(204 days)
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.
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.
The provided 510(k) summary for the Pioneer Nerve Monitoring Cable describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics in the way that would typically be presented for an AI/ML medical device.
The basis for substantial equivalence is primarily focused on comparisons of device performance data, materials, indications, and design/function to predicate devices. This suggests that the "study" demonstrating the device meets acceptance criteria is a comparison to already approved devices, rather than a novel clinical trial or performance evaluation with quantifiable metrics.
Therefore, many of the requested fields cannot be directly extracted from the provided text for this specific device. I will fill in what can be inferred or directly stated, and clearly mark where the information is not available in the document.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety | Implied to be equivalent to predicate devices through material conformance (ASTM Standard Specifications) and regulatory comparison. No specific safety endpoints or thresholds are provided. |
| Effectiveness/Functionality | Intended to stimulate peripheral motor nerves for locating and identifying them during surgery. Performance is deemed substantially equivalent to predicate devices (K063729, K063305, K013215, K002677, K062996, K050194). No specific quantitative performance metrics (e.g., stimulation threshold, signal fidelity) are provided. |
| Material Biocompatibility | Materials used are in conformance with ASTM Standard Specifications, implying biocompatibility. No specific acceptance criteria or test results are disclosed. |
| Electrical Safety | 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. Implies compliance with electrical safety standards, but no specific criteria or test results are provided. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device test set. The submission relies on comparison to predicate devices, which would have had their own historical performance data (provenance not specified in this document). No specific "test set" in the sense of a data set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a device like this would be established through direct physical testing and compliance with engineering standards, not expert annotation of a data set. No 'test set' requiring expert ground truth is described.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a nerve monitoring cable, not an AI/ML diagnostic tool typically evaluated with MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: For a physical device like this, ground truth would be established through engineering testing, e.g., electrical impedance measurements, current delivery, signal integrity, material properties, and functionality testing. The document states "comparisons of device performance data... to predicate devices" which implies such testing would have been done to demonstrate equivalence, but the specifics are not detailed.
- The sample size for the training set: Not applicable. The device is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable. See above.
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510(k) Summary
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| Sponsor: | Pioneer Surgical Technology375 River Park CircleMarquette, 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: | Neurology882.1350Needle electrodeGXZ |
| Predicate Device: | K063729 - Disposable Pedicle Screw Probe, Technomed EuropeK063305 - Stimulating Bur Guard, Medtronic XomedK013215 & K002677 - Intraoperative Nerve Surveillance, NuvasiveK062996 & 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 nervestimulator with common EMG monitors. Construction of the deviceallows nerve stimulation with general manual orthopedic surgicalinstruments, e.g. taps, awls, probes, etc. The terminal end of the cable isa 1.5 mm female DIN connector for use with a stimulating console with aType BF or CF rating. | |
| Intended Use: | The Pioneer Nerve Monitoring Cable, in conjunction with Pioneer pedicleprobes, taps, awls or screw drivers, is intended to stimulate peripheral motornerves during surgery for the purpose of locating and identifying these nerves,including spinal nerve roots during the incision and removal of soft and hardtissue or bone. | |
| Material: | Materials used to manufacture the instruments of this system are inconformance with ASTM Standard Specifications. | |
| Basis of SubstantialEquivalence: | Comparisons of device performance data, materials, indications anddesign/function to predicate devices were provided in making adetermination of substantial equivalence. |
Pioneer Surgical Technology, Inc.
K073229
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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.
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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
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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
§ 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).