(515 days)
Not Found
No
The device description and performance studies focus on established magnetic stimulation technology and do not mention AI or ML.
Yes
The device description explicitly states, "StarFormer is a non-invasive therapeutic device." Additionally, its intended use involves "therapy for the treatment of medical diseases and conditions" and various rehabilitative purposes, confirming its therapeutic nature.
No
The device is described as a "therapeutic device" intended for "therapy for the treatment of medical diseases and conditions" and for stimulating neuromuscular tissue for rehabilitative purposes. There is no mention of it being used to identify or diagnose diseases or conditions.
No
The device description explicitly states it comprises hardware components including a magnetic stimulation coil, applicator, system controller board, touchscreen, GUI, and a high voltage current power supply.
Based on the provided information, the Fotona StarFormer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Fotona StarFormer, as described, is a therapeutic device that applies magnetic stimulation externally to the body.
- The intended use and device description clearly state its purpose is for neuromuscular stimulation and muscle therapy. This involves direct interaction with the patient's body, not the analysis of biological samples.
- There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
Therefore, the Fotona StarFormer falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
IPF, NGX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs or arms, abdominal, buttocks and thighs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under medical supervision
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)
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: IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010 + A1:2013, IEC 62366-1:2015, IEC 62304:2006 + A1:2015, ISO 14971:2019.
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 both 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.
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 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) |
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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
(devices duty cycle) | 1 s to 30 s | Not publicly available | 1 s to 20 s | Clinical outcome is independent of duty cycle. | | OFF Time (devices 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.