The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are indicated for pedicle pilot hole preparation, locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.

Device Description

The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are single use devices composed of stainless steel and plastic and are sterile packaged. The devices are comprised of two main components: the cannula and stylet assembly. Also, in the package are two monopolar cables: a subdermal needle electrode and a connecting cable. The NIM® PAK devices are available in standard "NIM® PAK" or longer "NIM® XPAK" configurations with 3 different types of tips: bevel, trocar or blunt. The blunt tips are only offered for the NIM® XPAK. In addition, there are three (3) NIM Pedicle Probes in lumbar, straight, and thoracic configurations. The BE-ST NIM® product family has a total of four (4) pedicle access needle configurations, three (3) pedicle probe configurations, and one (1) blunt configuration. All configurations are packaged with two (2) accessory monopolar cables. One cable is used to ground the patient and the other cable is used to connect the device to a Medtronic Neural Integrity Monitor (NIM®). The connection to the NIM® allows the subject device to provide stimulation to nerves.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:

Acceptance Criteria and Device Performance Study

The provided document describes the BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe (the 'subject device') and its substantial equivalence to predicate devices. The studies conducted are primarily focused on demonstrating this equivalence through various performance and safety tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that each test was successfully passed, demonstrating substantial equivalence or meeting specified requirements.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Functional Use & Reliability Testing	Substantial equivalence to predicate device in functional use. All tests passed including impact, Hipot, continuity, visual analysis, and insertion/removal testing.	All functional use and reliability testing passed. Substantial equivalence has been shown.
Mechanical & Electrical Safety Testing	Meet requirements of IEC 60601-1:2005 Ed. 3.	Subject devices passed electrical safety testing, demonstrating that the devices meet the requirements for the subject device.
Biocompatibility Testing	Pass ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogen, Hemolysis).	All devices passed biocompatibility testing.
Sterility	Meet requirements of ISO 11137 for gamma sterilization validation using VDmax25 method.	Sterility validation met requirements of ISO 11137.
Transit Testing	Meet ISTA 1C Test requirements (pre-conditioning, compression, vibration, drop) and maintain visual integrity and seal integrity.	Packaging met transit testing requirements; transit testing adoption from PAK family of devices.
Sterile Barrier Heat Sealing	Successful validation of heat sealing process.	Heat sealing process successfully validated; packaging process adoption from the PAK family of devices.
Shelf Life Testing (Device)	Maintain functional use after 36-month accelerated aging.	Age testing in progress. (Note: This suggests criteria will be met upon completion)
Shelf Life Testing (Packaging)	Maintain seal strength, package conditioning, and seal integrity after 36-month accelerated aging.	36 month shelf life successfully validated; packaging shelf life adoption from the PAK family of devices.
Cadaver Lab Test (Pilot Hole Preparation)	Successfully create a pilot hole, tapped, and fitted with a pedicle screw. Device design outputs met user needs (design inputs).	The device successfully created a pilot hole which was successfully tapped and fitted with a pedicle screw. Results validated design outputs met user needs.
Pyrogen Status Testing	Pass LAL test for general medical devices.	Pyrogen status for general medical devices was evaluated using the LAL test.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes used for each test. For many tests (e.g., functional testing, electrical safety, biocompatibility, sterility), a sufficient number of devices would have been tested to ensure statistical validity and meet the requirements of the respective standards.

Origin: The study was conducted by Boston-Endo Surgical Technologies, located in Bridgeport, CT, USA. The data provenance is presumed to be internal testing at their facility or through contracted testing laboratories.
Retrospective/Prospective: The testing described appears to be prospective as it involves the physical testing of newly manufactured subject devices and their packaging to demonstrate their performance and safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of external experts or establishing ground truth through expert consensus for the presented performance data. The tests are primarily objective engineering and biological evaluations against established standards and predicate device performance. For the cadaver lab test, the "user needs (design inputs)" served as the "ground truth" criteria, but no specific number or qualification of experts is provided for its assessment beyond the internal team conducting the test.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as the tests performed are objective, quantitative, and standardized evaluations, rather than subjective assessments requiring expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device (a surgical nerve stimulator/locator and pedicle probe) is a physical tool, not an AI or imaging diagnostic device that would typically involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The device is a physical surgical instrument. The concept of an "algorithm only" or "standalone" performance is not relevant to this type of medical device. Its operation is always "human-in-the-loop" as it is used by a surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

Established Standards: Adherence to international and national standards (e.g., IEC 60601-1, ISO 10993, ASTM, USP, ISO 11137, ISTA 1C).
Predicate Device Performance: Demonstrating substantial equivalence to the performance characteristics of the legally marketed predicate devices (Medtronic Stimulation/Dissection Instruments, Ball-tip probes, K031003; Medtronic NIM Spine, K031510).
Design Inputs/User Needs: For the cadaver lab, the successful outcome was measured against predefined user needs and design inputs (e.g., successfully creating a pilot hole, tapping, and fitting a pedicle screw).

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument; therefore, there is no "training set" in the context of machine learning or AI models. The development and validation process involved engineering design, material selection, and rigorous physical testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a physical device, no training set or its associated ground truth was established in the context of statistical modeling or AI.

Summary

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August 22, 2018

Boston Endo Surgical Tech James Rogers Director of Regulatory Affairs, Safety and Environment Division of Lacey Manufacturing Co., LLC 1146 Barnum Ave Bridgeport, Connecticut 06610

Re: K180542

Trade/Device Name: BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDO Dated: July 26, 2018 Received: July 26, 2018

Dear James Rogers:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jay R. Gupta -S

For Carlos L. Peña, PhD, MS 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) K180542

Device Name

BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe

Indications for Use (Describe)

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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PEP BE-ST BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe

510(k) Summary

I. SUBMITTER

Boston-Endo Surgical Technologies, Division of Lacey Manufacturing Company, LLC 1146 Barnum Avenue Bridgeport, CT 06610 (203) 336-7453

Prepared by: James Rogers Director of Regulatory Affairs, Environment and Safety Email: jim.rogers@nninc.com Phone: (203)336-7453

Date Prepared: July 17, 2018

II. DEVICE Name of Device: BE-ST NIM®PAK Needle, Blunt, and Pedicle Probe Common Name: Nerve Stimulator/Locator Classification Name: 21 CFR 874.1820, Surgical nerve, stimulator/locator Review Panel: Neurology Regulatory Class: II Product Code: PDO

III. PREDICATE DEVICE

Medtronic Stimulation/Dissection Instruments, Ball-tip probes, K031003 Medtronic NIM Spine, K031510

No reference devices.

IV. DEVICE DESCRIPTION

The BE-ST NIM® product family has a total of four (4) pedicle access needle configurations, three (3) pedicle probe configurations, and one (1) blunt configuration. All configurations are packaged with two (2) accessory monopolar cables. One cable is used to ground the patient and the other cable is used to connect the device to a Medtronic Neural Integrity Monitor (NIM®).

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PEP BE-ST

BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe

The connection to the NIM® allows the subject device to provide stimulation to nerves. Refer to K031510 for NIM® submission.

The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are intended for use as a stimulating accessory to the Medtronic NIM® System.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The predicate devices and the subject device are the similar. The same technology and sterilization methods and similar materials are used to manufacture the subject devices. There are no technological differences between the two systems. The table below compares the subject and predicate devices.

Characteristic	Subject Device	Predicate Device
Manufacturer	Boston-Endo SurgicalTechnologies	Medtronic
510(k)	Pending (K180542)	K031003, K031510
Indications for Use	[...] indicated for pedicle pilothole formation, locating, andidentifying cranial and peripheralmotor nerves during surgery,including spinal nerve roots	[...] indicated for locating andidentifying cranial and peripheralmotor nerves during surgery,including spinal nerve roots
Technological features	Similar to predicate	Similar to subject
Polymer handle and hub	Yes	Yes
Stainless steel construction	Yes	Yes
Electrical insulation	On all surfaces not intended toprovide electrical contact withthe patient.	On all surfaces not intended toprovide electrical contact withthe patient.
Distal stainless steel patientcontact surface	Yes	Yes
Device geometry	Substantially equivalentgeometry to predicate	Substantially equivalentgeometry to subject
Proximal stimulator connector	Yes	Yes
Biocompatible	Yes	Yes
Sterile, single use only	Yes	Yes
IEC 60601-1 passing results	Yes	Yes

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Premarket Notification

PEP BE-ST

BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe

The subject devices were shown to be substantially equivalent to the predicate devices through dimensional and functional testing.

The main difference between the subject and predicate devices is the design of the handle. The subject devices also have an improved locking mechanism which allows the user to lock the stylet handle to the cannula with a quarter turn bayonet-type locking mechanism. In addition, an audible "click" provides the user with assurance that the handle is locked into place.

Additionally, the electrical insulation was changed from nylon to polyester. The polyester insulation material passed biocompatibility testing pursuant to ISO 10993-4. 10993-10, and 10993-11.

VII.PERFORMANCE DATA

The subject device conforms to the following standards:

. ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials (2017)
. ASTM F899-1, Standard specification for wrought stainless steel for surgical instruments (Version 11) (2009).
. IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General requirements for safety, Amendment 1, Amendment 2.
. ISO 10993-4:2017, Biological Evaluation of Medical Devices: Tests for interactions with blood
. ISO 10993-5:, Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity (1999)
. ISO 10993-10, Biological Evaluation of Medical Devices: Tests for irritation and sensitization.
. ISO 10993-11, Biological Evaluation of Medical Devices: Tests for systemic toxicity
ANSI/AAMI ST72:2011/(R) 2016, Bacterial endotoxins: Test methods, routine . monitoring, and alternatives to batch testing.
. USP <161>, Medical Devices: Bacterial Endotoxin and Pyrogen Tests.
. USP <151>, Pyrogen Test.
. USP <85>, Bacterial Endotoxins Test.
. ISO 11737-1, Sterilization of medical devices - Microbiological methods: Determination of a population of microorganisms on products (2006).
. ISO 11737-2, Sterilization of medical devices - Microbiological methods: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (2000).
. ISO 11607-1, Packaging for terminally sterilized medical devices: Requirements for materials, sterile barrier systems and packaging systems (2006).
. ISO 11607-2, Packaging for terminally sterilized medical devices: Validation requirements for forming, sealing and assembly processes (2006).

The table below summarizes the testing which was performed on the subject devices to show

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PEP BE-ST BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe

substantial equivalence to the predicate devices.

Test	Test Method Summary	Results
Functional use andreliability testing	The following functional use tests were performed on thesubject devices and the predicate devices. For all tests, theresults were compared to verify substantial equivalence.• Impact testing into simulated bone with snap lock testingof cannula and stylet handles• Hipot testing, continuity testing, and visual analysisfollowing impact testing• Instron insertion and removal testing in simulated bone	All functional use andreliability testing passed.Substantial equivalencehas been shown.
Mechanical andelectrical safetytesting	Testing was performed on the subject devices in accordancewith IEC 60601-1: 2005 Ed. 3. The following tests wereperformed: Dielectric strength test, mechanical strength,push test, drop test, mold stress relief test.	Subject devices passedelectrical safety testing,demonstrating that thedevices meet therequirements for thesubject device.
Biocompatibilitytesting	Biocompatibility testing conducted on gamma sterilized,finished devices per ISO 10993.• Cytotoxicity: MEM Elution testing• Sensitization: Magnusson-Kligman Method• Irritation: Intracutaneous Toxicity• Systemic Toxicity: Systemic Injection Test• Material Mediated Pyrogen test: Rabbit Pyrogen Test• Hemolysis: Extract method test	All devices passedbiocompatibility testing
Sterility	The devices have been gamma sterilization validated inaccordance with ISO 11137 using the VDmax25 method ofvalidation.	Sterility validation metrequirements of ISO11137.
Transit testing	Transit testing was adopted from the PAK family ofdevices. The subject devices utilize the same packaging andhave the same basic size, shape, and weight as the PAKdevices.• ISTA 1C Test: Environmental pre-conditioning,Compression test, Vibration test – fixed vibration,Vibration test – random vibration, Drop testing – corner,edge, and face drop• Visual analysis of outer packaging, inner and outerblisters, and device• Inner and outer blister seal integrity testing via dyeinjection	Packaging met transittesting requirements;transit testing adoptionfrom PAK family ofdevices
Sterile barrier heatsealing	Packaging heat sealing was adopted from the PAK familyof devices. The subject devices utilize the same packagingand have the same basic size, shape, and weight as the PAKdevices.	Heat sealing processsuccessfully validated;packaging processadoption from the PAKfamily of devices.
Shelf life testing(device)	36 month accelerated aging of packaged devices followedby functional use testing.	Age testing in progress.
Shelf life testing(packaging)	36 month accelerated aging of packaging followed by sealstrength testing, package conditioning, and seal integritytesting.	36 month shelf lifesuccessfully validated;packaging shelf lifeadoption from the PAKfamily of devices.

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PEP BE-ST BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe

BE-ST conducted a cadaver lab test where the subject devices, connected to the Medtronic NIM® System, were successfully used to create a pilot hole which was successfully tapped and fitted with a pedicle screw. The results of the lab validated that the device design outputs met the user needs (design inputs).

Pyrogen status for general medical devices was evaluated using the LAL test. Testing to monitor pyrogens will be performed periodically.

VIII. CONCLUSIONS

The subject device is only intended for use with the Medtronic NIM® System. As confirmed through bench, clinical, and lab testing; the subject device has the same safety and effectiveness profile as the predicate device.

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.