(487 days)
The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.
The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument. The stimulation function of the Mapping Suction Probe is used for monopolar stimulation during intraoperative surgical interventions and is connected to electrical stimulators of neuromonitoring devices outside the sterile field via an appropriate integrated connection cable. To ensure a correct monopolar stimulation, a counter electrode is also included in the sterile package which must be placed at the resection marqin. The suction function of the Mapping Suction Probe is used for aspiration during tumor resection and is connected to suction devices via a tube, which is not part of the delivered package.
The provided text is an FDA 510(k) summary for a medical device called the "Mapping Suction Probe." It contains information about the device's indications for use, comparison to a predicate device, and performance data related to biocompatibility and bench testing.
However, the request asks for specific details about acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).
The provided document does NOT contain any information about AI, software, or clinical studies that would align with the detailed acceptance criteria and study design requested (e.g., MRMC studies, expert ground truth, training/test set sample sizes for AI models).
The document explicitly states:
- "The Mapping Suction Probe does not contain any kind of software, Software: and therefore, this section does not apply to it." (Page 8)
- "Clinical testing was not performed for the Mapping Suction Probe." (Page 9)
Therefore, based on the provided text, it's impossible to answer the majority of the questions related to AI/SaMD acceptance criteria and performance studies. The information available pertains to the physical device's safety and performance characteristics (biocompatibility, electrical safety, mechanical tests, etc.) compared to a predicate device, which is typical for a 510(k) submission for a non-software, non-AI hardware device.
Given the limitations of the provided text, I must state that the requested information (related to AI/SaMD acceptance criteria and studies) is not present in the document.
I will indicate which sections cannot be answered based on the input.
Acceptance Criteria and Device Performance (Based on available data, primarily biocompatibility and bench testing for a hardware device)
Since this is a physical device without AI/software components, the "acceptance criteria" are related to its physical and functional safety and equivalence to the predicate, rather than AI performance metrics.
Table of Acceptance Criteria and Reported Device Performance:
| Category | Acceptance Criteria (based on standards/tests) | Reported Device Performance |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity: No reduction of cell proliferation/viability. | Cytotoxicity (Device): No reduction of cell proliferation/viability observed; dehydrogenase activity 101% at 100% extract conc.; no inhibition/lysis microscopically. Conclusion: Non-cytotoxic. |
| | Sensitization: 0% sensitization rate. | Sensitization (Device): 0% sensitization rate after application. Conclusion: No sensitizing properties. |
| | Irritation / Intracutaneous Reactivity: Primary irritation index of 0. | Irritation / Intracutaneous Reactivity (Device): Primary irritation index of 0 for polar and non-polar extracts. Conclusion: Not irritant. |
| | Acute Systemic Toxicity: No compound-related mortalities or signs of toxicity. | Acute Systemic Toxicity (Device): No compound-related mortalities or signs of toxicity within 72 hours post-dose. Conclusion: No acute systemic toxic characteristics. |
| | Material Mediated Pyrogenicity: Temperature increase for each rabbit not > 0.50°C. | Material Mediated Pyrogenicity (Device): Temperature increase for each rabbit not > 0.50°C. Conclusion: Materials considered non-pyrogenic. |
| | Hemolysis: Haemolytic indices < 2%. | Hemolysis (Device): Haemolytic indices: direct (0.11%) and indirect (0.08%) contact, both < 2%. Conclusion: Non-haemolytic. |
| | Bacterial Endotoxins: < 2.15 EU/device (for device); < 20.0 EU/device (for needle electrode). | Bacterial Endotoxins (Device): < 1.55 EU/test item. Conclusion: Non-pyrogenic. Bacterial Endotoxins (Needle Electrode): 0.6300, 0.7800, 0.6600 EU/test item. Conclusion: Non-pyrogenic. |
| Bench/Performance Testing | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40 and internal requirements for: Electrical Conductivity, Dielectric Strength, Impedance Measurement, Stimulation Current Test, Dimension of Components, Reached Vacuum in Air, Volumetric Flow Rate, Deformation Test, Leakage Test, Pull-out Force Test, Distractive Force Test, Mechanical Stability Test, Bending Stress Test, Insulation Test, Shelf-Life Tests. | Tests were performed on the subject device and/or its component according to the listed standards and internal requirements. Conclusion: "The testing and assessments performed demonstrate that the subject device performs comparable to the predicate device that is currently marketed for the same intended use." (Specific quantitative results for each bench test are not provided in the summary, only that they were performed and concluded comparability/compliance). |
Since the device is a physical instrument and not an AI/Software as a Medical Device (SaMD), the following points cannot be answered from the provided text:
- 2. Sample sized used for the test set and the data provenance: Not applicable. No AI test set.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for AI model.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication for AI.
- 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: Not applicable. No AI, no human reader study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth beyond physical tests and predicate device comparison.
- 8. The sample size for the training set: Not applicable. No AI training set.
- 9. How the ground truth for the training set was established: Not applicable. No AI training set.
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November 11, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
inomed Medizintechnik GmbH Shuofei Cheng Regulatory Affairs Manager Im Hausgruen 29 Emmendingen. Baden-Wuerttemberg 79312 Germany
Re: K212164
Trade/Device Name: Mapping Suction Probe Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: September 29, 2022 Received: October 3, 2022
Dear Ms. Cheng:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212164
Device Name
Mapping Suction Probe 3/90 monopolar (Art. No. 525650), Mapping Suction Probe 3/130 monopolar (Art. No. 525651), Mapping Suction Probe 2/90 monopolar (Art. No. 525655), Mapping Suction Probe 2/130 monopolar (Art. No. 525656)
Indications for Use (Describe)
The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| SubmissionDate: | 08 July 2021 | ||
|---|---|---|---|
| 510(k) Holder: | inomed Medizintechnik GmbHIm Hausgrün 2979312 Emmendingen, Germany | ||
| Contact Person: | Shuofei Cheng Ph.D.Phone: +49 7641 9414 849Email: S.Cheng@inomed.com | ||
| ManufacturingSite: | inomed Medizintechnik GmbHIm Hausgrün 2979312 Emmendingen, Germany | ||
| Name of Device: | Mapping Suction Probe | ||
| Common andClassificationName: | Suction Stimulator Probe | ||
| ClassificationName: | Surgical nerve stimulator/locator (21 CFR 874.1820) | ||
| RegulatoryClass: | II | ||
| Product Code: | ETN | ||
| RegulationMedicalSpecialty: | Surgical nerve stimulator/locator | ||
| Predicate510(k)Number | Predicate Manufacturer/ Model | ||
| Predicate Device: | K110712 | Neurovision™ MedicalProducts, Inc.™./ DryTouchSuction Stimulator Probe | |
| DeviceDescription: | The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument |
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| The stimulation function of the Mapping Suction Probe is used for | |||
|---|---|---|---|
| monopolar stimulation during intraoperative surgical interventions and | |||
| is connected to electrical stimulators of neuromonitoring devices outside | |||
| the sterile field via an appropriate integrated connection cable. To | |||
| ensure a correct monopolar stimulation, a counter electrode is also | |||
| included in the sterile package which must be placed at the resection | |||
| marqin. |
The suction function of the Mapping Suction Probe is used for aspiration during tumor resection and is connected to suction devices via a tube, which is not part of the delivered package.
The Mapping Suction Probe is a surgical instrument that allows the Indications for surgeon to remove secretions and test surgical tissue with nerve Use: stimulation simultaneously and with the same instrument.
The instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.
Comparison of Technological Characteristics with the Predicate Device:
| Characteristic | Subject device | Predicate device |
|---|---|---|
| System | Mapping Suction Probe | DryTouch Suction Stimulator Probe |
| Manufacturer | inomed Medizintechnik GmbH | Neurovision Medical Produtcts, Inc. |
| 510(k)Number | K212164 | K110712 |
| Picture | Image: Mapping Suction Probe | Image: DryTouch Suction Stimulator Probe |
| Indicationsfor use | The Mapping Suction Probe is a surgicalinstrument that allows the surgeon toremove secretions and test surgical tissuewith nerve stimulation simultaneously andwith the same instrument.The instrument is intended for use only by alicensed physician and in conjunction withcompatible nerve locator monitor systems." | The Suction Stimulator Probe is a dedicatedmanual surgical instrument that allows thesurgeon to clear secretions and test surgicaltissue with nerve stimulation at the sametime and with the same instrument.It is intended for use only by a licensedphysician and in conjunction with theNeurovision SE (Nerve; na) Nerve locatorMonitor System. |
| Contraindications | The use of muscle relaxants iscontraindicated, as these cause significant | The use of paralytic anaesthetics will causeabnormal EMG performance. Advise the |
| reductions in the evoked muscle potentials. | anaesthesia provider of thiscontraindication. | |
| User group | Surgeon and Neurophysiologist | Licensed physician |
| Riskmanagement | Risk Management according to standard:ISO 14971: 2019 | Risk Management according to standard:ISO 14971: 2007 |
| • The device is a disposable surgicalinstrument | • The device is a disposable surgicalinstrument | |
| • The product combines a surgicalsuction instrument and amonopolar stimulation probesimultaneously | • The product combines a surgicalsuction instrument and amonopolar stimulation probesimultaneously | |
| • Monopolar stimulation on the non-insulated tip of the suction probecomponent to localize and identifynervous structures and to preventtheir damage during surgery. | • Monopolar stimulation on the non-insulated tip of the suction probecomponent to localize and identifynervous structures and to preventtheir damage during surgery. | |
| OperatingPrinciple | • To ensure a specific stimulation atthe point of interest, the residualmetal part of the probe's shaft isinsulated. | • To ensure a specific stimulation atthe point of interest the residualmetal part of the probe's shaft isinsulated. |
| • The connector on the end of thesuction probe component is formechanical connection to suctiondevices via suction tubes. | • The connector on the end of thesuction probe component is formechanical connection to suctiondevices via suction tubes. | |
| • Depending on the case, thesuction function is used foraspiration during tumor resectionor to clear the surgical field fromfluids for better visualization. | • Depending on the case the suctionfunction is used for aspirationduring tumor resection or to clearthe surgical field from fluids forbetter visualization. | |
| Materials | The instrument consists of a stainless-steel shaft, partially insulated withbiocompatible PTFE and ending with anoblong hole suction. | The instrument consists of a stainless-steel shaft, partially insulated withbiocompatible PTFE and ending with aball- tip suction. |
| Tissuecontact | The medical device comes in direct tissuecontact. | The medical device comes in direct tissuecontact. |
| Shelf life | 3 years | 1 year |
| Sterilization | • EO validation is compliant withISO 11135:2014 + A1:2018• residuals analysis is compliant withISO 10993-7:2008• The Sterility Assurance Level is10-6• Device is not labeled non-pyrogenic. | • EO validation is compliant withISO 11135-1:2007• EO residuals analysis is compliantwith ISO 10993-7:2008• The Sterility Assurance Level is 10-6• Device is not labeled non-pyrogenic. |
| Product length | • 9 cm• 13 cm | • 13 cm |
| Innerdiameter(Lumen) | 9fg 6fg | 6fg |
| Insulated tiplength | 2mm | 2mm |
| Accessories | 1 Subdermal Needle Electrode(black lead wire) 3.0m wire, 20 mmNeedle-0.45mm gauge Connection Cable (red) 3.0m cablelength | 2 Neurovision™ Subdermal NeedleElectrodes (white and green leadwire) 2.5m wire, 12 mm Needle-0.4mm gauge, 27G 2 Alcohol Wipes |
| Site ofapplication | No specific site | No specific site |
| Duration ofuse | < 30 days | < 30 days |
| Single use orreusable | Single use | Single use |
| Provided sterile | Yes | Yes |
| Connectorstandard | DIN 42802 | DIN 42802 |
| Connector | Touch Proof | Touch Proof |
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inomed fi
K212164
510(k) Summary Mapping Suction Probe
FM 3-1
Page 3 of 7
Stand 1.1 vom 2017-11-02
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Performance Data:
Biocompatibility:
The Mapping Suction Probe and Needle Electrode component were tested according to the following standards:
- -ISO 10993-1:2018
- ISO 10993-5:2009 -
- ISO 10993-7:2008 .
- -ISO 10993-17:2002
- ISO 10993-18:2005 -
| Test | Test Performed | Results and Conclusion |
|---|---|---|
| Cytotoxicity | Cell GrowthAnalysis via XTT-Staining | The results showed no reduction of cell proliferationand/or cell viability. With the highest extractconcentration (100 %) the dehydrogenase activity was101 %.Microscopically, no inhibition of cell growth and no celllysis were observed at all extract concentrationsused. |
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| Conclusion: The item under test is considered non-cytotoxic. | ||
|---|---|---|
| Sensitization | Guinea PigMaximization Testwith polar and non-polar extract | The sensitization rate after application of the test itemextract was 0%.Conclusion: The item under test is considered to haveno sensitizing properties. |
| Irritation /IntracutaneousReactivity | Irritation Test(IntracutaneousReactivity) in theRabbit with polarand non-polarextract | The primary irritation index of the polar and the nonpolartest item extracts compared to the controls were 0.Conclusion: The item under test is classified as notirritant. |
| AcuteSystemicToxicity | Acute SystemicToxicity in theMouse with polarand non-polarextract | No compound-related mortalities and no other signs oftoxicity were recorded within 72 hours post-dose for anyof the animals.Conclusion: The item under test showed no acutesystemic toxic characteristics. |
| MaterialMediatedPyrogenicity | Rabbit PyrogenTest according toUSP | Temperature increase for each rabbit was not > 0.50°C.Conclusion: The materials of the item under test areconsidered non pyrogenic. |
| Hemolysis | Direct and indirectcontact test understatic conditionsaccording to ASTMF 756-17 | The data show that the haemolytic indices of the bloodsubstrate supernatants with direct (0.11%) and indirect(0.08%) contact to the test item were below 2% andtherefore the material is classified as non-haemolytic.Conclusion: The item under test does not inducehaemolysis. |
| BacterialEndotoxins | Limulus-Amoebocyte-Lysate(LAL) Test - KineticTurbidimetric Assay(KTA) | The endotoxin content of each test items was < 1.55EU/test item.Conclusion: The test items are non-pyrogenic underconsideration of the acceptance criterion (< 2.15EU/device) |
The tests are conducted on the Device: '525651 Mapping Suction Probe 3/130, monopolar'.
The following tests were performed for the Needle Electrode component.
| Test | Test Performed | Results and Conclusion |
|---|---|---|
| Cytotoxicity | Cell GrowthAnalysis via XTT-Staining | The results showed no relevant reduction (- relevantmeaning > 30 % reduction -) of cell proliferationand/or cell viability. With the highest extractconcentration (100 %) the dehydrogenase activity wasreduced to 89 %.Microscopically, slightly reduced cell growth wasobservable from 66.7 % extract concentrationonwards. Slight cell lysis was observable only in theundiluted extract.Conclusion: The item under test is considered non-cytotoxic. |
| Sensitization | Guinea PigMaximization Testwith polar and non-polar extract | The sensitization rate after application of the test itemextract was 0%.Conclusion: The item under test is considered to haveno sensitizing properties. |
| Irritation /IntracutaneousReactivity | Irritation Test(IntracutaneousReactivity) in theRabbit with polarand non-polarextract | The primary irritation index of the polar and the nonpolartest item extracts compared to the controls were 0.Conclusion: The item under test is classified as notirritant. |
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| AcuteSystemicToxicity | Acute SystemicToxicity in theMouse with polarand non-polarextract | No compound-related mortalities and no other signs oftoxicity were recorded within 72 hours post-dose for anyof the animals.Conclusion: The item under test showed no acutesystemic toxic characteristics. |
|---|---|---|
| MaterialMediatedPyrogenicity | Rabbit PyrogenTest according toUSP | Temperature increase for each rabbit was not > 0.50°C.Conclusion: The materials of the item under test areconsidered non pyrogenic. |
| BacterialEndotoxins | Limulus-Amoebocyte-Lysate(LAL) Test — KineticTurbidimetric Assay(KTA) | The endotoxin content of the test items was 0.6300,0.7800 and 0.6600 EU/test item.Conclusion: The test items are non-pyrogenic underconsideration of the acceptance criterion (< 20.0EU/device) |
Test results indicate that the Mapping Suction Probe and the Needle Electrode component comply with the applicable standards and demonstrated the safety of subject device.
The Mapping Suction Probe does not contain any kind of software, Software: and therefore, this section does not apply to it.
The Mapping Suction Probe is a device which is not electrically-Electrical Safety: powered, and therefore, this section does not apply to it.
Electromagnetic The Mapping Suction Probe is a device which is not electrically-Compatibility: powered, and therefore, this section does not apply to it.
The Mapping Suction Probe was tested for performance in Performance Testing - Bench accordance with internal requirements and the following standards:
- IEC 60601-1:2005/AMD1:2012 -
- IEC 60601-1-2:2014 -
- IEC 60601-2-40:2016 -
- . Electrical Tests: Electrical Conductivity, Dielectric Strength Functional Tests: Impedance Measurement, Stimulation Current Test Dimension Test: Dimension of Components
- Suction Performance Tests: Reached Vacuum in Air, . Volumetric Flow Rate
- . Mechanical Suction Tests: Deformation Test, Leakage Test
- Mechanical Tests: Pull-out Force Test, Distractive Force Test, . Mechanical Stability Test, Bending Stress Test
- Insulation Test Shelf-Life Tests
The tests were conducted on the subject device Mapping Suction Probe and/or its component.
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Performance Clinical testing was not performed for the Mapping Suction Probe. Testing – Clinical
- Conclusions The testing and assessments performed demonstrate that the subject device performs comparable to the predicate device that is currently marketed for the same intended use.
§ 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.