(133 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the physical principles of electromagnetic stimulation without mentioning any adaptive or learning algorithms.
Yes
The device is used to treat various muscle conditions, including spasms, atrophy, and to increase blood circulation and range of motion, which are therapeutic applications.
No
The device is a muscle stimulator for therapeutic use, not for diagnosing conditions. Its stated indications for use are for relaxation of muscle spasms, prevention of disuse atrophy, increasing circulation, muscle re-education, post-surgical stimulation, and maintaining/increasing range of motion.
No
The device description explicitly lists hardware components like a Control Unit, Handpiece Applicator, Applicator holder, Mains cable, and Trolley, and describes the physical principle of operation involving electromagnetic pulses generated by a treatment coil. While software is mentioned as being validated, the device is clearly a hardware-based system with accompanying software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct physical stimulation of muscle tissue for therapeutic purposes (relaxation, prevention of atrophy, circulation, re-education, prevention of thrombosis, range of motion). These are all in vivo applications, meaning they are performed on a living organism.
- Device Description: The description details a device that delivers electromagnetic pulses externally to the patient's body to stimulate muscles. This is a physical therapy or medical treatment device, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The MAGNETOLITH Muscle Stimulator does not fit this description.
N/A
Intended Use / Indications for Use
The MAGNETOLITH Muscle Stimulator is indicated for:
-Relaxation of muscle spasms,
-Prevention or retardation of disuse atrophy,
-Increase local blood circulation.
-Muscle re-education,
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
-Maintaining or increasing range of motion.
Product codes
IPF, NGX
Device Description
The MAGNETOLITH delivers electromagnetic pulses to stimulate muscle tissues by applying the Magnetic Induction Field Principle (high-energy magnetic pulses) directly over (but not in direct contact with) the patient in order to achieve the same powered muscle stimulation without having to place adhesive electrode pads directly onto the patient's body. Key components of the device are the Control Unit, Handpiece Applicator, Applicator holder, a Mains cable, and a Trolley. These device components are provided non-sterile and are intended to be reusable.
The principle of operation of the MAGNETOLITHis by the application of a treatment coil to generate electromagnetic induction. i.e., the production of voltage across an electrical conductor in a changing magnetic field. The duration of the individual pulses is short and therefore the system does not increase temperature within the tissues. In addition, the MAGNETOLITH Applicator is cooled by circulating water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Verification and validation testing was performed and demonstrated that the MAGNETOLITH meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed.
The MAGNETOLITH software was validated and demonstrated to be of a moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. While the MAGNETOLITH has cleaning and sanitation requirements, there are no body contacting components and therefore biocompatibility testing was not performed. The MAGNETOLITH was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2012; IEC 60601-6:2013; and electromagnetic compatibility requirements of IEC 60601-1-2:2014.
No performance standards applicable to this device have been adopted under Section 514 of the Act. The MAGNETOLITH complies with the applicable requirements of the following international consensus standards:
- ISO 14971:2000/A1:2007: Medical devices: Application of risk management to . medical devices.
- IEC 60601-1:2012, (Ed. 3.1): Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance.
- IEC 60601-1-2: 2014(4th Ed.): Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- . IEC 60601-1-6: 2012 (3.1 Ed.): Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 62304:2015: Medical Device Software - Software Life CycleProcess.
- ISO 13485:2016: Medical devices Ouality management systems -. Requirements for regulatory purposes.
The performance testing demonstrated that the MAGNETOLITH Muscle Stimulator is substantially equivalent to the predicate devices and that it is as safe, as effective, and performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo, which features a stylized eagle. To the right of the eagle is the FDA logo, with 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 below.
May 3, 2021
Storz Medical AG % Michael Dayton President & CEO Biomed Research, Inc. 3959 Van Dyke Road Suite 245 Lutz, Florida 33558
Re: K203710
Trade/Device Name: Storz Medical MAGNETOLITH Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, NGX Dated: February 1, 2021 Received: February 3, 2021
Dear Michael Dayton:
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 vour 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 53 1 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-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-ind-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,
Patrick Antkowiak -S
Patrick Antkowiak, PhD Assistant Director (Acting) 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) K203710
Device Name
MAGNETOLITH Muscle Stimulator
Indications for Use (Describe)
The MAGNETOLITH Muscle Stimulator is indicated for:
-Relaxation of muscle spasms,
-Prevention or retardation of disuse atrophy,
-Increase local blood circulation.
-Muscle re-education,
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
-Maintaining or increasing range of motion.
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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3
510(k) Summary
Storz Medical AG
MAGNETOLITH Muscle Stimulator
1. SPONSOR
Storz Medical AG Lohstampfestr. 8 CH-8274 Tägerwilen Switzerland
Contact Person: Pavel Novak, Ph.D. Telephone: 41 (0) 71 677 45 13 FAX: 41 (0) 71 677 45 05
Date Prepared: May 3, 2021
DEVICE NAME 2.
Proprietary Name: MAGNETOLITH Regulation Name: Powered Muscle Stimulator
| Regulation Number: | 21 CFR 890.5850 |
|---|---|
| Product Code: | IPF, NGX |
| Regulatory Class: | II |
3. PREDICATE DEVICES
Equivalence is claimed to the following predicate devices: HPM-6000 (K160992, primary), and Bemer Classic & Pro (K151834, secondary).
4. DEVICE DESCRIPTION
The MAGNETOLITH delivers electromagnetic pulses to stimulate muscle tissues by applying the Magnetic Induction Field Principle (high-energy magnetic pulses) directly over (but not in direct contact with) the patient in order to achieve the same powered muscle stimulation without having to place adhesive electrode pads directly onto the patient's body. Key components of the device are the Control Unit, Handpiece Applicator, Applicator holder, a Mains cable, and a Trolley. These device components are provided non-sterile and are intended to be reusable.
The principle of operation of the MAGNETOLITHis by the application of a treatment coil to generate electromagnetic induction. i.e., the production of voltage across an
4
electrical conductor in a changing magnetic field. The duration of the individual pulses is short and therefore the system does not increase temperature within the tissues. In addition, the MAGNETOLITH Applicator is cooled by circulating water.
5. INTENDED USE
The MAGNETOLITH is indicated for
- · Relaxation of muscle spasms,
- Prevention or retardation of disuse atrophy, .
- · Increasing local blood circulation,
- · Muscle re-education,
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, .
- Maintaining or increasing range of motion. .
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The technological characteristics of the MAGNETOLITH device and the predicate device is substantially equivalent in that each device is designed to non-invasively use electromagnetic induction to initiate action potential of nerves resulting in muscle contraction.
7. PERFORMANCE TESTING
Verification and validation testing was performed and demonstrated that the MAGNETOLITH meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed.
The MAGNETOLITH software was validated and demonstrated to be of a moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. While the MAGNETOLITH has cleaning and sanitation requirements, there are no body contacting components and therefore biocompatibility testing was not performed. The MAGNETOLITH was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2012; IEC 60601-6:2013; and electromagnetic compatibility requirements of IEC 60601-1-2:2014.
No performance standards applicable to this device have been adopted under Section 514 of the Act. The MAGNETOLITH complies with the applicable requirements of the following international consensus standards:
- ISO 14971:2000/A1:2007: Medical devices: Application of risk management to . medical devices.
5
- IEC 60601-1:2012, (Ed. 3.1): Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance.
- IEC 60601-1-2: 2014(4th Ed.): Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- . IEC 60601-1-6: 2012 (3.1 Ed.): Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 62304:2015: Medical Device Software - Software Life CycleProcess.
- ISO 13485:2016: Medical devices Ouality management systems -. Requirements for regulatory purposes.
The performance testing demonstrated that the MAGNETOLITH Muscle Stimulator is substantially equivalent to the predicate devices and that it is as safe, as effective, and performs as well as or better than the predicate devices. The table below compares the characteristics of the MAGNETOLITH to the predicate devices.
| 510(k) number
Device name
Company name | K160992
HPM-6000
BTL Industries, Inc. | K151834
Bemer Classic & Pro
Bemer Int'l AG | K203710
MAGNETOLITH
Storz Medical AG | Comparison |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code and
Regulation | Physical Medicine
21 CFR 890.5850
IPF - Stimulator,
Muscle, Powered | Physical Medicine
21 CFR 890.5850
NGX - Stimulator, Muscle,
Powered | Physical Medicine
21 CFR 890.5850
IPF - Stimulator,
Muscle, Powered
NGX - Stimulator, Muscle,
Powered | Same |
| Intended Use /
Indications for Use | The HPM-6000 device is intended
to be used under medical
supervision for adjunctive therapy
for the treatment of medical
diseases and conditions.
The HPM-6000 device is indicated
for use in stimulating
neuromuscular tissue for bulk
muscle excitation in the legs or
arms for rehabilitative purposes.
Indications for Use for Muscle
Stimulators:
-Relaxation of muscle spasms
-Prevention or retardation of disuse
atrophy
-Increasing local blood circulation
-Muscle re-education
-Immediate post- surgical
stimulation of calf muscles to
prevent venous thrombosis
-Maintaining or increasing range
of motion | Indications for Use:
-To temporarily increase local
blood circulation in healthy leg
muscles
-To stimulate healthy muscles in
order to improve and facilitate
muscle performance | Indications for Use:
-Relaxation of muscle spasms
-Prevention or retardation of
disuse atrophy
-Increasing local blood
circulation
-Muscle re-education
-Immediate post- surgical
stimulation of calf muscles to
prevent venous thrombosis
-Maintaining or increasing range
of motion
-To stimulate healthy muscles in
order to improve and facilitate
muscle performance | Similar |
8. SUBSTANTIAL EQUIVALENCE COMPARISON
6
| Principle of Action | Non- invasive tissue stimulation
via magnetic field induction | Non- invasive tissue stimulation
via magnetic field induction | Non- invasive tissue stimulation
via magnetic field induction | Same |
|--------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|----------|
| Clinical Use | Prescription use | Over the counter use | Prescription use | Same |
| Electrical
Protection | Class II, BF | unknown | Class I, B | Similar¹ |
| User
Interface | Touch screen | Touch screen | Touch Screen | Same |
| Firmware
Controlled | Yes | Yes | Yes | Same |
| Type of
Energy | Magnetic field | Magnetic field | Magnetic field | Same |
| Number
of outputs | 1 | 2 | 1 | Same |
| Number of
Magnetic Coils in
the Applicator | 1 | unknown | 1 | Same |
| Magnetic Field
Intensity | BTL 299-1 applicator: 0.5 - 1.8 T
BTL 299-2 applicator: 0.7 - 2.5 T | 35-100 μT | 0.4T ±20% at surface
0.08T ±20% at center of coil | Similar |
| Pulse Repetition
Rate | 1 - 150 Hz | 10-30 Hz | 1-10Hz | Similar |
| Pulse Duration | BTL 299-1 applicator: 280μs ±
20%
BTL 299-2 applicator: 280μs ±
20% | 10-33μs | 125μs ± 20% | Similar |
| Therapy Time | Up to 60 min | 20 minutes | 10-20 minutes | Similar |
| Energy Source | 100 - 240 VAC,
50-60 Hz | 100 - 240 VAC,
50/60 Hz | 100 - 240 VAC,
50/60 Hz | Same |
| System Dimensions
(W×H×D) | 500×970×580 mm (20×38×23 in) | 320 x 320 x 70 mm | 454 x 187 x 460 mm | Similar |
| Ambient
Temperature | 10° - 30°C | 10° - 30°C | 10° - 30°C | Same |
| Relative Humidity | 30 - 75% | unknown | 5-55% | Similar |
| Environmental
Specifications | For indoor use only | For indoor use only | For indoor use only | Same |
'Electrical Protection: The electrical security measures in devices are slightly different, but both comply with theIEC60601-1 standard for basic safety and essential performance.