Who is the manufacturer of STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750?

Stryker Corp. filed the 510(k) submission for STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 (K063480).

What is the FDA product code for STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750

Q: What are the predicate devices for STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750?

Smith & Nephew ElectroThermal 20S Spine Generator (K033981).

K063480 · Stryker Corp. · GEI · May 22, 2007 · General, Plastic Surgery

Device Facts

Record ID	K063480
Device Name	STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750
Applicant	Stryker Corp.
Product Code	GEI · General, Plastic Surgery
Decision Date	May 22, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Stryker RF Intradiscal Adapter is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Adapter will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATH™ & Acutherm™ catheters.

Device Story

Stryker RF Intradiscal Adapter acts as an electrosurgical connecting cable; facilitates electrical connection between a separately cleared Stryker RF Generator and compatible intradiscal catheters (e.g., Smith & Nephew SPINECATH or ACUTHERM). Used in clinical settings by physicians; enables delivery of radiofrequency energy to disc material for coagulation and decompression. Device serves as an interface; does not perform independent processing. Output is the delivery of RF energy to the target tissue; intended to treat symptomatic contained herniated discs. Benefits include minimally invasive decompression of disc material.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and intended use.

Technological Characteristics

Electrosurgical connecting cable; passive interface component. Connects RF generator to intradiscal catheters. No internal software or active sensing/actuation circuitry. Sterilization method not specified.

Indications for Use

Indicated for coagulation and decompression of disc material in symptomatic patients with annular disruption of contained herniated discs who would typically undergo automated or laser percutaneous lumbar discectomy. Contraindicated for patients with pain suspected to originate from structures other than contained herniated discs, free fragments, severe bony/spinal stenosis, or severely degenerative/disrupted discs.

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

Smith & Nephew ElectroThermal 20S Spine Generator (K033981)

Reference Devices

Smith & Nephew SPINECATH catheters (K993867)
Neurotherm NT1000 RF Lesioning System (K052878)

Related Devices

K063489 — STRYKER INTRADISCAL RF GENERATOR · Synergetics, Inc. · May 23, 2007
K993967 — ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 · Oratec Interventions, Inc. · Dec 17, 1999
K974464 — ORATEC SPINECATH INTRADISCAL CATHETER · Oratec Interventions, Inc. · Mar 19, 1998
K030954 — ARTHROCARE PERCD SPINEWAND · Arthrocare Corp. · Apr 16, 2003
K100353 — SPINEWAND SURGICAL DEVICE · Arthrocare Corp. · May 13, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ MAY 2 2 2007 4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505 www.stryker.com stryker Interventional Pain | 510(k) Summary | | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Sponsor: | Stryker Interventional Pain 4100 E. Milham Avenue Kalamazoo, MI 49001 (p) 269-323-7700 (f) 269-324-5412 | | Registration No.: | 3005182723 | | Trade Name: | Stryker RF Intradiscal Adapter | | Common Name: | Electrosurgical Connecting Cable | | Classification Name: | Generator, Radiofrequency Lesion (GXD) | | Equivalent to: | K033981 Smith & Nephew ElectroThermal 20S Spine Generator | | Device Description: | The Stryker RF Intradiscal Adaptor when used with the separately cleared Stryker RF Generator and the separately cleared Smith & Nephew SPINECATHTM Intradiscal Catheter(K993967) and ACUTHERM TM Decompression Catheter or equivalent. The Stryker RF Intradiscal Adaptor is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. | | Indications for Use: | The Stryker RF Intradiscal Adapter is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Adapter will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATHTM & AcuthermTM catheters. | | Contraindications: | The contraindications for the Stryker RF Intradiscal Adapter would be the same as those for the catheter to which it is attached. The contraindications included in the instructions for use for the Smith & Nephew SPINECATHTM Intradiscal Catheter and ACUTHERM TM Decompression Catheter are: Use of the SPINECATHTM Intradiscal Catheter is not appropriate for treating patients who present pain that is suspected to originate from structures other than contained herniated discs, or when free fragments or severe bony stenosis are present. In addition, patients presenting severely degenerative or disrupted discs should be excluded. and Use of the Decompression Catheter is not appropriate for treating patients who present pain that is suspected to originate from origins other than herniated discs, or when free fragments or severe spinal stenosis are present. In addition, patients presenting with severely degenerative or disrupted discs should be excluded. Use of the Smith & Nephew SPINECATHTM Intradiscal Catheter and ACUTHERM TM Decompression Catheter is appropriate for treating patients | | | with herniations of intervertebral discs who would typically undergo automated or laser percutaneous lumbar discectomy. Use of the Smith & Nephew SPINECATH™ Intradiscal Catheter and ACUTHERM™ Decompression Catheter is appropriate for treating patients with herniations of intervertebral discs who would typically undergo automated or laser percutaneous lumbar discectomy. | | Precautions: | Patients taking steroids and patients with pacemakers, lupus, gout, uncontrolled diabetes, Ehlers-Danlos syndrome, prior open capsular procedures, autoimmune disease, or etiologies where their immune systems are compromised require special consideration. | | Substantial Equivalence (SE) Rational: | The Stryker Intradiscal RF Generator has a similar intended use as: Smith & Nephew ElectroThermal 20S Spine Generator (K033981) Smith & Nephew SPINECATH™ catheters (Oratec K993867) Neurotherm NT1000 RF Lesioning System (K052878) Stryker claims this equivalence because the Stryker RF Intradiscal Adapter has an equivalent intended use, modes of operation, protocols for use, and quality check mechanisms as compared to the predicate devices. Furthermore, the Stryker RF Intradiscal Adapter has equivalent | | | technological characteristics as compared to the predicate devices. | | Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker RF Intradiscal Adapter is substantially equivalent to a legally marketed device. | | Submitted by: | Jean Sheppard | | | Regulatory Analyst | | | | | Date submitted: | March 8, 2007 | KOB34RD {1}------------------------------------------------ : . · . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" written around it. Inside the circle is an abstract image of an eagle. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 2 2007 Stryker Interventional Pain % Ms. Jean Sheppard Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, Michigan 49001 Re: K063480 Trade/Device Name: Stryker RF Intradiscal Adaptor Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GEI Dated: May 10, 2007 Received: May 11, 2007 Dear Ms. Sheppard: 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 he 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 (2) 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 - Ms. Jean Sheppard 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 N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): __ |< 063480 Device Name: Stryker RF Intradiscal Adaptor Indications for Use: The Stryker RF Intradiscal Adapter is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Adapter will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATH™ & Acutherm™ catheters. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Peter (Division Sign-Off) DRE DIRECTOR Division of General, Re Page 1 of 1 and Neurological Devices **510(k) Number** 5/22/10/x