(174 days)
Not Found
No
The device description and performance studies focus on the mechanical, electrical, and biological properties of the probes and needles, and their connection to a separate neural integrity monitor for stimulation. There is no mention of data processing, algorithms, or learning capabilities within the device itself.
Yes
The device is used to locate and identify motor nerves, including spinal nerve roots, during surgery. This function directly relates to the diagnosis or treatment of a condition by providing critical information to the surgeon to avoid nerve damage and ensure proper placement of implants (e.g., pedicle screws). It also provides stimulation to nerves, which can be considered a therapeutic or diagnostic function in the context of neural monitoring.
Yes
The device is indicated for "locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots," which is a diagnostic function. It connects to a Neural Integrity Monitor (NIM®) which allows it to provide stimulation to nerves and assess their integrity.
No
The device description explicitly states the devices are composed of stainless steel and plastic, are single-use, sterile packaged, and include physical components like cannulas, stylets, and cables. The performance studies also detail testing on physical attributes like impact, mechanical strength, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pedicle pilot hole preparation, locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots." This describes a surgical tool used in vivo (within the body) to interact with tissues and nerves.
- Device Description: The description details a physical instrument (cannula, stylet, probes) used for mechanical manipulation and electrical stimulation in vivo.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are specifically designed for testing samples in vitro.
The device is a surgical instrument used for nerve monitoring and access during surgery, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are intended for use as a stimulating accessory to the Medtronic NIM® System.
Product codes
PDO
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®).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial and peripheral motor nerves, spinal nerve roots
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
Bench Testing:
Functional use and reliability testing was performed comparing the subject devices and predicate devices, including impact testing into simulated bone with snap lock testing of cannula and stylet handles, hipot testing, continuity testing, visual analysis following impact testing, and Instron insertion and removal testing in simulated bone. All tests passed, showing substantial equivalence.
Mechanical and electrical safety testing was performed on the subject devices in accordance with IEC 60601-1:2005 Ed. 3, including Dielectric strength test, mechanical strength, push test, drop test, and mold stress relief test. Subject devices passed electrical safety testing.
Biocompatibility testing was conducted on gamma sterilized, finished devices per ISO 10993. Tests included cytotoxicity (MEM Elution testing), sensitization (Magnusson-Kligman Method), irritation (Intracutaneous Toxicity), systemic toxicity (Systemic Injection Test), material mediated pyrogen test (Rabbit Pyrogen Test), and hemolysis (Extract method test). All devices passed biocompatibility testing.
Sterility: Devices have been gamma sterilization validated in accordance with ISO 11137 using the VDmax25 method of validation. Sterility validation met requirements of ISO 11137.
Transit testing: Adopted from the PAK family of devices, using 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, and inner/outer blister seal integrity testing. Packaging met transit testing requirements.
Sterile barrier heat sealing: Adopted from the PAK family of devices. Heat sealing process successfully validated.
Shelf life testing (device): 36 month accelerated aging of packaged devices followed by functional use testing. Testing in progress.
Shelf life testing (packaging): 36 month accelerated aging of packaging followed by seal strength testing, package conditioning, and seal integrity testing. 36 month shelf life successfully validated.
Clinical Study:
A cadaver lab test was conducted 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 validated that the device design outputs met the user needs (design inputs).
Key Results: The subject device was shown to be substantially equivalent to the predicate devices through dimensional and functional testing, and cadaver lab testing confirmed successful performance for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K180542
Device Name
BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe
Indications for Use (Describe)
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.
| 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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3
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® 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®).
4
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
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.
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 Surgical | |
| Technologies | Medtronic | |
| 510(k) | Pending (K180542) | K031003, K031510 |
| Indications for Use | [...] indicated for pedicle pilot | |
| hole formation, locating, and | ||
| identifying cranial and peripheral | ||
| motor nerves during surgery, | ||
| including spinal nerve roots | [...] indicated for locating and | |
| identifying cranial and peripheral | ||
| motor 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 to | |
| provide electrical contact with | ||
| the patient. | On all surfaces not intended to | |
| provide electrical contact with | ||
| the patient. | ||
| Distal stainless steel patient | ||
| contact surface | Yes | Yes |
| Device geometry | Substantially equivalent | |
| geometry to predicate | Substantially equivalent | |
| geometry to subject | ||
| Proximal stimulator connector | Yes | Yes |
| Biocompatible | Yes | Yes |
| Sterile, single use only | Yes | Yes |
| IEC 60601-1 passing results | Yes | Yes |
5
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 , Medical Devices: Bacterial Endotoxin and Pyrogen Tests.
- . USP , Pyrogen Test.
- . USP , 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
6
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 and | ||
| reliability testing | The following functional use tests were performed on the | |
| subject devices and the predicate devices. For all tests, the | ||
| results were compared to verify substantial equivalence. | ||
| • Impact testing into simulated bone with snap lock testing | ||
| of cannula and stylet handles | ||
| • Hipot testing, continuity testing, and visual analysis | ||
| following impact testing | ||
| • Instron insertion and removal testing in simulated bone | All functional use and | |
| reliability testing passed. | ||
| Substantial equivalence | ||
| has been shown. | ||
| Mechanical and | ||
| electrical safety | ||
| testing | Testing was performed on the subject devices in accordance | |
| with IEC 60601-1: 2005 Ed. 3. The following tests were | ||
| performed: Dielectric strength test, mechanical strength, | ||
| push test, drop test, mold stress relief test. | Subject devices passed | |
| electrical safety testing, | ||
| demonstrating that the | ||
| devices meet the | ||
| requirements for the | ||
| subject device. | ||
| Biocompatibility | ||
| testing | 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 passed | |
| biocompatibility testing | ||
| Sterility | The devices have been gamma sterilization validated in | |
| accordance with ISO 11137 using the VDmax25 method of | ||
| validation. | Sterility validation met | |
| requirements of ISO |
-
|
| Transit testing | Transit testing was adopted from the PAK family of
devices. The subject devices utilize the same packaging and
have the same basic size, shape, and weight as the PAK
devices.
• 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 outer
blisters, and device
• Inner and outer blister seal integrity testing via dye
injection | Packaging met transit
testing requirements;
transit testing adoption
from PAK family of
devices |
| Sterile barrier heat
sealing | Packaging heat sealing was adopted from the PAK family
of devices. The subject devices utilize the same packaging
and have the same basic size, shape, and weight as the PAK
devices. | Heat sealing process
successfully validated;
packaging process
adoption from the PAK
family of devices. |
| Shelf life testing
(device) | 36 month accelerated aging of packaged devices followed
by functional use testing. | Age testing in progress. |
| Shelf life testing
(packaging) | 36 month accelerated aging of packaging followed by seal
strength testing, package conditioning, and seal integrity
testing. | 36 month shelf life
successfully validated;
packaging shelf life
adoption from the PAK
family of devices. |
7
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.