(91 days)
Not Found
No
The description focuses on electrical stimulation for nerve and muscle testing, with no mention of AI/ML terms or functionalities.
No.
The device is used to locate and identify nerves and test nerve and muscle excitability, which are diagnostic/monitoring functions rather than therapeutic.
Yes
The device is described as being used "to locate and identify nerves and to test nerve and muscle excitability" and "to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability," which are diagnostic functions.
No
The device description explicitly states it is a "small handheld device" and a "sterile disposable device," indicating it is a physical hardware product, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide electrical stimulation intraoperatively to locate and identify nerves and test nerve and muscle excitability. This is a direct interaction with the patient's body during surgery.
- Device Description: The device is described as a handheld device used by a surgeon to deliver electrical stimulation intraoperatively.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device does not perform tests on samples taken from the body. It directly interacts with the patient's nerves and muscle tissue during a surgical procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of this device includes biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: 919-968-4690
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.
1
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
K061365 | Modified Checkpoint |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------|
| 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. | 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
with no net DC current | Yes | Yes |
| Separate Stimulus Amplitude and
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.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three parallel lines forming its body and wings. The emblem is black, contrasting with the white background of the seal.
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.
3
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 (800) 638-2041 or (240) 276-3150 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