(280 days)
With handheld applicators:
PMS mode:
Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance.
Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation.
TENS mode:
Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.
Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
With Chair Back applicator:
TENS mode:
Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.
StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply, handheld applicators and a chair.
The provided document is a 510(k) summary for the Fotona StarFormer (M008-3T) device, a transcutaneous electrical nerve stimulator. However, it does not contain the specific details about acceptance criteria or a comparative effectiveness study that demonstrates how the device meets acceptance criteria.
The document indicates that:
- Nonclinical testing was performed, including electrical safety, mechanical strength, thermal safety, electromagnetic compatibility, software verification and validation, and cybersecurity testing. It explicitly states, "All pre-determined acceptance criteria were met" for these tests.
- No premarket clinical investigations were conducted. The rationale provided is that "performance of StarFormer is based on the well-established magnetic stimulation technology and does not carry significant residual risk for patients."
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance (since these are not specified beyond a general statement of compliance).
- Sample size used for a test set or data provenance (as no clinical test set is described).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size on human readers.
- Stand-alone performance (algorithm only) as this is a device and not an AI algorithm being evaluated in a clinical "standalone" sense.
- Type of ground truth used (as no clinical study is detailed).
- Sample size for the training set (as no AI/ML model training is described in the context of clinical performance evaluation).
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to predicate devices primarily through comparison of technological characteristics and compliance with nonclinical performance standards, rather than clinical efficacy studies with specific acceptance criteria that might be seen for novel AI/ML devices.
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March 27, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
Fotona d.o.o. Tina Bartolic Quality Assurance and Regulatory Affairs Specialist Stegne 7 Ljubljana, Slovenia
Re: K241785
Trade/Device Name: StarFormer (M008-3T) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: QPL, IPF, NGX Dated: June 20, 2024 Received: June 20, 2024
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.
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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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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-regulatory
{2}------------------------------------------------
assistance/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,
Amber T. Ballard -S
Amber Ballard, PhD 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
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K241785
Device Name StarFormer (M008-3T)
Indications for Use (Describe)
• With handheld applicators:
PMS mode:
Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance.
Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation.
TENS mode:
Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.
Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
· With Chair Back applicator:
TENS mode:
Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.
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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Image /page/4/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray font. There is a red circle to the right of the word "Fotona".
Fotona
Stegne 7, 1000 Ljubljana, Slovenia
t. +386 (0)1 500 91 00
f. +386 (0)1 500 92 00
www.fotona.com
Image /page/4/Picture/2 description: The image contains several logos and text. At the top is a TÜV Product Service logo with ISO 9001 and ISO 13485 certifications. Below that, it says "founding member: FOTONIKA 21" with a logo. At the bottom, it says "competency center" and "biomedical engineering" with a cube-like logo in between.
TRADITIONAL 510(K) SUMMARY
| 1. SUBMITTER INFORMATION | |
|---|---|
| Applicant & Official Correspondent | Ms. Tina BartolicQuality Assurance and Regulatory Affairs SpecialistFotona d.o.o.Stegne 7, Ljublijana, Slovenia+38615009100tina.bartolic@fotona.com |
| Date Prepared | September 13, 2024 |
| 2. DEVICE NAME | |
| Trade Name of the Device | StarFormer |
| Common Name: | StarFormer |
| Classification Name: | Transcutaneous electrical nerve stimulator for painrelief |
| Classification Regulation: | 882.5890 |
| Device Class: | II |
| Product Code: | QPLAssociated Product Code(s): IPF, NGX |
| Panel: | Neurology |
| 3. PREDICATE DEVICEIDENTIFICATION | K230014 MagVenture Pain Therapy: MagPro R30,MagPro R30 with MagOption, MagPro X100, MagProX100 with MagOptionK163393 Hi-Dow Wireless TENS/EMS System(Model HD-SN)K221274 StarFormer |
| 4. DEVICE DESCRIPTION: | StarFormer is a non-invasive therapeutic device. Thedevice comprises of a magnetic stimulation coillocated in the handheld applicators and in the back of achair. During the treatment, an alternating electriccurrent is sent into the stimulation coil. The coil buildsup a rapidly changing magnetic waves whichpropagate into the underlying tissue where they inducea secondary electric current. This current stimulatesneurons and activates muscle contractions.The device consists of a system controller board whichalso drives the touchscreen and the GUI, a highvoltage current power supply, handheld applicatorsand a chair. |
| 5. INDICATIONS FOR USE: | With handheld applicators:PMS mode:Fotona StarFormer is intended for muscleconditioning, used for stimulating muscles |
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Image /page/5/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray sans-serif font. To the right of the word "Fotona" is a red circle.
Fotona
tegne 7, 1000 Ljubliana, Slove 386 (0)1 500 91 00 386 (0)1 500 92 00 ww.fotona.com
Image /page/5/Picture/3 description: The image shows a logo with the text "TUV PRODUCT SERVICE" inside an octagon shape. Below the logo, the text "ISO 9001" and "ISO 13485" are written on either side of the octagon. Further down, the text "founding member: FOTONIKA 21" is displayed, along with the words "competency center" and "biomedical engineering".
including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation. TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. With Chair Back applicator: TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and postsurgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities. 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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Image /page/6/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a light gray sans-serif font. To the right of the word "Fotona" is a red circle.
Image /page/6/Picture/7 description: The image shows a gray octagon with the text "TUV PRODUCT SERVICE" in the center. The octagon also contains the text "ISO 9001" on the left and "ISO 13485" on the right. At the top of the octagon is a recycling symbol.
Fotona
Stegne 7, 1000 Ljubljana, Slovenia
t. +386 (0)1 500 91 00
f. +386 (0)1 500 92 00
dina me OOOFOTONIKA 21
competency biomedical
| f. +386 (0)1 500 92 00www.fotona.com | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | Fotona d.o.o. | Tonica Elektronik A/S | Hi-Dow ElectronTechnology (Hefei) Inc.,Ltd. | Fotona d.o.o | |||||||
| Device name | StarFormer | MagVenture PainTherapy: MagPro R30,MagPro R30 withMagOption, MagProX100, MagPro X100with MagOption | Hi-Dow WirelessTENS/EMS (Model HD-5N) | StarFormer | SEdetermination | ||||||
| 510 (k) number | SUBJECT DEVICEK241785 | PREDICATE DEVICE 1K230014 | PREDICATE DEVICE 2K163393 | PREDICATE DEVICE 3K221274 | |||||||
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 890.5850 | Same | ||||||
| Product codes | QPL,IPF, NGX | QPL | NUH,NGX | IPF,NGX | Same | ||||||
| Indications for use | With handheldapplicators:PMS mode:Fotona StarFormer isintended for muscleconditioning, used forstimulating musclesincluding abdomenmuscles in order toimprove or facilitatemuscle performance.Fotona StarFormer isintended to be usedunder medicalsupervision foradjunctive therapy.Fotona StarFormer isintended for stimulatingneuromuscular tissuefor bulk muscleexcitation in arms, legs,buttocks and thighs forrehabilitative purposes -Prevention of disuseatrophy and increasinglocal blood circulation.TENS mode:Fotona StarFormer isintended to stimulateperipheral nerves forrelief of chronicintractable, posttraumatic and post-surgical pain forpatients 18 years orolder. | To stimulate peripheralnerves for relief of chronicintractable, post traumaticand post-surgical pain forpatients 18 years or older. | TENS:To be used for thetemporary relief of painassociated with sore oraching muscles in theshoulder, waist, back,upper extremities (arm),and lower extremities(leg) due to strain fromexercise or normalhousehold workactivities.EMS: It is intendedfor muscleconditioning, used forstimulating musclesincluding abdomenmuscles in order toimprove or facilitatemuscle performance. | Fotona StarFormer isintended to be usedunder medicalsupervision foradjunctive therapy forthe treatment of medicaldiseases and conditions.Fotona StarFormer isindicated for use instimulatingneuromuscular tissue forbulk muscle excitationin the legs or arms forrehabilitative purposes.-Relaxation of musclespasm,-Prevention orretardation of disuseatrophy,-Increasing local bloodcirculation,-Muscle re-education,-Immediate post-surgical stimulation ofcalf muscles to preventvenous thrombosis,-Maintaining orincreasing range ofmotion.Fotona StarFormer isindicated forimprovement ofabdominal tone, forstrengthening of theabdominal muscles, fordevelopment of firmerabdomen-Strengthening, Toningand Firming of buttocks | and Firming of buttocksand thighs | Same.The TENS (21 CFR882.5890) and EMS (21CFR 882.5890) predicateelectric stimulation device(K163393) operates onsubstantially the sameprinciple as the subjectmagnetic stimulation devicei.e. by generating electricimpulses to stimulate nervesDepending on the locationand intensity of eitherelectrically or magneticallygenerated electric impulsesthe outcome can be primarilynerve stimulation for painreduction, or nerve-activated musclecontraction. | |||||
| Fotona StarFormer is to |
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Image /page/7/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, lighter gray font. There is a red circle to the right of the word "Fotona".
Fotona
Fotona
Stegne 7, 1000 Ljubljana, Slovenia
t. +386 (0)1 500 91 00
f. +386 (0)1 500 92 00
Image /page/7/Picture/3 description: The image shows a gray octagon with a white recycling symbol at the top. Inside the octagon is the text "TUV PRODUCT SERVICE" in a stacked format. The text "ISO 9001" is on the bottom left side of the octagon, and the text "ISO 13485" is on the bottom right side of the octagon.
OOFOTONIKA 21
biomedical compete
| t. +386 (0)1 500 92 00www.fotona.com | be used for thetemporary relief of painassociated with sore oraching muscles in theshoulder, waist, back,upper extremities(arm), and lowerextremities (leg) due tostrain from exercise ornormal household workactivities.With Chair Backapplicator:TENS mode:Fotona StarFormer isintended to stimulateperipheral nerves in theback for relief ofchronic intractable, posttraumatic and post-surgical pain forpatients 18 years orolder .Fotona StarFormer is tobe used for thetemporary relief of painassociated with sore oraching muscles in theback due to strain fromexercise or normal | householdworkactivities. | |||
|---|---|---|---|---|---|
| Anatomical Sites | With handheldapplicators:For PMS:Legs, hands and arms,shoulder, abdominalmuscles (for muscleconditioning only),waist, buttocks, thighs,calf muscles, middleback and lower backFor TENS:Legs, hands and arms,shoulder, waist,buttocks, thighs, calfmuscles, middle backand lower backWith Chair Backapplicator:For TENS mode only:Middle back and lowerback | Any area, such as hand,arm, waist, buttock, thigh,calf, back and lower backetc. | TENS:Shoulder, waist, back,upper extremities (arm),and lower extremities(leg)EMS:Muscles includingabdominal muscles | Arms and legs,abdomen, buttocks,thighs | Same |
| Treatment Facilities | Hospitals & clinics(Prescription Use Only) | Hospitals & clinics(Prescription Use Only) | Over-The-Counter Use | Prescription Use Only | Same as predicate devices1 and 3.Different than predicatedevice 2.However, professionalenvironment for subjectdevice assures its safe andeffective use. |
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Image /page/8/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray sans-serif font. To the right of the word "Fotona" is a red circle.
Image /page/8/Picture/1 description: The image shows a gray octagon with a white recycling symbol at the top. Inside the octagon is the "TUV PRODUCT SERVICE" logo. The text "ISO 9001" is on the bottom left of the octagon, and the text "ISO 13485" is on the bottom right.
founding member OOOFOTONIKA 21
Fotona
Stegne 7, 1000 Ljubljana, Slovenia
t. +386 (0)1 500 91 00
f. +386 (0)1 500 92 00
| t. +386 (0)1 500 91 00f. +386 (0)1 500 92 00 | competencycenter | biomedicalengineering | |||
|---|---|---|---|---|---|
| www.fotona.com | Handheld applicators: seconds)Up to 30 minChair Back applicator:Up to 30 minPMS:Handheld applicators:Up to 30 min | 45 min | Up to 30 min | Since the treatmentparameters are setindividually and are basedon a patient pain thresholdthis comparison is notrelevant for SE evaluation. | |
| Principle of Action | TENS: Non-invasivelystimulate peripheralnerves.PMS: Initiating actionpotential of nerves thatresults in musclecontraction. | Non-invasively stimulateperipheral nerves | Not publicly available | Initiating action potentialof nerves that results inmuscle contraction. | Same |
| Type of energy | Magnetic field | Magnetic field | Electrical | Magnetic field | Same as predicate devices1 and 3.Different than predicatedevice 2.However, this differencedoes not affect safety andeffectiveness since theprincipal of action is thesame, as explained above. |
| Energy source | 100 -240 V AC, 50 ~60 Hz | Power supply viaIsolation TransformerPower Supply: 120 V~,50/60Hz | DC 3.7V Lithium Battery | Not publicly available | Similar as predicate devices1, same as predicatedevice 3.Different than predicatedevice 2.Not relevant for SEevaluation since it does notaffect safety andeffectiveness. |
| Type of Applicator | TENS:Magnetic handheld coilapplicators includingcoil applicator in thechair backrest.PMS: Magnetichandheld coilapplicators | Magnetic coil applicators | Oval electrodepad(gel),4.53cm, 12cm²;Rectangularelectrode pad(gel),94cm, 36cm²;Rectangularelectrode pad(gel),9*6cm, 54cm²; | Magnetic coil inapplicators | Same as predicate devices 1and 3.Different than predicatedevice 2 due to differenttype of energy used forgenerating electric impulses. |
| Type of Operation | TENS:Handheld applicators:ContinuousChair Back applicator:ContinuousPMS:Handheld applicators:Continuous | Not publicly available | Continuous/complex;41~181 | Not publicly available | Same |
| Number of OutputModes | 2 | Not publicly available | 2 | 1 | Same |
| Number of OutputChannels | 4 | Not publicly available | 4 | 1 | Similar.The difference in thenumber of output channelsis not significant for thepurposes of substantialequivalence evaluation.This parameter is morerelated to the specificdevice design andtechnology, rather than afundamental difference insafety or effectiveness. |
| Magnetic FieldIntensity | TENS:Handheldapplicators: 1.8 T + | 1.15-2.6 T | N/A | Up to 2.2 T | Same as predicate devices1 and 3.Not applicable for |
| FotonaStegne 7, 1000 Ljubljana, Sloveniat. +386 (0)1 500 91 00f. +386 (0)1 500 92 00www.fotona.com | founding member:O O FOTONIKA 21 | ||||
| competencycenter | biomedicalengineering | ||||
| 20%Chair Back applicator:1.8 T ± 20%PMS:Handheld applicators:1.8 T ± 20% | predicate device 2 due todifferent type of energyapplied. | ||||
| Pulse repetition rate | TENS:Handheld applicators:1-80 HzChair Back applicator:1-80 HzPMS:Handheld applicators:1-80 Hz | MagPro 30 and MagPro30 with MagOption: 0.1-30 HzMagPro X100 andMagPro X100 withMagOption: 0.1-100 Hz | (TENS) MODE 3: 1.28Hz(TENS) MODE 4:1~59.8 Hz(EMS) MODE 1: 52.3 Hz(EMS) MODE 2: 5.8 Hz | 1-80 Hz | Same.Not significantly differentfrom the predicateelectrical stimulationdevice 2. |
| Pulse width | TENS:Handheld applicators:330 µs ± 10%Chair Back applicator:330 µs ± 10%PMS:Handheld applicators:330 µs ± 10% | 280-320 µs | TENS & EMS: 100 µs | 330 µs | Same as predicate devices1 and 3.Not significantly differentfrom the predicateelectrical stimulationdevice 2. No significantimpact on safety andefficacy of thedevice/therapy.The pulse width of subjectand predicate devices, arein the typical clinical rangeof 50 to 500µs.Reference: "The effect ofstimuluscurrent pulse width onnerve fiber size recruitmentpatterns" by Robert B.Szlavik and Hubert deBruin |
| Pulse Amplitude | TENS:Handheld applicators: 0- 100 %Chair Back applicator:0 - 100 %PMS:Handheld applicators: 0- 100 % | 0 - 100 % | N/A | Not publicly available | Same |
| Waveform | TENS:Handheld applicators:Sine, biphasicChair Back applicator:Sine, biphasicPMS:Handheld applicators:Sine, biphasic | MagPro 30: BiphasicMagPro30 withMagOption: Biphasic,MonophasicMagPro X100: Biphasic,Biphasic Burst,MonophasicMagPro X100 withMagOption: Biphasic,Halfsine, Biphasic Burst,Monophasic | Pulsed Biphasic | Symmetrical Biphasic | Not significantly different.All devices are capable ofbiphasic mode. |
| Maximum OutputPower | 100% at 15 pps | 100% at 15 pps | N/A | Not publicly available | Same |
| On Cycle Duty Period | 1-20 s | 2-800 s | 0.1 s | 1-20 s | Similar. The duty cyclerange expressed in % asdetermined by the range ofon cycle periods and therange of off cycle resetperiods is for the subjectdevice equal to0.4-100%, which is withinthe duty cycle range ofpredicate devices. |
| Off Cycle ResetPeriod | 0 – 240 s | N/A | 0.1 s | 0 -240 s | Similar. The duty cyclerange expressed in % asdetermined by the range ofon cycle periods and therange of off cycle resetperiods is for the subjectdevice equal to0.4-100%, which is withinthe duty cycle the range ofpredicate devices. |
| User interface | Touch screen | LED display | Not publicly available | Touch screen | Same |
| Software/Firmware/Microprocessorcontrol | Yes | Yes | Yes | Yes | Same |
| OperatingTemperature | + 10°C to +25°C (+ 50°F to 77 °F) | Not publicly available | + 5°C to + 40°C(41°F~104°F) | Not publicly available | Similar. Falls within therange of Predicate Device 2. |
| Main UnitDimensions(WxHxD) | 421 x 843 x 630 mm | Not publicly available | Remote: 4.25 (W) x 2.1"(H) x 0.6" (D)Receiver: Ф 2.25"(Diameter) x 0.47" (D) | 421 x 843 x 630 mm | Similar. Not relevant forSE evaluation since it doesnot affect safety andeffectiveness. |
| ApplicatorDimensions | Handheld applicatorsApplicator LARGEcoil:135 - 84 mm (outer -inner diameter)Applicator RADIALLARGE coil: 135 - 84mm (outer - innerdiameter)Chair Back coil:135 - 84 mm (outer -inner diameter) | Butterfly coils: 150 mmCircular coils: 110-126mmSpecial coils: 160x80 mm | Oval electrode pad(gel):4.5x3cm, 12cm2Rectangular electrodepad(gel):9x4cm, 36cm2Rectangular electrodepad(gel):9x6cm, 54cm2 | Not publicly available | Similar. Not relevant forSE evaluation since it doesnot affect safety andeffectiveness. |
| System Weight | 50 kg | Not publicly available | Remote: 2.2 ozReceiver: 0.85 oz | 50 kg | Not relevant for SEevaluation since it doesnot affect safety andeffectiveness. |
| Compliance withVoluntary Standards | • Electrical Safetytesting, mechanicalstrength testing andthermal safety testingaccording to IEC60601-1: 2020 -Medical electricalequipment -Basicsafety and essentialperformance.• ElectromagneticCompatibility testingaccording to IEC60601-1-2: 2020 -General requirementsfor basic safety andessential performance -- Collateral Standard:Electromagneticdisturbances --Requirements and tests. | Electrical Safety:IEC60601-1 v3.1Mechanical Safety:IEC60601-1 v3.1Chemical Safety:IEC60601-1 v3.1Thermal Safety:IEC60601-1 v3.1Radiation Safety: Noradiation generatedBiocompatibility: ISO10993Company complies withISO 13485 | Biocompatibility: Alluser directly contactingmaterials arecompliance withISO10993-1:2009/C1 :2010,ISO10993-5:2009,ISO10993-10:2010.Electrical Safety: IEC60601-1:2005 (ThirdEdition) + Corr.1:2006 + Corr. 2:2007 +A1:2012 (or IEC60601-1:2012 reprint);IEC 60601-2-10:2012; also complieswithANSI/AAMI ES60601-1:2005 + A1:2012,C1: 2009 and A2: 2010EN 60601-1: 2006EN 60601-2-10: 2000 +A1: 2001EMC: IEC 60601-1-2:2007, IEC 60601-1-11:2010 Clause 12, IEC60601-2- | IEC 60601-1:2005 +A1:2012Medical electricalequipment - Part 1:General requirementsfor basic safety andessentialperformance.IEC 60601-1-2:2014Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessentialperformance - CollateralStandard:Electromagneticdisturbances -Requirements and tests.IEC 60601-1-6:2010 +A1:2013Medical electricalequipment - Part 1-6:General requirementsfor basic safety andessentialperformance - Collateralstandard: Usability. | Same |
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Image /page/9/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, light gray font. There is a red circle to the right of the word "Fotona".
Image /page/9/Picture/1 description: The image is a gray octagon containing a white logo. The logo consists of the letters "TUV" stacked on top of the words "PRODUCT SERVICE". Above the letters is a recycling symbol. The text "ISO 9001" is on the bottom left of the octagon, and the text "ISO 13485" is on the bottom right of the octagon.
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Image /page/10/Picture/0 description: The image shows the logo for Fotona. The word "Fotona" is written in a dark gray sans-serif font. Below the word "Fotona" is the phrase "choose perfection" in a smaller, red sans-serif font. There is a red dot to the right of the word "Fotona".
Fotona
Stegne 7, 1000 Ljubljana, Slovenia
t. +386 (0)1 500 91 00
f. +386 (0)1 500 92 00
Image /page/10/Picture/2 description: The image is a gray octagon with the text "TUV PRODUCT SERVICE" in the center. The text "ISO 9001" is on the left side of the octagon, and the text "ISO 13485" is on the right side of the octagon. There is a recycling symbol at the top of the octagon. The octagon is a certification mark.
ling me OOOFOTONIKA 21
biomedical engineering competency 100
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Fotona
choose perfection
G
TÜV
ISO 9001
ISO 13485
Fotona
Stegne 7, 1000 Ljubljana, Slovenia
t. +386 (0)1 500 91 00
f. +386 (0)1 500 92 00
www.fotona.com
founding member:
OOFOTONIKA 21
competency
center
biomedical
engineering
10:2012 Clause
201.17&202;
Medical devices -
Application of usability
engineering to medical
devices.
IEC 62304:2006 +
A1:2015
Medical device Software
– software life-cycle
process
ISO 14971:2019
Medical devices
Application of risk
management to medical
devices
As evidenced by the above table, both the subject and the predicate devices have similar intended use, but the
subject and predicate devices have different technological characteristics. However, performance testing was
conducted on the subject device, and it was established that the differences in technological characteristics
between the subject and the predicate do not raise different questions of safety or effectiveness.
TENS mode of the StarFormer is substantially equivalent to the MagVenture Pain Therapy predicate device for
the relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older using the
treatment protocol as outlined in the Applications Manual. Treatment parameters (e.g., repetition rate, pulses per
train, number of trains, number of pulses, inter train interval, treatment time) that are not included in the
treatment protocol have not been evaluated for effectiveness in the relief of chronic intractable, post traumatic
and post-surgical pain for patients 18 years or older.
Treatment protocol:
Treatment level: Individually estimated (% of maximum output power)
Repetition rate: 0.5 pps
Pulses per train: 10
Number of trains: 40
Number of pulses: 400
Inter train interval: 2 s
Treatment time: 13min
7.SUMMARY OF NONCLINICAL TESTING:
Below is a list of the tests that were performed and
successfully completed for the subject device per
thespecified guidance and standards:
•Electrical Safety testing, mechanical strength testing
and thermal safety testing according to IEC 60601-1:
2020 - Medical electrical equipment –Basic safety and
essential performance.
•Electromagnetic Compatibility testing according to
IEC 60601-1-2: 2020 – General requirements for
basic safety and essential performance -- Collateral
Standard: Electromagnetic disturbances --
Requirements and tests.
•Software Verification and Validation Testing
according to FDA's Guidance (2023), "Content of
Premarket Submissions for Device Software Functions
FD4"
| FDA"
· Cybersecurity testing according to FDA Guidance
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Image /page/12/Picture/1 description: The image shows two logos. The top logo is a gray octagon with the text "TUV PRODUCT SERVICE" inside of it. The text "ISO 9001" is on the left side of the octagon, and the text "ISO 13485" is on the right side of the octagon. The bottom logo is for "FOTONIKA 21" and it says "founding member" above it.
| FotonaStegne 7, 1000 Ljubljana, Sloveniat. +386 (0)1 500 91 00f. +386 (0)1 500 92 00www.fotona.com | founding member:Image: Fotona logodocument (2023), "Cybersecurity in MedicalDevices:Quality System Considerations and Content ofPremarket Submissions FDA".Additionally, performance bench data was submittedfor device performance i.e., magnetic field strengthtesting.All pre-determined acceptance criteria were met. |
|---|---|
| 8.SUMMARY OF CLINICAL TESTING: | No premarket clinical investigations were conductedsince the performance of StarFormer is based on thewell-established magnetic stimulation technology anddoes not carry significant residual risk for patients. |
| 9. CONCLUSIONS | Based on the information presented in this submission,it can be concluded that the subject device issubstantially equivalent to predicate devices |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).