(218 days)
The TalisMann Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.
The TalisMann Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the pain management of adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.
The TalisMann Neuromodulation System works by providing electrical impulses to a target area in the body. These impulses may interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.
The TalisMann Neuromodulation System consists of three main parts – the implantable StimRouter Lead (cleared most recently in K211965), the implantable TalisMann Pulse Generator/Receiver that is connected to the implantable Lead, and the external (to the body) components. The Lead is implanted with the stimulation end located at or near the targeted peripheral nerve, whereas the end with the Pulse Generator/Receiver is located near the skin surface. Accessories for the TalisMann include the Clinician Programmer with Software (CPS), the optional Mobile Application (MAPP) installed on a SmartPhone, the StimRouter Electrode (a disposable electrode patch, cleared most recently in K221965), and the TalisMann External Electrical Field Conductor (E-EFC).
The TalisMann System incorporates both commercially available and specially designed components. The materials used in the TalisMann Pulse Generator/Receiver and Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the TalisMann System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.
The TalisMann uses the following components unchanged from the StimRouter System (K211965): the StimRouter Lead, the MAPP software, the E-EFC, and the StimRouter (Hydrogel Patch) Electrodes. The new components of the TalisMann System are: the TalisMann Pulse Generator/Receiver, new implant tools, and the updated Clinician Programmer Software (updated to enable TalisMann parameters).
The provided FDA 510(k) clearance letter and summary for the TalisMann Neuromodulation System does not contain the detailed acceptance criteria or a study proving that the device meets specific performance criteria in terms of accuracy, precision, or clinical efficacy.
The document primarily focuses on establishing substantial equivalence to predicate devices by comparing technological characteristics and listing the types of performance testing conducted for safety and effectiveness. It does not provide quantitative acceptance criteria for device performance nor the results of studies that would demonstrate the device meets such criteria.
The information provided confirms that the device underwent various forms of testing to demonstrate safety and general performance characteristics relative to its predicates, but not specific performance metrics such as accuracy or efficacy in pain relief that would typically have acceptance criteria.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis of what information is available and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document does not specify quantitative acceptance criteria for device performance (e.g., a specific percentage reduction in pain, or a certain accuracy for a diagnostic component). It focuses on direct comparisons of design and general safety/electrical parameters to predicate devices.
2. Sample size used for the test set and the data provenance
- Not provided for human clinical studies demonstrating efficacy.
- Animal Testing: Mentioned as "Acute and Long-term studies in porcine animal model" but sample size is not specified.
- Provenance: Not specified for any potential clinical data, as no clinical efficacy data is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The document discusses performance testing for safety, electrical characteristics, software validation, and usability. It does not describe a test set requiring expert-established ground truth for a diagnostic or efficacy claim. Usability testing involved "Implanting Physician, Treating Clinician and Patient" but specific numbers or qualifications are not given.
4. Adjudication method for the test set
- Not applicable/Not provided. No adjudication method is mentioned as there isn't a stated clinical efficacy or diagnostic performance study requiring ground truth establishment through expert review.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a neuromodulation system for pain relief, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implanted neuromodulation system used by a patient, with programming by a clinician. It's not an algorithm that performs a standalone function without human interaction in its therapeutic application. Software verification and validation were performed for the E-EFC, MAPP, and CPS, which are components of the system, but this is a different type of "standalone" than algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated for efficacy/clinical performance. For safety and engineering tests, the "ground truth" would be established engineering standards, biocompatibility testing results, and functional requirements. For software, it would be validation against specified requirements. No specific clinical outcomes data or pathology as a "ground truth" for device efficacy is mentioned in the context of performance criteria.
8. The sample size for the training set
- Not applicable/Not provided. The device is not described as involving machine learning or AI models that would require a "training set" in the traditional sense for an algorithmic performance claim.
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
Summary of what is present:
The document outlines a substantial equivalence argument based on:
- Comparison of Indications for Use: Similar to predicates for severe intractable chronic peripheral nerve pain, excluding craniofacial region.
- Comparison of Technological Characteristics: Detailed tables comparing the subject device (TalisMann Neuromodulation System) to three predicate devices (StimRouter, Nalu, Renew) across components like transmitter/receiver, leads, externally worn devices, clinician programmer, and patient remote control. These comparisons highlight similarities in mode of action, implant site, power sources, stimulation parameters (frequency, duration, charge, power), materials, and software configuration.
- Performance Testing Categories: A list of testing performed to support safety and effectiveness, including:
- Labeling Validation
- Software verification and validation (for E-EFC, MAPP, and CPS)
- EMC, Wireless Co-Existence, and Electrical Safety
- Usability testing (for Implanting Physician, Treating Clinician, and Patient)
- Bench testing (TalisMann implant, external modules, system testing)
- Animal testing (Acute and Long-term studies in porcine model)
- Sterilization and Shelf Life
- Biocompatibility
Conclusion based on the provided text:
The FDA 510(k) clearance letter focuses on establishing substantial equivalence for the TalisMann Neuromodulation System by demonstrating that its technological characteristics, intended use, and performance testing (with a focus on safety and established engineering principles) are comparable to legally marketed predicate devices. It does not present a study with specific, quantitative acceptance criteria for clinical performance or efficacy metrics against which the device's performance is measured and reported. The "performance testing" described is primarily geared towards validating individual components and system safety/functionality rather than an overarching clinical effectiveness study with defined endpoints and acceptance criteria in the context often seen for diagnostic or AI-driven devices.
FDA 510(k) Clearance Letter - TalisMann Neuromodulation System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 3, 2025
Bioventus LLC
Sageev George
Director, Regulatory Affairs
4721 Emperor Boulevard
Suite 100
Durham, North Carolina 27703
Re: K243678
Trade/Device Name: TalisMann Neuromodulation System
Regulation Number: 21 CFR 882.5870
Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: GZF
Dated: November 28, 2024
Received: June 4, 2025
Dear Sageev George:
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 (the 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 available 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.
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2K243678 - Sageev George Page
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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3K243678 - Sageev George Page
assistance/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,
Amber T. Ballard -S
Amber Ballard, PhD
Assistant Director
DHT5B: Division of Neuromodulation and Physical Medicine 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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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243678
Device Name: TalisMann Neuromodulation System
Indications for Use (Describe):
The TalisMann Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
I. Submitter Information
Company: Bioventus LLC
4721 Emperor Boulevard
Durham, NC 27703 USA
Phone Number: (661) 378-8036
Email: Sageev.George@Bioventus.com
Contact: Sageev George
Director, Regulatory Affairs
Phone Number: (661) 378-8036
Email: Sageev.George@Bioventus.com
Kellie Stefaniak
Vice-President, Global Regulatory and Quality
Phone Number: (919) 566-1224
Email: Kellie.Stefaniak@Bioventus.com
Date Prepared: July 2, 2025
II. Name of Device
Device Trade Name: TalisMann Neuromodulation System
Classification Name: Implantable peripheral nerve stimulator for pain relief
Common Name: Implantable Neurostimulator
Product Code: GZF
Regulation Number: 21 CFR §882.5870
Device Class: Class II
Panel Identification: Neurology
III. Predicate Devices
Predicate #1 Manufacturer: Bioness Inc.
Predicate #1 Trade Name: StimRouter Neuromodulation System
Predicate #1 510(k): K211965
Predicate #2 Manufacturer: Nalu Medical Inc.
Predicate#2 Trade Name: Nalu Neurostimulation System for Peripheral Nerve Stimulation
Predicate #2 510(k): K183579
Predicate #3 Manufacturer: Advanced Neuromodulation Systems, Inc.
Predicate #3 Trade Name: Renew System
Predicate #3 510(k): K000852
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IV. Device Description
The TalisMann Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the pain management of adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.
The TalisMann Neuromodulation System works by providing electrical impulses to a target area in the body. These impulses may interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.
The TalisMann Neuromodulation System consists of three main parts – the implantable StimRouter Lead (cleared most recently in K211965), the implantable TalisMann Pulse Generator/Receiver that is connected to the implantable Lead, and the external (to the body) components. The Lead is implanted with the stimulation end located at or near the targeted peripheral nerve, whereas the end with the Pulse Generator/Receiver is located near the skin surface. Accessories for the TalisMann include the Clinician Programmer with Software (CPS), the optional Mobile Application (MAPP) installed on a SmartPhone, the StimRouter Electrode (a disposable electrode patch, cleared most recently in K211965), and the TalisMann External Electrical Field Conductor (E-EFC).
The TalisMann System incorporates both commercially available and specially designed components. The materials used in the TalisMann Pulse Generator/Receiver and Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the TalisMann System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.
The TalisMann uses the following components unchanged from the StimRouter System (K211965): the StimRouter Lead, the MAPP software, the E-EFC, and the StimRouter (Hydrogel Patch) Electrodes. The new components of the TalisMann System are: the TalisMann Pulse Generator/Receiver, new implant tools, and the updated Clinician Programmer Software (updated to enable TalisMann parameters).
V. Indications for Use
The TalisMann Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.
VI. Comparison of Technological Characteristics
The table below compares the principles of operation and operational/technological characteristics for the TalisMann System and its predicate devices. These comparisons confirm that all of these PNS systems have very similar overall principles of operation
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and operational/technological characteristics, thereby supporting the substantial equivalence of the TalisMann System to these previously cleared predicates.
Comparison is listed per following aspects:
- Transmitter and Receiver
- Leads
- Externally Worn Devices
- Clinician Programmer
- Patient Remote Control
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Table 1: Substantial Equivalence - Transmitter and Receiver modules
| Transmitter and Receiver | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| 510(k) Number | K243678 | K211965 | K183579 | K000852 | |
| Device Name | TalisMann Neuromodulation System | Bioness StimRouter Neuromodulation System | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Renew Neurostimulation System | |
| Regulation and Product Codes | 21 CFR 882.5870 GZF | 21 CFR 882.5870 GZF | 21 CFR 882.5870 GZF | 21 CFR 882.5870 GZF | |
| Indication for Use | The TalisMann Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region. | The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region. | This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device. | Not publicly available | |
| Implant site | Subcutaneous, stimulating electrode(s) of the lead are at peripheral nerves, excluding craniofacial region. | Not publicly available | Peripheral nerves, excluding craniofacial region | Not publicly available | Similar. The subject device and predicates target the peripheral nerves. |
| Mode of action | Wireless electrical coupling, delivering high frequency electrical energy to the receiver lead to produce stimulation at stimulating electrodes. | Not publicly available | Radio Frequency (RF) coupling delivering energy to produce stimulation at stimulating electrodes. | Not publicly available | Similar. The subject device and predicates deliver wireless energy to the implanted receiver. |
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| Transmitter and Receiver | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| Receiver materials in contact with human body | Titanium electrode, PEEK (polyether ether ketone), silicone | Pt-Ir electrode, silicone insulator sheath | Silicone and Pellethane 2363- 55D | Not publicly available | Differences in the receiver materials do not impact safety or effectiveness. Non-clinical bench testing was conducted to support cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity, chemical characterization, toxicological risk assessment and implant endpoints. |
| Electrical components | Embedded receiver, rigid miniature circuit board in a hermetically sealed Titanium can | Not publicly available | Embedded receiver, flexible circuit board, sealed | Not publicly available | Similar. The subject device and Nalu predicate use an embedded receiver and circuitry that pick up externally applied stimulation which the circuitry transforms into electrical stimulation that is provided to the distally located stimulation electrodes. |
| Biocompatibility Testing | Yes | Yes | Yes | Not publicly available | All devices are confirmed through testing to be biocompatible. |
| Powersource (receiver) | No internal power source. Powered by external transmitter. | Not publicly available | No internal power source. Powered external transmitter. | Not publicly available | Equivalent |
| Powersource (transmitter) battery type | One Lithium Polymer, rechargeable | One Lithium Polymer, rechargeable | Rechargeable Lithium Ion Battery | Not publicly available | Similar: All devices use battery power source. Differences in battery materials/chemistry do not affect safety and effectiveness of intended use. |
| Location of transmitter | External | External | External | Not publicly available | same |
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| Transmitter and Receiver | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| Transdermal energy delivery | Wireless, Electrical coupling, 35 or 50 kHz | Not publicly available | Wireless, RF, 40.68 MHz | Not publicly available | Differences do not affect safety and effectiveness of intended use |
| Current / Voltage regulated | Current | Current | Current | Not publicly available | The difference in voltage regulated vs. current regulated does not bring up any issues of safety and effectiveness. |
| Amplitude of implant current (max) | 26 mA* | Not publicly available | 10.2 mA | Not publicly available | Subject device within range of predicates. |
| RMS value of implant current (max) | 2.15 mA* | Not publicly available | Not publicly available | Not publicly available | The differences do not affect safety and effectiveness of intended use |
| Repetition frequency | Burst repetition frequency 1 - 200 Hz Pulse repetition frequency 1 - 200 Hz | Pulse repetition frequency 2 - 1,500 Hz | Not publicly available | Similar: TalisMann repetition frequency range is the same as StimRouter predicate, and is within the range of the Nalu predicate device | |
| Duration | Burst duration 100 - 500 µsec | Not publicly available | Pulse duration (positive phase) 12 – 1,000 µsec | Not publicly available | Similar: TalisMann pulse width is within the range of predicate devices |
| Maximum charge | Charge per burst 5.6 µC* | Not publicly available | Charge per pulse (positive phase) 10.2 µC | Not publicly available | Subject device within range of predicates. |
| Maximum charge density | Charge during burst 29.6 µC/cm2 * Charge during pulse 15.9 µC/cm2* | Charge during pulse 83.3 µC/cm2 | Not publicly available | Subject device within range of predicates. | |
| Maximum current density | 137.6 mA/cm2 * | Not publicly available | 83.3 mA/cm2 | Not publicly available | Subject device within range of predicates. |
| Net charge | 0 µC | Not publicly available | 0 µC | Not publicly available | The same |
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| Transmitter and Receiver | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| Max average power | Power during burst 0.08 W * | Not publicly available | Power during pulse 0.031 W(300Ω load) 0.052 W(500Ω load) 0.083 W(800Ω load) | Not publicly available | Subject device within range of predicates. |
| Max average power density | Power during burst 0.42W/cm2 * | Not publicly available | Power during pulse 0.25 W/cm2 (300Ω load) 0.51 W/cm2 (500Ω load) 0.55 W/cm2 (800Ω load) | Not publicly available | Subject device within range of predicates. |
| Waveform | Charge balanced (delayed) biphasic asymmetrical | Charge balanced, symmetrical or asymmetrical | Charge balanced (delayed) biphasic asymmetrical | Not publicly available | Differences do not affect safety and effectiveness of intended use |
| Pulse shape | Positive phase: rectangular, Negative: Decaying exponential | Not publicly available | Decaying exponential | Not publicly available | Differences do not affect safety and effectiveness of intended use |
| Stimulation modality | Monopolar | Not publicly available | Bipolar | Not publicly available | Similar. Differences do not affect safety and effectiveness of intended use |
*For 20% max pick-up ratio, 300 Ω load. The principle of delivery of transcutaneous energy to the implant of TalisMann is identical to that StimRouter. A porcine model was used for both the StimRouter and TalisMann for determination of pick-up ratio. A similar implantation of the StimRouter Lead and the TalisMann Lead was performed.
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Table 2: Substantial Equivalence Table - Leads
| Leads | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| 510(k) Number | K243678 | K211965 | K183579 | K000852 | |
| Device Name | TalisMann Neuromodulation System | Bioness StimRouter Neuromodulation System | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Renew Neurostimulation System | |
| Number of stimulating electrodes | 3 | 3 | 8 | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Electrode shape | Cylindrical | Cylindrical | Circular | Not publicly available | The same |
| Electrode surface area | 6.3 mm2 (Total area for 3 electrodes is 18.9mm2) | Not publicly available | 12.25 mm2 | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Electrode array length | 5 mm | Not publicly available | 52 mm | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Individual electrode length | 1 mm | Not publicly available | 3 mm | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Electrode spacing | 1 mm | Not publicly available | 4 mm | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Electrode material | Platinum– Iridium (90:10) | Platinum– Iridium (90:10) | Platinum– Iridium (90:10) | Not publicly available | The same |
| Insulation body material | Silicone | Silicone | Pellethane 2363-55D | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
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| Leads | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| Cable features | Multi-strand, non-insulated, helical | Not publicly available | Multilumen tube | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Anchor | Silicone anchor | Not publicly available | Molded silicone anchor with Ti locking mechanism | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Lead length | 15 cm | 15 cm | 40cm, 60cm | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. Differences with other predicate devices do not affect safety and effectiveness of the intended use. |
| Lead body diameter | 1.2 mm | 1.2 mm | 1.30 mm | Not publicly available | The TalisMann Neuromodulation System uses the previously cleared StimRouter Lead. |
| Sterilization method | Ethylene Oxide | Not publicly available | Ethylene Oxide | Not publicly available | The same |
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Table 3: Substantial Equivalence Table – Externally Worn Devices
| Externally worn devices | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| 510(k) Number | K243678 | K211965 | K183579 | K000852 | |
| Device Name | TalisMann Neuromodulation System | Bioness StimRouter Neuromodulation System | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Renew Neurostimulation System | |
| Name | TalisMann External Electrical Field Conductor (E-EFC) | StimRouter External Electrical Field Conductor (E-EFC) | Therapy Disc and Trial Therapy Disc | Not publicly available | N/A |
| Electronics | A printed circuit board (PCB) that generates high frequency electrical current with embedded waveform parameter settings and buttons for setting amplitude and changing parameter settings as needed by the user. | A printed circuit board (PCB) that generates high frequency electrical current with embedded waveform parameter settings and buttons for setting amplitude and changing parameter settings as needed by the user. | A printed circuit board (PCB) that generates RF power with embedded waveform parameters settings and buttons for changing parameter settings as needed by the user. | Not publicly available | TalisMann E-EFC uses the same PCB and firmware as StimRouter E-EFC. Differences do not affect safety and effectiveness of intended use. |
| User interface | Integrated controls and indicators that allow the user to turn the device on/off, increase or decrease therapy levels, select from configured therapy profiles and monitor device status. | Integrated controls and indicators that allow the user to turn the device on/off, increase or decrease therapy levels, select from configured therapy profiles and monitor device status. | Integrated controls and indicators that allow the user to turn the device on/off, increase or decrease therapy levels, select from configured therapy profiles and monitor device status. | Not publicly available | The same |
| Delivery of energy | TalisMann E-EFC delivers 35 kHz or 50 kHz electrical pulses via hydrogel patch attached to the skin over the implanted receiver. | Not publicly available | Integrated antenna supporting 40.68 MHz power and data transfer. | Not publicly available | TalisMann E-EFC is TalisMann uses the same hydrogel patch as predicate StimRouter device. Difference with other predicate devices does not affect safety and effectiveness of intended use. |
| Area of skin electrodes | 14 cm2 | Not publicly available | N/A (not used for Nalu System) | Not publicly available | Difference with other predicate devices does not affect safety and effectiveness of intended use. |
| Max transcutaneous current (RMS) | 16.8 mA (RMS) | Not publicly available | N/A | N/A | Subject device within range of predicates. |
| Max current density (at gel patch electrode) | 1.2 mA/cm2 (RMS) | Not publicly available | N/A | Not publicly available | Subject device within range of predicates. |
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| Externally worn devices | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| Wearing | TalisMann E-EFC is plugged into a hydrogel electrode patch. The patch is positioned on the skin over the implanted receiver. Hydrogel patch serves as a mechanical attachment to the skin and as an electrical conductor to deliver transcutaneous stimulation. | StimRouter E-EFC is plugged into a hydrogel electrode patch. The patch is positioned on the skin over the implanted receiver. Hydrogel patch serves as a mechanical attachment to the skin and as an electrical conductor to deliver transcutaneous stimulation. | Therapy Disc is positioned over IPG via two options: - Adhesive clip (hydrocolloid adhesive) - Elastic Belt / Cuff | Not publicly available | Difference does not affect safety and effectiveness of intended use. |
| Size / Weight | TalisMann E-EFC: 5.7 x 3.7 x 1.2cm 28g Patch: 10.6 x 3.4 x 0.26cm 6g | StimRouter E-EFC: 5.7 x 3.7 x 1.2cm 28g | Disc: ~1.5cm thick, 7.5cm diameter Weight: ~80g | Not publicly available | Difference does not affect safety and effectiveness of intended use. |
| Externally contacting materials | E-EFC: Housing - Tritan™ Copolyester MX731 Button overlay: Polycarbonate polyform Snap connector: CDA 260 Brass 200 Series S.S Patch: Hydrogel, Non- woven fabric (Ml) | E-EFC: Housing - Tritan™ Copolyester MX731 Button overlay: Polycarbonate polyform Snap connector: CDA260 Brass 200 Series S.S | PC ABS housing. Textile material of belt / cuff may be worn over clothing. Hydrocolloid adhesive applied to skin. | Not publicly available | Difference does not affect safety and effectiveness of intended use. |
| Battery charging | Medical grade USB charger with a USB-A to USB-C cable that plugs into TalisMann E- EFC. E-EFC uses USB-C charging port | Electrically isolated cradle charger | Not publicly available | The differences do not affect safety and effectiveness of intended use |
Table 4: Substantial Equivalence Table – Clinician Programmer
| Clinician Programmer | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| 510(k) Number | K243678 | K211965 | K183579 | K000852 | |
| Device Name | TalisMann Neuromodulation System | Bioness StimRouter Neuromodulation System | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Renew Neurostimulation System |
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| Clinician Programmer | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| Configuration | Software installed on a Windows tablet. | Software installed on a Windows tablet. | Software installed on an Android tablet. | Not publicly available | similar |
| Purpose | Allows healthcare provider to set desired therapy levels and device settings on TalisMann E-EFC. | Allows healthcare provider to set desired therapy levels and device settings on StimRouter E-EFC. | Allows healthcare provider to set desired therapy levels and device settings across Therapy Disc and Patient Remote Control. | Not publicly available | similar |
| Communication | Bluetooth Low Energy (BLE) to E- EFC. | Bluetooth Low Energy (BLE) to E- EFC. | Bluetooth to Therapy Disc and Patient Remote Control. | Not publicly available | similar |
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Table 5: Substantial Equivalence Table – Patient Remote Control
| Patient Remote Control | Subject Device | Primary Predicate Device | Secondary Predicate Device | Tertiary Predicate Device | Equivalency discussion |
|---|---|---|---|---|---|
| 510(k) Number | K243678 | K211965 | K183579 | K000852 | |
| Device Name | TalisMann Neuromodulation System | Bioness StimRouter Neuromodulation System | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Renew Neurostimulation System | |
| Name | Patient Mobile App (MAPP) | Patient Mobile App (MAPP) | Patient Remote Control | Not publicly available | N/A |
| Remote Control Required? | Optional | Optional | Optional | Not publicly available | differences do not affect safety and effectiveness of intended use. |
| Configuration | Software app installed on a mobile device (Android / iOS) providing wireless selection among preconfigured options and status readout for paired TalisMann E-EFC. | Not publicly available | Software app installed on a mobile device (Android / iOS) providing wireless selection among preconfigured options and status readout for paired Therapy Disk. | Not publicly available | TalisMann MAPP and StimRouter MAPP uses the same Smartphone software. The differences with Nalu and ANS predicates do not affect safety and effectiveness of intended use. |
| Communication | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Bluetooth | Not publicly available | Differences do not affect safety and effectiveness of intended use. |
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Performance Testing
The TalisMann Neuromodulation System was qualified through the following labeling, software, electrical, usability, bench, functional and animal testing. Additionally, sterility, shelf life and biocompatibility testing were performed.
- Labeling Validation
- Software verification and validation (for E-EFC, MAPP and CPS software devices)
- EMC, Wireless Co-Existence and Electrical Safety
- Usability testing (for Implanting Physician, Treating Clinician and Patient)
- Bench testing
- Tests of the TalisMann implant
- Tests of the external modules (E-EFC)
- TalisMann System Testing
- Animal testing (Acute and Long-term studies in porcine animal model)
- Sterilization and Shelf Life (TalisMann Pulse Generator /Receiver and Implant Kit)
- Biocompatibility (for Receiver, Implant Tools and E-EFC)
VII. Conclusion
In conclusion, the TalisMann Neuromodulation System can be deemed to be as safe and effective as the predicate devices for the proposed indications for use and no new or differing questions of safety or effectiveness are raised. Therefore, it can be determined that the TalisMann Neuromodulation System is substantially equivalent to the predicate devices.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).