(90 days)
Not Found
No
The summary describes a magnetic stimulator with power electronics and a PC interface for control. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies. The performance studies focus on electrical safety, EMC, software validation, and output comparison, not on the performance of an AI/ML algorithm.
No
Explanation: The device is explicitly stated to be for "stimulation of peripheral nerves for diagnostic purposes". It is not intended for treating a condition, but rather for diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes."
No
The device description explicitly states that the Delphi Stimulator consists of "power electronics to generate the magnetic field" and is connected to a "Magnetic Coil which transfers the magnetic stimulation to the tissue." These are hardware components, indicating it is not a software-only device.
Based on the provided information, the Delphi Stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stimulation of peripheral nerves for diagnostic purposes." This involves interacting directly with the patient's body (in vivo) to elicit a response for diagnosis.
- Device Description: The device description confirms it's a magnetic stimulator that applies magnetic stimulation to tissue. This is an external application to the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body (in vitro).
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. The Delphi Stimulator's function is to stimulate the body itself for diagnostic purposes, which falls under the category of a therapeutic or diagnostic device used on the patient, not with patient samples.
N/A
Intended Use / Indications for Use
The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
Delphi stimulator is a Magnetic stimulator used for Magnetic stimulation of peripheral nerves for diagnostic purposes. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The Delphi stimulator is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue.
The stimulator consists of power electronics to generate the magnetic field in the Magnetic Coil. It is controlled via a user interface installed on a PC workstation connected to the stimulator. enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 3 pulses per second (pps).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Delphi Stimulator underwent successful nonclinical bench tests to establish substantially equivalent performance including EMC and electrical safety per IEC 60601-1 and IEC 60601-1-2, demonstration of compliance with IEC 60601-4-2, software validation, performance bench testing as well as comparative testing. The results of the bench testing support the safety profile of the device and demonstrate that the device functions as intended.
Test: Stimulator Output Comparison to Predicate
Test Method Summary: Stimulation output was measured in SMT units (Electrical field) and compared to the predicate (per FDA Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems)
Results: The obtained results demonstrated substantial equivalency
Test: System verification testing
Test Method Summary: The device was operated at various intensities to verify it functions as intended
Results: No failures were observed; test passed.
Test: ASCA test for basic safety and essential performance
Test Method Summary: Testing per IEC 60601-1 and IEC 60601-1-2
Results: Pass
Test: Software testing
Test Method Summary: Software testing per the requirement of the software life cycle as defined in IEC 62304:2006 Amendment 2015 - Medical device software - Software life cycle processes.
Results: Pass
Test: Cybersecurity assessment
Test Method Summary: Evaluation of threat per: - FDA Guidance, Post-market Management of Cybersecurity in Medical Devices - FDA Guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. - AAMI TIR57:2016Principles for Medical Device Security-Risk Management - FDA Guidance, Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act
Results: No vulnerabilities were found; labeling includes all required elements addressing cybersecurity
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
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
November 5, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
QuantalX Neuroscience % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 6026 Beech Cove Lane Charlotte, North Carolina 28269
Re: K242345
Trade/Device Name: Delphi Stimulator Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: August 5, 2024 Received: August 7, 2024
Dear Bosmat Friedman:
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.
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"
1
(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 OS 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 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-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 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 Rue"). 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-advicecomprehensive-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-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).
2
Sincerely,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242345
Device Name Delphi Stimulator
Indications for Use (Describe)
The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
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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4
Image /page/4/Picture/0 description: The image shows the word "Quantalx" in a bold, sans-serif font. Below the word "Quantalx" is the word "Neuroscience" in a smaller, purple font. The word "Neuroscience" is flanked by two small dots.
Traditional 510(k)
510(k) Summary
510(k) Summary [Traditional 510(k)] Delphi Stimulator 510(k) Number K242345
1 SUBMITTER
Applicant's Name: QuantalX Neuroscience 1 Hatachana St. Kfar-Saba Israel Primary Contact:
Bosmat Friedman Regulatory Affairs Consultant 6026 Beech Cove Ln. Charlotte, NC 28269 Phone: 980-308-1636 bosmat.f(@promedoss.com
Date Prepared: August 1, 2024
2 DEVICE Trade Name: Delphi Stimulator Classification Code: Device: Stimulator, Electrical, Evoked Response Product Code: GWF Regulation No: 21 CFR 882.1870 Class: 2 Review Panel: Neurology
3 PREDICATE DEVICE
Primary Predicate:
- MagPro, Model R20, by Tonica Elektronik A/S. Product code: GWF, cleared under: . K160280.
4 DEVICE DESCRIPTION
Delphi stimulator is a Magnetic stimulator used for Magnetic stimulation of peripheral nerves for diagnostic purposes. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The Delphi stimulator is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue.
The stimulator consists of power electronics to generate the magnetic field in the Magnetic Coil. It is controlled via a user interface installed on a PC workstation connected to the stimulator. enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a
5
frequency of up to 3 pulses per second (pps).
5 INDICATIONS FOR USE
The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
SUBSTANTIAL EQUIVALENCE 6
The Delphi Stimulator is substantially equivalent to the predicate device based on the following:
7 INTENDED USE
The intended use of the proposed device is the same as that of the cleared device.
8 TECHNOLOGY
The Delphi Stimulator device has similar overall technological characteristics as the predicate MagPro R20 (K160280). Both devices are comprised of a stimulator box and an attached probe. The stimulator box of both devices consists of power electronics circuitry which enables the action of accumulating energy in high voltage capacitor bank and discharge it rapidly on the probe load creating stimulation magnetic energy. Both devices have the same biphasic output stimulation shape and a very similar pulse width. Overall, the devices are very similar, however, the maximal available Delphi Stimulator output parameters are slightly lower than those of the predicate (per design). A comparative assessment between the Delphi Stimulator and predicate was conducted demonstrating that 100% amplitude of the Delphi stimulator is identical to 83% amplitude of the predicate device, and both have the same biphasic pulse duration. With respect to magnetic field parameters, the Peak Magnetic field strength at 2 cm [Tesla] at stimulators maximum output is 0.374 T for Delphi and 0.45 T for the predicate which correspond to 83% of predicate device which still provides the appropriate range for peripheral nerve stimulation for majority of cases with the likelihood of reduced occurrence of adverse events.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Attribute | Delphi Stimulator | MagPro R20 + MC-B65HO-2m | |
| Tonica Elektronik A/S | Comparison | ||
| 510(k) Number | NA | K160280 | -- |
| Classification | GWF | GWF | Same |
| Regulation Number | 882.1870 | 882.1870 | Same |
| Indications | |||
| for use | The Delphi Stimulator is intended to | ||
| be used for stimulation of peripheral | |||
| nerves for diagnostic purposes. | MagPro R20 is intended to be used for | ||
| stimulation of peripheral nerves for | |||
| diagnostic purposes. | Same | ||
| Probe (coil) | |||
| Probe configuration | Figure-8 coil shape | Figure-8 coil shape | Same |
| Probe core material | Air core | Air core | Same |
| Probe dimensions | Inner diameter: 26.3mm | ||
| Outer diameter: 60mm | |||
| Winding height: 5.3mm | |||
| Number of windings: $2 \times (2 \times 13)$ | Inner diameter: 35mm | ||
| Outer diameter: 75mm | |||
| Winding height: 11mm | |||
| Number of windings: $2 \times (2 \times 5)$ | Similar; the | ||
| dimensions of the | |||
| Delphi Probe are | |||
| slightly smaller; the | |||
| probe and stimulator | |||
| as a system produce | |||
| the same magnetic | |||
| stimulation up to 83% | |||
| of predicate amplitude. | |||
| Output Stimulation Parameters |
6
| Quantalx | ||
|---|---|---|
· Neuroscience ·
Traditional 510(k)
510(k) Summary
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Attribute | Delphi Stimulator | MagPro R20 + MC-B65HO-2m | |
| Tonica Elektronik A/S | Comparison | ||
| Amplitude | [0 – 1.42] SMT | [0 – 1.7] SMT | Delphi amplitude is |
| slightly lower than the | |||
| predicate. | |||
| Output stimulation shape | Biphasic | Biphasic | Same |
| Pulse width | 285 $ \textmu $ sec | 280 $ \textmu $ sec | Same |
| Pulse per second | 3 pps | 20 pps | Delphi maximal pps is |
| lower than the | |||
| predicate. | |||
| Maximum coil current at coil | |||
| SMT | 5260A peak @ 1.42 SMT | 6630A peak @ 1.7 SMT | Delphi result is lower |
| than the predicate | |||
| Magnetic Field | |||
| Peak Magnetic field strength | |||
| at 2 cm [Tesla] at stimulators | |||
| maximum output | 0.374 T | 0.45 T | Delphi peak magnetic |
| field strength is | |||
| slightly lower than the | |||
| predicate. | |||
| Peak dB/dt at 2 cm [Tesla/ | |||
| $ \textmu $ sec] at stimulators | |||
| maximum output | 0.0081 | 0.01 | Delphi result is lower |
| than the predicate | |||
| Peak dB/dt at coil surface | |||
| [Tesla/ $ \textmu $ sec] at stimulators | |||
| maximum output | 0.0067 | 0.016 | Delphi result is lower |
| than the predicate | |||
| General | |||
| Input power | Power Supply: 110V–240V, 50/60 | ||
| Hz | |||
| Power consumption: Maximum | |||
| 1200VA | |||
| No isolation transformer | Power Supply via Isolation Transformer | ||
| Power Supply: 120V~, 50/60 Hz. | |||
| Power consumption: Maximum 800VA | Different; electrical | ||
| safety demonstrated | |||
| per IEC 60601-1 | |||
| Mechanical data | Dimensions (HxWxD): | ||
| 210 x 440 x 500mm | |||
| Weight: 20 kg | Dimensions (HxWxD): | ||
| 150 x 390 x 440mm | |||
| Weight: 20 kg | Similar; Delphi is | ||
| larger than the | |||
| predicate and has the | |||
| same weight | |||
| Console | Delphi consists of a power module and | ||
| a processor control module | MagPro R20 consists of a power module, a | ||
| processor module and built in displays. | Similar, however, | ||
| Delphi Stimulator does | |||
| not have a built-in | |||
| display. | |||
| User Interface | User interface located on a PC and | ||
| displays: | |||
| • Intensity display (%) | |||
| • Coil temperature | |||
| Menu display and indicators can | |||
| show: | |||
| • Repetition rate | |||
| • Pulses in train | |||
| • Number of trains | |||
| • Inter train interval | |||
| • System mode (inactive/active) | MagPro R20 has 2 displays | ||
| • Intensity display | |||
| • Coil temperature | |||
| Menu display and indicators can show: | |||
| • Repetition rate | |||
| • Pulses in train | |||
| • Number of trains | |||
| • Inter train interval | |||
| • Start delay | |||
| • Volume | |||
| • Status: enable/disable | Similar; Delphi | ||
| provides user control | |||
| over stimulation | |||
| output. |
9 DISCUSSION
Based on the comparison presented in our submission, the Delphi Stimulator shares the same indications for use as its predicate, as both are intended to be used for stimulation of peripheral nerves for diagnostic purposes. Additionally, while some technological differences do exist between the Delphi Stimulator and its predicate, comprehensive testing have demonstrated that
7
| Quantalx
| • Neuroscience • | Delphi Stimulator | |
|---|---|---|
| Traditional 510(k) | 510(k) Summary |
the device is substantially equivalent to its predicate and that the technological differences do not raise new safety and effectiveness concerns and support the company's substantial equivalency claim.
10 PERFORMANCE DATA
The Delphi Stimulator underwent successful nonclinical bench tests to establish substantially equivalent performance including EMC and electrical safety per IEC 60601-1 and IEC 60601-1-2, demonstration of compliance with IEC 60601-4-2, software validation, performance bench testing as well as comparative testing. The results of the bench testing support the safety profile of the device and demonstrate that the device functions as intended.
| Test | Test Method Summary | Results |
|---|---|---|
| Stimulator Output | ||
| Comparison to | ||
| Predicate | Stimulation output was measured in SMT | |
| units (Electrical field) and compared to the | ||
| predicate (per FDA Class II Special | ||
| Controls Guidance Document: Repetitive | ||
| Transcranial Magnetic Stimulation (rTMS) | ||
| Systems) | The obtained results demonstrated substantial | |
| equivalency | ||
| System verification | ||
| testing | The device was operated at various | |
| intensities to verify it functions as intended | No failures were observed; test passed. | |
| ASCA test for basic | ||
| safety and essential | ||
| performance | Testing per IEC 60601-1 and IEC 60601-1- | |
| 2 | Pass | |
| Software testing | Software testing per the requirement of the | |
| software life cycle as defined in IEC | ||
| 62304:2006 Amendment 2015 - Medical | ||
| device software - Software life cycle | ||
| processes. | Pass | |
| Cybersecurity | ||
| assessment | Evaluation of threat per: |
- FDA Guidance, Post-market
Management of Cybersecurity in
Medical Devices - FDA Guidance, Cybersecurity in
Medical Devices: Quality System
Considerations and Content of
Premarket Submissions. - AAMI TIR57:2016Principles for
Medical Device Security-Risk
Management - FDA Guidance, Select Updates for the
Premarket Cybersecurity Guidance:
Section 524B of the FD&C Act | No vulnerabilities were found; labeling includes all
required elements addressing cybersecurity |
11 CONCLUSION
The Delphi Stimulator has similar intended use, technological characteristics, and principles of operation as the predicate. Any differences between the subject and predicate device were evaluated through design verification and validation testing and comparative testing which
8
| Quantalx
| · Neuroscience · | Delphi Stimulator | |
|---|---|---|
| Traditional 510(k) | 510(k) Summary |
demonstrated device performance and safety, and do not raise any new questions of safety and effectiveness.
Based on the information submitted in this 510(k), the Delphi Stimulator is substantially equivalent to the currently marketed predicate MagPro R20.