(155 days)
No
The device description and performance studies focus on mechanical and electrical functionality for electrosurgical procedures, with no mention of AI or ML.
Yes.
The device is used for medical procedures (cannulation and sphincterotomy) to treat conditions, which aligns with the definition of a therapeutic device.
No
The device, the TeslaTome Bipolar Sphincterotome, is described as an endoscopic electrosurgical accessory intended for therapeutic procedures such as cannulation of the ductal system, sphincterotomy, and aiding in bridging strictures. Its function is to perform a physical action (cutting via electrosurgery) rather than to provide information about a patient's medical condition. While it interacts with the body, its primary purpose is intervention, not diagnosis.
No
The device description clearly details physical components such as a stainless steel drive wire, polymer catheter, handle, cutting wire, and an active cord. Performance studies also focus on the physical and electrical properties of these 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 for cannulation, sphincterotomy, and aiding in bridging strictures during ERCP procedures. These are all surgical or interventional procedures performed directly on the patient's body.
- Device Description: The device is a physical tool (sphincterotome) used for cutting and manipulation within the body. It's an endoscopic accessory.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide diagnostic information. IVDs are typically used to test blood, urine, tissue samples, etc.
- Performance Studies: The performance studies focus on the device's mechanical function, electrical safety, and ability to perform the intended surgical actions within a simulated or clinical setting. They do not involve analyzing biological samples for diagnostic purposes.
Therefore, the TeslaTome Bipolar Sphincterotome and the Tesla Bipolar Active Cord are considered surgical or interventional devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The TeslaTome™ Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
The Tesla Bipolar Active Cord is used to connect the TeslaTome™ Bipolar Sphincterotome to compatible electrosurgical generators.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The TeslaTome Bipolar Sphincterotome is an endoscopic electrosurgical accessory composed of a single stainless steel drive wire within a triple-lumen polymer catheter. The proximal end of the catheter/wire assembly terminates in a handle, held by the physician or assistant during ERCP procedures and fulfills three (3) functions: connection to an electrosurgical generator, injection of diluted contrast, introduction of an endoscopic wire guide and manipulation of the cutting wire. The distal end contains a stainless steel cutting wire and ink and band markings. Half of the cutting wire is insulated with a non-conductive polymer coating. The device allows for short-wire, distal wire guide exchange through the separation of a weakened wall in the wire guide lumen that separates with manual control. It is also compatible with traditional long wire guides. The device is cleared for eight model numbers reflecting cutting wire length (20 or 25 mm) and a .035" Acrobat II wire guide in either 260 cm or 450 cm length, with an optional rotatable handle. The minimum compatible endoscope channel size is 4.2 mm.
The Tesla Bipolar Active Cord (TESLA-ACU-B) connects the TeslaTome Bipolar Sphincterotome to a compatible electrosurgical generator (ESU). It uses a magnetic connection at the sphincterotome alignment and facilitates connection with ERBE generators on the distal end with conventional ESU-compatible plugs. The active cord is 223 cm long, non-sterile, and reusable.
The primary distinction of the TeslaTome Bipolar Sphincterotomes is its bipolar electrosurgical current pathway, where grounding occurs close to the active electrode at the distal end by placement of an adjacent neutral electrode (silver ink).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ductal system (biliary ducts)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or assistant during ERCP procedures. Prescription Use.
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)
Cook verification and clinically relevant simulated use testing was performed. These tests include verification at time zero or post six-month accelerated aging. Clinically relevant simulated use testing post six-month accelerated aging demonstrates that the sphincterotome and active cord meet design inputs/user needs.
Key results:
- User must be able to remove functional device from packaging and prepare for sphincterotomy.
- User must be able to advance and remove sphincterotome through compatible endoscope and wire lock.
- User must be able to perform contrast-based or wire-guided cannulation.
- User must be able to perform sphincterotomy using an electrosurgical generator and Tesla Bipolar Active Cord.
- User must be able to advance device into ductal system to perform selective cannulation of the hepatic system utilizing a wire guide.
- User must be able to remove sphincterotome from a compatible endoscope while maintaining wire guide access to the ductal system.
- Electrical testing for patients leads, handle and catheter temperature rise, single fault testing, leakage current, dielectric strength and contact impedance.
- Finished product qualification to determine sterility, and EO residual levels. Simulated distribution testing.
- Testing specific to the bipolar transfer of electrosurgical energy establishes neutral electrode thermal performance by verifying that current is transferred to the neutral electrode to the cutting wire and no patient grounding pad is required for safe use. When used with the cut mode of an ERBE generator, the cutting wire produces functional results comparable to the predicate devices.
Additional tests specific to the Tesla Bipolar Active Cord include:
- Connectivity to a TeslaTome Bipolar Sphincterotome and electrosurgical generator (ESU).
- Delivery of current from ESU to a TeslaTome Bipolar Sphincterotome through the active cord.
- Disconnection from ESU and the TeslaTome Bipolar Sphincterotome.
- Electrical testing included patient leads, leakage current, dielectric strength, protection against excessive temperatures, excessive cord flexure or tension, mechanical strength and test finger.
Biocompatibility tests: cytotoxicity, irritation, sensitization, acute systemic toxicity and material mediated pyrogenicity were conducted for the sphincterotome.
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.
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.
January 30, 2020
Wilson-Cook Medical, Inc. Marge Walls-Walker Sr. Regulatory Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K192339
Trade/Device Name: TeslaTome Bipolar Sphincterotome Tesla Bipolar Active Cord Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KNS Dated: January 6, 2020 Received: January 10, 2020
Dear Marge Walls-Walker:
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.
1
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 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 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.
Daniel G. Walter, Jr. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K192339
Device Name
TeslaTome Bipolar Sphincterotome and Tesla Bipolar Active Cord
Indications for Use (Describe)
The TeslaTome Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
The Tesla Bipolar Active Cord is used to connect the TeslaTome to compatible electrosurgical generators.
| 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
Submitted By:
Marge Walls-Walker, Senior Regulatory Specialist Wilson-Cook Medical, Inc./Cook Endoscopy 4900 Bethania Station Road (336) 744-0157, x396290 January 6, 2020
Name of Device
| Trade Names: | TeslaTome™ Bipolar Sphincterotome |
|---|---|
| Tesla Bipolar Active Cord | |
| Common/Usual Name: | Sphincterotome and Accessories |
| Proposed Classification Name(s): | Endoscopic Electrosurgical Unit and accessories |
| 21CFR 876.4300, KNS, Class II |
Predicate Devices
Olympus Single Use Preloaded Sphincterotome V (Clevercut); 510(k) No. K141991, cleared March 31. 2015.
Wilson-Cook Fusion OMNI Sphincterotome; 510(k) No. K172288, cleared April 17.2018
Reference Predicate device
Bitome Bipolar Sphincterotome; 510(k) No. K895842, cleared to market January 1.1990
Intended Use
The TeslaTome Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
The Tesla Bipolar Active Cord is used to connect the TeslaTome Bipolar Sphincterotome to compatible electrosurgical generators.
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Substantial Equivalence
The TeslaTome Bipolar Sphincterotome is substantially equivalent to the Olympus Single Use Preloaded Sphincterotome V (distal wire guided), K141991, cleared March 31, 2015 and the Fusion Omnitome, K172288, cleared April 17, 2018.
All three devices are endoscopic electrosurgical accessories composed of a single stainless steel drive wire within a triple-lumen polymer catheter. The proximal end of the catheter/wire assembly terminates in a handle, held by the physician or assistant during ERCP procedures and fulfills three (3) functions: connection to an electrosurgical generator, injection of diluted contrast, introduction of an endoscopic wire guide and manipulation of the cutting wire. The distal end contains a stainless steel cutting wire and ink and band markings. In the subject device and the Olympus distal wire guided sphincterotome, half of the cutting wire is insulated with a non-conductive polymer coating. All devices allow for short-wire, distal wire guide exchange through the separation of a weakened wall in the wire guide lumen that separates with manual control. The ability to separate the wire guide from the sphincterotome allows for the wire guide to be left in position in the ductal system once the sphincterotome is removed; additional therapeutic devices are then introduced without requiring additional cannulations. The subject device and predicate devices are also compatible with traditional long wire guides. The wire guide associated with the TeslaTome Bipolar line and referred to in this submission is the Acrobat Calibrated Wire Guide cleared to market via K142950 on 11.05.2014 and included in the Fusion Omni Sphincterotome submission as an accessory to the sphincterotome.
The TeslaTome Bipolar Sphincterotome seeks clearance for eight model numbers reflecting cutting wire length or 20 or 25 mm, and a .035" Acrobat II wire guide in either 260 cm or 450 cm length, and an optional rotatable handle. Cutting wire lengths and wire guide compatibility are the same as the Fusion OMNI predicate and similar to the Olympus sphincterotome. The distal ink markings and band placement are identical to the Fusion OMNI device and comparable to the Olympus device. All three devices are compatible with a range of endoscopes with the minimum channel size ranging from 4.2 mm (TeslaTome, OMNI) to 2.8 mm (Olympus). Details on the exact re-order numbers and accessory compatibility are in Table 1.
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| RPN | Rotatable
Handle | Cutting
Wire
length
(mm) | Max Compatible
Wire guide (WG)
Diameter (in) | WG Length
(cm) | WG Brand |
|------------------|---------------------|-----------------------------------|----------------------------------------------------|-------------------|-----------|
| TESLA-B2535-260 | No | 25 | 0.035 | 260 | Acrobat 2 |
| TESLA-B2035-260 | No | 20 | 0.035 | 260 | Acrobat 2 |
| TESLA-B2535-450 | No | 25 | 0.035 | 450 | Acrobat 2 |
| TESLA-B2035-450 | No | 20 | 0.035 | 450 | Acrobat 2 |
| TESLA-BR2535-260 | Yes | 25 | 0.035 | 260 | Acrobat 2 |
| TESLA-BR2035-260 | Yes | 20 | 0.035 | 260 | Acrobat 2 |
| TESLA-BR2535-450 | Yes | 25 | 0.035 | 450 | Acrobat 2 |
| TESLA-BR2035-450 | Yes | 20 | 0.035 | 450 | Acrobat 2 |
Table 1: Reorder numbers for the subject device
The Tesla product family also includes the Tesla Bipolar Active Cord (TESLA-ACU-B) to facilitate connection to an Electrosurgical generator (ESU). As compared to the plug-fit active cords currently on the market for the predicate devices, the Tesla Bipolar Active Cords use a magnetic connection at the sphincterotome alignment but facilitate connection with ERBE generators on the distal end with conventional ESU-compatible plugs.
The minor differences in the Intended Uses reflect the scope of modern GI endoscopic practice in accessing and cannulating the biliary ductal system and do not impact the safety or the effectiveness of the subject device as labeled.
The primary distinction of the TeslaTome Bipolar Sphincterotomes from the named predicates is the electrosurgical current pathway. The Bipolar nomenclature indicates that the grounding of the current occurs close to the active electrode at the distal end of the sphincterotome by placement of an adjacent neutral electrode. Figure 1 illustrates the difference in the current pathways. The lower figure illustrates the bipolar pathway of the subject device. This bipolar current pathway was described in the reference predicate Bitome Bipolar Sphincterotome; 510(k) No. K895842, cleared to market January 1.1990 marketed by Everest
Medical.
The bipolar current circuit is an established means of delivering energy well known in other endoscopic devices such as electric (hot) forceps and coagulation probes. The neutral electrode is the silver ink; the entire return pathway on the device from the ESU (endoscopic surgical unit) generator to the patient includes the silver ink, return wire and handle electrode. This silver ink neutral electrode is similarly placed to the coiled metal neutral electrode on the original Bitome.
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Image /page/6/Figure/1 description: The image shows two diagrams of electrosurgical procedures. In both diagrams, an electrosurgical generator is connected to a surgical instrument via a blue arrow, indicating the flow of electrical current. A red arrow shows the return path of the current from the instrument to the generator, with the top diagram including a "Patient Grounding Pad" in the circuit.
Fiqure 1: Monopolar (upper) and Bipolar (lower-subject device) circuits
The rotatable handle feature is a known technology in several lines of endoscopic accessories and allows controlled placement of the wire guide in the ductal system by rotation of the sphincterotome handle. The rotatable mechanism is separated from the electrical connection to prevent damage to current transfer components.
The Tesla Bipolar Active Cord is 223 cm long and in its current iteration compatible with ERBE generators. The Active cord is non-sterile and reusable. The cleaning instructions in the device IFU (Instructions for Use) have been validated with respect to the FDA guidance "Reprocessing medical devices in healthcare settings: validation methods and labeling (June 2017)" as well as relevant standards. Levels of hemoglobin and protein were found to be below the set acceptable level and all surface soiling was removed. The IFU also contains details on determining if the device has reached the end of its useful life. The Tesla Bipolar Active Cord is compatible only with the TeslaTome Bipolar Sphincterotome.
Discussion of Performance Tests and Test Results
Cook verification and clinically relevant simulated use testing established that design outputs met the design inputs and user needs for both the TeslaTome Bipolar Sphincterotome and the Tesla Bipolar Active Cord. These tests include verification at time zero or post six-month accelerated aging. Clinically relevant simulated use testing post six-month accelerated aging,
7
demonstrates that the sphincterotome and active cord meet the following design inputs/user needs:
User must be able to remove functional device from packaging and prepare for sphincterotomy.
User must be able to advance and remove sphincterotome through compatible endoscope and wire lock.
User must be able to perform contrast-based or wire-guided cannulation.
User must be able to perform sphincterotomy using an electrosurgical generator and Tesla Bipolar Active Cord.
User must be able to advance device into ductal system to perform selective cannulation of the hepatic system utilizing a wire guide.
User must be able to remove sphincterotome from a compatible endoscope while maintaining wire guide access to the ductal system.
Electrical testing for patients leads, handle and catheter temperature rise, single fault testing, leakage current, dielectric strength and contact impedance.
Finished product qualification to determine sterility, and EO residual levels. Simulated distribution testing.
Testing specific to the bipolar transfer of electrosurgical energy establishes neutral electrode thermal performance by verifying that current is transferred to the neutral electrode to the cutting wire and no patient grounding pad is required for safe use. When used with the cut mode of an ERBE generator, the cutting wire produces functional results comparable to the predicate devices.
Additional tests specific to the Tesla Bipolar Active Cord include:
Connectivity to a TeslaTome Bipolar Sphincterotome and electrosurgical generator (ESU).
Delivery of current from ESU to a TeslaTome Bipolar Sphincterotome through the active cord.
Disconnection from ESU and the TeslaTome Bipolar Sphincterotome.
Electrical testing included patient leads, leakage current, dielectric strength, protection against excessive temperatures, excessive cord flexure or tension, mechanical strength and test finger.
The following biocompatibility tests: cytotoxicity, irritation, sensitization, acute systemic toxicity and material mediated pyrogenicity were conducted to establish the biological safety of the subject sphincterotome. As the subject active cord is unlikely to contact the patient and all
8
members of the endoscopy team wear conventional hand and eye protection, no biocompatibility testing was deemed necessary for the Tesla Bipolar Active Cord.
Conclusions Drawn from the Tests
Outcomes from the evaluation of the TeslaTome Bipolar Sphincterotome provide evidence of its ability to pass through the channel of a sphincterotome, cannulate and allow for contrast injection, accommodate either a short or long wire guide, facilitate distal (short wire) exchange and achieve sphincterotomy. Testing to verify performance of the Tesla Bipolar Active cord also provides evidence that the device will work as intended with the subject sphincterotome and an ERBE generator.
The subject and predicate devices are compliant with the relevant internationally recognized standards for electrosurgical medical equipment (ANSI/AAMI 60601-1) electrosurgical accessories (ANSI/AAMI 60601-2-2) and endoscopic equipment (ANSI/AAMI60601-2-18) and demonstrate substantial equivalence to the predicate devices in terms of intended use, biological safety and technological characteristics.