DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 by TECHNOMED EUROPE

Disposable pedicle screw probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The disposable pedicle screw probes are supplied sterile and are for single use only. The disposable pedicle screw probes are connected to an electrical stimulator using a flexible lead wire and a "touch-proof" safety connector on the distal end. Disposable pedicle screw probes require a separate stimulator return electrode. Disposable pedicle screw probes are used by the surgeon to locate and identify spinal nerve roots and to assess nerve function. The disposable pedicle screw probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The disposable pedicle screw probes shaft may be bent to allow viewing access under a microscope.

Technomed Europe Disposable pedicle screw probes consist of an insulated probe shaft mounted to plastic handle. The probe shaft is electrically connected to a DIN 42802 "touch-proof" safety connector on the other end. The electrode is supplied in a sterile pouch.

AI/ML Overview

The provided text is a 510(k) summary for the Technomed Europe Needle electrodes (Disposable pedicle screw probe). A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies.

Based on the provided document, the device is considered substantially equivalent to K062996. Therefore, the information requested, which pertains to detailed performance studies with acceptance criteria, expert ground truth, and training sets, is not present in this type of submission.

Here's an explanation based on the available information:

Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or provide detailed performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Study That Proves the Device Meets Acceptance Criteria: The document mentions "Non-clinical data: Technomed Europe has been bench testing the Disposable pedicle screw probe for stimulating electrode to confirm performance characteristics of this device." However, it does not provide details of these bench tests, their methodology, sample sizes, or results against specific acceptance criteria.

Therefore, most of the specific questions cannot be answered from the provided text.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
Implicit: Substantial equivalence to predicate K062996 in design, materials, chemical composition, packaging, and technological characteristics.	The manufacturer states the device is "substantially equivalent" to predicate K062996. "Bench testing... to confirm performance characteristics" was conducted, but no specific results are provided.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only mentions "bench testing."
Data Provenance: Not applicable, as no clinical study or specific test set with provenance is detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no expert-derived ground truth for a test set is mentioned.

4. Adjudication method for the test set:

Not applicable, as no test set with adjudication is mentioned.

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:

No. This is a medical device (electrode probe), not an AI diagnostic tool, so an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is a medical device, not an algorithm.

7. The type of ground truth used:

Not applicable, as no ground truth for performance evaluation is specified beyond the implicit demonstration of substantial equivalence to a predicate device based on its intended use and design characteristics.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/machine learning device.

Summary

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K063729

Attachment D:

	510(k) Summary	AUG 21 2007
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Manufacturer:	Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands
Submitted by:	Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands
Contact person:	Maurice RoostManager R&DTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888E-mail: mroost@technomed.nl
Date:	July 10, 2007
Proprietary Name:	Needle electrodes
Common/usual Name:	Disposable probe for stimulating electrode
Classification Name:	Needle electrode (21 CFR section 882.1350)

Substantial Equivalence: K062996: Disposable probe for pedicle hole stimulation

Intended Use:	To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
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Comparison to predicates:

The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are equivalent to those of the predicate devices.

Non-clinical data: Technomed Europe has been bench testing the Disposable pedicle screw probe for stimulating electrode to confirm performance characteristics of this device.

Conclusion:

Technomed Europe Disposable pedicle screw probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.

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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 with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2007

Technomed Europe % Mr. Maurice Roost Manager R & D Amerikalaan 71 Maastricht Airport, Limburg 6199 AE The Netherlands

K063729 Re:

Trade/Device Name: Disposable Pedicle Screw Probe, Model 3603-00 Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: Class II Product Code: GXZ Dated: July 10, 2007 Received: July 16, 2007

Dear Mr. Roost:

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, 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 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

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Page 2 -- Mr. Maurice Roost

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. 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 legally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. Statement Indications for Use

510(k) Number (if known): _

Device Name: Disposable pedicle screw probe, Model 3603-00

July 10, 2007

Indications for Use:

The disposable pedicle screw probe is used to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OMN ANOTHER PAGE IF NEEDED)

(Division Division of General, Restorative, and Neurological Devices

510(k) Number L013729

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

Over-The-Counter Use (21 CFR 801 Subpart C)

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).