These instruments are intended to be used for pedicle preparation or access to the vertebral body. The instruments are used for screw placement in open and minimally invasive procedures to reduce the risk of nerve root injury and deficits from misplaced screws by providing early warning of pedicle breach.
These instruments are indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

Device Description

Axon Systems' Stimulus Dissection Instruments are disposable (for "Single Use Only"), sterile devices used for tissue dissection and stimulation of spinal nerve roots for location and identification during surgery.
These instruments consists of probes of differing shapes and sizes with biocompatible electrical insulation applied to select portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for probing and tissue stimulation. The probes are a protected pin design and meet the requirements of IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12
The instruments consist of needles, probes and dilators (expanding set of cannulas) designed to provide physicians with the ability to perform tissue dissection and stimulation intraoperatively.
The designs of the proposed Stimulus Dissection accessories are similar to Class I exempt surgical instruments such as those described in 21 CFR 888.4540 Orthopedic Manual Surgical Instrument. The instruments consists of stainless steel and aluminum alloy needles, probes and dilators with biocompatible electrical insulation applied to selected portions, proximal electrical connectors to attach the instruments to a monopolar electrical stimulator and in some cases, a proximal ABS handle. The distal surfaces of the instruments are non-insulated and provide for manual dissection / resection / probing and tissue stimulation.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Axon Systems' Stimulus Dissection Instruments), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be found in a clinical study report.

Therefore, many of the requested sections cannot be filled from the provided text because this type of information is generally not included in a 510(k) summary. A 510(k) emphasizes comparison to legally marketed predicate devices and addresses safety and effectiveness through that comparison, rather than through de novo performance studies with specific statistical endpoints.

Here's how much of your request can be answered based on the provided document:

Acceptance Criteria and Device Performance

The 510(k) summary does not define specific acceptance criteria (e.g., target specificity, sensitivity, or accuracy thresholds) for the device's performance in stimulating spinal nerve roots or for tissue dissection. Instead, it relies on demonstrating substantial equivalence to predicate devices whose safety and effectiveness are already established.

The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use of tissue dissection and stimulation of spinal nerve roots. The document states: "Axon Systems' Stimulus Dissection Instruments are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in this 510(k) summary. The device is seeking clearance based on substantial equivalence to predicate devices, not specific performance metrics.	The device is deemed "substantially equivalent" to predicate devices for its intended use, implying comparable safety and effectiveness in tissue dissection and stimulation of spinal nerve roots for location and identification during surgery.

Study Details Not Available in 510(k) Summary:

The following information cannot be extracted from the provided 510(k) summary because it typically pertains to clinical performance studies, which are not usually detailed in a 510(k) submission focused on substantial equivalence to existing devices.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available. A 510(k) of this type typically relies on bench testing, materials testing, and comparison of technological characteristics rather than a clinical "test set" in the context of diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not available/Applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available/Applicable.
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: Not applicable. This device is a surgical instrument, not an AI-powered diagnostic tool requiring MRMC studies for human reader improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical instrument, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available/Applicable.
The sample size for the training set: Not applicable. As a physical medical device, there is no "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Information Available from 510(k) Summary (Relevant to Device Description and Comparison):

Device Type: Stimulus Dissection Instruments (needles, probes, dilators)
Intended Use: Tissue dissection and stimulation of spinal nerve roots for location and identification during surgery. Specifically, for pedicle preparation or access to the vertebral body for screw placement in open and minimally invasive procedures to reduce nerve root injury.
Technological Characteristics: Disposable, sterile, biocompatible electrical insulation, non-insulated stainless steel distal surfaces, proximal connectors, protected pin design meeting IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12. Materials are the same as in predicate devices.
Predicate Devices:
- Medtronic Xomed, "Stimulus Dissection Instruments" (K031003)
- Axon Systems, Inc., "Disposable Stimulator Probes" (K062996)
- Nuvasive, "Surgical Nerve Stimulator/Locator" (K002677)

The clearance is based on the argument that the device's technological characteristics, materials, and intended use are similar to those of previously cleared predicate devices, thus demonstrating substantial equivalence.

Summary

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90238

Appendix J 510(k) Summary of Substantial Equivalence

JUL 20 2009

510k Summary of Safety and Effectiveness

Company Name: Axon Systems, Inc. 80-5 Davids Drive Hauppauge, NY 11788

Contact: Howard Bailin Vice President, C.O.O. Phone: 631 436 5112 Fax: 631 436 5141 Email: hbailin@axonsystems.com

Summary Date February 26, 2009

Proprietary Name: ХРАК ІІ ХРАК

Common Name:

Nerve Stimulator/Locator

Classification:

Class II (Performance Standards) Number: 874.1820 Nerve Stimulator/Locator Procode: ETN

Predicate Devices

Manufacturer: Medtronic Xomed Trade Name: Stimulus Dissection Instruments FDA number: K031003

Manufacturer: Axon Systems, Inc Trade Name: Disposable Stimulator Probes FDA number: K062996

Manufacturer: Nuvasive Trade Name: Surgical Nerve Stimulator/Locator FDA number: K002677

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Appendix J 510(k) Summary of Substantial Equivalence

Device Description

These instruments consists of probes of differing shapes and sizes with biocompatible electrical insulation applied to select portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for probing and tissue stimulation. The probes are a protected pin design and meet the requirements of IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12

The instruments consist of needles, probes and dilators (expanding set of cannulas) designed to provide physicians with the ability to perform tissue dissection and stimulation intraoperatively.

The designs of the proposed Stimulus Dissection accessories are similar to Class I exempt surgical instruments such as those described in 21 CFR 888.4540 Orthopedic Manual Surgical Instrument. The instruments consists of stainless steel and aluminum alloy needles, probes and dilators with biocompatible electrical insulation applied to selected portions, proximal electrical connectors to attach the instruments to a monopolar electrical stimulator and in some cases, a proximal ABS handle. The distal surfaces of the instruments are non-insulated and provide for manual dissection / resection / probing and tissue stimulation.

Intended Use

Technological Characteristics

These Stimulus Dissection Instruments consists of needles, probes and dilators of differing shapes and sizes with biocompatible electrical insulation applied to select portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for probing and tissue stimulation. The connector is specifically designed so that it cannot be plugged into AC power outlet. The Stimulus Dissection Instruments are supplied in dual barrier sterile trays. Materials used are the same as in the predicate devices.

Conclusions

Axon Systems' Stimulus Dissection Instruments are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2009

Axon Systems, Inc. % Howard Bailin Vice President, C.O.O. 80-5 Davids Drive Hauppauge, NY 11788

Re: K090838

Trade Name: Axon Systems, Inc. Stimulus/dissection instruments Regulation Number: 21 CFR § 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: May 27, 2009 Received: June 9, 2009

Dear Mr. Bailin:

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 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 devicerelated 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.

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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,

Malvina B. Eydelman, M.D.

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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Indications for Use

510(k) Number: K090838

Device Name: Axon Systems, Inc. Stimulus/dissection instruments

Indications For Use:

These instruments are indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,	Page 1 of 1
Nose and Throat Devices

510(k) Number	K090838
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Regulation Number and Section

§ 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.