Who is the manufacturer of StarFormer, TightWave?

Fotona D.O.O. filed the 510(k) submission for StarFormer, TightWave (K221274).

What is the FDA product code for StarFormer, TightWave?

IPF. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for StarFormer, TightWave?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like StarFormer, TightWave?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

StarFormer, TightWave

Q: What are the predicate devices for StarFormer, TightWave?

Neotonus MS-101 Magnetic Muscle Stimulator System (K973929); Johari Digital Healthcare Ltd., TORC BODY (K131291).

K221274 · Fotona D.O.O. · IPF · Sep 29, 2023 · Physical Medicine

Device Facts

Record ID	K221274
Device Name	StarFormer, TightWave
Applicant	Fotona D.O.O.
Product Code	IPF · Physical Medicine
Decision Date	Sep 29, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5850
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. -Relaxation of muscle spasm, -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. Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen -Strengthening, Toning and Firming of buttocks and thighs

Device Story

Non-invasive therapeutic device; utilizes magnetic stimulation coil within applicator placed over treatment area. System controller board drives touchscreen GUI; high-voltage power supply energizes electromagnetic coil. Alternating electric current in coil generates electromagnetic field; interacts with human body tissues to initiate nerve action potentials, resulting in muscle contraction. Used in clinical settings under medical supervision. Output parameters (pulse repetition rate, duration) controlled via interface. Benefits include muscle strengthening, toning, and rehabilitative support. No patient-contact materials; device body constructed of steel and plastic.

Clinical Evidence

No clinical investigations conducted. Performance established via non-clinical verification and validation testing, including adherence to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, and ISO 14971 standards.

Technological Characteristics

Powered muscle stimulator; magnetic field energy source. Max magnetic field intensity 2.2 T. Pulse repetition rate 1-80 Hz; pulse duration 330 µs; symmetrical biphasic pulse shape. Construction: steel and plastic body, plastic applicators. Connectivity: touchscreen GUI, microprocessor control. Software lifecycle per IEC 62304.

Indications for Use

Indicated for patients requiring neuromuscular stimulation for rehabilitation (legs/arms) or muscle conditioning (abdomen, buttocks, thighs). Uses include relaxation of muscle spasm, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, post-surgical calf stimulation to prevent venous thrombosis, and maintaining/increasing range of motion.

Regulatory Classification

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.

Predicate Devices

Neotonus MS-101 Magnetic Muscle Stimulator System (K973929)
Johari Digital Healthcare Ltd., TORC BODY (K131291)

Submission Summary (Full Text)

{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. September 29, 2023 Fotona d.o.o. Tina Bartolic Quality Assurance and Regulatory Affairs Stegne 7 Ljubljana, 1000. Slovenia ## Re: K221274 Trade/Device Name: StarFormer, TightWave Regulation Number: 21 CFR 21CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, NGX Dated: April 12, 2022 Received: May 2, 2022 Dear Tina Bartolic: 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" (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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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. 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). Sincerely, # Jitendra V. Virani -S CDR Jitendra Virani, MS, MBA 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221274 Device Name StarFormer Indications for Use (Describe) Fotona StarFormer is intended to be used under medical supervision for therapy for the treatment of medical diseases and conditions. Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. -Relaxation of muscle spasm, -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. Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen -Strengthening, Toning and Firming of buttocks and thighs Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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}------------------------------------------------ ## 510k Summary ## SUBMITTER'S INFORMATION | Submitter: | Fotona d.o.o. | |-----------------|--------------------------------------------------------------------| | | Stegne 7 | | | 1000 Ljubljana, Slovenia | | | Phone: +386 1 5009 100 | | | Fax: +386 1 5009 200 | | Contact Person: | Tina Bartolic, Quality Assurance and Regulatory Affairs Specialist | | | Phone: +386 1 5009 100 | | | E-mail: tina.bartolic@fotona.com | | Date: | April 12, 2022 | ## DEVICE INFORMATION | Device Trade Name: | StarFormer | |----------------------|----------------------------------------------------------| | Common name: | Magnetic Stimulator | | Classification name: | Stimulator, Muscle, Powered 21 CFR 890.5850, Class II | | Product Code: | IPF, NGX | ## PREDICATE DEVICES - Neotonus MS-101 Magnetic Muscle Stimulator System (K973929) - - Johari Digital Healthcare Ltd., TORC BODY (K131291) - ## DEVICE DESCRIPTION SUMMARY StarFormer is a non-invasive therapeutic device. The device comprises a magnetic stimulation coil located in the applicator which is placed over the treatment area. During the treatment, an alternating electric current is sent into the stimulation coil. The alternations in the electric current produce electromagnetic field that interacts with the tissues of the human body. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and an applicator with electromagnetic coil. {4}------------------------------------------------ ## INDICATIONS FOR USE Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. -Relaxation of muscle spasm, -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. Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen -Strengthening, Toning and Firming of buttocks and thighs ## INDICATIONS FOR USE COMPARISON The indications for use are based on previously cleared indications for the substantially equivalent predicate devices, Neotonus MS-101 Magnetic Stimulator System (K973929) (primary predicate) and Johari Digital Healthcare Ltd., TORC BODY (K131291) (second predicate). ## TECHNOLOGICAL COMPARISON A technical specifications comparison of StarFormer with predicate devices, Neotonus MS-101 Magnetic Stimulator System (K973929) (primary predicate) and Johari Digital Healthcare Ltd., TORC BODY (K131291) (second predicate), is presented in the table below. {5}------------------------------------------------ | Manufacturer | Neotonus, Inc. | Johari Digital HealthCare Ltd. | Fotona d.o.o. | | Product code regulation | Physical medicine 21 CFR 890.5850 IPF-Stimulator, Muscle, Powered | Physical medicine 21 CFR 890.5850 NGX-Stimulator, Muscle, Powered, For Muscle Conditioning | Physical medicine 21 CFR 890.5850 IPF-Stimulator, Muscle, Powered NGX-Stimulator, Muscle, Powered, For Muscle Conditioning | different questions on safety and effectiveness therefore not important for SE determination. Principal of action is the same. Same | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | MS-101 Magnetic Muscle Stimulator System (Primary predicate) | TORC BODY (Second predicate) | StarFormer (Subject device) | SE determination | Pulse repetition rate | 1-55 Hz | 1-200 Hz | 1-80 Hz | No impact. The pulse repetition rate of StarFormer it is not significantly different from the primary predicate. Pulse repetition rate of StarFormer is witih the range of the second predicate. The pulse repetition rates of StarFormer and predicate devices are in the typical clinical range of devices intended for muscle stimulation of up to 200 Hz (from 510(k) database). | | 510 (k) number | K973929 | K131291 | K221274 | | Pulse duration | 275 $\mu$ s ± 20% | 290 $\mu$ s | 330 $\mu$ s | No impact. StarFormer`s pulse duration is within the range of the primary predicate (± 20%). StarFormer`s pulse duration is not significantly different from the second predicate (within 10% range) and has no significant impact on safety and efficacy of the device/therapy. The pulse width of the StarFormer device and the predicate devices are in the typical clinical range of 50 to 500 $\mu$ s. | | Indications for use | The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The Neotonus MS-101 Magnetic Muscle Stimulator System 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 | TORC BODY is indicated to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, Toning and Firming of buttocks and thighs. | Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. -Relaxation of muscle spasm, -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. Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen -Strengthening, Toning and Firming of buttocks and thighs | Same | | | | | | | Primary function | Muscle stimulation | Muscle stimulation | Muscle stimulation | Same | | | | | | | Principle of action | Initiating action potential of nerves that results in muscle contraction. | Initiating action potential of nerves that results in muscle contraction. | Initiating action potential of nerves that results in muscle contraction. | Same | | | | | | | Type of energy | Magnetic field | Electrical | Magnetic field | Same as primary predicate, different to second predicate but the difference does not raise | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ | | | | | of stimulus current pulse width of nerve fiber size recruitment patterns by Robert B. Szlavik and Hubert de Bruin. | |-----------------------------------------------------|------------------------------------|------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Pulse shape | Symmetrical biphasic | Symmetrical biphasic | Symmetrical biphasic | Same | | Magnetic field intensity | Up to 2.2 T | NA | Up to 2.2 T | Same | | User interface | Graphical Display | Touch screen | Touch screen | Same | | Number of Output Modes | 1 | 1 | 1 | Same | | Number of Output Channels | 1 | 2 | 1 | Similar, but not significantly different. This information is not relevant for SE evaluation. The number of output channel is related to the device type. | | Software/ Firmware/ Microprocessor Control | Yes | Yes | Yes | Same | | Timer Ranger | Yes | Yes | Yes | Same | | ON Time (device`s duty cycle) | 1 s to 30 s | Not publicly available | 1 s to 20 s | Clinical outcome is independent of duty cycle. | | OFF Time (device`s duty cycle) | 0 s to 60 s | Not publicly available | 0 s to 240 s | ON/OFF periods are more related to technological limitations, namely overheating of the coil (OFF period). Therefore, this comparison is not relevant for SE evaluation. | | Therapy Time | 30, 60 min | Up to 60 min | Up to 30 min | Similar. Since the treatment parameters are set individually and are based on a patient pain threshold, this comparison is not relevant for SE evaluation. | | Weight | 28 kg | / | 50 kg | Similar. Not relevant for SE evaluation since it does not affect safety and effectiveness. | | Dimension [W x H x D] | 500 x 580 x 230 mm | 200 x 150 x 100 mm | 421 x 843 x 630 mm | Similar. Not relevant for SE evaluation since it does not affect safety and | | | Housing Materials and Construction | | | effectiveness. | | | Not publicly available | ABS body enclosure | Device body is made of steel and plastic. Applicators are made of plastics. | This information is not relevant for SE evaluation since no part of the (subject) device comes in the direct contact with the patient. | {8}------------------------------------------------ Technological differences between subject and predicate devices do not raise new type of safety and effectiveness questions and are therefore deemed substantial equivalent. ## NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY AND CONCLUSIONS ## Non-Clinical Summary: StarFormer has been evaluated via verification and validation tests for conformance to the applicable regulations and safety standards. StarFormer is designed, tested, and will be manufactured in accordance with following standards: CB Scheme standards: {9}------------------------------------------------ ## IEC 60601-1:2005 + A1:2012 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 disturbances - Requirements and tests. ## IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. ## IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices. ## IEC 62304:2006 + A1:2015 Medical device Software - software life-cycle process. ## ISO standards: ## ISO 14971:2019 Medical devices - Application of risk management to medical devices ## Clinical Summary: No premarket clinical investigations were conducted since the performance of StarFormer is based on the well-established magnetic stimulation technology and does not carry significant residual risk for patients. ## Conclusions: StarFormer's indications for use and technological characteristics do not raise new type of questions regarding safety and efficacy when compared to b o th predicates. Based on technical characteristics, design, functional features, and indications for use as listed above, StarFormer is considered to be substantially equivalent to the selected predicate devices.

StarFormer, TightWave

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