(29 days)
Not Found
None
No
The provided 510(k) summary does not contain any keywords or descriptions related to AI, ML, image processing, or data analysis that would suggest the use of such technologies. The description focuses solely on the intended use for strengthening pelvic floor muscles.
Yes
The system is intended for strengthening pelvic floor muscles to help with stress urinary incontinence, which is a therapeutic purpose.
No
The device is intended for strengthening pelvic floor muscles to help with stress urinary incontinence, which is a treatment or therapy, not a diagnostic purpose.
Unknown
The provided summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The "Intended Use" describes a "System," which often implies hardware is involved.
Based on the provided information, the Pelvital Flyte™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "strengthening of the pelvic floor muscles," which is a physical therapy or rehabilitation function. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic testing of biological samples.
- No Mention of Biological Samples: There is no mention of the device interacting with or analyzing any biological samples.
- Anatomical Site: The anatomical site is "pelvic floor muscles," which is a physical structure, not a biological sample being analyzed.
Therefore, the Pelvital Flyte™ System falls under the category of a therapeutic or rehabilitative device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pelvital Flyte™ System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.
Product codes
HIR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
Indicated Patient Age Range
women
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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April 13, 2021
Pelvital USA, Inc. % Mike Winegar Principal Winegar Consulting, Inc. 7829 Ithaca Ln N Maple Grove, MN 55311
Re: K210764
Trade/Device Name: Pelvital Flyte™ System Regulation Number: 21 CFR& 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: March 10, 2021 Received: March 15, 2021
Dear Mike Winegar:
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 (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 located 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.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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
2
Indications for Use
510(k) Number (if known) K210764
Device Name Pelvital Flyte™ System
Indications for Use (Describe)
The Pelvital Flyte™ System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| -- | ------------------------------------------------- | -- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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