NUCLEOTOMY INTRADISCAL CATHETER

K013622 · Oratec Interventions, Inc. · GEI · Jan 31, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013622
• Device Name: NUCLEOTOMY INTRADISCAL CATHETER
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 31, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nucleotomy Catheter is intended to be used for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

Device Story

The Nucleotomy Catheter is a minimally invasive thermoelectric device used for treating contained herniated discs. The device features a flexible distal tip containing a resistive metal coil that generates thermal energy when electrical current is applied. A thermocouple integrated into the tip monitors and controls tissue temperature during the procedure. The device is operated by a physician to deliver heat to targeted intradiscal locations, facilitating coagulation and decompression of disc material. This process aims to alleviate symptoms associated with herniated discs. The device is used in a clinical setting.

Clinical Evidence

Bench testing and biocompatibility testing were conducted to support the claim of substantial equivalence. No clinical data was provided.

Technological Characteristics

Minimally invasive thermoelectric catheter; flexible distal tip with resistive metal coil; integrated thermocouple for temperature monitoring/control; energy source: electrical current; intended for coagulation and decompression of disc material.

Indications for Use

Indicated for symptomatic patients with contained herniated discs requiring coagulation and decompression of disc material.

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

• SpineCATH Intradiscal Catheter (K993967)

Submission Summary (Full Text)

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# Section 2 - 510(K) Summary of Safety and Effectiveness

## KO13622

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Contact Person: Linda Guthrie Manager, Regulatory Affairs and Compliance Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025

### Device Name:

Nucleotomy Catheter

#### Device Description:

Device Dessription:
The Nucleotomy Catheter is a minimally invasive thermoelectric device. When used in The Nucleolonity Cuthers is a missanerator the Nucleotomy Catheter delivers thermal energy to targeted locations inside the disc. The distal portion of the tip is flexible such that the device can targeted locations instice the answ The flexible tip contains a resistive metal coil, which produces heat when current flows through it. The device contains a thermocouple for monitoring and controlling the temperature of the treated tissue.

#### Indications for Use:

The Nucleotomy Catheter is intended to be used for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

#### Predicate Device:

SpineCATH Intradiscal Catheter K993967, cleared December 28, 1999

#### Safety and Performance

Sately and biocompatibility testing were conducted to support this claim of substantial equivalence.

#### Conclusion

Conclusion
The Nucleotomy Catheter has the same technological characteristics and similar intended use as the The Naccebonly Canever has and biocompatibility testing, as presented in this prepreciedic devices results is the Nucleotomy Catheter is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with healthcare. The caduceus is depicted with a single staff entwined by a serpent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 3 1 2002

Ms. Linda Guthrie MS: Ennad Ogulatory Affairs and Compliance ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, California 94025

Re: K013622

Trade Name: Nucleotomy Catheter Regulation Number: 888.1100; 878.4400 Regulation Name: 888.1100, 676.4100
Regulation Name: Arthroscope; Electrosurgical cutting and coagulation device and accessories

Regulatory Class: II Product Code: HRX; GEI Dated: October 31, 2001 Received: November 5, 2001

Dear Ms. Guthrie:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premarke is substantially equivalent (for the referenced above and we have accumited the covices marketed in interstate commerce prior to indications for use stated in the enclosury to Governments, or to devices that have
May 28, 1976, the enactment date of the Medical Food. Drug, and Cosmetic A May 28, 1976, the enactment date of the Mcciran Food, Drug, and Cosmetic Act
been reclassified in accordance with the provisions of the Federal Food, Drug, MAA You may been reclassified in accordance with are proval application (PMA). You may,
(Act) that do not require approval of a premarket approval applications of the Act. The gen (Act) that do not require approval of a pleanse approvisions of the Act. The general
therefore, market the device, subject to the general portrols provisions of the general therefore, market the device, subject to the general segistration, listing of devices, controls provisions of the Act mender requirements for annual of the manufacturing and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio entire). Existing major regulations affecting your device can
may be subject to such additional controls. may be subject to such additions. Existing may regal to 898 In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addion, FDA m be lound in the Code of Federal Regarations)
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 Please be advised that FDA s issuality of a subscurer equirements of the Act
that FDA has made a determination that your device asker legares . You must that FDA nas made a decemmanon alat your as a ministered by other Federal agencies. You must or any Federal statules and regulations administers, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not associae req comply with all the Act s requirements, menomas manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and 820); and if annlicable, the electro CFR Part 807); labeling (21 CFR Part 800); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Q5) regulation (DF OF S5 1-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-10

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Page 2 - Ms. Linda Guthrie

This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the many of the of a lies of a lot stick as welce to legal This letter will allow you to begin harketing your advice of your device of your device to a legally premarket notification. The PDA miding of substantial equice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and If you desire specific advice for your avited diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitto diagnostic devices the responsion additionally 21 CFR Part 809.10 thi With Critics on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and advertisi Compliance at [phone]. Adultionally, for questions of additions of the Part Port Rott One your device, prease comact the Orited of concerner to premarket notifications (21CFR Part 807.97).
regulation entitled, «Misbranding by reference to premarket movels of the regulation entitled, Millsoranting of responsibilities under the Act may be obtainco at its toll-free number Other general information on your responsional and Consumer Assistance at its toll-free number Division of Binan (1201) 443-6597 or at its Internet address (600) 030vw.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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

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Section 1 - General Information

## INDICATIONS FOR USE STATEMENT

510(k) Number: K013622

Nucleotomy Catheter Device Name:

Indications for Use:

The Nucleotomy Catheter is intended to be used for the coagulation I he Nucleouonly Catherer is and in the material to treat symptomatic patients with contained hemiated discs.

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEW - NEEDED - NEED - NEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over The Counter Use _

Muriam C.-Proost

OR

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

<013622 510(k) Number .

Nucleoromy Catheter 510(k)

Oratec Interventions, Inc. Section I, Page 4 of 4