K Number
K061365
Device Name
CHECKPOINT WITH ACCUSTIM TECHNOLOGY
Manufacturer
Date Cleared
2006-07-12

(57 days)

Product Code
Regulation Number
874.1820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

Not Found

No
The summary describes a simple electrical stimulation device with no mention of AI/ML, image processing, or data-driven analysis.

No.
The device is used for electrical stimulation to locate and identify nerves and test nerve and muscle excitability, not to treat a condition. While it delivers electrical stimulation, its purpose is diagnostic/monitoring, not therapeutic.

Yes.
The device is used to locate and identify nerves and to test nerve and muscle excitability, which are diagnostic purposes.

No

The device description explicitly states it is a "small handheld device" and a "sterile disposable device," indicating it is a physical hardware product that delivers electrical stimulation.

Based on the provided information, the Checkpoint™ device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used to provide electrical stimulation of exposed motor nerves or muscle tissue intraoperatively to locate and identify nerves and test nerve and muscle excitability. This is a direct interaction with living tissue within the body during surgery.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to detect diseases, conditions, or infections.
  • Device Description: The description reinforces that it's a handheld device used by a surgeon to deliver electrical stimulation intraoperatively.

The Checkpoint™ is a surgical device used for nerve and muscle stimulation during surgery, not a diagnostic test performed on samples outside the body.

N/A

Intended Use / 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 nerve and muscle excitability.

Product codes

ETN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon / intraoperatively

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

Aaron Neuro-Pulse (K905045), Xomed Nerve Integrity Monitor Response 2.0 and NIM2-XL (K934426)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.

0

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: 919-968-4690

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.

1

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.

2

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.

3

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 (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,

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

4

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 .

Page 1 of 1

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