Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrical properties of a stimulating electrode and its accessories, with no mention of AI or ML. The performance studies are bench tests evaluating physical strength and electrical safety, not algorithmic performance.

Therapeutic

Yes
The device is used for pedicle pilot hole preparation and locating/identifying spinal roots/nerves, which are medical diagnostic and treatment functions.

Diagnostic

Yes
The device is indicated for "locating, and identifying spinal roots / nerves by providing proximity feedback," which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components like needles, sheaths, handles, and alligator clips, and the performance studies focus on the mechanical and electrical safety of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the ALARA Neuro Access Kit is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for "pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback." This describes a surgical tool used directly on the patient's body during a procedure.
Device Description: The description details a sterile stimulating electrode, needle, sheath, and handle, all designed for physical interaction with tissue and nerves.
Anatomical Site: The device is used on "Spinal roots / nerves," which are part of the living organism.
Performance Studies: The performance studies focus on mechanical strength, functionality in simulated surgical scenarios, and electrical safety, all relevant to a surgical instrument used in vivo.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the defining characteristic of an IVD. The device provides "proximity feedback," which is a direct interaction with the patient's anatomy, not an analysis of a biological sample.

Therefore, the ALARA Neuro Access Kit is a surgical instrument used for direct interaction with the patient's body, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ALARA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

Product codes (comma separated list FDA assigned to the subject device)

PDQ

Device Description

The ALARA Neuro Access Kit with Access Needle, Sheath and Extension Handle is a single use: sterile stimulating electrode is manufactured with the following materials: 316 and LVM Stainless Steel, IXEF 1022/9008 and Lustram ABS. The disposable ALARA Neuro Access Kit is an Access Needle insulated with a sheath (see figure 1). The sheath is full length except for the distal tip (either a diamond or bevel tip) which provides tissue stimulation. The needle utilizes an extension handle as an accessory (see figure 2) to provide the surgeon stability in placement of the access needle and by providing support by allowing for more working space during a surgical procedure.

The device is kitted with a set of individually packaged and (single use) disposable Alligator Clips (Rhythmlink International Alligator Clip RLSP487) see figure 3. The device registered with Rhythmlink (FDA registered FEI: 3003831320).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

spinal roots / nerves

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was performed with the device in simulated use cases to determine that the device met its performance specifications. Where applicable, functionality testing included materials that simulate relevant mechanical properties of bone.

ALARA Cannula Handle Torque Test The cannula handle meets all acceptance ● criteria since the torque required to cause the cannula to fail as over twice the required torque of 25 in-lbs.
ALARA Cannula Handle Pull Test The cannula handle meets all acceptance ● criteria since the force required to cause the cannula to fail as over the required force of 60 lbf.
. ALARA Stylet Handle Pull Test - The stylet handle meets all acceptance criteria since the force required to cause the stylet to fail as over the required force of 60 lbf.
ALARA Bevel Sheath Needle Functionality Test The bevel sheath needleand ● extension handle meets all acceptance criteria since the samples were able to functionally perform the test without failure.
. ALARA Diamond Sheath Needle Functionality Test - The diamond sheath needle and extension handle meets all acceptance criteria since the samples were able to functionally perform the test without failure.
Electrical Safety IEC 60601-1 Edition 3.1. with AAMI/CSA/EN Deviations: ● Leakage Current Test: (Clause 8.7), Dielectric Voltage Withstand: (Clause 8.8.3), Humidity Preconditioning Treatment: (Clause 5.7), Enclosure Mechanical Strength: (Clause 15.3), Drop Test: (Clause 15.3.4), Ball Pressure: (Clause 8.8.4.1), Patient Leads and Cables: (Clause 8.5.2.3). SUMMARY: The limited evaluation and testing of the ALARA 11 Gauge Access Needle with Sheath, found the sample(s) to be in compliance with the above specified standards.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K171807

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 16, 2019

SurGenTec. LLC % Stephen Inglese Founder/CEO Quality Solutions and Support, LLC PO Box 8271 Holland, Michigan 49422

Re: K190163

Trade/Device Name: ALARA Neuro Access Kit Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ Dated: June 13, 2019 Received: June 17, 2019

Dear Stephen Inglese:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190163

Device Name ALARA Neuro Access Kit

Indications for Use (Describe)

The ALARA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ALARA Neuro Access Kit is provided below.

Device Common Name:	Nerve Stimulator / Locator
Classification Name:	Neurosurgical Nerve Locator
Device Proprietary Name:	ALARA Neuro Access Kit
Submitter:	SurGenTec, LLC
7601 N Federal Hwy, Suite 150A
Boca Raton, FL 33487

Predicate Device: -
510k	Product Name	Clearance Date
K171807	ES2 Neuromonitoring Accessory
Instruments	July 18,2017

Indication for Use:

The ALARA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

Device Description:

The ALARA Neuro Access Kit with Access Needle, Sheath and Extension Handle is a single use: sterile stimulating electrode is manufactured with the following materials: 316 and LVM Stainless Steel, IXEF 1022/9008 and Lustram ABS. The disposable ALARA Neuro Access Kit is an Access Needle insulated with a sheath (see figure 1). The sheath is full length except for the distal tip (either a diamond or bevel tip) which provides tissue stimulation. The needle

4

utilizes an extension handle as an accessory (see figure 2) to provide the surgeon stability in placement of the access needle and by providing support by allowing for more working space during a surgical procedure.

The device is kitted with a set of individually packaged and (single use) disposable Alligator Clips (Rhythmlink International Alligator Clip RLSP487) see figure 3. The device registered with Rhythmlink (FDA registered FEI: 3003831320).

Image /page/4/Picture/2 description: The image shows a black and blue tool on a white surface. The tool has a black handle with a blue top. The tool has a long, thin metal rod that extends from the handle. The tool is likely used for precision work.

Figure 1- ALARA Access Needle with Sheath

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Image /page/5/Picture/0 description: The image shows a medical device on a white table. The device has a long, white handle with a silver circular piece in the middle. At the end of the handle, there is a black and blue component with a thin, black probe extending from it, and a black wire is connected to the device.

Figure 2- Extension Handle attached to the Access Needle

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Image /page/6/Picture/0 description: The image contains three separate photos. The first photo shows a medical device with two wires connected to it via alligator clips. The second photo shows a sealed package with the brand name "Rhythmlink" and other information such as the company address, phone number, and a statement that it is for single use only. The third photo shows a similar sealed package, but this time the contents are visible, revealing a black wire with an alligator clip attached to one end.

Figure 3- Access Needle with Extension Handle and Alligator Clip Attached / Packaged

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Performance Testing:

Bench testing was performed with the device in simulated use cases to determine that the device met its performance specifications. Where applicable, functionality testing included materials that simulate relevant mechanical properties of bone.

ALARA Cannula Handle Torque Test The cannula handle meets all acceptance ● criteria since the torque required to cause the cannula to fail as over twice the required torque of 25 in-lbs.
ALARA Cannula Handle Pull Test The cannula handle meets all acceptance ● criteria since the force required to cause the cannula to fail as over the required force of 60 lbf.
. ALARA Stylet Handle Pull Test - The stylet handle meets all acceptance criteria since the force required to cause the stylet to fail as over the required force of 60 lbf.
ALARA Bevel Sheath Needle Functionality Test The bevel sheath needleand ● extension handle meets all acceptance criteria since the samples were able to functionally perform the test without failure.
. ALARA Diamond Sheath Needle Functionality Test - The diamond sheath needle and extension handle meets all acceptance criteria since the samples were able to functionally perform the test without failure.
Electrical Safety IEC 60601-1 Edition 3.1. with AAMI/CSA/EN Deviations: ● Leakage Current Test: (Clause 8.7), Dielectric Voltage Withstand: (Clause 8.8.3), Humidity Preconditioning Treatment: (Clause 5.7), Enclosure Mechanical Strength: (Clause 15.3), Drop Test: (Clause 15.3.4), Ball Pressure: (Clause 8.8.4.1), Patient Leads and Cables: (Clause 8.5.2.3). SUMMARY: The limited evaluation and testing of the ALARA 11 Gauge Access Needle with Sheath, found the sample(s) to be in compliance with the above specified standards.

Substantial Equivalence:

Based on similar intended use and technological characteristics, the ALARA Neuro Access Kit is Substantially equivalent to the predict device: K171807 - ES2 Neuromonitoring Accessory Instruments Table 1 demonstrates the technological features; both similar and different.

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Administrative	Subject Device	Predicate Device
Characteristic	SurGenTec, LLC –
K190163	Stryker -
K171807

Device Name	ALARA Neuro Access Kit	ES2 Neuromonitoring
Accessory Instruments – 200,
300 and 400 LITE Y-Needles
Regulation	21 CFR § 874.1820, Class II	21 CFR § 874.1820, Class II
Product Code	PDQ	PDQ
Device Characteristic:
Indications For Use	The ALARA Neuro
Access Kit is indicated for
pedicle pilot hole
preparation, locating, and
identifying
spinal roots / nerves by
providing proximity
feedback.	The ES2 Neuromonitoring
instruments (Awls, Taps,
Screwdriver and LITe Y-
NEEDLE 200, 300 and 400) can
be used by the surgeon to assist
in location of the spinal nerves
by providing proximity
information before, during or
after bone preparation and
placement of bone screws in
open and percutaneous
minimally invasive posterior
surgical approaches of the non-
cervical spine.
Material	Surgical Stainless Steel,
lxef® 1022/9008 and
Acrylonitrile Butadiene
Styrene (ABS)	Surgical Stainless Steel and
Acrylonitrile Butadiene Styrene
(ABS)
IEC 60601 Compliant	Yes	Yes
Use of the Needle	Needle depth stop	Needle depth stop
Sterility	Sterile (gamma)	Sterile and Non Sterile
Non-sterile devices are provided
with validated steam sterilization
parameters to assure an SAL of
10-6
Reusable /Single Use	Single Use	200, 300, and 400 LITe Y Needle

Single Use

Table 1: Device Comparison Table for Substantial Equivalence

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*Bold text denotes a difference between the subject device and the predicate device.

Summary of Substantial Equivalence:

As described above, the difference in technological characteristics do not raise new types of safety and effectiveness issues. The testing data (biocompatibility, bench testing and electrical safety) provided in this 510(k) show equivalence to the predicate as cleared in K171807 and therefore the ALARA Neuro Access Kit can be found substantially equivalent to the predicate device.