Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

Device Description

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the seat 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 which causes muscle contraction in the entire pelvic floor area, increasing the strength and endurance of the pelvic floor. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and a chair.

AI/ML Overview

This document describes the StarFormer device, a non-invasive electromagnetic stimulator for pelvic floor muscles, and its substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System).

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for clinical efficacy and corresponding device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Neotonus Model 100 Muscle Stimulator System). The acceptance criteria were met for nonclinical testing.

Test Category	Acceptance Criteria (Implied by equivalence)	Reported Device Performance (StarFormer)
Clinical Efficacy	Efficacy in rehabilitation of weak pelvic muscles and restoration of neuromuscular control for urinary incontinence in women, similar to K973096.	No direct clinical efficacy data or explicit performance metric is provided. Substantial equivalence to predicate (K973096) implies similar efficacy.
Electrical Safety	Compliance with IEC 60601-1: 2020	Tests performed and successfully completed.
Mechanical Strength	Compliance with IEC 60601-1: 2020	Tests performed and successfully completed.
Thermal Safety	Compliance with IEC 60601-1: 2020	Tests performed and successfully completed.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2: 2020	Tests performed and successfully completed.
Software Verification & Validation	Compliance with FDA's 2023 guidance "Content of Premarket Submissions for Device Software Functions	FDA"
Cybersecurity	Compliance with FDA's 2023 guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions	FDA"
Magnetic Field Strength	No explicit acceptance criterion given, but performance bench data was submitted for comparison.	1.8 T ± 20%

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study for the StarFormer device's efficacy, nor does it specify a test set for clinical performance. The clearance is based on substantial equivalence to a predicate device and non-clinical bench testing. Therefore, there is no sample size for a clinical test set or data provenance related to a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical study is described for the StarFormer device itself, there is no mention of experts used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

As there is no described clinical test set for the StarFormer device's efficacy, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned or performed. The clearance is based on non-clinical testing and substantial equivalence to a predicate device, not on a clinical trial comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The StarFormer device provides electromagnetic stimulation; it is a therapeutic device, not an AI-based diagnostic tool or analysis algorithm meant to operate standalone in a diagnostic context. Therefore, a standalone algorithm-only performance study, as typically understood for AI/ML devices, was not performed or relevant. The device's performance relies on its physical output (magnetic fields) and its mechanism of action on the human body.

7. The Type of Ground Truth Used

For the non-clinical tests (electrical safety, EMC, software, cybersecurity), the ground truth is established by adherence to recognized international and FDA standards/guidances. For the magnetic field strength, the "ground truth" would be the measured output of the device itself compared to its design specifications.

There is no ground truth described for clinical efficacy for the StarFormer device, as no clinical study for its efficacy is presented. The substantial equivalence argument relies on the predicate device's proven efficacy for similar indications.

8. The Sample Size for the Training Set

The StarFormer device is described as a non-invasive therapeutic device that uses electromagnetic stimulation; it is not presented as an AI/ML-based diagnostic or predictive system that typically requires "training sets." Therefore, there is no mention of a training set or its sample size.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML component, this question is not applicable.

Summary

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July 1, 2024

Fotona d.o.o. Tina Bartolic Ouality Assurance and Regulatory Affairs Specialist Stegne 7 Ljubljana SLOVENIA

Re: K234061

Trade/Device Name: StarFormer Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Received: June 4, 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.

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).

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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 OS 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 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

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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,

Angel A. Soler-garcia -S

For, Jessica K. Nguyen, Ph.D. Assistant Director DHTB: Division of Reproductive, Gynecology, and Urology Devices Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K234061

Device Name StarFormer

Indications for Use (Describe)

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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TRADITIONAL 510(K) SUMMARY

1. SUBMITTER INFORMATION

Applicant & OfficialCorrespondent	Ms. Tina BartolicQuality Assurance and Regulatory Affairs SpecialistFotona d.o.o.Stegne 7, Ljublijana, Slovenia+38615009100tina.bartolic@fotona.com
Date Prepared	July 01, 2024
2. DEVICE NAME
Trade Name of the Device	StarFormer
Common Name:	StarFormer
Classification Name:	Nonimplanted electrical continence device
Classification Regulation:	21 CFR 876.5320
Device Class:	II
Product Code:	KPI, HIR
Panel:	Gastroenterology/Urology
3. PREDICATE DEVICEIDENTIFICATION	K973096 Neotonus Model 100 Muscle Stimulator system
	Subject Device:StarFormer	Predicate Device:Neotonus Model 100 Muscle Stimulatorsystem
Comparison Element
510(k) Number	K234061	K973096
Indications for Use	Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.	The neotonus model 1000 muscle stimulator system is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
Function	Pelvic floor muscle stimulation	Pelvic floor muscle stimulation
Principal of action	Initiating action potential of nerves that results in muscle contraction.	Initiating action potential of nerves that results in muscle contraction.
Prescription (Rx) orOver the counter (OTC)	Rx	Rx
Type of energy	Magnetic field	Magnetic field
Energy source	100 -240 V AC, 50 ~ 60 Hz	110 V AC, 50-60 Hz, max 12 A
Type of coil	Single magnetic coil	Single magnetic coil
Type of applicator	Chair	Chair
Position of coil	Center of applicator seat	Center of applicator seat
Patient position duringtherapy	Sitting position	Sitting position
Type of operation	Continuous	Continuous
Magnetic Field Intensity	1.8 T ± 20%	Up to 2.2 T
Pulse repetition rate	1-80 Hz	1-55 Hz
Step of Frequency Setting	1 Hz	1 Hz
Pulse duration	330 $μ$ s	275 $μ$ s
Pulse Amplitude	0-100 %	0-100 %
Pulse shape	Sine, biphasic	Sine, biphasic
Therapy time	30 min twice a week for 6-12 weeks	30 min twice a week for 6-12 weeks
User interface	Touch screen	Graphical Display
Operating Temperature	+ 10°C to +25 °C(50 - 77 °F)	+10 to + 30°C(50 - 86 °F)
Number of Output Modes	1	1
Firmware Controlled	Yes	Yes

EnvironmentalSpecifications	For indoor use only	For indoor use only
External ExchangeableFuse	No	Yes
Main Unit Dimensions(WxHxD)	421 x 843 x 630 mm	580 x 170 x 320 mm
Applicator Dimensions(WxHxD)	730 mm x 1050 mm x 740 mm	700 x 1250 x 785 mm
System Weight	50 kg	42.5 kg
Position	Horizontal	Horizontal

The predicate device was never subjected to a design related recall.

4. DEVICE DESCRIPTION:

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5. INDICATIONS FOR USE:

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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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 does not raise different questions of safety or effectiveness.

7. SUMMARY OF NONCLINICAL TESTING:

Below is a list of the tests that were performed and successfully completed for the subject device per the specified 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 | FDA"
Cybersecurity testing according to FDA Guidance document (2023), "Cybersecurity in Medical ● Devices: 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. CONCLUSIONS

Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).