(188 days)
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.
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.
The provided text describes the 510(k) premarket notification for the Pioneer Surgical Technology, Inc. Nerve Monitoring Cable System (K142438). This submission focuses on demonstrating substantial equivalence to predicate devices, particularly for new sterile/single-use dilators.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to predicate devices across various characteristics, including safety, electrical performance, and biocompatibility. The performance data presented in the 510(k) summary serves as the "reported device performance."
| Acceptance Criteria Category | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritant, non-sensitizing, not systemically toxic (per ISO 10993-1) | - 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. | ||
| Electrical Performance | Capable of transferring electrical current with little or no resistance; adequate insulation; electrical parameters within range of predicates. | - Electrical/Resistance Bench Testing: Confirmed capability of transferring electrical current with little or no resistance, similar to predicate devices. Confirmed adequate electrical insulation (in-process Hipot testing). |
| Max Charge Density (µC/cm²) comparable to predicates (e.g., K132373's 0.097, K140400's 0.306) | - Maximum Charge Density (µC/cm²): 0.108 | |
| Max Current Density (mA/cm²) comparable to predicates (e.g., K132373's 0.970, K140400's 3.057) | - Maximum Current Density (mA/cm²): 1.080 | |
| Max Power Density (500 Ω load) (mW/cm²) comparable to predicates (e.g., K132373's 0.079, K140400's 0.248) | - Maximum Power Density (500 Ω load) (mW/cm²): 0.087 | |
| Max Power Density (10kΩ load) (mW/cm²) comparable to predicates (e.g., K132373's 1.571, K140400's 4.952) | - Maximum Power Density (10kΩ load) (mW/cm²): 1.750 | |
| Electrical Safety | Compliance with IEC 60601-1 | - IEC 60601-1 testing: Supplied (implies compliance). Subject system compliant with applicable sections of IEC 60601-1. |
| Mechanical Performance | Adequate to perform intended function (tissue dilation/dissection, nerve stimulation) | - Engineering analysis: Confirmed maximum charge, current, and power densities of subject devices fall within the range of predicate devices. |
| Sterilization, Packaging, Shelf-life | Compliance with relevant standards (ISO 11137-2, ISO 11607, ASTM D4169) | - Validation studies: Sterilization, packaging, and shelf-life validations completed per applicable test standards (ISO 11137-2, ISO 11607, and ASTM D4169, respectively). |
| Functionality (in vivo) | Assess performance, functionality, and safety in a surgical setting; comparable to intended use | - Porcine animal study: Conducted to assess the performance, functionality, and safety of the subject dilators as neuromonitoring accessory instruments. (The specific findings/results beyond "assessed" are not detailed in this summary, but the conclusion is that the data confirmed substantial equivalence and that the devices perform as well as or better than predicates). |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Biocompatibility: Not explicitly stated, but typically involves a defined number of samples per test type (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) as per ISO 10993-1.
- Electrical/Resistance Bench Testing: Not explicitly stated.
- In-process Hipot Testing: Not explicitly stated, but likely represents a portion or all units from a production run.
- Porcine Animal Study: Not explicitly stated, but standard animal study protocols would define the number of animals.
- Sterilization, Packaging, Shelf-life Validations: Not explicitly stated, but these involve statistical sampling as per the relevant ISO and ASTM standards.
- Data Provenance: The document does not specify the country of origin for the testing data. Given it's a U.S. FDA submission, it's highly probable the testing was conducted in the USA or by facilities recognized by the manufacturer as compliant with relevant standards. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes a medical device seeking 510(k) clearance, which is based on demonstrating substantial equivalence to existing legally marketed predicate devices. It is not an AI/ML device that typically requires human expert consensus for "ground truth" to evaluate diagnostic or predictive performance.
- For Biocompatibility: Ground truth is established by standardized laboratory tests and interpretation by qualified toxicologists/biocompatibility specialists against ISO 10993-1 criteria.
- For Electrical Performance: Ground truth is established by physics principles, engineering specifications, and comparison against established predicate device performance specifications.
- For Animal Study (Functionality/Safety): Ground truth is established by observations and measurements taken during the veterinary surgical procedure, interpreted by veterinarians and potentially surgeons specialized in the relevant field.
Therefore, the concept of "number of experts used to establish ground truth" as it applies to AI/ML clinical studies is not directly applicable here. The "experts" would be the scientists, engineers, and medical professionals conducting and interpreting the various technical and animal studies.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, especially those involving human judgment (like image interpretation in AI diagnostics), to resolve disagreements in ground truth determination. Since this 510(k) submission is for a physical device and relies on technical and animal studies, no such adjudication method is mentioned or typically required. The results of the technical studies (biocompatibility, electrical, mechanical) are generally objective measurements against predefined criteria or established scientific methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic or interpretive AI/ML devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) both with and without AI assistance to measure the impact of the AI on their performance. The Nerve Monitoring Cable System is a surgical accessory, not an interpretive diagnostic device, and therefore this type of study is irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. Again, this device is a physical surgical accessory, not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not through algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for evaluating this device primarily comes from:
- Standardized Test Results/Specifications: For biocompatibility (ISO 10993-1), electrical performance (IEC 60601-1, engineering calculations), mechanical durability, sterilization efficacy, packaging integrity, and shelf-life. These are objective measurements against established international and industry standards.
- Animal Study Observations: For in-vivo performance, functionality, and safety, observations from the porcine animal study serve as empirical ground truth.
8. The Sample Size for the Training Set
This device is not an AI/ML device and therefore does not have a "training set." The concept of a training set is specific to machine learning algorithms where data is used to teach the algorithm to perform a task.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
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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
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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
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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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510(k) Summary Pursuant to 21 CFR 807.92
| 510(k) Owner: | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USAPh.: (906) 225-5861Fax: (906) 226-4459Contact: Sarah (McIntyre) PleaughPrepared: 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 stimulator21 CFR 882.1350, GXZ, Needle electrode |
| PredicateDevices: | K073229 Pioneer Surgical Technology, Inc. - Nerve Monitoring Cable SystemK132373 Biomet Spine - Biomet Probes/Guidewires and DilatorsK140400 Stryker Spine - ES2® Neuromonitoring Accessory Instruments |
| DeviceDescription: | The Nerve Monitoring Cable System, which consists of Nerve Monitoring Cablesin conjunction with various stimulation accessories, allow for tissue dilation andstimulation of peripheral nerve roots for location and identification during open andpercutaneous / minimally invasive spinal surgery. The Nerve Monitoring Cableincludes a 1.5 mm female DIN connector for use with a stimulating console with aType BF or CF rating. The other end of the Nerve Monitoring Cable includes a clipfor connection to the stimulation accessories of this system.The stimulation accessories include general manual orthopedic surgical instrumentspreviously 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 thepurpose of dilating tissue in preparation for spinal surgery. Similar to the predicateinstrument accessories, they are made from a conducting metal (Aluminum 6061-T6) with an insulated outer coating (Parylene C) to allow passage of current from apoint on the proximal end where it connects to the Nerve Monitoring Cable to anun-insulated portion of the distal tip. The purpose of this is to allow controlledmonitoring of neural elements near and around the point of access. The subjectdilators 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 ofperipheral nerves including spinal nerve roots for location and identification duringspinal surgery.The dilators are also intended for use in surgical procedures to provide surgicalaccess by dilating the soft tissue to the intended surgical site to allow passage ofcurrent 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 |
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| around the point of access. The dilators are offered sterile/single use. | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TechnologicalCharacteristics: | The subject dilators are substantially equivalent to the predicate devices in terms ofdesign, function, principles of operation, technological characteristics, intended use,and performance.As compared to the Biomet predicate, the subject dilators are similar in that theyare a series of hollow tubes intended for tissue dilation and stimulation of nervesfor neuromonitoring applications. They are made from metal with an insulatedouter coating. Similar to the Biomet and Stryker predicates, the electrical signal issupplied via FDA cleared neuromonitoring systems attached to a clip or probe thatis attached to the neuromonitoring contact zone on the proximal end. The electricalsignal 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 B221with an insulated outer coating (Parylene C). | |||||||||||||||
| Biocompatibility: | Biocompatibility testing was conducted on the subject dilators in accordance withthe testing recommendations in ISO 10993-1 (Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing). The test results are summarized in thetable 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 ofPerformanceData: | This 510(k) premarket notification is seeking clearance of subject dilators asaccessory instruments during neuromonitoring applications. Performance testingand engineering calculations were performed to demonstrate that the subjectdevices are substantially equivalent to the identified predicates in terms of design,performance and intended use.Engineering analysis confirmed the maximum charge, current, and power densitiesof the subject devices fall within the range of predicate devices. IEC 60601-1testing for electrical safety on applicable devices of the subject system wassupplied. A porcine animal study was conducted to assess the performance,functionality, and safety or the subject dilators as neuromonitoring accessoryinstruments. Electrical/resistance bench testing confirmed the subject dilators arecapable of transferring an electrical current with little or no resistance in a similarmanner to predicate devices. This bench testing, along with in-process Hipottesting, also confirmed the coating of each device provides adequate electricalinsulation. Sterilization, packaging, and shelf-life validations were also completedper applicable test standards (ISO 11137-2, ISO 11607, and ASTM D4169respectively). |
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| 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 | SubjectK142438 NerveMonitoring CableSystem | PredicateK073229 NerveMonitoring Cableand ReusableAccessoryInstruments | PredicateK132373Biomet SpineProbes/Guidewires andDilators | Predicate K140400ES2® Neuro-monitoringAccessoryInstruments | SubstantialEquivalence |
|---|---|---|---|---|---|
| NeuromonitoringAccessoriesInstruments | Dilators | General, manualorthopedic reusablesurgicalinstruments (e.g.probes, awls, taps,inserters) | Probes,guidewires anddilators | Awls, Taps andScrewdriver to beused with Dilators orTap Sleeves | Yes |
| Use of Dilators | Dilators | No dilators inK073229 | Dilators | Dilators or TapSleeve | Yes |
| Compatible withCommonNeuromonitoringConsoles &Software | Compatible withFDA clearedneuromonitoringsystems | Compatible withFDA clearedneuromonitoringsystems | Compatible withFDA clearedneuromonitoringsystems | Compatible withFDA clearedneuromonitoringsystems | Yes |
| Connection toNeuromonitoringUnit | Clip | Clip | Clip or Probe | Clip or Probe (basedon NeuromonitoringSystem used) | Yes |
| Materials | ASTM B221 6061Aluminum (UNSA96061) withParylene C Coating | -ASTM F899 17-4SST with Halar®6014 Coating-Detachablesilicone handles orRADEL® handles | ASTM F899Stainless steelwith polymericdielectriccoating | -Awl, Taps, &Screwdriver:Surgical GradeStainless Steel-Dilators & TapSleeve: RADEL® | Yes |
| Indications forUse | The NerveMonitoring Cable inconjunction withdilators, pedicleprobes, taps, awls orscrew drivers, areintended for tissuedilation/ dissectionand stimulation ofperipheral nervesincluding spinal nerveroots for location andidentification duringspinal surgery.The dilators arealso intended for usein surgical proceduresto provide surgicalaccess by dilating thesoft tissue to theintended surgical siteto allow passage ofcurrent from a point | The Pioneer NerveMonitoring Cable,in conjunction withPioneer pedicleprobes, taps, awlsor screw drivers, isintended tostimulateperipheral motornerves duringsurgery for thepurpose of locatingand identifyingthese nerves,including spinalnerve roots duringthe incision andremoval of soft andhard tissue or bone. | The Biometprobes/guidewires anddilators areintended fortissue dilationand stimulationof peripheralnerves includingspinal nerveroots forlocation andidentificationduring spinalsurgery. | The ES2® Awl,ES2® Taps, andES2® Screwdrivercan be used to assistin location of thespinal nerves byproviding proximityinformation before,during or after bonepreparation andplacement of bonescrews in open andpercutaneousposterior surgicalapproaches of thenon-cervical spine. | Yes – There areno new ordifferentintended uses ascompared to thepredicates. Thesubject andpredicateinstruments areemployed in thesame mannerwhen used fortissue dilationand as tools toassist thesurgeon inlocating spinalnerves before,during, or aftersurgery foropen and |
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| on the proximal endto an uninsulatedportion of the distaltip. The purpose ofthis is to allowcontrolled monitoringof neural elementsnear and around thepoint of access. Thedilators are offeredsterile/single use. | percutaneoussurgicalapproaches. | ||||
|---|---|---|---|---|---|
| Sterilization | Instrumentsprovided as single-use sterile packeddevices. | NeuromonitoringClip provided assingle-use sterilepacked devices.Accessoryinstruments providedas reusable non-sterile devices withvalidated sterilizationparameters to assurea SAL of 10-6 | Instrumentsprovided assingle-use sterilepacked devices. | Instruments providedas reusable non-sterile devices withvalidatedsterilizationparameters to assurea SAL of 10-6 | Yes |
| SurgicalApproach | Open orPercutaneous/Minimally Invasive | None specified | None specified | Open orPercutaneous/Minimally Invasive | Yes |
| ElectromagneticCompatibility &Electrical Safety | IEC 60601-1 | IEC 60601-1 | ASTM D149:2009 | IEC 60601-1IEC 60601-1-2IEC 60601-3-2IEC 60601-3-3 | Yes - Subjectsystemcompliant withapplicablesections of IEC60601-1. |
| Min. exposed sur-face area duringtissue stimulation | 0.02 in2 | 0.02 in2 | .167 cm2 (.026in2) | 0.53 mm2 (.0008 in2) | Yes |
| MaximumCharge Density( $\mu$ C/cm2) | 0.108 | N/A | 0.097 | 0.306 | Yes |
| MaximumCurrent Density(mA/cm2) | 1.080 | N/A | 0.970 | 3.057 | Yes |
| Maximum PowerDensity (500 Ωload) (mW/cm2) | 0.087 | N/A | 0.079 | 0.248 | Yes |
| Maximum PowerDensity (10kΩload) (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. |
|---|---|
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.