(222 days)
StimSite is a non-sterile device intended to provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability.
StimSite is a non-sterile, non-patient contacting device that generates an electrical signal that elicits visible contractions of smooth muscle tissue. StimSite is a software-controlled signal box that is placed outside of the surgical field, and connects to standard, FDA cleared surgical instruments (sterile disposable, and reprocessed) that are designed to carry bipolar electrical signals through them such as laparoscopic Kleppingers, Maryland graspers and atraumatic graspers among others. StimSite is designed to provide the surgeon with the ability to generate a visible physiologic smooth muscle contraction response intraoperatively to identify and verify the ureter via characteristic muscle tissue movement. This device is intended for use as an adjunct to the standard of care visual assessment currently performed by surgeons to manually stimulate muscle tissue to identify ureters during surgical procedures.
StimSite is non-sterile, a piece of durable medical equipment that resides in the operating room. It is comprised of a Signal Box, a connected Footswitch with cable, and an Interconnect Cable. StimSite also utilizes a disposable Activation Card which tracks and manages device use, allowing a select number of procedures before it is exhausted and needs to be replaced. All materials of construction are common to use and comply with industry standards for use as durable medical equipment. Using the provided Interconnect Cable, surgeons have the option to connect to a currently marketed electrosurgical unit (ESU) or generator such as the Medtronic FT10, Conmed 2450, and the Megadyne Mega Power. StimSite is controlled by user selection buttons on the face of the device and a Footswitch is used to trigger a stimulation signal by the user. Through the selection buttons, StimSite can be placed in one of two modes: STIM (for stimulation) or ESU (for passthrough from the generator).
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly presented in a table format within the provided document. However, based on the non-clinical and clinical testing summaries, we can infer the performance aspects that were evaluated. The document focuses more on safety and functionality rather than specific quantitative performance metrics for identifying ureters.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Electrical Safety and Essential Performance (IEC 60601-1, -2-2, -2-10) | StimSite complies with IEC 60601-1 (General Requirements), IEC 60601-2-2 (Particular Requirements for high-frequency surgical equipment), and IEC 60601-2-10 (Particular Requirements for nerve and muscle stimulators). |
| Electromagnetic Compatibility (IEC 60601-1-2) | StimSite complies with IEC 60601-1-2 (Electromagnetic Disturbances). |
| Software Verification and Validation | Software verification and validation testing were conducted; documentation provided as recommended by FDA guidance. Software considered "moderate" level of concern. |
| ESU Compatibility | (Tested, passed implicitly as no issues reported) |
| Temperature Rise after StimSite Activation | (Tested, passed implicitly as no issues reported regarding thermal injury) |
| User Acceptance and Efficacy in Ureter Identification (Animal Study) | Users (2 Ob/Gyn surgeons, 1 General and Trauma Surgeon) were able to identify ureters in all cases with StimSite during simulated exploratory surgery. No use errors noted. Users concluded the device meets user needs. |
| Absence of Tissue Injury (Animal Study) | No evidence of thermal injury or trauma to any specimen after StimSite stimulation. |
| Usability and Human Factors (ISO 62366-1) | Initial testing with 5 users: No issues noted. Subsequent testing with 19 surgeons (14 general, 5 Ob/Gyn): All surgeons successfully performed procedures. Two minor errors (instrument tips touching) with no potential harm; users self-corrected. Feedback led to increased error tone duration. |
| Clinical Safety, Specificity, and Efficacy in Eliciting Ureter Contraction (Clinical Pilot) | Determined to be safe, specific for, and efficacious in eliciting a visible ureter muscular contraction during surgery. Signal delivered appropriately across different procedures/instruments when 3rd party instrument assembled correctly. Surgeon feedback confirmed clinical utility. |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Study: The animal study used a female Yorkshire pig model. The specific number of pigs is not explicitly stated, but it mentions "a laparotomy was then performed on the other side of the animal," implying at least one animal, possibly more, to allow for the comparison of stimulated vs. non-stimulated tissue.
- Human Factors Testing:
- Initial testing: 5 intended users.
- Subsequent testing: 19 surgeons (14 general and 5 Ob/Gyn surgeons).
- Clinical Testing (Pilot): 11 total procedures were performed. The procedures were gynecological (robotic, handheld laparoscopic, and open abdominal).
- Data Provenance:
- Animal Study: Retrospective (implicitly, as the study was completed and reported). The "Yorkshire pig model" suggests a controlled laboratory setting, likely within the US, but the country of origin is not explicitly stated.
- Human Factors Testing: Retrospective. Conducted on animal models (porcine).
- Clinical Testing: Retrospective (pilot data collected between September 2018 and December 2019). The location of these clinical procedures is not specified but is implicitly within the context of a US submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Animal Study (User Acceptance/Efficacy): 3 representative device users (2 Ob/Gyn surgeons and 1 General and Trauma Surgeon) conducted the simulated surgery. Their experience level is not specified beyond their specialty. The effectiveness was based on their ability to identify ureters and their feedback.
- Animal Study (Tissue Injury): Pathology was used. The report states "a StimSite stimulation was delivered to tissue...and in another the grasper was used to grasp tissue but no stimulation was provided. There was no evidence of thermal injury or trauma to any specimen." This implies a pathologist reviewed the tissue specimens, but the number and qualifications of the pathologist(s) are not mentioned.
- Human Factors Testing: Involves observation of surgeons (19 of them) performing tasks. The "ground truth" here is compliance with the task and identification of use errors, which was collected via direct observation by the study staff. The "experts" in this context are the surgeons themselves, evaluating the usability.
- Clinical Testing (Pilot): The clinical procedures were carried out by 2 Ob/Gyn surgeons (one performed 10 procedures, the other 1). The ground truth for safety, specificity, and efficacy in eliciting contraction was based on "surgeon feedback through the questionnaire" and implicitly derived from the surgeons' observations during the procedures. Their qualifications are "Ob/Gyns" but years of experience are not noted.
4. Adjudication Method for the Test Set
- Animal Study: No explicit adjudication method is described beyond the surgeons' consensus on identification and the pathological assessment for injury.
- Human Factors Testing: Adjudication was through direct observation by study staff and self-correction by users. No formal consensus or 2+1/3+1 method is mentioned for specific task outcomes.
- Clinical Testing (Pilot): The pilot study's findings are based on the operating surgeons' observations and questionnaire feedback. No external adjudication or multi-reader review is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The StimSite device is a surgical tool that aids in direct identification of smooth muscle contraction, not an AI-assisted diagnostic imaging tool interpreted by readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The StimSite is a hardware device that provides electrical stimulation with a software-controlled signal box. Its function is to elicit a physical response (muscle contraction) that a human surgeon observes and interprets. It is inherently a human-in-the-loop device.
7. The Type of Ground Truth Used
- Animal Study: User (surgeon) observation of ureter identification and pathological assessment of tissue for injury.
- Human Factors Testing: Direct observation of task performance by study staff and user feedback.
- Clinical Testing (Pilot): Surgeon observation of visible ureter muscular contraction and subjective surgeon feedback via questionnaires.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or AI. The StimSite is an electrical stimulation device, not an AI-driven vision system that requires a training set for model development. The software mentioned is for controlling the signal box and processing data, not for making diagnostic or identification decisions based on image data. Therefore, a "training set" in the common AI sense is not applicable here.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or an AI algorithm that requires one, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 10, 2020
Allotrope Medical Inc % Allison Komiyama, Ph.D., R.A.C. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92110
Re: K200886 Trade/Device Name: StimSite Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: March 31, 2020 Received: April 2, 2020
Dear Allison Komiyama, Ph.D., R.A.C.:
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
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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 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 (OS) 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 mediation-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,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K200886
Device Name StimSite
Indications for Use (Describe)
StimSite is a non-sterile device intended to provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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 K200886
DATE PREPARED
November 9, 2020
MANUFACTURER AND 510(k) OWNER
Allotrope Medical Inc. 2450 Holcombe Blvd., Suite X, Houston, TX 77021, USA Telephone: Official Contact: Albert Huang, CEO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Pierre Bounaud, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: akomiyama@acknowledge-rs.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | StimSite |
|---|---|
| Common Name: | Surgical Nerve Stimulator/Locator |
| Regulation Number: | 21 CFR 874.1820 |
| Class: | II |
| Product Code: | ETN |
| Review Panel: | Ear, Nose and Throat |
PREDICATE DEVICE IDENTIFICATION
The StimSite is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K993436 | UroMed CaverMap Surgical Aid / UroMed Corp. | ✓ |
| K092292 | Checkpoint / NDI Medical LLC |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
StimSite is a non-sterile, non-patient contacting device that generates an electrical signal that elicits visible contractions of smooth muscle tissue. StimSite is a software-controlled signal box that is placed outside of the surgical field, and connects to standard, FDA cleared surgical instruments (sterile disposable, and reprocessed) that are designed to carry bipolar electrical signals through them such as laparoscopic Kleppingers, Maryland graspers and atraumatic graspers among others. StimSite is designed to provide the surgeon with the ability to generate a visible physiologic smooth muscle contraction response intraoperatively to identify and verify the ureter via characteristic muscle tissue movement. This device is intended for use as an adjunct to the standard of care visual assessment currently performed by surgeons to manually stimulate muscle tissue to identify ureters during surgical procedures.
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StimSite is non-sterile, a piece of durable medical equipment that resides in the operating room. It is comprised of a Signal Box, a connected Footswitch with cable, and an Interconnect Cable. StimSite also utilizes a disposable Activation Card which tracks and manages device use, allowing a select number of procedures before it is exhausted and needs to be replaced. All materials of construction are common to use and comply with industry standards for use as durable medical equipment. Using the provided Interconnect Cable, surgeons have the option to connect to a currently marketed electrosurgical unit (ESU) or generator such as the Medtronic FT10, Conmed 2450, and the Megadyne Mega Power. StimSite is controlled by user selection buttons on the face of the device and a Footswitch is used to trigger a stimulation signal by the user. Through the selection buttons, StimSite can be placed in one of two modes: STIM (for stimulation) or ESU (for passthrough from the generator).
INDICATIONS FOR USE
StimSite is a non-sterile device intended to provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability.
COMPARISON TO PREDICATES
The subject device StimSite does not have the same indication for use as the predicates; however, the differences do not raise different safety or effectiveness questions. The subject and predicate devices have intended use to provide electrical stimulation to identify target tissues and test their excitability during surgery with delivery of signal into tissues done through a hand-held instrument.
| CHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE |
|---|---|---|---|
| StimSite | UroMed CaverMapSurgical Aid | Checkpoint 9041 | |
| 510(k) Number | K200886 | K993436 | K092292 |
| Product Code /RegulatoryClassification | ETN/Class II | ETN/Class II | ETN/Class II |
| Surgical NerveStimulator/Locator21 CFR § 874.1820 | Surgical NerveStimulator/Locator21 CFR § 874.1820 | Surgical NerveStimulator/Locator21 CFR § 874.1820 | |
| Intended Use | Intended to provideelectrical stimulation tomuscle tissue to locateand identify smoothmuscle and test itsexcitability. | Intended to provideelectrical stimulationto the body to locateand identify nervesand to test theirexcitability. | Intended to provideelectrical stimulation ofexposed motor nerves ormuscle tissue to locate andidentify nerves and to testnerve and muscleexcitability. |
| CHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE |
| StimSite | UroMed CaverMap | Checkpoint 9041 | |
| Surgical Aid | |||
| Technological Characteristics | |||
| IEC 60601 ElectricalSafety StandardsCertification | Yes | Yes | Yes |
| Single-Use v. Re-Use | Re-Usable, Non-Disposable | Re-Usable, Non-Disposable | Single-Use |
| Device Configuration | Non-Disposable signalbox that allows forconnections to hand-held surgicalinstruments that deliverstimulation signal | Non-Disposable signalbox that allows forconnections to hand-held instruments thatdeliver stimulationsignal | Hand-Held |
| Stimulus Tip | Metal bipolar-enabledsurgical instrumentsdesigned to carryelectrical signals totarget tissues* | Metal bipolar-enabledinstrument designedto carry electricalsignals to targettissues | Metal ends designed tocarry electrical signals totarget tissues |
| Monopolar/BipolarStimulation | Bipolar stimulationsignal (electrons flowfrom one tip to theother on the surgicalinstruments) | Bipolar stimulationsignal (electrons flowfrom tip of instrumentthrough the body to aclip applied to anothersurgical instrument) | Monopolar stimulationsignal (electrons flowbetween blunt tip toneedle tip) |
| Battery / AC Power | AC Powered | AC Powered | Battery Powered |
| Regulated Output | Fixed (single setting)output voltage | Fixed (single setting)output voltage, withadjustable current | Fixed (multi-setting) outputcurrent |
| Type of Waveform | Capacitor dischargewaveform | Biphasic | capacitor discharge andsquare (biphasic waveform) |
| Stimulus Voltage andCurrent | 40V peak5.2V rms (maximum at2500 ohm resistance)5.9mA rms (maximum at150 ohm resistance) | 20mA maximum | 30V maximum20mA (maximum)1.13mA rms (cathodicportion of waveform) |
| Stimulus PulseDuration | 250ms maximum pulseduration at 2500 ohmresistance | 800us | 200us maximum pulseduration up to 1500 ohmresistance |
| CHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE |
| StimSite | UroMed CaverMapSurgical Aid | Checkpoint 9041 | |
| Stimulus Frequency | Single impulse deliveryor maximum 1 Hz if footpedal held down | 16Hz | 16Hz |
| Storage | In operating room or insurgical supply room | In operating room orin surgical supplyroom | In operating room or insurgical supply room |
| Compatibility withSurgical Generators | Connects with surgicalgenerators to allowsurgeons to still usetheir bipolarinstruments in thetraditional manner | Does not connect withany other surgicalgenerators | Does not connect with anyother surgical equipment |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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These differences in technological characteristics do not raise different questions of safety and effectiveness.
SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate substantial equivalence:
-
Electrical Safety and EMC -StimSite complies with the following standards:
- . Safety and Essential Performance, per IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirements
- . Safety and Essential Performance, per IEC 60601-2-2, Medical Electrical Equipment, Part 2-2: Particular Requirements of high frequency surgical equipment and accessories
- . Safety and Essential Performance, per IEC 60601-2-10, Medical Equipment, Part 2-10: Particular Requirements of nerve and muscle stimulators
- . Safety and Essential Performance, Per IEC 60601-1-2, Medical Electrical Equipment, Part 1-2, Collateral Standard: Electromagnetic disturbances
- ► Software Verification and Validation
- . Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
-
ESU Compatibility
-
Temperature rise after StimSite Activation
- A Animal Studies
- . GLP Animal Study "Evaluation of StimSite during laparoscopic surgery to locate retroperitoneal ureters without surgical dissection in a female Yorkshire pig model" for validating user acceptance and pathology to assure use without tissue injury. Three representative device users (2 Ob/Gyn surgeons and 1 General and Trauma Surgeon) conducted a simulated exploratory surgery in which they were instructed to identify the
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ureters using traditional methods followed by StimSite activation. StimSite was connected to an ESU and also evaluated for successful bipolar cautery performance. Users were able to identify the ureters in all cases with StimSite. No use errors were noted and users concluded that the device meets user needs. A laparotomy was then performed on the other side of the animal and a StimSite stimulation was delivered to tissue in one location and in another the grasper was used to grasp tissue but no stimulation was provided. There was no evidence of thermal injury or trauma to any specimen.
-
Human Factors testing, per ISO 62366-1 Medical devices Part 1: Application of usability engineering to medical device
- . Initial testing included 5 intended users. Participants were provided with the Instructions for Use (IFU) to review and then were observed for performance of tasks and any use errors or problem in an animal model. No issues were noted.
- . Subsequent testing included 19 surgeons (14 general and 5 Ob/Gyn surgeons) with varying levels of clinical experience and training. The participants reviewed the IFU, Summary Use Card, and participated in an in-service training session. The general/colorectal surgeons performed a laparoscopy with peritoneal biopsy near the ureter and the Ob/Gyn surgeons performed a laparoscopic hysterectomy in a live porcine model in an operating room with support staff after a 1 hour break. Observational data was collected via direct observation. Knowledge task data was obtained from participants following completion of the IFU, Summary Use Card and in-service training. All surgeons were able to successfully perform their surgical procedures. There were two errors noted in which the surgeons allowed the instrument tips to touch. There is no potential harm associated with this error and the users were able to self-correct. There was some feedback provided on the error tone length which led to an increase in the tone duration for the StimSite.
SUMMARY OF CLINICAL TESTING
Between September 11, 2018 and December 3, 2019, 11 total procedures were performed where StimSite was used during the operation. All procedures were gynecologic procedures with 2 being robotic gynecologic operations, 8 being handheld laparoscopic instrument operations and 1 case being an open abdominal procedure. These procedures included hysterectomies (open, laparoscopic and robotic), endometriosis ablation/resections (laparoscopic), and fibroid ablation/resections (laparoscopic). These procedures were carried out by 2 Ob/Gyns with 10 procedures carried out by one surgeon and 1 by the other surgeon.
Through this first in human clinical pilot, the StimSite smooth muscle stimulation technology was determined to be safe to use, specific for and efficacious in eliciting a visible ureter muscular contraction during surgery. Across a range of different procedures and instruments including handheld bipolar instruments and robotic bipolar instruments, the StimSite signal was delivered appropriately as long as the 3rd party instrument was itself assembled correctly. Surgeon feedback through the questionnaire confirmed clinical utility of the technology.
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CONCLUSION
The testing performed, including software testing, electromagnetic compatibility testing, electrical safety testing, bench performance testing, animal testing, human factors testing and clinical evaluation, support a substantial equivalence determination.
§ 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.