(342 days)
NatraTone® is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, Urinary Incontinence in women.
NatraTone® is a pelvic floor muscle exerciser. It is a single, reusable device that comes into contact with the vaginal mucosal membrane for a limited (<24 hours) duration per each use. The device is 3.25 inches in length, 1.35 inch in width at its buibous base end and weighs 1 once or 28 grams. The registered trade name 'NatraTone' is embedded in the thumb-hold area of the device. The device is fully inserted to sit low in the vagina in contact with the perineal muscles.
The provided text is a 510(k) summary for the NatraTone® device, which is a perineometer. This document is a regulatory submission to the FDA for market clearance and does not contain the results of a study designed to prove the device meets specific acceptance criteria.
Instead, the submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (GyneFlex Perineometer, K021115). This means the manufacturer is asserting that their device is as safe and effective as the predicate device, primarily based on similarities in intended use, design, materials, and mechanism of action, rather than reporting on new clinical trial data with predefined acceptance criteria.
The document states: "The information in this 510(k) demonstrates that the subject Orelle Corporation NatraTone® is substantially equivalent to the existing GyneFlex device (K021115) with respect to safety and effectiveness."
Therefore, based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving their fulfillment, as such a study with explicit acceptance criteria is not presented in this 510(k) summary.
In summary, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.
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Orelle Corporation Limited
| 510(k) Summary | K121902JUN 6 2013 |
|---|---|
| Submitter: | Orelle Corporation Ltd7 Highland Drive, Suite 704Seattle, Washington 98109Telephone: (206) 420-4703Fax: (206) 420-4703 |
| Contact: | Patricia CoombesChief Executive Officer |
| Summary Prepared: | May 24, 2013 |
| Trade Name: | NatraTone® |
| Regulation Name: | Perineometer |
| Classification Regulation: | 21 CFR 884.1425Class II Device |
| Product Code: | 85 HIR |
| Predicate Device: | K021115 - The Naissance Holdings, LLC 'GyneFlex Perineometer' |
Device Description:
NatraTone® is a pelvic floor muscle exerciser. It is a single, reusable device that comes into contact with the vaginal mucosal membrane for a limited (<24 hours) duration per each use. The device is 3.25 inches in length, 1.35 inch in width at its buibous base end and weighs 1 once or 28 grams. The registered trade name 'NatraTone' is embedded in the thumb-hold area of the device. The device is fully inserted to sit low in the vagina in contact with the perineal muscles.
Indications for Use:
The NatraTone® is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, Urinary Incontinence in Women.
7 Highland Drive, Ste.704, Seattle, WA 98109. USA. T: +1 206-420-4703 E: info@natratone.com
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Orelle Corporation Limited
Predicate Device Comparison:
| Feature | NatraTone® | GyneFlex (K021115) |
|---|---|---|
| Intended Use | Treatment of urinary incontinence | Treatment of urinary incontinence |
| Design | Symmetrically S-shaped | V-shaped |
| Mechanism of action | Strengthen the perineal pelvic floormuscles by offering resistance to anindividual's voluntary contractions | Strengthen the perineal pelvic floormuscles by offering resistance to anindividual's voluntary contractions |
| Material | Molded medical grade polycarbonate | Molded medical grade plastic polymer |
| Color | Natural color | Multiple color |
| Sterilization | Clean, but not sterile | Clean, but not sterile |
| Prescription | Not required | Not required |
| Single Patient Device | Yes | Yes |
| Anatomical Sites | Intra-vaginal | Intra-vaginal |
| Reusability | Yes | Yes |
| Duration of Use | Transient | Transient |
| Instructions | Instructions Manual for patient homeuse | Instructions Manual for patient homeuse |
| Regular Visits to MedicalService Provider | Not required | Not required |
| Maintenance | Clean with soap and water; towel dry | Clean with soap and water; towel dry |
| Packaging | Training Aid, Carry Case, Sealableplastic bag for Carry Case, andInstructional Manual in cardboard box | Training Aid and Manual in cardboardbox |
Material Safety
NatraToner is manufactured with Lexan resin HP4-1H111 that is used in 510(k)-cleared Kolpexin Sphere (K032664). The manufacturing process is identical and there are no additional materials, additives or colorants added to the NatraToner during the manufacturing process or at any other time.
Conclusion
The information in this 510(k) demonstrates that the subject Orelle Corporation NatraTone® is substantially equivalent to the existing GyneFlex device (K021115) with respect to safety and effectiveness.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2013
Orelle Corporation Ltd. % Ms. Patricia Coombes CEO 7 Highland Drive, Ste. 704 SEATTLE WA 98109
Re: K121902
Trade/Device Name: NatraTone® Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: May 24, 2013 Received: May 29, 2013
Dear Ms. Coombes:
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. 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.
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Page 2 - Ms. Patricia Coombes
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/6 description: The image shows the name "Benjamin R Fisher -S" in a stylized font. The words "Benjamin", "Fisher", and "S" are written in a standard font. The letters "R" and "F" are stylized with a geometric pattern. The text is black on a white background.
| Benjamin R. Fisher, Ph.D. |
|---|
| Director |
| Division of Reproductive, Gastro-Renal, |
| and Urological Devices |
| Office of Device Evaluation |
| Center for Devices and Radiological Health |
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number: K121902
Device Name: NatraTone®
Indications for Use:
NatraTone® is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, Urinary Incontinence in women.
Prescription Use: _
AND/OR
Over-The-Counter Use: الا
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K121902 510(k) Number
§ 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).