(204 days)
Not Found
No
The document describes a nerve monitoring cable and associated surgical instruments for electrical stimulation and monitoring, with no mention of AI or ML technologies.
No
The device is described as an intra-operative motor nerve stimulator used for locating and identifying nerves, not for treating a disease or condition.
Yes
The device is intended to "locate and identify" nerves, which is a form of diagnosis during surgery.
No
The device description explicitly states it is a "Pioneer Nerve Monitoring Cable" and describes its physical construction and connectors, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states the device is used during surgery to stimulate peripheral motor nerves and spinal nerve roots for the purpose of locating and identifying them. This is an in vivo (within the living body) procedure.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples taken from the patient. The device directly interacts with the patient's nerves.
Therefore, the Pioneer Nerve Monitoring Cable is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GXZ, ETN
Device Description
This device is intended for use as an intra-operative motor nerve stimulator with common EMG monitors. Construction of the device allows nerve stimulation with general manual orthopedic surgical instruments, e.g. taps, awls, probes, etc. The terminal end of the cable is a 1.5 mm female DIN connector for use with a stimulating console with a Type BF or CF rating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral motor nerves, spinal nerve roots
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intra-operative, during surgery
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063729, K063305, K013215, K002677, K062996, K050194
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
510(k) Summary
。
- .
| Sponsor: | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855 | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Contact Name: | Jonathan M. Gilbert
(906) 226-4812 | |
| Device Name: | Nerve Monitoring Cable System | |
| Classification: | Panel:
Regulation Number:
Regulation Name:
Classification Product Code: | Neurology
882.1350
Needle electrode
GXZ |
| Predicate Device: | K063729 - Disposable Pedicle Screw Probe, Technomed Europe
K063305 - Stimulating Bur Guard, Medtronic Xomed
K013215 & K002677 - Intraoperative Nerve Surveillance, Nuvasive
K062996 & K050194 - Disp. Monopolar and Bipolar Stimulator Probes &
Subdermal Needle Electrodes, -, Axon Systems, Inc | |
| Device Description: | This device is intended for use as an intra-operative motor nerve
stimulator with common EMG monitors. Construction of the device
allows nerve stimulation with general manual orthopedic surgical
instruments, e.g. taps, awls, probes, etc. The terminal end of the cable is
a 1.5 mm female DIN connector for use with a stimulating console with a
Type BF or CF rating. | |
| Intended Use: | 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. | |
| Material: | Materials used to manufacture the instruments of this system are in
conformance with ASTM Standard Specifications. | |
| Basis of Substantial
Equivalence: | Comparisons of device performance data, materials, indications and
design/function to predicate devices were provided in making a
determination of substantial equivalence. | |
Pioneer Surgical Technology, Inc.
K073229
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2008
Pioneer Surgical Technology % Mr. Jonathan Gilbert Vice President, Regulatory and Clinical Affairs 375 River Park Circle Marquette. Michigan 49855-0627
K073229 Re:
Trade/Device Name: Nerve Monitoring Cable Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ, ETN Dated: May 27, 2008 Received: May 28, 2008
Dear Mr. Gilbert:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K073229 510(k) Number (if known):
Device Name: Nerve Monitoring Cable
Indications for Use: 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,
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neilkeoghan for mxm
Division of General, Restorative, and Neurological Devices
510(k) Number K073229
Pioneer Surgical Technology, Inc. K073229