NERVE MONITORING CABLE

K073229 · Pioneer Surgical Technology · GXZ · Jun 6, 2008 · Neurology

Device Facts

• Record ID: K073229
• Device Name: NERVE MONITORING CABLE
• Applicant: Pioneer Surgical Technology
• Product Code: GXZ · Neurology
• Decision Date: Jun 6, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

The Pioneer Nerve Monitoring Cable, in conjunction with Pioneer pedicle probes, taps, awls or screw drivers, is intended to stimulate peripheral motor nerves during surgery for the purpose of locating and identifying these nerves, including spinal nerve roots during the incision and removal of soft and hard tissue or bone.

Device Story

Nerve Monitoring Cable System functions as intra-operative motor nerve stimulator; connects to common EMG monitors. Device enables nerve stimulation via manual orthopedic surgical instruments (taps, awls, probes). Terminal end features 1.5 mm female DIN connector for interface with stimulating consoles (Type BF or CF rating). Used in OR by surgeons to locate/identify peripheral motor nerves and spinal nerve roots during tissue/bone resection. Output facilitates real-time nerve identification, aiding surgical navigation and potentially reducing risk of nerve injury.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials conform to ASTM standards. Device is a passive cable system with a 1.5 mm female DIN connector. Interfaces with external stimulating consoles (Type BF or CF). No active electronic components or software.

Indications for Use

Indicated for use in patients undergoing surgery requiring peripheral motor nerve or spinal nerve root identification and location during soft/hard tissue or bone removal.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

• Disposable Pedicle Screw Probe (K063729)
• Stimulating Bur Guard (K063305)
• Intraoperative Nerve Surveillance (K013215)
• Intraoperative Nerve Surveillance (K002677)
• Disp. Monopolar and Bipolar Stimulator Probes & Subdermal Needle Electrodes (K062996)
• Disp. Monopolar and Bipolar Stimulator Probes & Subdermal Needle Electrodes (K050194)

Submission Summary (Full Text)

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## 510(k) Summary

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| Sponsor: | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855 | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Contact Name: | Jonathan M. Gilbert<br>[phone] | |
| Device Name: | Nerve Monitoring Cable System | |
| Classification: | Panel:<br>Regulation Number:<br>Regulation Name:<br>Classification Product Code: | Neurology<br>882.1350<br>Needle electrode<br>GXZ |
| Predicate Device: | K063729 - Disposable Pedicle Screw Probe, Technomed Europe<br>K063305 - Stimulating Bur Guard, Medtronic Xomed<br>K013215 & K002677 - Intraoperative Nerve Surveillance, Nuvasive<br>K062996 & K050194 - Disp. Monopolar and Bipolar Stimulator Probes &<br>Subdermal Needle Electrodes, -, Axon Systems, Inc | |
| Device Description: | This device is intended for use as an intra-operative motor nerve<br>stimulator with common EMG monitors. Construction of the device<br>allows nerve stimulation with general manual orthopedic surgical<br>instruments, e.g. taps, awls, probes, etc. The terminal end of the cable is<br>a 1.5 mm female DIN connector for use with a stimulating console with a<br>Type BF or CF rating. | |
| Intended Use: | The Pioneer Nerve Monitoring Cable, in conjunction with Pioneer pedicle<br>probes, taps, awls or screw drivers, is intended to stimulate peripheral motor<br>nerves during surgery for the purpose of locating and identifying these nerves,<br>including spinal nerve roots during the incision and removal of soft and hard<br>tissue or bone. | |
| Material: | Materials used to manufacture the instruments of this system are in<br>conformance with ASTM Standard Specifications. | |
| Basis of Substantial<br>Equivalence: | Comparisons of device performance data, materials, indications and<br>design/function to predicate devices were provided in making a<br>determination of substantial equivalence. | |

Pioneer Surgical Technology, Inc.
K073229

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2008

Pioneer Surgical Technology % Mr. Jonathan Gilbert Vice President, Regulatory and Clinical Affairs 375 River Park Circle Marquette. Michigan 49855-0627

K073229 Re:

> Trade/Device Name: Nerve Monitoring Cable Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ, ETN Dated: May 27, 2008 Received: May 28, 2008

Dear Mr. Gilbert:

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. Jonathan Gilbert

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.

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 Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark H. Millman

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

K073229 510(k) Number (if known):

Device Name: Nerve Monitoring Cable

Indications for Use: The Pioneer Nerve Monitoring Cable, in conjunction with Pioneer pedicle probes, taps, awls or screw drivers, is intended to stimulate peripheral motor nerves during surgery for the purpose of locating and identifying these nerves, including spinal nerve roots during the incision and removal of soft and hard tissue or bone,

> Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilkeoghan for mxm

Division of General, Restorative, and Neurological Devices

510(k) Number K073229

Pioneer Surgical Technology, Inc. K073229