(188 days)
Not Found
No
The summary describes a system for nerve monitoring during spinal surgery using electrical stimulation and physical instruments. There is no mention of AI or ML in the intended use, device description, performance studies, or key metrics. The technology described is based on electrical current transfer and physical dilation.
No.
The device is used for monitoring and identification of nerves during surgery, not for treating a condition or restoring function.
Yes
The device is intended for "location and identification" of peripheral nerves and spinal nerve roots through "controlled monitoring of neural elements," which are diagnostic functions.
No
The device description explicitly details physical components like cables, dilators, probes, taps, awls, and screw drivers, made from materials like Aluminum 6061-T6 with an insulated coating. Performance studies also include testing on these physical components (electrical safety, animal study, bench testing). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a system of cables and surgical instruments (dilators, probes, taps, awls, screw drivers) used to facilitate surgical access and monitor neural elements during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens.
The device is a surgical accessory used to aid in the identification and monitoring of nerves during a surgical procedure.
N/A
Intended Use / Indications for Use
The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, ETN, GXZ
Device Description
The Nerve Monitoring Cable System, which consists of Nerve Monitoring Cables in conjunction with various stimulation accessories, allow for tissue dilation and stimulation of peripheral nerve roots for location and identification during open and percutaneous / minimally invasive spinal surgery. The Nerve Monitoring Cable includes a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating. The other end of the Nerve Monitoring Cable includes a clip for connection to the stimulation accessories of this system.
The stimulation accessories include general manual orthopedic surgical instruments previously cleared via K073227 (i.e. pedicle probes, taps, awls and screw drivers) and also include sterile/ single-use dilators which are subject of this submission. The subject dilators are a series of hollow tubes that fit over one another for the purpose of dilating tissue in preparation for spinal surgery. Similar to the predicate instrument accessories, they are made from a conducting metal (Aluminum 6061-T6) with an insulated outer coating (Parylene C) to allow passage of current from a point on the proximal end where it connects to the Nerve Monitoring Cable to an un-insulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The subject dilators are offered sterile/single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves including 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This 510(k) premarket notification is seeking clearance of subject dilators as accessory instruments during neuromonitoring applications. Performance testing and engineering calculations were performed to demonstrate that the subject devices are substantially equivalent to the identified predicates in terms of design, performance and intended use.
Engineering analysis confirmed the maximum charge, current, and power densities of the subject devices fall within the range of predicate devices. IEC 60601-1 testing for electrical safety on applicable devices of the subject system was supplied. A porcine animal study was conducted to assess the performance, functionality, and safety or the subject dilators as neuromonitoring accessory instruments. Electrical/resistance bench testing confirmed the subject dilators are capable of transferring an electrical current with little or no resistance in a similar manner to predicate devices. This bench testing, along with in-process Hipot testing, also confirmed the coating of each device provides adequate electrical insulation. Sterilization, packaging, and shelf-life validations were also completed per applicable test standards (ISO 11137-2, ISO 11607, and ASTM D4169 respectively). The performance data confirmed the substantial equivalence of the subject devices and demonstrates the subject devices are as safe, as effective, and perform as well as, or better than, the predicate devices.
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.
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
§ 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2015
Pioneer Surgical Technology, Inc. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, MI 49855 USA
Re: K142438
Trade/Device Name: Nerve Monitoring Cable System Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ, ETN, GXZ Dated: January 30, 2015 Receive: February 2, 2015
Dear Ms. Pleaugh:
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.
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 mav 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
1
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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for Carlos L 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) K142438
Device Name Nerve Monitoring Cable System
Indications for Use (Describe)
The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Pursuant to 21 CFR 807.92
| 510(k) Owner: | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 USA
Ph.: (906) 225-5861
Fax: (906) 226-4459
Contact: Sarah (McIntyre) Pleaugh
Prepared: January 30, 2015 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name: | Nerve Monitoring Cable System |
| Common name: | Neurosurgical Nerve Locator |
| Classification: | Class II;
21 CFR 874.1820, PDQ, Neurosurgical nerve locator and ETN, Nerve stimulator
21 CFR 882.1350, GXZ, Needle electrode |
| Predicate
Devices: | K073229 Pioneer Surgical Technology, Inc. - Nerve Monitoring Cable System
K132373 Biomet Spine - Biomet Probes/Guidewires and Dilators
K140400 Stryker Spine - ES2® Neuromonitoring Accessory Instruments |
| Device
Description: | The Nerve Monitoring Cable System, which consists of Nerve Monitoring Cables
in conjunction with various stimulation accessories, allow for tissue dilation and
stimulation of peripheral nerve roots for location and identification during open and
percutaneous / minimally invasive spinal surgery. The Nerve Monitoring Cable
includes a 1.5 mm female DIN connector for use with a stimulating console with a
Type BF or CF rating. The other end of the Nerve Monitoring Cable includes a clip
for connection to the stimulation accessories of this system.
The stimulation accessories include general manual orthopedic surgical instruments
previously cleared via K073227 (i.e. pedicle probes, taps, awls and screw drivers)
and also include sterile/ single-use dilators which are subject of this submission.
The subject dilators are a series of hollow tubes that fit over one another for the
purpose of dilating tissue in preparation for spinal surgery. Similar to the predicate
instrument accessories, they are made from a conducting metal (Aluminum 6061-
T6) with an insulated outer coating (Parylene C) to allow passage of current from a
point on the proximal end where it connects to the Nerve Monitoring Cable to an
un-insulated portion of the distal tip. The purpose of this is to allow controlled
monitoring of neural elements near and around the point of access. The subject
dilators are offered sterile/single-use. |
| Intended Use: | The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps,
awls or screw drivers, are intended for tissue dilation/dissection and stimulation of
peripheral nerves including spinal nerve roots for location and identification during
spinal surgery.
The dilators are also intended for use in surgical procedures to provide surgical
access by dilating the soft tissue to the intended surgical site to allow passage of
current from a point on the proximal end to an uninsulated portion of the distal tip.
The purpose of this is to allow controlled monitoring of neural elements near and |
4
| around the point of access. The dilators are offered sterile/single use. | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technological | ||||||||||||||||
| Characteristics: | The subject dilators are substantially equivalent to the predicate devices in terms of | |||||||||||||||
| design, function, principles of operation, technological characteristics, intended use, | ||||||||||||||||
| and performance. |
As compared to the Biomet predicate, the subject dilators are similar in that they
are a series of hollow tubes intended for tissue dilation and stimulation of nerves
for neuromonitoring applications. They are made from metal with an insulated
outer coating. Similar to the Biomet and Stryker predicates, the electrical signal is
supplied via FDA cleared neuromonitoring systems attached to a clip or probe that
is attached to the neuromonitoring contact zone on the proximal end. The electrical
signal is then transferred to a point on the distal end which is uninsulated
(minimum exposed surface area is SE to the predicate devices). | | | | | | | | | | | | | | | |
| Materials: | The subject dilators are made from Aluminum 6061-T6 conforming to ASTM B221
with an insulated outer coating (Parylene C). | | | | | | | | | | | | | | | |
| Biocompatibility: | Biocompatibility testing was conducted on the subject dilators in accordance with
the testing recommendations in ISO 10993-1 (Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing). The test results are summarized in the
table below:
Test Results Conclusion Cytotoxicity No evidence of cytotoxicity. Non-cytotoxic Irritation No evidence of irritation. Non-irritant Sensitization No evidence of sensitization. Non-sensitizing Systemic Toxicity No evidence of toxicity. Not systemically toxic | | | | | | | | | | | | | | | |
| | As shown in the table, biocompatibility testing found the subject dilators to be non-
cytotoxic, non-irritant, non-sensitizing, and not systemically toxic. | | | | | | | | | | | | | | | |
| Summary of
Performance
Data: | This 510(k) premarket notification is seeking clearance of subject dilators as
accessory instruments during neuromonitoring applications. Performance testing
and engineering calculations were performed to demonstrate that the subject
devices are substantially equivalent to the identified predicates in terms of design,
performance and intended use.
Engineering analysis confirmed the maximum charge, current, and power densities
of the subject devices fall within the range of predicate devices. IEC 60601-1
testing for electrical safety on applicable devices of the subject system was
supplied. A porcine animal study was conducted to assess the performance,
functionality, and safety or the subject dilators as neuromonitoring accessory
instruments. Electrical/resistance bench testing confirmed the subject dilators are
capable of transferring an electrical current with little or no resistance in a similar
manner to predicate devices. This bench testing, along with in-process Hipot
testing, also confirmed the coating of each device provides adequate electrical
insulation. Sterilization, packaging, and shelf-life validations were also completed
per applicable test standards (ISO 11137-2, ISO 11607, and ASTM D4169
respectively). | | | | | | | | | | | | | | | |
5
| The performance data confirmed the substantial equivalence of the subject devices |
|---|
| and demonstrates the subject devices are as safe, as effective, and perform as well |
| as, or better than, the predicate devices. |
Substantial Equivalence Summary - Comparison of Subject and Predicate Systems
| Characteristic | Subject
K142438 Nerve
Monitoring Cable
System | Predicate
K073229 Nerve
Monitoring Cable
and Reusable
Accessory
Instruments | Predicate
K132373
Biomet Spine
Probes/
Guidewires and
Dilators | Predicate K140400
ES2® Neuro-
monitoring
Accessory
Instruments | Substantial
Equivalence |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Neuromonitoring
Accessories
Instruments | Dilators | General, manual
orthopedic reusable
surgical
instruments (e.g.
probes, awls, taps,
inserters) | Probes,
guidewires and
dilators | Awls, Taps and
Screwdriver to be
used with Dilators or
Tap Sleeves | Yes |
| Use of Dilators | Dilators | No dilators in
K073229 | Dilators | Dilators or Tap
Sleeve | Yes |
| Compatible with
Common
Neuromonitoring
Consoles &
Software | Compatible with
FDA cleared
neuromonitoring
systems | Compatible with
FDA cleared
neuromonitoring
systems | Compatible with
FDA cleared
neuromonitoring
systems | Compatible with
FDA cleared
neuromonitoring
systems | Yes |
| Connection to
Neuromonitoring
Unit | Clip | Clip | Clip or Probe | Clip or Probe (based
on Neuromonitoring
System used) | Yes |
| Materials | ASTM B221 6061
Aluminum (UNS
A96061) with
Parylene C Coating | -ASTM F899 17-4
SST with Halar®
6014 Coating
-Detachable
silicone handles or
RADEL® handles | ASTM F899
Stainless steel
with polymeric
dielectric
coating | -Awl, Taps, &
Screwdriver:
Surgical Grade
Stainless Steel
-Dilators & Tap
Sleeve: RADEL® | Yes |
| Indications for
Use | The Nerve
Monitoring Cable in
conjunction with
dilators, pedicle
probes, taps, awls or
screw drivers, are
intended for tissue
dilation/ dissection
and stimulation of
peripheral nerves
including spinal nerve
roots for location and
identification during
spinal surgery.
The dilators are
also intended for use
in surgical procedures
to provide surgical
access by dilating the
soft tissue to the
intended surgical site
to allow passage of
current from a point | The Pioneer Nerve
Monitoring Cable,
in conjunction with
Pioneer pedicle
probes, taps, awls
or screw drivers, is
intended to
stimulate
peripheral motor
nerves during
surgery for the
purpose of locating
and identifying
these nerves,
including spinal
nerve roots during
the incision and
removal of soft and
hard tissue or bone. | The Biomet
probes/
guidewires and
dilators are
intended for
tissue dilation
and stimulation
of peripheral
nerves including
spinal nerve
roots for
location and
identification
during spinal
surgery. | The ES2® Awl,
ES2® Taps, and
ES2® Screwdriver
can be used 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
posterior surgical
approaches of the
non-cervical spine. | Yes – There are
no new or
different
intended uses as
compared to the
predicates. The
subject and
predicate
instruments are
employed in the
same manner
when used for
tissue dilation
and as tools to
assist the
surgeon in
locating spinal
nerves before,
during, or after
surgery for
open and |
6
| | on the proximal end
to an uninsulated
portion of the distal
tip. The purpose of
this is to allow
controlled monitoring
of neural elements
near and around the
point of access. The
dilators are offered
sterile/single use. | | | | percutaneous
surgical
approaches. |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Sterilization | Instruments
provided as single-
use sterile packed
devices. | Neuromonitoring
Clip provided as
single-use sterile
packed devices.
Accessory
instruments provided
as reusable non-
sterile devices with
validated sterilization
parameters to assure
a SAL of 10-6 | Instruments
provided as
single-use sterile
packed devices. | Instruments provided
as reusable non-
sterile devices with
validated
sterilization
parameters to assure
a SAL of 10-6 | Yes |
| Surgical
Approach | Open or
Percutaneous/
Minimally Invasive | None specified | None specified | Open or
Percutaneous/
Minimally Invasive | Yes |
| Electromagnetic
Compatibility &
Electrical Safety | IEC 60601-1 | IEC 60601-1 | ASTM D149:
2009 | IEC 60601-1
IEC 60601-1-2
IEC 60601-3-2
IEC 60601-3-3 | Yes - Subject
system
compliant with
applicable
sections of IEC
60601-1. |
| Min. exposed sur-
face area during
tissue stimulation | 0.02 in2 | 0.02 in2 | .167 cm2 (.026
in2) | 0.53 mm2 (.0008 in2) | Yes |
| Maximum
Charge Density
( $\mu$ C/cm2) | 0.108 | N/A | 0.097 | 0.306 | Yes |
| Maximum
Current Density
(mA/cm2) | 1.080 | N/A | 0.970 | 3.057 | Yes |
| Maximum Power
Density (500 Ω
load) (mW/cm2) | 0.087 | N/A | 0.079 | 0.248 | Yes |
| Maximum Power
Density (10kΩ
load) (mW/cm2) | 1.750 | N/A | 1.571 | 4.952 | Yes |
| Conclusion: | Based on the information included in this premarket notification, the subject system is substantially equivalent to the predicates. The subject dilators are employed in the same manner, have similar intended uses, principles of operation, technological characteristics, and performance. There are no new issues of safety or efficacy. |
|---|---|
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |