The Cadwell Disposable Probe Handle is a component of the Cadwell Kilowin System that is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.

Device Description

The Cadwell Disposable Probe Handle is a handheld, single-patient-use, sterile, disposable probe holder intended for use in a surgical setting with a Cadwell Kilowin (K971214) instrument. The Cadwell Disposable Probe Handle allows the user to interact with the surgical monitoring instrument. Cadwell Disposable Monopolar Stimulator Probes (from K 103128) specific to the Cadwell Disposable Probe Handle are inserted and removed from the tip of the handle, and make contact with an electrical connector when inserted. The user can select the probe appropriate to the task at hand, removing, repositioning, or changing probes as needed. Electrical stimulation is applied to the Cadwell Disposable Monopolar Stimulator Probe, and used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

AI/ML Overview

The provided 510(k) summary for the Cadwell Disposable Probe Handle (K123589) does not include a detailed study proving device performance against specific quantitative acceptance criteria in the way a diagnostic AI device summary would. This device is a surgical accessory, and its clearance relies on demonstrating substantial equivalence to predicate devices rather than meeting discrete performance metrics in a clinical study.

Therefore, the following information is based on what is available in the document, and many fields will indicate "Not applicable" or "Not specified" as the document primarily focuses on comparisons to predicate devices and general testing, not quantitative performance metrics of a diagnostic nature.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from predicate comparison or general requirements)	Reported Device Performance (from "Same" in table or testing performed)
Intended Use	Perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.	The Cadwell Disposable Probe Handle is used for the same purpose as the predicate devices. (Substantially equivalent)
Compatibility	Compatible with a specific surgical monitoring instrument (Cadwell Kilowin).	Compatible with Cadwell Kilowin (K971214).
Stimulator Probes	Detachable, Disposable, Monopolar Ball or Flush Tip.	"Same" as predicate: Detachable, Disposable, Monopolar Ball or Flush Tip.
Electrical Insulation	Electrical insulation on surfaces not intended to provide electrical stimulation.	"Same" as predicate: Electrical insulation on surfaces not intended to provide electrical stimulation.
IEC 60601-1 Protected Pin Design	Touch Proof Handle Connector.	"Same" as predicate: Touch Proof Handle Connector.
Patient Contact Material	Stainless Steel Stimulator Probe with Insulated Shaft.	"Same" as predicate: Stainless Steel Stimulator Probe with Insulated Shaft.
Handle Material	Plastic.	Medical Grade Polycarbonate Plastic (considered equivalent to predicate's plastic).
Use and Delivery	Single use and sterile.	"Same" as predicate: Single use and sterile.
Lead Wire Insulation	Medical Grade Plastic.	"Same" as predicate: Medical Grade Plastic.
Actuators	Presence of actuators.	"Same" as predicate: Yes.
Theoretical Maximum Voltage	400 V (Medtronic predicate), 300 V (NuVasive predicate).	400 V (matches higher predicate value).
Stimulation Current	0-100 mA (Medtronic predicate), 0-90 mA (NuVasive predicate).	0-100 mA (matches higher predicate value).
Stimulation Waveform	Monophasic and Biphasic (Medtronic predicate), Monophasic (NuVasive predicate).	Matches Medtronic predicate: Monophasic and Biphasic.
Maximum Pulse/S	100 (Medtronic predicate), 5 (NuVasive predicate).	Matches Medtronic predicate: 100.
Software Performance	Functional as intended.	Software verification and validation (performed).
Sterility	Sterile.	Sterility protocol development and validation (performed).
Electromagnetic Compatibility (EMC)	Compliant with relevant EMC standards.	Electromagnetic compatibility testing (performed).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is not a diagnostic AI/CAD device, and therefore does not have a "test set" in the context of clinical images or patient data to evaluate performance metrics like sensitivity or specificity. The "testing" referred to (software, sterility, EMC) would involve engineering and laboratory verification, not a clinical test set from patients.

3. 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 applicable. As above, there is no "ground truth" established by clinical experts for a diagnostic test set in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 device is a surgical instrument accessory; it does not involve AI assistance or human readers for diagnostic interpretation. Its function is to facilitate direct nerve stimulation for monitoring during surgery.

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

Not applicable. This device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for the clearance of this device is based on demonstrating that its design, materials, and function are substantially equivalent to legally marketed predicate devices and that it meets general safety and performance requirements through engineering and laboratory testing (e.g., software functionality, sterility, electrical safety).

8. The sample size for the training set

Not applicable. There is no machine learning model or "training set" for this device.

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

Not applicable.

Summary

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$\mathcal{K}$123589

CADVELL 510k Summary MAR 1 9 2013 Submitter: Cadwell 909 N. Kellogg Street Kennewick. Washington 99336 509-735-6481 Chris Bolkan Contact Person: Safety / Regulatory Specialist Cadwell Laboratories, Inc. Date Prepared: November 7, 2012 Trade Name: Cadwell Disposable Probe Handle Accessory to Surgical Nerve Stimulator/Locator Regulation Name: 21 CFR 874.1820 Regulation Number: Regulatory Classification: Class II PDQ ETN, GXZ Product Code: Ear. Nose and Throat Classification Panel: Medtronic/Xomed NIM Incrementing Probe Handle Predicate Devices: NuVasive Neurovision Probe Handle The Cadwell Disposable Probe Handle is a handheld, Device Description: single-patient-use, sterile, disposable probe holder intended for use in a surgical setting with a Cadwell Kilowin (K971214) instrument. The Cadwell Disposable Probe Handle allows the user to interact with the surgical monitoring instrument. Cadwell Disposable Monopolar Stimulator Probes (from K 103128) specific to the Cadwell Disposable Probe Handle are inserted and removed from the tip of the handle, and make contact with an electrical connector when inserted. The user can select the probe appropriate to the task at hand, removing, repositioning, or changing probes as needed. Electrical stimulation is applied to the Cadwell Disposable Monopolar Stimulator Probe, and used to

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510k Summary

perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Indications for Use:

The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.

Substantial Equivalence:

Data was provided which demonstrates that the Cadwell Disposable Probe Handle is substantially equivalent to previously cleared devices.

The use, design, materials and function of the subject device are considered to be the equivalent of the predicate devices.

Comparisons of Indications of Use and Features for Cadwell Disposable Probe Handle and Predicate Devices

Device	Intended Use
Cadwell Disposable ProbeHandle	The Cadwell Disposable Probe Handle is used to perform precise localizedstimulation of neural tissue and to locate, identify and monitor cranial motornerves, peripheral nerves and spinal nerve roots during surgery. The CadwellDisposable Probe Handle is a sterile, disposable, single patient use device.
Medtronic/Xomed NIMIncrementing Probe	This device is intended for use in surgical procedures for patient-connectedintraoperative nerve monitoring, i.e. assisting the surgeon in locating andmapping motor nerves through the use of electromyographic (EMG) signalsand electrical stimulus of nerves. This device is indicated for locating andidentifying cranial and peripheral motor nerves during surgery, including spinalnerve roots.
NuVasive Neurovision ProbeHandle	The NeuroVision JJB System is used for intraoperative monitoring andneurological status assessment by the administration of brief electrical stimuluspulses to neural tissues and the EMG monitoring of the associated musclegroups. The System is used in conjunction with other NuVasive devices toassist in gaining controlled access to, and visualization of, the spine.

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510k Summary

	Medtronic/XomedIncrementing ProbeHandle	Nu VasiveNeurovision ProbeHandle	Cadwell DisposableProbe Handle
Compatible SurgicalMonitoringInstrument	Medtronic NIM Eclipse(K061113)	NuVasive NVM5(K112718)	Cadwell Kilowin(K971214)
Stimulator Probes	Detachable, Disposable.Monopolar Ball or Flush Tip	Detachable, Disposable,Monopolar	Detachable, Disposable,Monopolar Ball or Flush Tip
Electrical Insulation	Electrical insulation onsurfaces not intended toprovide electrical stimulation	Electrical insulation onsurfaces not intended toprovide electrical stimulation	Same
IEC 60601-1Protected Pin Design	Touch Proof HandleConnector	Touch Proof HandleConnector	Same
Patient ContactMaterial	Stainless Steel StimulatorProbe with Insulated Shaft	Stainless Steel StimulatorProbe with Insulated Shaft	Same
Handle Material	Plastic	Plastic	Medical Grade PolycarbonatePlastic
Use and Delivery	Single use and sterile	Single use and sterile	Same
Lead WireInsulation	Medical Grade Plastic	Medical Grade Plastic	Same
Use and Delivery	Single use and sterile	Single use and sterile	Same
Actuators	Yes	Yes	Same
TheoreticalMaximum Voltage	400 V	300 V	400 V
Stimulation Current	0-100 mA	0-90 mA	0-100 mA
StimulationWaveform	Monophasic and Biphasic	Monophasic	Monophasic and Biphasic
Maximum Pulse/S	100	5	100

Testing:

Software verification and validation, sterility protocol development and validation, and electromagnetic compatibility testing were performed.

Conclusion:

The Cadwell Disposable Probe Handle is substantially equivalent to predicate devices in design, materials, packaging, use, technology, and function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Cadwell Laboratories c/o Mr. Chris Bolkan Regulatory Affairs Engineer 909 N. Kellogg Street Kennewick, WA 99336

Re: K123589/S001

Trade/Device Name: Cadwell Disposable Probe Handle Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical nerve locator Regulatory Class: Class II Product Code: PDQ, ETN, GXZ Dated: January 24, 2013 Received: February 15, 2013

Dear Mr. Bolkan:

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.

March 19,2013

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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Page 2 - Mr. Bolkan

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

JoyceMWhang

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123589

Device Name: Cadwell Disposable Probe Handle

Indications For Use:

The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Jovce MDW

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123589

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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.