(57 days)
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.
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.
The NDI Medical Checkpoint™ is a surgical nerve stimulator/locator. The provided text from the 510(k) submission describes the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain details about specific acceptance criteria or an analytical study comparing the device's performance against such criteria.
The "PERFORMANCE TESTING" section states that testing included "biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing." This is a general statement about the types of tests conducted, but it doesn't provide specific device performance metrics or the acceptance criteria for those metrics.
Therefore, many of the requested details about acceptance criteria and study design cannot be extracted from the provided text.
Here's an attempt to answer the questions based on the available information, noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document only states that "biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing" were performed. Specific quantitative or qualitative acceptance criteria for these tests, or the results demonstrating the device met them, are not detailed in this summary. | Not provided in the document. The document states testing was performed, implying the device met the necessary performance standards to gain 510(k) clearance, but no specific performance statistics or metrics are reported. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided.
- Data provenance: Not provided. The document mentions general testing categories but does not specify the origin or nature of the data used for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method for the test set
- Adjudication method: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study done: No. This device is a surgical nerve stimulator/locator, not an AI-powered diagnostic imaging device that would typically involve human "readers" or AI assistance in interpretation. The document does not mention any AI component.
- Effect size: Not applicable, as there was no MRMC study or AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done: Not applicable. The device itself is a "small handheld device used by a surgeon to deliver electrical stimulation intraoperatively." Its performance is inherently linked to the surgeon's use, and there's no mention of an "algorithm only" component in the context of its primary function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not provided. For a device like this, ground truth would likely be established through objective measurements (e.g., electrical output, duration, mechanical integrity) and potentially clinical observation of its ability to stimulate nerves/muscles as expected. However, the document does not specify.
8. The sample size for the training set
- Sample size for training set: Not applicable. This document describes a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable, as there is no training set for this type of device.
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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.
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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 (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
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Indications for Use
510(k) Number (if known): To be assigned
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
§ 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.