The NuVasive® Disposable Stimulating Electrode is indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

Device Description

The Disposable Stimulating Electrode is a single-use; sterile stimulating electrode composed of polyphenylsulfone (PPSU) and a conductive silver. The Disposable Stimulating Electrode is insulated along its length with a dielectric coating, a non-insulated proximal connector to attach to any compatible neuromonitoring stimulator, and a non-insulated distal tip to deliver tissue stimulation.

AI/ML Overview

The provided text describes the 510(k) summary for the NuVasive® Disposable Stimulating Electrode, focusing on demonstrating its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study with an AI component.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or not present in the provided document.

However, I can extract the information related to the performance data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested)	Reported Device Performance (Result)
Impedance and Durability	Meets or exceeds predicate device performance
Biocompatibility (per ISO 10993-1, -10, -11, -5)	Meets or exceeds predicate device performance
Sterilization assessment (per AAMI TIR 28)	Meets or exceeds predicate device performance
Sterilization validation (per ISO 11135-1)	Meets or exceeds predicate device performance
Bioburden analysis (per ISO 11737-1)	Meets or exceeds predicate device performance
EO sterilization residual analysis (per ISO 10993-7)	Meets or exceeds predicate device performance
Shelf life validation (per ASTM F1980, ASTM D4332-01, ISO 11607, ASTM F2096, ASTM F88)	Meets or exceeds predicate device performance

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

Not applicable / Not provided. The document describes non-clinical testing (e.g., impedance, biocompatibility, sterilization, shelf life) rather than a clinical study with a "test set" of patient data. The purpose was to demonstrate substantial equivalence to predicate devices through technical performance and safety testing.

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

Not applicable / Not provided. No clinical "test set" or human expert ground truth establishment is described for this type of non-clinical, substantial equivalence testing.

4. Adjudication method for the test set:

Not applicable / Not provided. No clinical "test set" requiring adjudication by experts is described.

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. An MRMC comparative effectiveness study was not performed. This device is a disposable stimulating electrode, not an AI-powered diagnostic or assistive tool for human readers.

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

No. This device is a physical medical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used:

For the non-clinical tests conducted, the "ground truth" would be defined by the validated standards and specifications themselves (e.g., ISO standards for biocompatibility/sterilization, ASTM standards for shelf-life, and pre-defined acceptable ranges for impedance and durability tests). The goal was to meet or exceed the performance of the predicate device based on these engineering and safety benchmarks.

8. The sample size for the training set:

Not applicable / Not provided. No training set for an algorithm is relevant to this device.

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

Not applicable / Not provided. No training set for an algorithm is relevant to this device.

Summary of the Study:

The study described is a non-clinical performance evaluation aimed at demonstrating that the NuVasive® Disposable Stimulating Electrode is "substantially equivalent" to already legally marketed predicate devices. This is a common pathway for 510(k) clearance. The "study" consisted of a series of laboratory and bench tests covering:

Electrical and Mechanical Performance: Impedance and Durability Testing.
Biocompatibility: Tests to ensure the device materials are safe for biological contact, following ISO 10993 standards.
Sterilization: Validation of the sterilization process and assessment of residuals, following ISO and AAMI standards.
Shelf Life: Testing to determine the stability and integrity of the device over its intended storage period, following ASTM and ISO standards.

The "proof" that the device meets the acceptance criteria is stated as: "The results of these studies showed that the subject Disposable Stimulating Electrode meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent." No specific quantitative results are provided in this summary, but it confirms that the tests were conducted and the performance was deemed acceptable in comparison to predicate devices, thereby enabling its clearance by the FDA.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter N on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the tagline "Speed of Innovation".

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121

Date Prepared: September 29, 2011

Device Name B.

Trade or Proprietary Name:	NuVasive ® Disposable Stimulating Electrode
Common or Usual Name:	Nerve Stimulator/Locator
Classification Name:	Surgical Nerve Stimulator/Locator

Device Class:	Class II
Classification:	21 CFR § 874.1820
Product Code:	ETN

C. Predicate Devices

The subject Disposable Stimulating Electrode is substantially equivalent to the following predicate devices currently distributed commercially in the U.S.:

K103128 Cadwell Disposable Stimulator Probe ●
K090838 Axon Systems Stimulus/dissection Instruments ●
K031003 Medtronic Xomed Stimulus / Dissection Instruments .

Device Description D.

E. Intended Use

The NuVasive Disposable Stimulating Electrode is indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "Speed of Innovation".

Technological Characteristics F.

As was established in this submission. the subject Disposable Stimulating Electrode is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, pyrogenicitylabeling, and functions. The device is not labeled as non-pyrogenic. The shelf life of the device is

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject Disposable Stimulating Electrode is substantially equivalent to other predicate devices. The following testing was performed:

Impedance and Durability Testing
트 Biocompatibility testing per:
- ISO 10993-1:2009, ISO 10993-10:2002/Amd. 1:2006(E), ISO 10993-11:2006, ISO 10993-5:2009
Sterilization assessment and adoption per AAMI TIR 28: 2009
Sterilization validation on a master device per ISO 11135-1: 2007
트 Bioburden analysis per ISO 11737-1:2006
EO sterilization residual analysis per ISO 10993-7:2008
I Shelf life validation per:

ASTM F1980: 2007. ASTM D4332-01: 2006. ISO 11607: 2006. ASTM F2096: 2004, and ASTM F88:2009.

The results of these studies showed that the subject Disposable Stimulating Electrode meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Disposable Stimulating Electrode has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NuVasive, Inc. c/o Ms. Sheila Bruschi 7475 Lusk Boulevard San Diego, CA 92121

OCT 1 3 2011

Re: K111597

Trade/Device Name: Disposable Stimulating Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: September 20, 2011 Received: September 21, 2011

Dear Ms. Bruschi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Q. A. Peterson L

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 (if known):_K111597

Device Name: NuVasive® Disposable Stimulating Electrode

Indications For Use:

The NuVasive® Disposable Stimulating Electrode is 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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Nall

Division Sign-Off) Division of Ophthalmic, Neurological and Ear, ·Jose and Throat Devices

Prescription Use
X
(Per 21 CFR 801.109)

510(k) Number K111597

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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.