(222 days)
Not Found
No
The description focuses on electrical stimulation and user-controlled modes, with no mention of AI or ML algorithms for signal processing, interpretation, or decision-making.
No
Explanation: The device is intended to help locate and identify ureters by testing ureter smooth muscle excitability, not to directly treat a medical condition or disease. It is an adjunct to visual assessment, used for identification purposes during surgery.
Yes
The device is intended to help locate and identify ureters by testing ureter smooth muscle excitability, which involves assessing a physiological response to provide information for diagnosis (identification of the ureter). The description states it 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 act of identification and verification is a diagnostic function.
No
The device description explicitly states that StimSite is comprised of a Signal Box, a connected Footswitch with cable, and an Interconnect Cable, all of which are hardware components. It also mentions connecting to standard surgical instruments and potentially an electrosurgical unit (ESU) or generator. While software controls the signal box, the device itself is a physical system with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide electrical stimulation to ureter smooth muscle tissue to help locate and identify ureters by testing ureter smooth muscle excitability." This is a direct interaction with living tissue in vivo (within the body) during a surgical procedure.
- Device Description: The description reinforces this by stating it's a "non-patient contacting device that generates an electrical signal that elicits visible contractions of smooth muscle tissue." It connects to surgical instruments used in vivo.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed in vitro (outside the body).
StimSite is a surgical aid that provides electrical stimulation in vivo to help surgeons identify anatomical structures. It does not analyze samples taken from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ETN
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter smooth muscle tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons/operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
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 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.
-
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
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.
4
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 CaverMap | ||
| Surgical Aid | Checkpoint 9041 | ||
| 510(k) Number | K200886 | K993436 | K092292 |
| Product Code / | |||
| Regulatory | |||
| Classification | ETN/Class II | ETN/Class II | ETN/Class II |
| Surgical Nerve | |||
| Stimulator/Locator | |||
| 21 CFR § 874.1820 | Surgical Nerve | ||
| Stimulator/Locator | |||
| 21 CFR § 874.1820 | Surgical Nerve | ||
| Stimulator/Locator | |||
| 21 CFR § 874.1820 | |||
| Intended Use | Intended to provide | ||
| electrical stimulation to | |||
| muscle tissue to locate | |||
| and identify smooth | |||
| muscle and test its | |||
| excitability. | Intended to provide | ||
| electrical stimulation | |||
| to the body to locate | |||
| and identify nerves | |||
| and to test their | |||
| excitability. | Intended to provide | ||
| electrical stimulation of | |||
| exposed motor nerves or | |||
| muscle tissue to locate and | |||
| identify nerves and to test | |||
| nerve and muscle | |||
| excitability. | |||
| CHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE |
| StimSite | UroMed CaverMap | Checkpoint 9041 | |
| Surgical Aid | |||
| Technological Characteristics | |||
| IEC 60601 Electrical | |||
| Safety Standards | |||
| Certification | Yes | Yes | Yes |
| Single-Use v. Re-Use | Re-Usable, Non- | ||
| Disposable | Re-Usable, Non- | ||
| Disposable | Single-Use | ||
| Device Configuration | Non-Disposable signal | ||
| box that allows for | |||
| connections to hand- | |||
| held surgical | |||
| instruments that deliver | |||
| stimulation signal | Non-Disposable signal | ||
| box that allows for | |||
| connections to hand- | |||
| held instruments that | |||
| deliver stimulation | |||
| signal | Hand-Held | ||
| Stimulus Tip | Metal bipolar-enabled | ||
| surgical instruments | |||
| designed to carry | |||
| electrical signals to | |||
| target tissues* | Metal bipolar-enabled | ||
| instrument designed | |||
| to carry electrical | |||
| signals to target | |||
| tissues | Metal ends designed to | ||
| carry electrical signals to | |||
| target tissues | |||
| Monopolar/Bipolar | |||
| Stimulation | Bipolar stimulation | ||
| signal (electrons flow | |||
| from one tip to the | |||
| other on the surgical | |||
| instruments) | Bipolar stimulation | ||
| signal (electrons flow | |||
| from tip of instrument | |||
| through the body to a | |||
| clip applied to another | |||
| surgical instrument) | Monopolar stimulation | ||
| signal (electrons flow | |||
| between blunt tip to | |||
| needle tip) | |||
| Battery / AC Power | AC Powered | AC Powered | Battery Powered |
| Regulated Output | Fixed (single setting) | ||
| output voltage | Fixed (single setting) | ||
| output voltage, with | |||
| adjustable current | Fixed (multi-setting) output | ||
| current | |||
| Type of Waveform | Capacitor discharge | ||
| waveform | Biphasic | capacitor discharge and | |
| square (biphasic waveform) | |||
| Stimulus Voltage and | |||
| Current | 40V peak | ||
| 5.2V rms (maximum at | |||
| 2500 ohm resistance) | |||
| 5.9mA rms (maximum at | |||
| 150 ohm resistance) | 20mA maximum | 30V maximum | |
| 20mA (maximum) | |||
| 1.13mA rms (cathodic | |||
| portion of waveform) | |||
| Stimulus Pulse | |||
| Duration | 250ms maximum pulse | ||
| duration at 2500 ohm | |||
| resistance | 800us | 200us maximum pulse | |
| duration up to 1500 ohm | |||
| resistance | |||
| CHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE |
| StimSite | UroMed CaverMap | ||
| Surgical Aid | Checkpoint 9041 | ||
| Stimulus Frequency | Single impulse delivery | ||
| or maximum 1 Hz if foot | |||
| pedal held down | 16Hz | 16Hz | |
| Storage | In operating room or in | ||
| surgical supply room | In operating room or | ||
| in surgical supply | |||
| room | In operating room or in | ||
| surgical supply room | |||
| Compatibility with | |||
| Surgical Generators | Connects with surgical | ||
| generators to allow | |||
| surgeons to still use | |||
| their bipolar | |||
| instruments in the | |||
| traditional manner | Does not connect with | ||
| any other surgical | |||
| generators | Does not connect with any | ||
| other surgical equipment |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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6
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
7
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.
8
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.