CHECKPOINT

K092292 · Ndi Medical, LLC · ETN · Oct 28, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K092292
• Device Name: CHECKPOINT
• Applicant: Ndi Medical, LLC
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Oct 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Checkpoint® is a single-use sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability. The Checkpoint is available for prescription use only.

Device Story

Checkpoint is a sterile, single-use, handheld surgical nerve stimulator/locator. Operated by surgeons intraoperatively, it delivers electrical stimulation to exposed motor nerves or muscle tissue. The device is battery-powered and features an integral stimulus probe. It generates a biphasic rectangular waveform with no net DC current. The surgeon uses separate controls for stimulus amplitude and pulse duration to adjust the output. By observing muscle response to the stimulation, the surgeon can locate and identify nerves and assess their excitability. This assists in preserving nerve function during surgical procedures. The device is designed for simple, one-handed operation.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility, electrical safety, electromagnetic compatibility (EMC), and design verification and validation testing.

Technological Characteristics

Handheld, battery-powered, single-use, sterile device. Features integral stimulus probe. Delivers monopolar stimulation via biphasic rectangular waveform (no net DC current). Includes separate controls for stimulus amplitude and pulse duration.

Indications for Use

Indicated for electrical stimulation of exposed motor nerves or muscle tissue to locate/identify nerves and test nerve/muscle excitability in patients requiring intraoperative nerve monitoring.

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

• Checkpoint Surgical Nerve Stimulator/Locator (K061365)

Submission Summary (Full Text)

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KO 92292

# 510(k) Summary for the NDI Medical Checkpoint®

#### 1. SPONSOR/APPLICANT

NDI Medical 22901 Millcreek Boulevard, Suite 110 Cleveland. OH 44122 216-378-9106

OCT 2 8 2009

Contact Person: Julie Grill, VP, Regulatory Affairs Telephone: [phone]

Date Prepared: July 29, 2009

### 2. Device Name

Trade/Proprietary Name: Checkpoint® Surgical Nerve Stimulator/Locator Common/Usual Name: Surgical Nerve Stimulator/Locator Classification Name:

### 3. PREDICATE DEVICE

K061365 - Checkpoint Surgical Nerve Stimulator/Locator

### 4. DEVICE DESCRIPTION

The Checkpoint® is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability. This is a sterile disposable device designed to be simple to use with one-handed control.

### ട്. INTENDED USE

The Checkpoint® is a single-use sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.

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## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The determination of substantial equivalence of the modified Checkpoint and original Checkpoint® devices was based on equivalence of intended use, indications for use, operational characteristics, and fundamental technological characteristics.

| Feature/Characteristic | Checkpoint<br>K061365 | Modified Checkpoint |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------|
| The Checkpoint is a single-use,<br>sterile device intended to provide<br>electrical stimulation of exposed<br>motor nerves or muscle tissue to<br>locate and identify nerves and to<br>test nerve and muscle excitability. | Yes | Yes |
| Hand-held | Yes | Yes |
| Disposable | Yes | Yes |
| Integral stimulus probe | Yes | Yes |
| Monopolar stimulation | Yes | Yes |
| Battery Powered | Yes | Yes |
| Regulated Current | Yes | Yes |
| Biphasic rectangular waveform<br>with no net DC current | Yes | Yes |
| Separate Stimulus Amplitude and<br>Pulse Duration controls | Yes | Yes |

## · PERFORMANCE TESTING 7.

Testing of this device includes biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing.

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

NDI Medical, LLC c/o Ms. Julie Grill VP, Regulatory Affairs and Quality Systems 22901 Millcreek Blvd. Suite 110 Cleveland, OH 44122

Re: K092292

OCT 2 8 2009

Trade/Device Name: Checkpoint, Model 9014 Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: September 24, 2009 Received: September 25, 2009

Dear Ms. Grill.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalient (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 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); 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.

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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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Erich, m
Melvin R. Bobbin, M.D.

Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K092292

Checkpoint® Device Name:

Indications for Use:

The Checkpoint® is a single-use sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability. The Checkpoint is available for prescription use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AZ

(Division Sign-Off) Meurological and Ear, Division of Ophthalmjo Nose and Throat Devices

510(k) Number K092292