CADWELL DISPOSABLE PROBE HANDLE

K123589 · Cadwell · PDQ · Mar 19, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K123589
• Device Name: CADWELL DISPOSABLE PROBE HANDLE
• Applicant: Cadwell
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Mar 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Cadwell Disposable Probe Handle is a component of the Cadwell Kilowin System that is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.

Device Story

Handheld, sterile, single-patient-use probe handle; accessory to Cadwell Kilowin surgical monitoring instrument. User inserts detachable, disposable monopolar stimulator probes into handle tip; electrical contact established via internal connector. Device delivers electrical stimulation to neural tissue; enables surgeon to locate, identify, and monitor cranial motor nerves, peripheral nerves, and spinal nerve roots during surgery. Used in surgical environment by clinical staff. Output consists of electrical stimulation pulses; surgeon observes physiological response (e.g., EMG) via the connected monitoring system to guide surgical navigation and avoid nerve damage.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software verification and validation, sterility protocol development and validation, and electromagnetic compatibility testing.

Technological Characteristics

Medical grade polycarbonate handle; stainless steel stimulator probe with insulated shaft. Electrical stimulation: 0-100 mA, monophasic/biphasic waveforms, max 400V. Features touch-proof handle connector per IEC 60601-1. Sterile, single-use, disposable. Connects to Cadwell Kilowin system.

Indications for Use

Indicated for use in surgical settings to perform localized stimulation of neural tissue and to locate, identify, and monitor cranial motor nerves, peripheral nerves, and spinal nerve roots. Intended for use as a component of the Cadwell Kilowin System.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• Medtronic/Xomed NIM Incrementing Probe Handle
• NuVasive Neurovision Probe Handle

Reference Devices

• Cadwell Kilowin (K971214)
• Cadwell Disposable Monopolar Stimulator Probes (K103128)
• Medtronic NIM Eclipse (K061113)
• NuVasive NVM5 (K112718)

Submission Summary (Full Text)

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\$\mathcal{K}\$123589

### CADVELL 510k Summary MAR 1 9 2013 Submitter: Cadwell 909 N. Kellogg Street Kennewick. Washington 99336 509-735-6481 Chris Bolkan Contact Person: Safety / Regulatory Specialist Cadwell Laboratories, Inc. Date Prepared: November 7, 2012 Trade Name: Cadwell Disposable Probe Handle Accessory to Surgical Nerve Stimulator/Locator Regulation Name: 21 CFR 874.1820 Regulation Number: Regulatory Classification: Class II PDQ ETN, GXZ Product Code: Ear. Nose and Throat Classification Panel: Medtronic/Xomed NIM Incrementing Probe Handle Predicate Devices: NuVasive Neurovision Probe Handle The Cadwell Disposable Probe Handle is a handheld, Device Description: single-patient-use, sterile, disposable probe holder intended for use in a surgical setting with a Cadwell Kilowin (K971214) instrument. The Cadwell Disposable Probe Handle allows the user to interact with the surgical monitoring instrument. Cadwell Disposable Monopolar Stimulator Probes (from K 103128) specific to the Cadwell Disposable Probe Handle are inserted and removed from the tip of the handle, and make contact with an electrical connector when inserted. The user can select the probe appropriate to the task at hand, removing, repositioning, or changing probes as needed. Electrical stimulation is applied to the Cadwell Disposable Monopolar Stimulator Probe, and used to

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### 510k Summary

perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Indications for Use:

The Cadwell Disposable Probe Handle is a component of the Cadwell Kilowin System that is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.

Substantial Equivalence:

Data was provided which demonstrates that the Cadwell Disposable Probe Handle is substantially equivalent to previously cleared devices.

The use, design, materials and function of the subject device are considered to be the equivalent of the predicate devices.

Comparisons of Indications of Use and Features for Cadwell Disposable Probe Handle and Predicate Devices

| Device | Intended Use |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cadwell Disposable Probe<br>Handle | The Cadwell Disposable Probe Handle is used to perform precise localized<br>stimulation of neural tissue and to locate, identify and monitor cranial motor<br>nerves, peripheral nerves and spinal nerve roots during surgery. The Cadwell<br>Disposable Probe Handle is a sterile, disposable, single patient use device. |
| Medtronic/Xomed NIM<br>Incrementing Probe | This device is intended for use in surgical procedures for patient-connected<br>intraoperative nerve monitoring, i.e. assisting the surgeon in locating and<br>mapping motor nerves through the use of electromyographic (EMG) signals<br>and electrical stimulus of nerves. This device is indicated for locating and<br>identifying cranial and peripheral motor nerves during surgery, including spinal<br>nerve roots. |
| NuVasive Neurovision Probe<br>Handle | The NeuroVision JJB System is used for intraoperative monitoring and<br>neurological status assessment by the administration of brief electrical stimulus<br>pulses to neural tissues and the EMG monitoring of the associated muscle<br>groups. The System is used in conjunction with other NuVasive devices to<br>assist in gaining controlled access to, and visualization of, the spine. |

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## 510k Summary

| | Medtronic/Xomed<br>Incrementing Probe<br>Handle | Nu Vasive<br>Neurovision Probe<br>Handle | Cadwell Disposable<br>Probe Handle |
|-------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------|
| Compatible Surgical<br>Monitoring<br>Instrument | Medtronic NIM Eclipse<br>(K061113) | NuVasive NVM5<br>(K112718) | Cadwell Kilowin<br>(K971214) |
| Stimulator Probes | Detachable, Disposable.<br>Monopolar Ball or Flush Tip | Detachable, Disposable,<br>Monopolar | Detachable, Disposable,<br>Monopolar Ball or Flush Tip |
| Electrical Insulation | Electrical insulation on<br>surfaces not intended to<br>provide electrical stimulation | Electrical insulation on<br>surfaces not intended to<br>provide electrical stimulation | Same |
| IEC 60601-1<br>Protected Pin Design | Touch Proof Handle<br>Connector | Touch Proof Handle<br>Connector | Same |
| Patient Contact<br>Material | Stainless Steel Stimulator<br>Probe with Insulated Shaft | Stainless Steel Stimulator<br>Probe with Insulated Shaft | Same |
| Handle Material | Plastic | Plastic | Medical Grade Polycarbonate<br>Plastic |
| Use and Delivery | Single use and sterile | Single use and sterile | Same |
| Lead Wire<br>Insulation | Medical Grade Plastic | Medical Grade Plastic | Same |
| Use and Delivery | Single use and sterile | Single use and sterile | Same |
| Actuators | Yes | Yes | Same |
| Theoretical<br>Maximum Voltage | 400 V | 300 V | 400 V |
| Stimulation Current | 0-100 mA | 0-90 mA | 0-100 mA |
| Stimulation<br>Waveform | Monophasic and Biphasic | Monophasic | Monophasic and Biphasic |
| Maximum Pulse/S | 100 | 5 | 100 |

Testing:

Software verification and validation, sterility protocol development and validation, and electromagnetic compatibility testing were performed.

Conclusion:

The Cadwell Disposable Probe Handle is substantially equivalent to predicate devices in design, materials, packaging, use, technology, and function.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Cadwell Laboratories c/o Mr. Chris Bolkan Regulatory Affairs Engineer 909 N. Kellogg Street Kennewick, WA 99336

Re: K123589/S001

Trade/Device Name: Cadwell Disposable Probe Handle Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical nerve locator Regulatory Class: Class II Product Code: PDQ, ETN, GXZ Dated: January 24, 2013 Received: February 15, 2013

#### Dear Mr. Bolkan:

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.

March 19,2013

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.

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Page 2 - Mr. Bolkan

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); 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,

JoyceMWhang

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K123589

Device Name: Cadwell Disposable Probe Handle

Indications For Use:

The Cadwell Disposable Probe Handle is a component of the Cadwell Kilowin System that is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Jovce MDW

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123589

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