The MagVenture Pain Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic and post-surgical pain. The subject device is intended to be used in hospitals and clinics such as pain management clinics. The device consists of Magnetic Stimulator, Stimulation Coils, Liquid Cool Unit (optional), and a Trolley. All coils of the MagVenture Pain Therapy have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the skin of the patient or operator. The temperature allowed by the system is maximum 43°C or between 44°C for less than 10 minutes. The system will automatically disable if this maximum temperature is reached.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the MagVenture Pain Therapy device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness. Therefore, the information regarding specific acceptance criteria and a study proving those criteria are not directly presented in the format requested for a device with novel claims.

However, based on the document, we can infer acceptance criteria from the comparison to the predicate device and the discussion of technological characteristics. The study proving the device meets these inferred criteria is essentially a comparison study against the predicate device and an assessment of why any differences do not raise new questions of safety or effectiveness.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for a 510(k) are typically that the new device is "substantially equivalent" to a predicate device, meaning it has the same intended use and either has the same technological characteristics or, if it has different technological characteristics, those do not raise different questions of safety and effectiveness. The performance is reported by comparing it to the predicate.

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance (MagVenture Pain Therapy)
Intended Use: Stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.	Same as predicate device, Axon Therapy (K210021).
Anatomical Sites: Similar range of application areas.	Same as predicate device.
Treatment Facilities: Hospitals & Clinics.	Same as predicate device.
Treatment Time: 13 min per session (800 seconds).	Same as predicate device.
Pulse Amplitude: 0-100%.	Same as predicate device.
On-cycle duty period: 2-800 seconds (0.5 Hz and up to 400 pulses)	Same as predicate device.
Off-cycle reset period: N/A.	Same as predicate device.
Pulse Mode: Standard.	Same as predicate device.
Maximum coil temperature: 43°C (system automatically disables if reached).	Same as predicate device (predicate 41°C, but both disable at max).
Software/Firmware/Microprocessor control: Yes.	Same as predicate device.
Power Source: Similar electrical specifications.	Similar (subject: 120V~, 50/60 Hz; predicate: 110V to 220V ac, 50/60 Hz). Deemed "Same".
User Interface: LED display.	Same as predicate device.
Sterilization: Non-sterile when used.	Same as predicate device.
Electrical Safety: Complies with IEC60601-1 v3.1.	Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same".
Mechanical Safety: Complies with IEC60601-1 v3.1.	Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same".
Chemical Safety: Complies with IEC60601-1 v3.1.	Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same".
Thermal Safety: Complies with IEC60601-1 v3.1.	Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same".
Radiation Safety: No radiation generated.	Complies (from predicate, implies no radiation). Deemed "Same".
Biocompatibility: Complies with ISO 10993.	Complies with ISO 10993 (from predicate). Deemed "Same".
Standards: Company complies with EN ISO 13485.	Complies (from predicate). Deemed "Same".
Pulse frequency: Acceptable range without new safety/effectiveness questions.	0.1-30 Hz (pps) for R30, 0.1-100 Hz (pps) for X100. Predicate: 0-2 Hz (pps). Deemed "Substantially equivalent" because 0.5 Hz is shared and higher rates are physiologically within range.
Maximum repetition rate: Acceptable rate without new safety/effectiveness questions.	30 pps for R30, 100 pps for X100. Predicate: 2 pps. Deemed "Substantially equivalent" for reasons similar to pulse frequency.
Pulse Width: Biphasic (similar µsec).	Biphasic (280-320 µsec). Predicate: Biphasic (290 µsec). Deemed "Substantially equivalent".
Maximum output power: Acceptable power without new safety/effectiveness questions.	100% at 15 pps for subject. Predicate: 100% at 2 pps. Deemed "Substantially equivalent" because both achieve 100% at 2 pps.
Waveform: Biphasic functionality.	Biphasic (and Monophasic for X100). Predicate: Biphasic. Deemed "Substantially equivalent" because all can do biphasic.
Peak Magnetic Field at coil surface (T): No new issues.	1.15-2.6 T*. Predicate: Not publicly available. Deemed "Substantially equivalent".
Peak Magnetic Field Gradient dB/dt in coil center at 20mm distance from coil surface: No new issues.	9-24 kT/s*. Predicate: Not publicly available. Deemed "Substantially equivalent".
Housing Material Construction: No new safety issues.	Stimulator: Aluminum, Aluzinc; Coils: PVC, ABS, PA, POM. Predicate: Stimulator: Al sheet EN AW 5754; Coil: ABS. Deemed "Substantially equivalent".
Applied Parts: Magnetic coils, no new safety issues.	Various coils (MMC-140-II, MCF-140, RT-120-II, MMC-90, MCF-125, Cool-B65, Cool-125). Predicate: Magnetic coil 60BF-NL. Deemed "Substantially equivalent".
Applied Parts area: Acceptable coil dimensions.	Butterfly coils: 150 mm; Circular coils:110-126 mm; Special coils: 160x80 mm. Predicate: 160 mm. Deemed "Substantially equivalent".

The "study" demonstrating these criteria are met is the comparison presented in the 510(k) submission, specifically the "Comparison of Technological Characteristics" table and the "Substantial Equivalence Notes" which explain why differences do not raise new safety or effectiveness questions.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the traditional sense of a clinical trial. Instead, the "testing" references non-clinical testing performed on the predicate device (K094019) and the argument that the current device is "identical in all features (e.g., design, dimensions, materials, biocompatibility), except for the indications for use." Therefore, "no new bench testing is needed."

This implies that the "data provenance" for the foundational performance characteristics comes from the testing previously conducted for the predicate devices (MagPro Family device K094019 and Axon Therapy K210021), not a new test set for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a 510(k) submission based on substantial equivalence, not a de novo clinical study with a new "test set" requiring expert ground truth establishment. The ground truth for safety and effectiveness is established by the prior clearance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, there is no new clinical "test set" with adjudication.

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

Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator for Pain Relief, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (magnetic stimulator), not an algorithm or AI system. Its performance is intrinsic to the device's physical operation, not an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the safety and effectiveness of the device's underlying technology and performance characteristics is established through:

Prior FDA clearances: The substantial equivalence relies on the fact that the predicate devices (MagPro Family and Axon Therapy) were previously cleared by the FDA based on their demonstrated safety and effectiveness.
Compliance with recognized standards: The document explicitly states compliance with standards like IEC60601-1 v3.1 (electrical, mechanical, chemical, thermal safety) and ISO 10993 (biocompatibility). These standards represent established "ground truths" for various aspects of device safety.
Physiological understanding: The justification for wider pulse frequencies and repetition rates refers to the "range of physiological action potentials (from 0.05 to 500 Hz) of the human nervous system," indicating an appeal to established physiological knowledge as a "ground truth" for safety.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

August 25, 2023

Tonica Elektronik A/S Dr. Kirstine Schou Medical Writer MagVenture A/S Lucernemarken 15 Farum, DK-3520 Denmark

Re: K230014

Trade/Device Name: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: OPL Dated: August 8, 2023 Received: August 8, 2023

Dear Dr. Schou:

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 medical devices and radiation-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.

AmberT. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230014

Device Name

MagVenture Pain Therapy: MagPro R30 with MagOption, MagPro X100, MagPro X100, MagPro X100 with MagOption

Indications for Use (Describe)

To stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older

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)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Traditional 510(k) Premarket Submission MagVenture Pain Therapy TONICA ELEKTRONIK A/S

Image /page/3/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one blue and one red, that are connected. The puzzle pieces are arranged vertically, with the blue piece on top and the red piece on the bottom.

510(k) Summary

510(k) Number K230014

DATE PREPARED

08/25/2023

MANUFACTURER AND 510(k) OWNER

Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum, Denmark Telephone: +45 4499 1544 Official Contact: Jan Kjøller

REPRESENTATIVE

Kirstine Klitgaard Schou, Ph.D. Email: kks(@magventure.com Telephone: +45 6114 6675

DEVICE INFORMATION

Proprietary Name/Trade Name: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption

Common name:	Electromagnetic stimulator, pain relief
Regulation Number:	21 CFR 882.5890
Regulation Name:	Transcutaneous electrical nerve stimulator for pain relief
Class:	Class II
Product Code:	QPL
Review Panel:	Physical Medicine

PREDICATE DEVICE IDENTIFICATION

The MagVenture Pain Therapy (K230014) is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Predicate
K210021	Axon Therapy/ NeuraLace Medical, Inc.	√

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one blue and one red. The puzzle pieces are interlocked, with the blue piece on top and the red piece on the bottom. The image appears to be a logo or branding element for the company Tonica Elektronik A/S.

DEVICE DESCRIPTION

INDICATIONS FOR USE

The MagVenture Pain Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Tonica Elektronik A/S believes that the MagVenture Pain Therapy is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar design and dimensions and uses similar or identical materials as the predicate device cleared in K210021. The subject device has identical technological characteristics to the MagPro Family cleared in K091940. These technological characteristics have undergone testing ensuring that the device is as safe and effective as the predicate. While both the subject and predicate device are magnetic stimulators, with similar technological characteristics, and stimulation patterns, the subject device includes circular magnetic coils in addition to the butterfly geometry of the predicate devices differ in the ranges of pulse frequencies, maximum repetition rates, and maximum output power. As discussed below, these technological differences do not raise different questions of safety and effectiveness.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image contains the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue. To the right of the text are two puzzle pieces, one red and one blue, that are connected together.

Items	Subject device			Predicate device	Statement ofequivalence
Trade Name	MagVenture Pain Therapy			Axon Therapy	Not applicable
Model Name	MagPro R30(K091940)	MagPro X100(K091940)	MagPro X100with MagOption(K091940)	MagPro X100with MagOption(K091940)	Not applicable
510(k)	K230014			K210021	Not applicable
Manufacturer	Tonica Elektronik A/S			NeuraLace Medical, Inc.	Not applicable
Product codes/RegulationNumbers	QPL (21 CFR 882.5890)			QPL (21 CFR 882.5890)IPF (21 CFR 890.5850)	Same
Indications for use	The MagVenture Pain Therapy is intended to stimulate peripheral nerves forrelief of chronic intractable, post traumatic and post-surgical pain forpatients 18 years or older.			The Axon Therapy isintended to stimulateperipheral nerves for reliefof chronic intractable, posttraumatic and post-surgicalpain for patients 18 andolder	Same
Anatomical sites	Any area, such as hand, arm,waist, buttock, thigh, calf, back and lower backetc.			Any area, such as hand, arm,chest, waist, buttock, thigh,calf, back and lower backetc.	Same
Treatment Facilities	Hospitals & Clinics			Hospitals & Clinics	Same
Treatment time	13 min per session (800 seconds)			13 min per session (800seconds)	Same
Pulse frequency	0.1-30 Hz (pps)	0.1-100 Hz (pps)		0-2 Hz (pps)	Substantially equivalentRefer to SE note 1
Pulse amplitude	0-100%			0-100%	Same

On-cycle dutyperiod	2-800 seconds(0.5 Hz and up to 400 pulses)		2-800 seconds(0.5 Hz and up to 400 pulses)	Same
Off-cycle resetperiod	N/A		N/A	Same
Maximumrepetition rate	30 pulses per second	100 pulses per second	2 pulses per second (pps)	Substantially equivalentRefer to SE note 1
Pulse Width	Biphasic (280-320 µsec)		Biphasic (290 µsec)	Substantially equivalent
Pulse mode	Standard		Standard	Same
Maximum outputpower	100% at 15 pps		100% at 2 pps	Substantially equivalentRefer to SE note 2
Waveform	Biphasic	Biphasic,Monophasic	Biphasic	Substantially equivalentAll devices are capableof biphasic mode
Maximum coiltemperature	43°C		41°C	Same.The system willautomatically disable ifthis maximumtemperature is reached
Peak MagneticField at coil surface(T)	1.15-2.6 T*		Not publicly available	Substantially equivalentRefer to SE note 3
Peak MagneticFieldGradient dB/dt incoil center at 20mmdistance from thecoil surface	9-24 kT/s*		Not publicly available	Substantially equivalentRefer to SE note 3
Software/Firmware/Microprocessorcontrol	Yes		Yes	Same
Power Source	Power Supply via Isolation TransformerPower Supply: 120V~, 50/60 Hz.Power consumption: Maximum 2700VA		Power Supply: 110V to220V ac, 50/60 Hz.Power consumption: 800VAMaximum, 115W idle	Same
User Interface	LED display		LED display	Same

{6}------------------------------------------------

Traditional 510(k) Premarket Submission MagVenture Pain Therapy TONICA ELEKTRONIK A/S

Image /page/6/Picture/1 description: The image shows the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue. To the right of the text are two puzzle pieces, one blue and one red, that are partially connected.

{7}------------------------------------------------

Traditional 510(k) Premarket Submission MaqVenture Pain Therapy TONICA ELEKTRONIK A/S

Image /page/7/Picture/1 description: The image shows the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue. To the right of the text are two puzzle pieces, one red and one blue, that are connected.

Housing MaterialConstruction	Stimulator: Aluminum, AluzincCoils: PVC, ABS, PA, POM	Stimulator: Al sheet EN AW5754Coil: ABS	Substantially equivalent
Applied Parts	Magnetic coils:MMC-140-II (K061645)MCF-140 (K061645)RT-120-II (K061645)MMC-90 (K061645)MCF-125 (K071821)Cool-B65 (K071821)Cool-125 (K071821)	Magnetic coil 60BF-NL	Substantially equivalentRefer to SE note 3
Applied Parts area	Butterfly coils: 150 mmCircular coils:110-126 mmSpecial coils: 160×80 mm	160 mm	Substantially equivalentRefer to SE note 3
Sterilization	Non-sterile when used	Non-sterile when used	Same
	PERFORMANCE DATA
Electrical Safety	Complies with IEC60601-1 v3.1	Complies	Same
Mechanical Safety	Complies with IEC60601-1 v3.1	Complies	Same
Chemical Safety	Complies with IEC60601-1 v3.1	Complies	Same
Thermal Safety	Complies with IEC60601-1 v3.1	Complies	Same
Radiation Safety	No radiation generated	Complies	Same
Biocompatibility	Complies with ISO 10993	Complies	Same
Standards	Company complies with EN ISO 13485	Complies	Same

*No technological differences from K.(91940, but the definition of Peak Magnetic Field at coil surface changed. Likewise Field Gradient at coil surface changed to lower values at a distance of 20mm from coil surface.

Substantial Equivalence Note 1

Comparison of subject and predicate pulse frequencies and maximum repetition rates.

The pulse frequencies of 0.1-30 Hz and maximum repetition rates of 30 pps and 100 pps of the subject device are wider and higher, respectively, than the predicate device with pulse frequencies of 0-2 Hz and a maximum repetition rate of 2 pps. These differences do not raise different questions of safety and effectiveness since:

The subject device can stimulate at 0.5 Hz the same as the predicate device. O
In the instructions for use, it is specified that the treatment parameter is 0.5 Hz. O

{8}------------------------------------------------

Traditional 510(k) Premarket Submission MaqVenture Pain Therapy TONICA ELEKTRONIK A/S

Image /page/8/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one red and one blue. The blue puzzle piece is located above and to the right of the red puzzle piece. The image appears to be a logo for Tonica Elektronik A/S.

o The maximum repetition rates of 30 and 100 Hz are both within the range of physiological action potentials (from 0.05 to 500 Hz) of the human nervous system and thus pose no new risk to the patients.
The subject device is substantially equivalent to the following treatment protocol as outlined in the O instructions for use. Treatment parameters (e.g., repetition rate, pulses per trains, number of pulses, inter train interval, treatment time) that are not included in the treatment protocol have not been evaluated for effectiveness in the relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.

TREATMENT PROTOCOL

Three to four treatments over two months and maintenance therapy every 6 to 8 weeks is recommended.

Treatment level:	Individually estimated (% of maximum output power)
Repetition rate:	0.5 pps
Pulses per train:	10
Number of trains:	40
Number of pulses:	400
Inter train interval:	2 s
Treatment time:	13 min

In conclusion, higher ranges of pulse frequencies and higher maximum repetition rates do not raise any new or different questions of safety and effectiveness.

Substantial Equivalence Note 2

Comparison of subject and predicate maximum output power.

The maximum output power of the subject device is 100% in the range of 0.1 to 15 pps while the predicate device is 100% in the range of 0.5 to 2 pps. Consequently, at 2 pps the subject device are both able to obtain a maximum output of 100% signifying they are equally effective.

In conclusion, since both devices perform 100% at 2 pps there are no new issues of safety and effectivence in maximum output power does not raise new or different questions of safety and effectiveness.

Substantial Equivalence Note 3

Comparison of Subject and Predicate Magnetic Coils

{9}------------------------------------------------

Traditional 510(k) Premarket Submission MaqVenture Pain Therapy TONICA ELEKTRONIK A/S

Image /page/9/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one red and one blue. The puzzle pieces are interlocked, with the red piece slightly below and to the left of the blue piece.

The subject device has both circular and butterfly coils while the predicate only has a butterfly coil. However, all the coils are basically constructed the same way: A cobber winding element encapsulated in a plastic housing.

The size of the magnetic field depends on the diameter and number of windings only varies slightly and the diameters of the subject device coils are close to the predicate coil.

Except for minor differences in geometry, the butterfly coils of the predicate and subject devices are similar. In comparison to the butterfly geometry, the circular coil element. This gives a better usability with no roation limitation. All coils achieve the same intended use. The differences in the electric field and spatial characteristics (maximum magnetic fields at the coil surface (T) and the magnetic gradients (dB/dt)) of the circular and butterfly geometries are negligible and have no documented impact on effectiveness or safety of the intended use.

It is concluded that the differences in coil geometry do not raise new or different questions of safety and effectiveness.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one blue and one red. The puzzle pieces are interlocked, with the blue piece on top and the red piece on the bottom.

SUMMARY OF NON-CLINICAL TESTING

The subject device is identical to the MagPro Family device (K094019) in all features (e.g., design, dimensions, materials, biocompatibility), except for the indications for use. Therefore, no new bench testing is needed.

DISCUSSION

The subject device has the same intended use, indications for use, and similar technological characteristics, and principles of operation as the predicate device. Also, the target population, the dosage, the treatment procedure, and all specific protocol parameters (intensity, repetition rate, number of pulses) are identical for the subject and the predicate device.

The subject device has a broader range of pulse frequencies and higher maximum repetition rates compared to the predicate device. Still, both devices are able to run the stimulation protocol of 400 pulses at 0.5 Hz. Furthermore, the maximum repetition rates of the predicate device are all within the range of physiological action potentials of the human nervous system and thus pose no new risk to the patients. The maximum output power of the subject device is higher than the predicate devices. Nevertheless, both devices perform 100% at 2 pps signifying they are equally effective. The subject device is substantially equivalent to the predicate device for the treatment protocol as described above. Treatment parameters (e.g., repetition rate, pulses per train, number of trains, number of pulses, inter train interval, treatment time) that are not included in the treatment protocol above have not been evaluated for effectiveness in the relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.

Finally, the subject device has both circular and butterfly coils while the predicate only has a butterfly coil. However, all the coils are basically constructed the same way: a cobber winding element encapsulated in a plastic housing. Except for minor differences in geometry, the butterfly coils of the predicate and subject devices are similar. In comparison to the butterfly geometry, the circular coils have just one coil element. This gives a better usability with no rotation limitation. All coils achieve the same intended use. The differences of the circular and butterfly geometries are negligible and do not raise new or different questions of safety and effectiveness.

CONCLUSION

Except for the indication for use, the subject device is identical to the previously cleared MagPro family device. Thus, software validation, electrical safety testing, and performance testing can be leveraged for this device. The similar indications for use, stimulation patterns, technological characteristics, and performance characteristics for the proposed MagVenture Pain Therapy are assessed to be substantially equivalent to the predicate device.

{11}------------------------------------------------

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).