to facilitate the use of the device through a laparoscopic port. The Habib 4X Laparoscopic has similar technological characteristics as the Cool-Tip RF System (K984552) in that they both use electrodes and RF energy to coagulate tissue and have the same intended use.
Performance Data:
Performance testing was done to ensure that the Habib 4 X Laparoscopic 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2006
Rita Medical Systems, Inc. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 East Trimble Road San Jose, California 95131-1230
Re: K062935
Trade/Device Name: Habib 4X Laparoscopic Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2006 Received: September 28, 2006
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 3 legal) marketed predicate device results in a classification for your device and thus, permitts 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 ventitled, "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 vours.
Mark A. Milkersen
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) __
Habib 4X Laparoscopic Device Name
The Habib 4X Laparoscopic is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milburn
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number K062935
V Prescription Use OR Over the Counter Use ______________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)
§ 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.