Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on established magnetic stimulation technology without mentioning any AI/ML components or functions.

Therapeutic

Yes.
The device description explicitly states, "StarFormer is a non-invasive therapeutic device." Furthermore, its intended uses, such as muscle conditioning, pain relief, and rehabilitative purposes, align with the definition of a therapeutic device.

Diagnostic

No

Explanation: The Fotona StarFormer's intended uses are muscle conditioning, stimulating muscles for performance improvement, rehabilitative purposes (prevention of disuse atrophy, increasing local blood circulation), and pain relief. These are therapeutic applications, not diagnostic ones. The device stimulates tissue to induce effects, rather than collecting or analyzing data to identify a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device comprises hardware components including a system controller board, a high voltage current power supply, handheld applicators, and a chair, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Fotona StarFormer is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Fotona StarFormer's Function: The Fotona StarFormer is a therapeutic device that uses magnetic stimulation to directly interact with the human body. It stimulates muscles and nerves for purposes like muscle conditioning, pain relief, and rehabilitation.
Lack of Specimen Analysis: The device description and intended use clearly indicate that it does not analyze any biological specimens. It applies energy to the body externally.

Therefore, the Fotona StarFormer falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• 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.

Product codes (comma separated list FDA assigned to the subject device)

QPL, IPF, NGX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

With handheld applicators:

For PMS:
Legs, hands and arms, shoulder, abdominal muscles (for muscle conditioning only), waist, buttocks, thighs, calf muscles, middle back and lower back

For TENS:
Legs, hands and arms, shoulder, waist, buttocks, thighs, calf muscles, middle back and lower back

With Chair Back applicator:
For TENS mode only:
Middle back and lower back

Indicated Patient Age Range

18 years or older

Intended User / Care Setting

Hospitals & clinics (Prescription Use Only)

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, K163393 Hi-Dow Wireless TENS/EMS System (Model HD-SN), K221274 StarFormer

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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.

1

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)

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."

4

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 Bartolic
Quality Assurance and Regulatory Affairs Specialist
Fotona d.o.o.
Stegne 7, Ljublijana, Slovenia
+38615009100
tina.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 pain
relief
Classification Regulation:	882.5890
Device Class:	II
Product Code:	QPL
Associated Product Code(s): IPF, NGX
Panel:	Neurology
3. PREDICATE DEVICEIDENTIFICATION	K230014 MagVenture Pain Therapy: MagPro R30,
MagPro R30 with MagOption, MagPro X100, MagPro
X100 with MagOption

K163393 Hi-Dow Wireless TENS/EMS System
(Model HD-SN)

K221274 StarFormer |
| 4. DEVICE DESCRIPTION: | 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. |
| 5. INDICATIONS FOR USE: | With handheld applicators:

PMS mode:
Fotona StarFormer is intended for muscle
conditioning, used for stimulating muscles |

5

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

6

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 00

www.fotona.com
Manufacturer	Fotona d.o.o.	Tonica Elektronik A/S	Hi-Dow Electron
Technology (Hefei) Inc.,
Ltd.	Fotona d.o.o
Device name	StarFormer	MagVenture Pain
Therapy: MagPro R30,
MagPro R30 with
MagOption, MagPro
X100, MagPro X100
with MagOption	Hi-Dow Wireless
TENS/EMS (Model HD-
5N)	StarFormer	SE
determination
510 (k) number	SUBJECT DEVICE
K241785	PREDICATE DEVICE 1
K230014	PREDICATE DEVICE 2
K163393	PREDICATE DEVICE 3
K221274
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 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. | | To stimulate peripheral
nerves for relief of chronic
intractable, post traumatic
and post-surgical pain for
patients 18 years or older. | | TENS:
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.

EMS: It 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 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 Firming of buttocks
and thighs | Same.
The TENS (21 CFR
882.5890) and EMS (21
CFR 882.5890) predicate
electric stimulation device
(K163393) operates on
substantially the same
principle as the subject
magnetic stimulation device
i.e. by generating electric
impulses to stimulate nerves
Depending on the location
and intensity of either
electrically or magnetically
generated electric impulses
the outcome can be primarily
nerve stimulation for pain
reduction, or nerve-
activated muscle
contraction. | |
| | Fotona StarFormer is to | | | | | | | | | | |

7

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 00
www.fotona.com | 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. | | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anatomical Sites | With handheld
applicators:

For PMS:
Legs, hands and arms,
shoulder, abdominal
muscles (for muscle
conditioning only),
waist, buttocks, thighs,
calf muscles, middle
back and lower back

For TENS:
Legs, hands and arms,
shoulder, waist,
buttocks, thighs, calf
muscles, middle back
and lower back

With Chair Back
applicator:
For TENS mode only:
Middle back and lower
back | Any area, such as hand,
arm, waist, buttock, thigh,
calf, back and lower back
etc. | TENS:
Shoulder, waist, back,
upper extremities (arm),
and lower extremities
(leg)

EMS:
Muscles including
abdominal 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 devices
1 and 3.
Different than predicate
device 2.
However, professional
environment for subject
device assures its safe and
effective use. |

8

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 00
f. +386 (0)1 500 92 00 | | | | competency
center | biomedical
engineering |
|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| www.fotona.com | Handheld applicators: seconds)
Up to 30 min
Chair Back applicator:
Up to 30 min
PMS:
Handheld applicators:
Up to 30 min | | 45 min | Up to 30 min | Since the treatment
parameters are set
individually and are based
on a patient pain threshold
this comparison is not
relevant for SE evaluation. |
| Principle of Action | TENS: Non-invasively
stimulate peripheral
nerves.
PMS: Initiating action
potential of nerves that
results in muscle
contraction. | Non-invasively stimulate
peripheral nerves | Not publicly available | Initiating action potential
of nerves that results in
muscle contraction. | Same |
| Type of energy | Magnetic field | Magnetic field | Electrical | Magnetic field | Same as predicate devices
1 and 3.
Different than predicate
device 2.
However, this difference
does not affect safety and
effectiveness since the
principal of action is the
same, as explained above. |
| Energy source | 100 -240 V AC, 50 ~
60 Hz | Power supply via
Isolation Transformer
Power Supply: 120 V~,
50/60Hz | DC 3.7V Lithium Battery | Not publicly available | Similar as predicate devices
1, same as predicate
device 3.
Different than predicate
device 2.
Not relevant for SE
evaluation since it does not
affect safety and
effectiveness. |
| Type of Applicator | TENS:
Magnetic handheld coil
applicators including
coil applicator in the
chair backrest.
PMS: Magnetic
handheld coil
applicators | Magnetic coil applicators | Oval electrode
pad(gel),
4.53cm, 12cm²;
Rectangular
electrode pad(gel),
94cm, 36cm²;
Rectangular
electrode pad(gel),
9*6cm, 54cm²; | Magnetic coil in
applicators | Same as predicate devices 1
and 3.
Different than predicate
device 2 due to different
type of energy used for
generating electric impulses. |
| Type of Operation | TENS:
Handheld applicators:
Continuous
Chair Back applicator:
Continuous
PMS:
Handheld applicators:
Continuous | Not publicly available | Continuous/complex;
41~181 | Not publicly available | Same |
| Number of Output
Modes | 2 | Not publicly available | 2 | 1 | Same |
| Number of Output
Channels | 4 | Not publicly available | 4 | 1 | Similar.
The difference in the
number of output channels
is not significant for the
purposes of substantial
equivalence evaluation.
This parameter is more
related to the specific
device design and
technology, rather than a
fundamental difference in
safety or effectiveness. |
| Magnetic Field
Intensity | TENS:
Handheld
applicators: 1.8 T + | 1.15-2.6 T | N/A | Up to 2.2 T | Same as predicate devices
1 and 3.
Not applicable for |
| 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:
O O FOTONIKA 21 | | | | |
| | | | competency
center | biomedical
engineering | |
| | 20%
Chair Back applicator:
1.8 T ± 20%
PMS:
Handheld applicators:
1.8 T ± 20% | | | predicate device 2 due to
different type of energy
applied. | |
| Pulse repetition rate | TENS:
Handheld applicators:
1-80 Hz
Chair Back applicator:
1-80 Hz
PMS:
Handheld applicators:
1-80 Hz | MagPro 30 and MagPro30 with MagOption: 0.1-30 Hz

MagPro X100 and
MagPro X100 with
MagOption: 0.1-100 Hz | (TENS) MODE 3: 1.28
Hz
(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 different
from the predicate
electrical stimulation
device 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 devices
1 and 3.
Not significantly different
from the predicate
electrical stimulation
device 2. No significant
impact on safety and
efficacy of the
device/therapy.
The pulse width of subject
and predicate devices, are
in the typical clinical range
of 50 to 500µs.
Reference: "The effect of
stimulus
current pulse width on
nerve fiber size recruitment
patterns" by Robert B.
Szlavik and Hubert de
Bruin |
| 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, biphasic
Chair Back applicator:
Sine, biphasic
PMS:
Handheld applicators:
Sine, biphasic | MagPro 30: Biphasic
MagPro30 with
MagOption: Biphasic,
Monophasic

MagPro X100: Biphasic,
Biphasic Burst,
Monophasic

Collateral Standard:
Electromagnetic
disturbances --
Requirements and tests. | Electrical Safety:
IEC60601-1 v3.1
Mechanical Safety:
IEC60601-1 v3.1
Chemical Safety:
IEC60601-1 v3.1
Thermal Safety:
IEC60601-1 v3.1
Radiation Safety: No
radiation generated
Biocompatibility: ISO
10993
Company complies with
ISO 13485 | Biocompatibility: All
user directly contacting
materials are
compliance with
ISO10993-1:2009/C1 :
2010,
ISO10993-5:2009,
ISO10993-10:2010.
Electrical Safety: IEC
60601-1:2005 (Third
Edition) + Corr.
1:2006 + Corr. 2:2007 +
A1:2012 (or IEC
60601-1:2012 reprint);
IEC 60601-2-
10:2012; also complies
with
ANSI/AAMI ES60601-
1:2005 + A1:2012,
C1: 2009 and A2: 2010
EN 60601-1: 2006
EN 60601-2-10: 2000 +
A1: 2001
EMC: IEC 60601-1-
2:2007, IEC 60601-1-
11:2010 Clause 12, IEC
60601-2- | 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. | Same |

9

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.

10

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

11

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

12

Image /page/12/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 circle to the right of the word "Fotona".

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.

| 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:
Image: Fotona logo
document (2023), "Cybersecurity in MedicalDevices:
Quality System Considerations and Content of
Premarket Submissions FDA".

Additionally, performance bench data was submitted
for device performance i.e., magnetic field strength
testing.

All pre-determined acceptance criteria were met. |
|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8.SUMMARY OF CLINICAL TESTING: | 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. |
| 9. CONCLUSIONS | Based on the information presented in this submission,
it can be concluded that the subject device is
substantially equivalent to predicate devices |