(192 days)
Not Found
No
The description focuses on electromagnetic stimulation and hardware components, with no mention of AI or ML terms or functionalities.
Yes
The "Device Description" explicitly states, "StarFormer is a non-invasive therapeutic device." Additionally, its "Intended Use" describes treating urinary incontinence and rehabilitating weak pelvic muscles, which are therapeutic goals.
No
The device description states it is a "therapeutic device" and its intended use is "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." It does not mention any diagnostic capabilities.
No
The device description explicitly states it comprises hardware components including a magnetic stimulation coil, a system controller board, a high voltage current power supply, and a chair.
Based on the provided information, the Fotona StarFormer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "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." This describes a therapeutic treatment applied directly to the patient's body.
- Device Description: The description details a device that uses magnetic stimulation to induce muscle contraction within the body. This is an in-vivo (within a living organism) application.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The StarFormer does not perform any tests on samples.
Therefore, the Fotona StarFormer is a therapeutic device, not an IVD.
N/A
Intended Use / 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.
Product codes
KPI, HIR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor musculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Nonclinical testing was performed including:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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).
1
2
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
2
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
3
Indications for Use
510(k) Number (if known) K234061
Device Name StarFormer
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ▢ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 | 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 DEVICE
IDENTIFICATION | K973096 Neotonus Model 100 Muscle Stimulator system | |
| | Subject Device:
StarFormer | Predicate Device:
Neotonus Model 100 Muscle Stimulator
system |
| 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) or
Over 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 during
therapy | 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 |
| | | |
| Environmental
Specifications | For indoor use only | For indoor use only |
| External Exchangeable
Fuse | 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:
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.
5
5. 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.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
6
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.