(342 days)
No
The device description and intended use describe a simple mechanical exerciser with no mention of computational analysis, data processing, or adaptive features that would suggest AI/ML.
Yes
The device is indicated for strengthening muscles and correcting urinary incontinence, which are therapeutic purposes.
No
The device is described as an exerciser for strengthening pelvic floor muscles by providing resistance, and it seeks to correct urinary incontinence through exercise. It does not mention diagnosing any condition or reporting any diagnostic measurements.
No
The device description clearly states it is a "single, reusable device" that is physically inserted into the vagina, indicating it is a hardware device, not software-only.
Based on the provided information, the NatraTone® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NatraTone® Function: The description clearly states that NatraTone® is a pelvic floor muscle exerciser that provides resistance to voluntary muscle contractions. It is a physical device used internally for exercise, not for analyzing biological samples.
- Intended Use: The intended use is for strengthening muscles to correct urinary incontinence, which is a physical therapy/exercise application, not a diagnostic test.
Therefore, NatraTone® falls under the category of a physical medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
85 HIR
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 (
§ 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
Orelle Corporation Limited
| 510(k) Summary | K121902
JUN 6 2013 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Orelle Corporation Ltd
7 Highland Drive, Suite 704
Seattle, Washington 98109
Telephone: (206) 420-4703
Fax: (206) 420-4703 |
| Contact: | Patricia Coombes
Chief Executive Officer |
| Summary Prepared: | May 24, 2013 |
| Trade Name: | NatraTone® |
| Regulation Name: | Perineometer |
| Classification Regulation: | 21 CFR 884.1425
Class 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 (