CHECKPOINT WITH ACCUSTIM TECHNOLOGY

K061365 · Ndi Medical, LLC · ETN · Jul 12, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K061365
• Device Name: CHECKPOINT WITH ACCUSTIM TECHNOLOGY
• Applicant: Ndi Medical, LLC
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Checkpoint™ is a single-use 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.

Device Story

Checkpoint™ is a sterile, single-use, handheld surgical nerve stimulator/locator. Operated by a surgeon intraoperatively, it delivers electrical stimulation to exposed motor nerves or muscle tissue. The device facilitates nerve identification and assessment of nerve/muscle excitability. It features Accustim Technology for controlled stimulation. The surgeon uses the device to confirm nerve integrity during procedures. The output is a physical muscle response observed by the surgeon, which informs clinical decision-making regarding nerve preservation or surgical approach. The device is designed for simple, one-handed operation in an operating room setting.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility, electrical safety, electromagnetic compatibility, and design verification and validation testing.

Technological Characteristics

Handheld, sterile, single-use surgical nerve stimulator. Features Accustim Technology for electrical stimulation. Operates via electrical output to stimulate motor nerves/muscle. Design is optimized for one-handed use. Testing includes biocompatibility, electrical safety, and electromagnetic compatibility.

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

• Medtronic Xomed Vari-Stim III
• Aaron Neuro-Pulse (K905045)
• Xomed Nerve Integrity Monitor Response 2.0 and NIM2-XL (K934426)

Submission Summary (Full Text)

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K061365

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

JUL 1 2 2006

#### 1. SPONSOR/APPLICANT

NDI Medical One Chagrin Highlands 2000 Auburn Drive Suite 320 Cleveland, OH 44122 216-378-9106

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

Date Prepared: May 15, 2006

#### 2. Device Name

Trade/Proprietary Name: Checkpoint™ with Accustim Technology Common/Usual Name: Surgical Nerve Stimulator/Locator Classification Name: Surgical Nerve Stimulator/Locator

#### 3. PREDICATE DEVICES

- . Medtronic Xomed Vari-Stim III (pre-amendment device) Medtronic Xomed (originally Concept Medical)
- . Aaron Neuro-Pulse (K905045), Aaron Medical
- Xomed Nerve Integrity Monitor Response 2.0 and NIM2-XL (K934426) . Medtronic Xomed-Treace, Inc.

#### 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.

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#### 5. INTENDED USE

The Checkpoint™ is a single-use 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.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The determination of substantial equivalence of the Checkpoint™ and cited predicate devices was based on equivalence of intended use, indications for use, operational characteristics, and fundamental technological characteristics.

## 7. PERFORMANCE TESTING

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NDI Medical c/o Julie Grill Vice President, Regulatory Affairs One Chagrin Highlands 2000 Auburn Drive, Suite 320 Cleveland, OH 44122

JUL 1 2 2006

Re: K061365

Trade/Device Name: NDI Medical Checkpoint™ Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: June 30, 2006 Received: July 3, 2006

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 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. Iisting 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 – Julie Grill

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 logally 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours,

M.B. Egelman, MD

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

Enclosure

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# Indications for Use

510(k) Number (if known): To be assigned

K061365

Device Name: Checkpoint™

Indications for Use:

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

Prescription Use X Over-The-Counter Usc AND/OR (Part 21 CFR 801 Subpart D) (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)

Chiabolut

sion of Ophthalmic Ear Nose and Throat Devise

510(k) Number .

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NDI Medical May 15, 2006 Traditional 510(k): Check Point™ with Accustim Technology