(129 days)
Not Found
No
The description details a device that uses mechanical vibrations and sensor data (accelerometer and gyroscope) to guide and monitor pelvic floor exercises. While it includes a mobile app for data viewing and tracking, there is no mention of AI or ML being used for analysis, diagnosis, or treatment adjustments. The system appears to be based on pre-programmed responses and data display rather than learning or adaptive algorithms.
Yes
The device is described as "intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence," which indicates a therapeutic purpose.
No
Explanation: The device is described as a treatment device for strengthening pelvic floor muscles to treat urinary incontinence through mechanotherapy and guiding Kegel exercises. While it provides "visual information to inform the user when the correct muscles are being contracted," this feedback mechanism is for guiding treatment, not for diagnosing a condition.
No
The device description clearly outlines physical hardware components including an intravaginal wand, a hand-held controller with a battery and PCB, a charging cable, and a charging block. While there is an optional software app and provider portal, the core functionality and treatment delivery rely on the physical hardware.
Based on the provided information, the Flyte System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Flyte System's Function: The Flyte System is a physical device that is inserted into the vagina to provide mechanical vibration and resistance to the pelvic floor muscles. It is used for strengthening these muscles to treat stress urinary incontinence. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence." This is a therapeutic purpose, not a diagnostic one.
Therefore, the Flyte System falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence
Product codes (comma separated list FDA assigned to the subject device)
HIR
Device Description
The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system to treat women with urinary incontinence. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of an intravaginal wand and a hand-held controller. The Flyte wand is placed in the vagina and, under the direction of the controller, delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. This treatment is called mechanotherapy.
The Flyte controller controls the wand, guides the user through the treatment session and provides visual information to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand is designed to make optimal contact within the vaginal canal and to deliver vibrations via an eccentric weight driven by an electric motor which causes the wand to oscillate at a specific frequency as directed by the controller. The wand additionally provides a resistive surface against which the user can contract the PFM. A cable connects the wand and the controller.
Controller: The controller consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 700-750 mAh and built-in safety protection. The controller also contains a PCB assembly used to control the motor speed and frequency and to provide the user with visual information. The controller housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer).
Wand: The wand contains an accelerometer and gyroscope which enable the Controller to generate visual information. It also houses the motor and weight used to generate mechanical vibrations. The wand is available in large and small sizes. The wand housing is cylindrical and is made of ABS plastic. The wand is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact, 70g. In the study cohort, there were 43 participants with mild, 57 with moderate, and 18 with severe baseline incontinence.
The study hypothesis was that use of the Flyte mechanotherapy device with or without mechanical pulses would improve outcomes as compared to baseline, and that therapy with mechanical pulses in conjunction with PFMT would quantitatively improve urinary incontinence as compared to PFMT without device pulses.
The primary efficacy endpoint was the change in the severity of involuntary urine loss, determined by an improvement in 24 Hour pad weight (24-HR PW) from Baseline to week 6.
Secondary endpoints included 24-HR PW at 12 weeks, 24-HR PW for the full cohort from baseline to 6 and 12 weeks, and changes in quality of life (QoL) from Baseline to 6 and 12 weeks using validated, disease-specific instruments [International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) and Urinary Incontinence Quality of Life (I-OOL)]. Subject adherence to treatment was also assessed at 6 and 12 weeks. Voluntary follow-up was continued for up to 24 months.
A reduction in 24-hour pad weight occurred among all participants from baseline to 6-weeks (P50% reduction in 24-hour pad weight in the first 6 weeks, and 71% (81/114) achieved a clinically meaningful reduction (>50%) in pad weight by 12 weeks of therapy. The median reduction in 24-HR PW was 68% by 12 weeks. Overall, 61% of participants achieved continence with
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).
0
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August 1, 2024
Pelvital USA, Inc. % Ming Cheng Chew Regulatory Consultant Ram+ 2790 Mosside Blvd, #800 Monroeville, Pennsylvania 15146
Re: K240805
Trade/Device Name: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: March 22, 2024 Received: July 1, 2024
Dear Ming Cheng Chew:
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"
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(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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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,
Sharon M. Andrews -S
For Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: 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
Submission Number (if known)
Device Name
Flyte System, MTI-1.5 (MTI-1.5)
Indications for Use (Describe)
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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1 Traditional 510(k) Summary
Contact Information
Sponsor/Manufacturer
Pelvital USA, Inc. 860 Blue Gentian Road, Suite 200 Eagan, MN 55121 Phone: 612-643-9724 Email: lydia@flytetherapy.com
Correspondent
Ming Cheng Chew Regulatory Consultant, RQM+ Phone: 763-232-3701 Email: mchew@rqmplus.com
Date prepared: August 1, 2024
Device Information
| Name of Device: | Flyte System (MTI-1.5) |
|---|---|
| Common or Usual Name: | Perineometer |
| Classification Name: | Perineometer |
| Regulation Number: | 21 CFR 884.1425 |
| Regulatory Class: | II |
| Product Code: | HIR (Perineometer) |
Predicate Device
Flyte System (MTI-1.0), K233362
Note: the predicate device has not been subject to a design-related recall.
Device Description
The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system to treat women with urinary incontinence. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of an intravaginal wand and a hand-held controller. The Flyte wand is placed in the vagina and, under the direction of the controller,
5
delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. This treatment is called mechanotherapy.
The Flyte controller controls the wand, guides the user through the treatment session and provides visual information to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand is designed to make optimal contact within the vaginal canal and to deliver vibrations via an eccentric weight driven by an electric motor which causes the wand to oscillate at a specific frequency as directed by the controller. The wand additionally provides a resistive surface against which the user can contract the PFM. A cable connects the wand and the controller.
Controller: The controller consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 700-750 mAh and built-in safety protection. The controller also contains a PCB assembly used to control the motor speed and frequency and to provide the user with visual information. The controller housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer).
Wand: The wand contains an accelerometer and gyroscope which enable the Controller to generate visual information. It also houses the motor and weight used to generate mechanical vibrations. The wand is available in large and small sizes. The wand housing is cylindrical and is made of ABS plastic. The wand is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact, 70g. In the study cohort, there were 43 participants with mild, 57 with moderate, and 18 with severe baseline incontinence.
The study hypothesis was that use of the Flyte mechanotherapy device with or without mechanical pulses would improve outcomes as compared to baseline, and that therapy with mechanical pulses in conjunction with PFMT would quantitatively improve urinary incontinence as compared to PFMT without device pulses.
The primary efficacy endpoint was the change in the severity of involuntary urine loss, determined by an improvement in 24 Hour pad weight (24-HR PW) from Baseline to week 6.
Secondary endpoints included 24-HR PW at 12 weeks, 24-HR PW for the full cohort from baseline to 6 and 12 weeks, and changes in quality of life (QoL) from Baseline to 6 and 12 weeks using validated, disease-specific instruments [International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) and Urinary Incontinence Quality of Life (I-OOL)]. Subject adherence to treatment was also assessed at 6 and 12 weeks. Voluntary follow-up was continued for up to 24 months.
A reduction in 24-hour pad weight occurred among all participants from baseline to 6-weeks (P50% reduction in 24-hour pad weight in the first 6 weeks, and 71% (81/114) achieved a clinically meaningful reduction (>50%) in pad weight by 12 weeks of therapy. The median reduction in 24-HR PW was 68% by 12 weeks. Overall, 61% of participants achieved continence with 1 Nakib N, Sutherland S, Hallman K, Mianulli M, R Boulware D. Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women. Therapeutic Advances in Urology. 2024;16. doi:10.1177/17562872241228023
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SUBSTANTIAL EQUIVALENCE
Based on the non-clinical and clinical data submitted, the Flyte System (MTI-1.5) is found to be substantially equivalent to the predicate device. The supporting bench and clinical data support the expansion of the indications for use without raising different questions of safety and effectiveness. Additionally, the addition of the mobile app and provider portal, and the new reprocessing instructions to reprocess the MTI-1.5 controller by the manufacturer or its agent do not raise any different questions of safety and effectiveness.
Conclusion
The differences do not raise any different questions regarding safety and effectiveness. The Flyte System, as designed and manufactured, is substantially equivalent to the predicate device, K233362 Flyte System.