(515 days)
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
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.
The provided text is a 510(k) summary for the Fotona StarFormer device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. In the context of a 510(k), "acceptance criteria" are typically related to the device's ability to perform as intended and raise no new questions of safety or effectiveness compared to a predicate device.
Therefore, the requested information regarding acceptance criteria and a study proving those criteria are met is not directly present in this document in the format you've requested for AI/software performance. The information provided is about the device's technical specifications and the comparison to predicate devices to establish substantial equivalence.
Here's an attempt to extract and interpret the information based on the premise of the FDA 510(k) process for this type of medical device:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a physical medical device (muscle stimulator) rather than an AI/software device with measurable performance metrics like sensitivity/specificity, the acceptance criteria are not in the form of numerical performance targets. Instead, the acceptance criteria for a 510(k) revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied by 510(k) process for a physical device) | Reported Device Performance (from the document) |
|---|---|
| No new questions of safety or effectiveness are raised compared to predicate devices. | "StarFormer's indications for use and technological characteristics do not raise new type of questions regarding safety and efficacy when compared to both predicates." |
| Device performs its intended function. | "StarFormer is a non-invasive therapeutic device. ... The alternations in the electric current produce electromagnetic field that interacts with the tissues of the human body." (Function is muscle stimulation.) |
| Device meets applicable recognized consensus standards. | StarFormer was evaluated for conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, and ISO 14971. |
| Indications for Use are substantially equivalent to predicate devices. | "The indications for use are based on previously cleared indications for the substantially equivalent predicate devices, Neotonus MS-101 Magnetic Muscle Stimulator System (K973929) (primary predicate) and Johari Digital Healthcare Ltd., TORC BODY (K131291) (second predicate)." (See table below for specific IU comparison) |
| Technological characteristics are substantially equivalent to predicate devices. | Technical specifications comparison provided in the table on pages 5-7. Key differences (e.g., pulse repetition rate, pulse duration, type of energy) were assessed and deemed not to raise new safety/effectiveness questions. |
Indications for Use Comparison Table (Extracted from the document, relevant to equivalence):
| Feature/Criterion | Predicate 1 (Neotonus MS-101) | Predicate 2 (TORC BODY) | Subject Device (StarFormer) | SE Determination Comment |
|---|---|---|---|---|
| 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 | - Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen.- Strengthening, Toning and Firming of buttocks and thighs. | - 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.- Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen.- Strengthening, Toning and Firming of buttocks and thighs. | Same (StarFormer combines the indications of both predicates) |
Technological Comparison (Selected key parameters from the document):
| Feature/Criterion | Predicate 1 (Neotonus MS-101) | Predicate 2 (TORC BODY) | Subject Device (StarFormer) | SE Determination Comment |
|---|---|---|---|---|
| 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 does not raise different questions on safety and effectiveness (Principal of action is same). |
| Pulse Repetition Rate | 1-55 Hz | 1-200 Hz | 1-80 Hz | No impact. StarFormer's rate is not significantly different from primary predicate and within range of second predicate. |
| Pulse Duration | 275 µs ± 20% | 290 µs | 330 µs | No impact. Within range of primary predicate (±20%) and not significantly different from second predicate (within 10%). |
| Magnetic field intensity | Up to 2.2 T | NA | Up to 2.2 T | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "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." Therefore, there is no clinical test set, sample size, or data provenance to report. The evaluation relies on non-clinical testing and comparison to predicates.
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)
Not applicable, as no clinical investigations were conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical investigations were conducted.
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 physical muscle stimulator, not an AI-assisted diagnostic or interpretive device that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical investigations were conducted. The "ground truth" for a 510(k) submission for a physical device is primarily the established safety and effectiveness of the legally marketed predicate devices and their underlying technology.
8. The sample size for the training set
Not applicable, as no clinical investigations were conducted and this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
{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, Powered21 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 DigitalHealthCare Ltd. | Fotona d.o.o. | Product coderegulation | Physical medicine21 CFR 890.5850IPF-Stimulator, Muscle,Powered | Physical medicine21 CFR 890.5850NGX-Stimulator,Muscle, Powered, ForMuscle Conditioning | Physical medicine21 CFR 890.5850IPF-Stimulator, Muscle,PoweredNGX-Stimulator, Muscle,Powered, For MuscleConditioning | different questionson safety andeffectivenesstherefore notimportant for SEdetermination.Principal of actionis the same.Same | |
|---|---|---|---|---|---|---|---|---|---|
| Device name | MS-101 MagneticMuscle StimulatorSystem(Primarypredicate) | TORC BODY(Second predicate) | StarFormer(Subject device) | SE determination | Pulse repetitionrate | 1-55 Hz | 1-200 Hz | 1-80 Hz | No impact.The pulserepetition rate ofStarFormer it is notsignificantlydifferent from theprimary predicate.Pulse repetitionrate of StarFormeris witih the rangeof the secondpredicate.The pulserepetition rates ofStarFormer andpredicate devicesare in the typicalclinical range ofdevices intendedfor musclestimulation of up to200 Hz (from510(k) database). |
| 510 (k) number | K973929 | K131291 | K221274 | Pulse duration | 275 $\mu$ s ± 20% | 290 $\mu$ s | 330 $\mu$ s | No impact.StarFormers pulse<br>duration is within the<br>range of the primary<br>predicate (± 20%).<br><br>StarFormers pulseduration is notsignificantly differentfrom the secondpredicate (within 10%range) and has nosignificant impact onsafety and efficacy ofthe device/therapy.The pulse width of theStarFormer device andthe predicate devicesare in the typicalclinical rangeof 50 to 500 $\mu$ s. | |
| Indications foruse | The Neotonus MS-101Magnetic MuscleStimulator System isintended to be used undermedical supervision foradjunctive therapy for thetreatment of medicaldiseases and conditions.The Neotonus MS-101Magnetic MuscleStimulator System isindicated for use instimulating neuromusculartissue for bulk muscleexcitation in the legs orarms for rehabilitativepurposes.Indications for Use forMuscle Stimulators:-Relaxation of musclespasms-Prevention orretardation of disuseatrophy-Increasing local bloodcirculation-Muscle re-education-Immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis-Maintaining orincreasing range of motion | TORC BODY isindicated to be used for:- Improvement ofabdominal tone, forstrengthening of theabdominal muscles, fordevelopment of firmerabdomen.- Strengthening, Toningand Firming of buttocksand thighs. | Fotona StarFormer isintended to be usedunder medicalsupervision foradjunctive therapy forthe treatment of medicaldiseases and conditions.Fotona StarFormer isindicated for use instimulatingneuromuscular tissue forbulk muscle excitation inthe legs or arms forrehabilitative purposes.-Relaxation of musclespasm,-Prevention orretardation of disuseatrophy,-Increasing local bloodcirculation,-Muscle re-education,-Immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis,-Maintaining orincreasing range ofmotion.Fotona StarFormer isindicated forimprovement ofabdominal tone, forstrengthening of theabdominal muscles, fordevelopment of firmerabdomen-Strengthening, Toningand Firming of buttocksand thighs | Same | |||||
| Primary function | Muscle stimulation | Muscle stimulation | Muscle stimulation | Same | |||||
| Principle ofaction | Initiating action potentialof nerves that results inmuscle contraction. | Initiating actionpotential of nerves thatresults in musclecontraction. | Initiating action potentialof nerves that results inmuscle contraction. | Same | |||||
| Type of energy | Magnetic field | Electrical | Magnetic field | Same as primarypredicate, differentto second predicatebut the differencedoes not raise |
{6}------------------------------------------------
{7}------------------------------------------------
| of stimuluscurrent pulse width ofnerve fiber sizerecruitment patternsby Robert B.Szlavik and Hubert deBruin. | ||||
|---|---|---|---|---|
| Pulse shape | Symmetrical biphasic | Symmetrical biphasic | Symmetrical biphasic | Same |
| Magnetic fieldintensity | Up to 2.2 T | NA | Up to 2.2 T | Same |
| User interface | Graphical Display | Touch screen | Touch screen | Same |
| Number ofOutput Modes | 1 | 1 | 1 | Same |
| Number ofOutput Channels | 1 | 2 | 1 | Similar, but notsignificantlydifferent. Thisinformation is notrelevant for SEevaluation. Thenumber of outputchannel is relatedto the device type. |
| Software/Firmware/MicroprocessorControl | Yes | Yes | Yes | Same |
| Timer Ranger | Yes | Yes | Yes | Same |
| ON Time(device`s dutycycle) | 1 s to 30 s | Not publicly available | 1 s to 20 s | Clinical outcome isindependent ofduty cycle. |
| OFF Time(device`s dutycycle) | 0 s to 60 s | Not publicly available | 0 s to 240 s | ON/OFF periodsare more related totechnologicallimitations, namelyoverheating of thecoil (OFF period).Therefore, thiscomparison is notrelevant for SEevaluation. |
| Therapy Time | 30, 60 min | Up to 60 min | Up to 30 min | Similar.Since the treatmentparameters are setindividually andare based on apatient painthreshold, thiscomparison is notrelevant for SEevaluation. |
| Weight | 28 kg | / | 50 kg | Similar. Notrelevant for SEevaluation since itdoes not affectsafety andeffectiveness. |
| 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. Notrelevant for SEevaluation since itdoes not affectsafety 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.
§ 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).