The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System.

The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems.

Device Description

The BE-ST Navigated PAK Needles are single use surgical instruments composed of stainless steel and plastic. They are sterile packaged. The devices are comprised of three main components: the cannula, stylet assembly, and tracker subassembly.

There are two devices in the family: the BE-ST Navigated NIM® PAK Needle and the BE-ST Navigated PAK Needle. The BE-ST Navigated NIM® PAK Needle is an accessory to the Medtronic StealthStation® System and is intended for use as a stimulating accessory to the Medtronic NIM® System. The BE-ST Navigated PAK Needle is an accessory to the Medtronic StealthStation® System.

The only significant differences between the two subject devices are the electrical insulation on the cannula and the connection to the NIM® System. The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but is not an accessory to the Medtronic NIM® system and therefore cannot be used for nerve monitoring.

AI/ML Overview

The provided document is a 510(k) Summary for the BE-ST Navigated PAK Needles. It describes the device, its indications for use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner for most tests (e.g., minimum tensile strength), but rather by concluding that the devices "passed" or "successfully completed" the tests. However, one specific quantitative acceptance criterion is mentioned: the device navigational accuracy met "the confidence/reliability tolerance interval requirement." Another is the "SAL of 10-6" for ETO sterilization.

Acceptance Criteria	Reported Device Performance
Functional use and reliability: Withstand impact, maintain electrical integrity, proper insertion/removal. Assessed by comparison to predicate.	Devices passed all functional use and reliability testing.
Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, non-systemic toxic, non-pyrogenic, non-hemolytic.	Devices passed biocompatibility testing.
ETO Sterilization: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶.	ETO sterilization validation completed successfully, achieving a SAL of 10⁻⁶.
Packaging durability: Withstand shipping (environmental pre-conditioning, compression, vibration, drop), maintain seal integrity.	Devices passed ship testing.
Packaging process validation: Meet specified heat sealing parameters (width, visual, strength).	Packaging process validation completed successfully (Heat sealing OQ and PQ).
Age testing (device and packaging): Maintain functional use and packaging integrity after accelerated aging (36 months).	Devices and packaging passed age testing.
Surface area: Substantially equivalent to predicate.	Surface area found to be substantially equivalent.
Device navigational accuracy and compatibility with Medtronic StealthStation® System: Meet accuracy criteria for the StealthStation® System.	Devices passed accuracy testing, meeting the confidence/reliability tolerance interval requirement. Devices registered by the StealthStation® System.

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

The document does not explicitly state the sample sizes used for most of the performance tests. For "functional use and reliability testing," it mentions "the subject devices and the predicate devices" without specifying the number of units. Similarly, for biocompatibility, packaging, and age testing, only "finished devices" or "devices" are mentioned.

The data provenance is retrospective as the tests were conducted as part of the 510(k) submission process, using manufactured devices. There is no mention of country of origin of the data; it's implied to be from the manufacturer's testing or contracted labs.

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

This information is not applicable in the context of this device. The BE-ST Navigated PAK Needles are medical instruments for navigated pedicle pilot hole preparation and nerve monitoring. The "ground truth" for the performance tests is established through objective engineering and biological measurements (e.g., impact forces, electrical continuity, cell viability, sterility levels, accuracy measurements against a known standard from the StealthStation® System), not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to the type of testing described for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between readers need to be resolved. The performance data here is based on objective bench and lab testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves multiple human readers evaluating medical cases, often to compare the effectiveness of a diagnostic tool or AI assistance. The BE-ST Navigated PAK Needles are surgical instruments, not diagnostic AI software, and their evaluation focuses on technical performance and safety, not human interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study, in the sense of an algorithm operating independently, was not performed because the device is a physical surgical instrument. However, the "device navigational accuracy and compatibility with Medtronic StealthStation® System" testing can be considered an evaluation of the device's technical performance in conjunction with the StealthStation® System, without explicit human variability being the primary focus of the test itself. The device's accuracy was tested against the StealthStation® system's inherent accuracy criteria.

7. Type of Ground Truth Used

For most tests, the "ground truth" refers to established engineering standards, material specifications, and biological safety limits.

Functional Use & Reliability: Engineering specifications, predicate device performance, basic principles of mechanical and electrical integrity.
Biocompatibility: ISO 10993 standards (e.g., in vitro cytotoxicity, irritation, systemic toxicity, hemolysis, sensitization, pyrogenicity).
Sterilization: ISO 11135 standard (SAL of 10⁻⁶).
Packaging: ISTA 1C Test standard, ISO 11607 standards, and typical packaging integrity tests (dye injection, seal strength).
Age Testing: Controlled accelerated aging, followed by re-evaluation against functional and packaging integrity benchmarks.
Surface Area: Dimensional measurements and comparison to predicate.
Navigational Accuracy: The accuracy criteria set forth by the Medtronic StealthStation® System served as the ground truth/reference for navigational accuracy.

8. Sample Size for the Training Set

This information is not applicable. The BE-ST Navigated PAK Needles are physical medical devices, not AI/machine learning algorithms that require training sets. The development and testing revolve around engineering principles, materials science, and biological safety, not data-driven model training.

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

This information is not applicable as there is no training set for a physical medical device.

Summary

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April 10, 2019

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

Re: K182662

Trade/Device Name: NAV PAK Needle, NIM NAV PAK Needle Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, PDQ, HAW Dated: Undated Received: March 11, 2019

Dear Mr. 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

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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 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,

Matthew C. Krueger -S

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) K182662

Device Name BE-ST Navigated PAK and Navigated NIM® PAK

Indications for Use (Describe)

The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System.

Type of Use (Select one or both, as applicable)
✓ Prescription Use (Part 21 CFR 801 Subpart D)
❍ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: September 18, 2018

II. DEVICE

Name of Device:	BE-ST Navigated PAK Needles
510(k) Number:	K182662
Common Name:	Nerve Stimulator/Locator
Classification Name:	21 CFR 882.4560, Stereotaxic instrument21 CFR 874.1820, Surgical nerve, stimulator/locator
Review Panel	Neurology
Regulatory Class:	II
Product Code:	OLO, PDO

III. IDENTIFICATION OF LEGALLY MARKETED DEVICES (PREDICATE DEVICES)

Predicate Device

K180542	BE-ST NIM PAK Needle, Blunt, and Pedicle Probe
K170011	Medtronic StealthStation® S8 Spine Software v1.0.0
K050438	Medtronic StealthStation® System Update

IV. DEVICE DESCRIPTION

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The Medtronic StealthStation® System and Medtronic NIM® System are not included in the scope of this premarket notification.

V. INDICATIONS FOR USE

The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The BE-ST Navigated NIM® PAK device is based on the predicate Medtronic Navigated NIM-SPINE® PAK Needle. The BE-ST Navigated NIM® PAK device is similar to the BE-ST NIM® PAK device with the addition of a tracker assembly which allows the device to be used with the Medtronic StealthStation® System. The subject device and the BE-ST NIM® PAK device have the same technological features, the same basic geometry, and are manufactured from the same materials, with the exception that the subject device has a tracker assembly which is substantially equivalent to the tracker assembly on the Medtronic predicate device.

The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but does not have neural integrity monitoring capabilities.

Comparison of Subject and Predicate Devices
Characteristic	Subject Device	Predicate Device	Predicate	Reference Predicate
	BE-ST Navigated NIM® PAKNeedle	StealthStation SystemUpdate	BE-ST NIM® PAKNeedle	StealthStation S8Spine Software v1.0.0
Manufacturer	Boston-Endo SurgicalTechnologies	Medtronic Navigation	Boston-Endo SurgicalTechnologies	Medtronic Navigation
510(k)	K182662	K050438	K180542	K170011
Indications forUse	The BE-ST NAV PAK isindicated for navigated pediclepilot hole preparation. The BE-ST NAV PAK should only beused with a compatible	[...] is indicated for anymedical condition inwhich the use ofstereotactic surgerymay be appropriate,	[...] is indicated forpedicle pilot holepreparation, locating,and identifying cranialand peripheral motor	[...] is indicated forany medical conditionin which the use ofstereotactic surgerymay be appropriate,

The tables below compare the subject and predicate devices.

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Medtronic StealthStation® System.	and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.	nerves during surgery, including spinal nerve roots.	and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.
The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems

Technological Comparison of Subject and Predicate Devices
Characteristic	BE-ST Navigated NIM® PAK Needle	Medtronic Navigated NIM-SPINE® PAK Needle	BE-ST NIM® PAK Needle
Manufacturer	Boston-Endo Surgical Technologies	Medtronic Navigation	Boston-Endo Surgical Technologies
Accessory to Medtronic StealthStation® System	Yes	Yes	No
Accessory to Medtronic NIM® System	Yes	Yes	Yes
Technological features	Same as predicate	Same as subject	Same as subject with exception of tracker assembly used for navigation
Construction Materials	Stainless steel - stylet, cannula, self-tapping screws, and postsPolymer - stylet handle, cannula hub, and tracker assemblyPolyester – cannula electrical insulation	Stainless steel – stylet, cannula, self-tapping screw, and postsPolymer - stylet handle, locking ring, cannula hub, and tracker assemblyNylon - cannula electrical insulation	Stainless steel – stylet and cannulaPolymer - stylet handle, cannula hubPolyester - cannula electrical insulation
Electrical insulation	On all cannula surfaces not intended to provide electrical contact with the patient.	On all cannula surfaces not intended to provide electrical contact with the patient.	On all cannula surfaces not intended to provide electrical contact with the patient.
Distal tip	Same as predicate	Same as subject	Same as subject
Stylet handle/cannula Hub connection	Overmolded stylet handle that locks to overmolded cannula hub	Removable handle with a locking ring the locks the handle to the cannula and/or stylet.	Overmolded stylet handle that locks to overmolded cannula hub
Biocompatible	Yes	Yes	Yes

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Single Use	Yes	Yes	Yes
Sterilization Method(s)	Sterile (ETO)	Sterile (ETO)	Sterile (gamma)
Environment of Use	Intraoperative	Intraoperative	Intraoperative
Duration of Use	< 24 hours	< 24 hours	< 24 hours

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

VII. PERFORMANCE DATA

The subject device conforms to the following standards:

· ANSI/AAMI ST72:2011/(R) 2016, Bacterial endotoxins: Test methods, routine monitoring, and alternatives to batch testing.
ASTM A313, Standard Specification for Stainless Steel Spring Wire . (2017)
· ASTM A269, Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing (2015a)
· ISO 10993-4:2017, Biological Evaluation of Medical Devices: Tests for interactions with blood
· ISO 10993-5:2009, Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Devices: Tests for irritation and sensitization.
ISO 10993-11:2017, Biological Evaluation of Medical Devices: Tests for . systemic toxicity.
· ISO 11135:2014, Sterilization of health-care products Ethylene oxide -Requirements for the development, validation, and routine control of a sterilization process for medical devices.
· ISO 11607-1:2006, Packaging for terminally sterilized medical devices: Requirements for materials, sterile barrier systems and packaging systems.
· ISO 11607-2:2006, Packaging for terminally sterilized medical devices: Validation requirements for forming, sealing andassembly processes.
· ISO 11737-1:2018, Sterilization of medical devices Microbiological methods: Determination of a population of microorganisms on products.
· ISO 11737-2:2009, Sterilization of medical devices Microbiological methods: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
· USP <85>, Bacterial Endotoxins Test.
· USP <151>, Rabbit Pyrogen Test
· USP <161>, Medical Devices: Bacterial Endotoxin and Pyrogen Tests

The table below summarizes the testing which was performed on the subject devices to show substantial equivalence to the predicate devices.

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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 testing ofcannula and stylet handles• Hipot testing, continuity testing, and visual analysis followingimpact testing• Instron insertion and removal testing in simulated bone	Devices passed allfunctional use andreliability testing
Biocompatibilitytesting	Biocompatibility testing conducted on ETO sterilized, finisheddevices 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	Devices passedbiocompatibility testing
ETO sterilizationvalidation	ETO sterilization validation per ISO 11135. Validation achieveda SAL of 10-6. The residual ETO limit for the devices is<4mg/device EO and <9mg/device ECH per ISO 10993-7.Following validation, routine bioburden testing will beperformed on the devices.	ETO sterilizationvalidation completedsuccessfully
Packagingdurability testing	Ship testing on final finished, packaged, sterilized, devices. Theship testing was comprised of the following steps:• ISTA 1C Testo Environmental pre-conditioningo Compression testo Vibration test – fixed vibrationo Vibration test - random vibrationo Drop testing – corner, edge, and face drop• Visual analysis of outer packaging, inner and outer blisters,and device• Inner and outer blister seal integrity testing via dye injection	Devices passed shiptesting
Packaging processvalidation	Packaging heat sealing process validation• Heat sealing OQo Seal width verificationo Visual inspectiono Seal strength process capability analysis• Heat sealing PQ conducted at nominal heat sealing parameters	Packaging processvalidation completedsuccessfully

Age testing(device andpackaging)	36 month accelerated aging on packaging and devices followedby functional use testing and packaging integrity testing.Accelerated aging to 36 months Device Functional use testing of devices including impact testing Visual, Hipot, and conductivity verification is conducted before and after impact testing. Snap lock testing of cannula and stylet handles Packaging Seal integrity testing using dye penetration method Seal strength testing	Devices and packagingpassed age testing.
Surface areavalidation	Performed dimensional analysis	Surface area found to besubstantially equivalent.
Devicenavigationalaccuracy andcompatibility withMedtronicStealthStation®System	Accuracy and compatibility testing with MedtronicStealthStation® System. Testing conducted by Medtronic Devices registered by the StealthStation® System Devices tested to the accuracy criteria for the StealthStation® System	Devices passed accuracytesting, meeting theconfidence/reliabilitytolerance intervalrequirement.

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VIII. CONCLUSIONS

The Navigated NIM® PAK Needle and the Navigated PAK Needle are intended for use as accessories to the Medtronic StealthStation® System. The Navigated NIM® PAK Needle is additionally intended for use as a stimulating accessory to the Medtronic NIM® System.

As confirmed through bench testing; the subject devices have the same safety and effectiveness profile as the predicate devices.

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.