The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore, and MagnetiKa, consists of a main unit, handpiece tools, and a power cable. The main unit has a power supply unit, a control unit, and a cooling unit. The control unit has a control element and a liquid crystal display. The handpiece tools have electromagnetic induction coils and cooling fans, it is a non-invasive device.

The device generates an electromagnetic field that interacts with human body tissues, aiding in muscle stimulation to strengthen and tone the abdomen, buttocks, and thighs. With two outputs, it allows simultaneous treatment using two applicators.

AI/ML Overview

This document is a 510(k) summary for a medical device (Electromagnetic Stimulator Device, EMS) for muscle conditioning. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about clinical study acceptance criteria and device performance based on those criteria, which would be typical for an AI/ML medical device.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic accuracy, sample size for test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training/test sets) are not present in this document because they are characteristic of a different type of medical device submission (e.g., an AI-based diagnostic tool) and are not required for demonstrating substantial equivalence for a physical muscle stimulator.

The provided text details non-clinical tests and comparisons of physical and functional characteristics.

Here's an analysis based on the provided document:

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

The document does not present "acceptance criteria" in terms of diagnostic accuracy metrics or clinical outcomes with corresponding performance values that would be typical for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence in terms of technical characteristics and safety/performance standards.

The acceptance criteria here are implicitly related to meeting the "substantial equivalence" definition, meaning the device is as safe and effective as the predicate. The "performance" is shown through the comparison table and non-clinical testing.

Implicit Acceptance Criteria and Reported Performance (from the Comparison Table and Non-Clinical Tests Summary):

Acceptance Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance (Subject Device)
Intended Use/Indications for Use	Must be identical to the predicate device.	Identical: Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen; Strengthening, toning, and firming of buttocks and thighs.
Principle of Action	Must be identical to the predicate device.	Identical: Initiating action potential of nerves results in muscle contraction.
Energy Type	Must be identical to the predicate device.	Identical: Magnetic field.
Magnetic Field Intensity	Within acceptable range of the predicate device.	Maximum Magnetic Field Intensity at Applicator Center Surface: 1.0T ± 20%. The document states: "The maximum field intensity at the center surface of the applicator is 1.0T, in comparison to 1.154T for the predicate device. Nonetheless, the magnetic field intensity falls within the acceptable range of the predicate device."
Pulse Repetition Rate	Identical to the predicate device.	1 – 150 Hz. Identical to predicate.
Pulse Duration	Within acceptable range, demonstrating safety and effectiveness.	270 ± 20% µs. The document states: "The subject device has a slightly shorter pulse width compared to the predicate device but falls within the range between the predicate and reference devices." This is implicitly accepted as equivalent or safer.
Induced Current in Tissues	Comparable to or safer than the predicate device while achieving the same effect.	20.6mA. The document states: "The current induced in the tissue by the subject device is lower than that of the predicate device (28-30mA), making it safer while achieving the same effect." This is implicitly accepted as safer and equivalent for effect.
Safety and Essential Performance	Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10.	Non-clinical tests demonstrated compliance with these standards (ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010((R)2012; IEC 60601-1-2:2014; IEC60601-2-10:2016).
Usability	Conformance to IEC 60601-1-6.	Non-clinical tests demonstrated compliance with IEC 60601-1-6: 2013.
Biocompatibility	Conformance to ISO 10993-5, ISO 10993-10.	Non-clinical tests demonstrated compliance with ISO 10993-5:2009 and ISO10993-10:2010.
Software Verification & Validation (V&V)	Software V&V testing conducted as per FDA guidance for "moderate" level of concern software.	"Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff... The software was considered as a 'moderate' level of concern." This indicates the V&V was successful per the guidance.
Physical Characteristics (e.g., dimensions)	Any differences in physical characteristics should not impact safety or effectiveness.	System Dimensions: 525x433x1279mm/640×560×1390mm (varying from predicate's 500×1380×580 mm). The document states: "The varying dimensions do not impact the safety or effectiveness of the device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes non-clinical engineering and safety compliance tests, not clinical performance studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Ground truth establishment by experts is relevant for AI-based diagnostic devices where human interpretation is the gold standard or part of the evaluation. This document is for a physical muscle stimulator.

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

This information is not applicable and not provided. Adjudication methods are used in clinical studies, particularly for diagnostic accuracy assessments, which are not detailed here.

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

This information is not applicable and not provided. MRMC studies are typically for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. This device is not an AI-based diagnostic tool.

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

This information is not applicable and not provided. Standalone performance is a metric for AI algorithms. This device does not feature such an algorithm. It's a physical muscle stimulator.

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

This information is not applicable and not provided. "Ground truth" in the context of this submission refers to the performance of the predicate device and the established safety and performance standards (like IEC and ISO). There isn't a "ground truth" derived from patient outcomes or expert consensus on a diagnostic task, as this is not a diagnostic device.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML device that requires machine learning training sets.

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

This information is not applicable and not provided. Similar to point 8, this is not an AI/ML device requiring labeled training data.

Summary

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February 25, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

CPMT LASER (Canadian Pioneer Medical Technology Corporation) Dr. Rashid Reza Mir Sayah Managing Director 460 Garyray Drive, North York Toronto, ON M9L1P8 Canada

Re: K241601

Trade/Device Name: EMS (FlexPulse, MagnaCore, Magnetika) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 4, 2024 Received: June 4, 2024

Dear Dr. Sayah:

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"

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(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).

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Sincerely, Tushar Bansal -S

for Heather Dean, PhD

Assistant Director, Acute Injury Devices Team 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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Indications for Use

Submission Number (if known)

K241601

Device Name

Electromagnetic Stimulator Device (FlexPulse, MagnaCore, MagnetiKa)

Indications for Use (Describe)

The device is indicated to be used for:

· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

· Strengthening, Toning and Firming of buttocks and thigh
Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) summary

Submitter:

CPMT Laser (Canadian Pioneer Medical Technology Corporation) 460 Garyray Drive #1, North York, Toronto, ON, M9L 1P8, Canada Contact Person: Dr. Rashid Reza Mir Sayah Phone: (437) 772-7788 Email: canadianpioneer@yahoo.com Date Prepared: February 10, 2025

Subject Device:

Trade/Device Name: Electromagnetic Stimulator Device Models: FlexPulse, MagnaCore, MagnetiKa Regulation Number: 21CFR 890.5850 Regulation Name: Stimulator, Muscle, Powered, For Muscle Conditioning Regulatory Class: II Product code: NGX 510(k) number: K241601 Manufacturer: CPMT Laser (Canadian Pioneer Medical Technology Corporation)

Predicate Device:

Trade/Device Name: BTL 799-2 Regulation Number: 21CFR 890.5850 Regulation Name: Stimulator, Muscle, Powered, For Muscle Conditioning Regulatory Class: II Product code: NGX 510(k) number: K180813 Manufacturer: BTL Industries, Inc.

Device Description:

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Indications for Use:

The device is indicated to be used for:

Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
Strengthening, Toning and Firming of buttocks and thighs.

Comparison of Technological Characteristics with the Predicate Device:

Substantial equivalence discussion

The comparison and discussion between the subject device and the predicate device is listed in the table below:

	Subject Device	Predicate Device	ReferenceDevice	Comparison
510(K)	K241601	K180813	K190456	-
Manufacturer	CPMT Laser	BTL Industries,Inc.	BTL Industries,Inc.	-
Trade Name	EMS	BTL 799-2	BTL 799-2L	-
Regulationnumber	21 CFR 890.5850	21 CFR890.5850	21 CFR890.5850	Identical (thesame)
RegulationName	Powered musclestimulator	Powered musclestimulator	Poweredmusclestimulator	Identical (thesame)
Product code	NGX	NGX	NGX	Identical (thesame)
Class	II	II	II

Table: Substantial equivalence comparison

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Indications foruse/Intendeduse	The device isindicated to beused for:	The device isindicated to beused for:	The device isindicated to beused for:
	• Improvement ofabdominal tone,strengthening ofthe abdominalmuscles,development offirmer abdomen.• Strengthening,Toning andFirming of buttocksand thighs.	• Improvement ofabdominal tone,strengthening ofthe abdominalmuscles,development offirmer abdomen.• Strengthening,Toning andFirming ofbuttocks andthighs.	• Improvementof abdominaltone,strengtheningof theabdominalmuscles,development offirmerabdomen.• Strengthening,Toningand Firmingof buttocksandthighs.	Identical

Primary Function	Muscle stimulation	Muscle stimulation	Muscle stimulation	Identical
Principal of Action	Initiating action potential of nerves results in muscle contraction	Initiating action potential of nerves results in muscle contraction	Initiating action potential of nerves results in muscle contraction	Identical
User Interface	Touch screen	Touch screen	Touch screen	Identical
Touch Screen size	15.6 inches	15.6 inches	15.6 inches	Identical
Firmware Controlled	Yes	Yes	Yes	Identical
Type of Energy	Magnetic field	Magnetic field	Magnetic field	Identical
Magnetic Field Intensity (on the coil surface)	0.5-1.8T,±20%	299-6 applicator:0.5–1.8 T	BTL 299-6 applicator: 0.5 - 1.8 T ,±20%BTL 299-7 applicator: 0.7 - 2.0 T ,±20%	Identical
Number of Outputs	2	2	2	Identical

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Maximum Magnetic Field Intensity at Applicator Center Surface	1.0T±20%	BTL 299-6 applicator: 1.154 T±20%;	BTL 299-6 applicator: 1.154 T±20%;BTL 299-7 applicator: 1.173 T±20%.	The maximum field intensity at the center surface of the applicator is 1.0T, in comparison to 1.154T for the predicate device. Nonetheless, the magnetic field intensity falls within the acceptable range of the predicate device.
Number of Magnetic Coils in the Applicator	1	1	1	Identical
Type of Operation	Continuous	Continuous	Continuous	Identical
Pulse Repletion Rate	1 – 150 Hz	1 – 150 Hz	1 – 150 Hz	Identical
Pulse Duration	$270 \pm 20% \mu s$	$280 \pm 20% \mu s$	BTL 299-6applicator: $280 \pm 20% \mu s$BTL 299-7applicator: $190 \pm 20% \mu s$	The subject device has a slightly shorter pulse width compared to the predicate device but falls within the range between the predicate and reference devices.
Pulse Amplitude	0 – 100%, step 1%	0 – 100%	Not publicly available	Identical
Selection ofparameters(Intensity, Time)	Yes	Yes	Yes	Identical
Shape ofStimulationPulse	Symmetrical Biphasic Sine Wave	Symmetrical Biphasic Sine Wave	Symmetrical Biphasic Sine Wave	Identical
Induced Currentin the Tissues	20.6mA	28-30mA	Not Publicly Available	The current induced in the tissue by the subject device is lower than that of the predicate device, making it safer while achieving the same effect.

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Therapy Time	Up to 60 min	Up to 60 min	Up to 60 min	Identical
Application	Hands-free,applicator fixed byfixation belt	Hands-free,applicator fixed byfixation belt	Hands-free,applicator fixed byfixation belt	Identical
Energy Source	100–240 VAC, 50–60 Hz	100–240 VAC, 50–60 Hz	100–240 VAC, 50–60 Hz	Identical

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SystemDimensions(WxHxD)	525x433x1279mm/640×560×1390mm	500×1380×580 mm(20x55x23 in)	500×1380×580 mm(20x55x23 in)	The varyingdimensions donot impact thesafety oreffectiveness ofthe device.
EnvironmentalSpecifications	For indoor useonly	For indoor useonly	For indoor useonly	Identical
AmbientTemperature	-20°C ~ +55°C	-10°C to +55°C	-10°C to +55°C	This variationdoes not affectthe safety oreffectiveness ofthe device.
ConformanceStandard	IEC 60601-1; IEC60601-1-2; IEC60601-1-6; IEC60601-2-10	IEC 60601-1;IEC 60601-1-2;IEC 60601-1-6;IEC 60601-2-10	IEC 60601-1;IEC 60601-1-2;IEC 60601-1-6;IEC 60601-2-10	Identical
Biocompatibility	ISO 10993-5 ISO10993-10	ISO 10993-5 ISO10993-10	ISO 10993-5ISO 10993-10	Identical

Summary of Non-Clinical Tests:

Non clinical tests were conducted to verify that the subject devices met all design specifications and was substantially equivalent (SE) to the predicate device. The test

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results demonstrated that the proposed device complies with the following:

● ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010((R)2012 (Consolidated Text) Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and essential performance

● IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC60601-2-10:2016, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

● IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "moderate" level of concern.

Conclusion

The EMS device is considered to have substantial equivalence to its predicate device. The intended uses of the proposed device are included within the scope of the predicate device. All three models fall under the umbrella of the predicate device.

Non-clinical testing has shown that the device is equally safe, effective, and is substantially equivalent to the legally marketed device.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).