INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)

K100641 · Relievant Medsystems · GEI · Mar 30, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100641
• Device Name: INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)
• Applicant: Relievant Medsystems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 30, 2010
• 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 Easy Access Instrument Set are intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

Device Story

System delivers temperature-controlled radiofrequency (RF) energy to soft tissue to create lesions; used in conjunction with Stockert NEURO N50 RF Generator and Interconnect Cable. Device consists of flexible bi-polar RF probe and easy access instrument set. Operated by clinicians in clinical settings to provide access to target tissue and perform coagulation. Modification to predicate device focuses on upgraded access and deployment instrumentation to improve ergonomics, reduce procedural complexity, and decrease procedure time. Output is thermal lesion in soft tissue; assists in surgical procedures requiring tissue coagulation.

Clinical Evidence

Bench testing only. Ex vivo and in vitro data compared the subject device to the predicate. Results demonstrated that the Easy Access Instrument Set achieves RF probe placements with reduced procedural complexity and improved ergonomics, potentially reducing overall procedure time and improving instrument exchange efficiency.

Technological Characteristics

Bi-polar RF probe; temperature-controlled energy delivery; used with external RF generator (Stockert NEURO N50). System includes flexible probe and access/deployment instrumentation. No specific materials or software algorithm class specified beyond standard electrosurgical accessory classification (21 CFR 878.4400).

Indications for Use

Indicated for thermal coagulation of soft tissues using radiofrequency energy.

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 Flexible Bi-Polar RF Probe and Curved Instrument Set (K100641)

Submission Summary (Full Text)

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Relievant Medsystems, Inc.

Special 510(k) Premarket Notification

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March 4, 2010 INTRACEPT Flexible RF Probe and Easy Access Instrument Set

K i 00641

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MAR 8 0 2010

## 510(k) Summary of Safety and Effectiveness

- 1. Submitter's Name Relievant MedSystems, Inc. 2688 Middlefield Rd, Suite A Redwood City, CA 94063
- 2. Company Contact Adam Savakus Executive Vice President Telephone: [phone] Fax: [phone]
- 3. Device Name Trade Name:

Common Name: Classification Name: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set Radiofrequency Probe Electrosurgical, cutting & coagulation & accessories

- 4. Date Summary Prepared March 3, 2010
- ર. Predicate Device Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set

## 6. Description of Device

The Relievant INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The device is a modification to the Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set incorporating upgraded access and deployment instrumentation. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions 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 Easy Access Instrument Set are intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

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K100641

Relievant Medsystems, Inc. and

- 8. Comparison of Technological Characteristics The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution: Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set
- 9. Summary of Performance Data

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The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set were tested and compared to the predicate device. Ex vivo and in vitro data demonstrated that the INTRACEPT Easy Access Instrument Set achieves RF Probe placements with less procedural complexity and improved ergonomics, which may result in reduced overall procedure time and more efficient instrument exchange. The test data gathered demonstrate that this device is substantially equivalent to the predicate device. No new safety or effectiveness issues have been raised.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird, indicating the department's name and the country it represents.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Relievant Medsystems, Inc. % Mr. Adam Savakus Executive Vice President 2688 Middlefield Road, Suite A Redwood City, California 94063

MAR 3 0 2010

Re: K100641

Trade/Device Name: INTRACEPT Flexible RF Probe and Easy Access Instrument Set Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 04, 2010 Received: March 05, 2010

Dear Mr. Savakus:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Adam Savakus

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark N. Milkeran

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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)

Neil R. Ogle for men

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100641

Confidential

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