INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026

K083856 · Relievant Medsystems, Inc. · GEI · Jan 22, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083856
• Device Name: INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026
• Applicant: Relievant Medsystems, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues

Device Story

The INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set is a surgical accessory used with the Stockert NEURO N50 RF Generator and Interconnect Cable. The system delivers temperature-controlled radiofrequency (RF) energy to targeted soft tissue to create thermal lesions. The curved instrument set provides access to the target tissue. The device is a modification of the predicate, featuring a curved instrument set and a more flexible probe tip. It is used by clinicians to perform thermal coagulation, aiding in tissue management.

Clinical Evidence

Bench testing and in vivo data were used to compare the subject device to the predicate. The study demonstrated that the INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set creates clinically relevant lesions equivalent in size to those produced by the predicate device.

Technological Characteristics

System consists of a flexible bi-polar RF probe and curved instrument set. Operates via temperature-controlled RF energy delivered through an external RF generator (Stockert NEURO N50). Designed for thermal coagulation of soft tissue.

Indications for Use

Indicated for thermal coagulation of soft tissues using radiofrequency energy. Intended for prescription use.

Regulatory Classification

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.

Predicate Devices

• Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set (K070443)

Submission Summary (Full Text)

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K083856

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## 510(k) Summary of Safety and Effectiveness

- I Submitter's Name Relievant MedSystems, Inc 713 Sandoval Way Hayward, CA 94544
JAN 2 2 2009

- 2 Company Contact Mark Smutka Regulatory, Clinical, and Quality Consultant Telephone - 510-489-1080 Fax - 510-489-1082
3 Device Name INTRACEPT Flexible B1-Polar RF Probe and Trade Name Curved Instrument Set Common Name Radiofrequency Probe Electrosurgical, cutting & coagulation & Classification Name accessories

- Date Summary Prepared 4 December 19, 2008
- 5 Predicate Device Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set (K070443)
- Description of Device 6

The Relievant INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Sets are used in comunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lessons 11 soft tissue The device is a modification to the Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set to incorporate a curved instrument set and a more flexible tip of the radiofrequency probe The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lessons in soft tissue The Instrument Sets are used to provide access to the target tissue

- 7 Intended Use The INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set 1s intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues
- Comparison of Technological Characteristics 8

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K083856

The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrament Set are substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set (K070443)

## 9 Summary of Performance Data

The INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set was tested and compared to the predicate device In vivo data demonstrated that the INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set creates clinically relevant lessons that are equivalent in size to the predicate device The test data gathered demonstrate that this device is substantially equivalent to the predicate device No new safety or effectiveness issues have been ra1sed

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Admınıstratıon 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2009

Relievant MedSystems, Inc % Mr Mark Smutka Regulatory, Clinical and Quality Consultant 713 Sandoval Way Hayward, California 94544

Re K083856

Trade/Device Name INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set Regulation Number 21 CFR 878 4400 Regulation Name Electrosurgical cutting and coagulation device and accessories Regulatory Class II Product Code GEI Dated December 23, 2008 Received December 24, 2008

Dear Mr Smutka

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

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 Reguster

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

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Page 2 - Mr Mark Smutka

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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Drvision of Postmarket Surveillance at [phone] For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone] 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 [phone] or [phone] or at its Internet address http //www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Mark N. Wilkerson

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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Indications for Use Statement

510(k) Number (if known) K083856

Device Name INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set

Indications for Use

The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set 1s ıntended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues

Prescription Use X (Per 21 C F R 801 109) AND/OR

Over-The-Counter Use (Per 21 C F R 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kramer for MyM 1/22/2009

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K083856