(264 days)
Not Found
No
The device description and performance studies focus on mechanical resistance and biocompatibility, with no mention of AI/ML terms or data processing.
Yes
The device is indicated for strengthening muscles to correct low tone, which can cause or contribute to health issues like urinary incontinence and sexual dysfunction, thus fitting the definition of a therapeutic device.
No
The device is used for strengthening pelvic floor muscles by providing resistance, not for diagnosing any medical conditions. Its purpose is therapeutic exercise rather than diagnostic assessment.
No
The device description explicitly states it is comprised of "6 progressively heavier and color-coded silicone weights," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for strengthening pelvic floor muscles through exercise and resistance. This is a physical therapy/exercise application, not a diagnostic test performed on biological samples.
- Device Description: The device is a physical weight inserted into the vagina to provide resistance for muscle contractions. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Intimate Rose Kegel Exercise System 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, low tone in the pelvic floor, which can cause or contribute to health issues including urinary incontinence and sexual dysfunction.
Product codes (comma separated list FDA assigned to the subject device)
HIR
Device Description
The Intimate Rose Kegel Exercise System is a pelvic floor exercise device for use in strengthening the pelvic floor musculature. It is a reusable, over-the-counter device that is comprised of 6 progressively heavier and color-coded silicone weights. An Intimate Rose Kegel Exercise System weight is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The weight of the Intimate Rose Kegel Exercise System device provides resistance as it is lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical performance information was provided for the subject device:
Biocompatibility
- Cytotoxicity testing per ISO 10993-5:2009 O
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 O
- O Vaginal irritation testing per ISO 10993-10:2010
Reprocessing
Information per FDA's 2015 Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
Mechanical Performance - Joint strength testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in a sans-serif font.
August 24, 2020
Plus EV Holdings dba Intimate Rose % Elizabeth Proctor Consultant Q-Metrics LLC 860 Lindenwood Lane Medina, OH 44256
Re: K193364
Trade/Device Name: Intimate Rose Kegel Exercise System Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: July 20, 2020 Received: July 23, 2020
Dear Elizabeth Proctor:
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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 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.
Monica D. Garcia, Ph.D. Acting 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
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)
Device Name
Indications for Use (Describe)
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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510(k) Summary — K193364
I. SUBMITTER
| Submitted by: | Plus EV Holdings dba Intimate Rose
1700 Iron Street
North Kansas City, MO 64116
Phone: 816-805-6722 |
|-----------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Aaron Wilt |
| Date Prepared: | August 21, 2020 |
II. DEVICE
| Device Name: | Intimate Rose Kegel Exercise System |
|---|---|
| Common Name: | Kegel Exercise and Pelvic Floor Workout |
| Device Regulation Number: | 21 CFR § 884.1425 |
| Regulation Name: | Perineometer |
| Regulatory Class: | II |
| Product Code: | HIR (Perineometer) |
| Classification Panel: | Obstetrics/Gynecology |
III. PREDICATE DEVICE
| 510(k) Number | Trade or Proprietary or
Model Name | Manufacturer |
|---------------|---------------------------------------|---------------|
| K171896 | Feminine Personal Trainer
(FPT) | Ralston Group |
This predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Intimate Rose Kegel Exercise System is a pelvic floor exercise device for use in strengthening the pelvic floor musculature. It is a reusable, over-the-counter device that is comprised of 6 progressively heavier and color-coded silicone weights. An Intimate Rose
4
Kegel Exercise System weight is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The weight of the Intimate Rose Kegel Exercise System device provides resistance as it is lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.
V. INDICATIONS FOR USE
The Intimate Rose Kegel Exercise System 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, low tone in the pelvic floor, which can cause or contribute to health issues including urinary incontinence and sexual dysfunction.
| APPLICANT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Device Name | Intimate Rose Kegel Exercise System | Feminine Personal Trainer (FPT) |
| 510(k) Number | K193364 | K171896 |
| Regulation | ||
| Number | 21 CFR§ 884.1425 | 21 CFR§ 884.1425 |
| Regulation | ||
| Name | Perineometer | Perineometer |
| Regulatory Class | II | II |
| Product Code | HIR | HIR |
| Indications for | ||
| Use | The Intimate Rose Kegel Exercise System is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It | The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these |
| seeks to correct, through exercise, | ||
| low tone in the pelvic floor, which | ||
| can cause or contribute to health | ||
| issues including urinary incontinence | ||
| and sexual dysfunction. | muscles. It seeks to correct, | |
| through exercise, urinary | ||
| incontinence in women. | ||
| Over the | ||
| Counter | Yes | Yes |
| Anatomical Site | Vagina | Vagina |
| Single Patient | ||
| Device | Yes | Yes |
| Reusable | Yes | Yes |
| Sterile | No | No |
| Device Design | Egg shaped with tail to remove the | |
| device | Hourglass-shaped | |
| Materials | Silicone, stainless steel | Stainless steel |
| Dimensions | Six varying weights {25g, 40g, 60g, | |
| 85g, 105g and 125g), each: | ||
| Main Section of Device - Length: 2.5 | ||
| inches/62mm, Diameter {widest | ||
| point): 1 inch/23mm | ||
| Tail Section of Device - Length: 3.15 | ||
| inches/80mm, Diameter: 3mm body | ||
| of tail, 5mm bulb end of tail | Standard FPT: Large end diameter: | |
| 1.628 in Small end diameter: 1.248 | ||
| in Length: 3.503 in Weight: 450 g. | ||
| Small FPT: Large end diameter: | ||
| 1.500 in Small end diameter: 1.125 | ||
| in Length: 3.500 in Weight: 340 g_ | ||
| Petite FPT: Large end diameter: | ||
| 1.250 in Small end diameter: 1.100 | ||
| in Length: 4.564 in Weight: 340 g. | ||
| Packaging | The Intimate Rose Kegel Exercise | |
| System is packed with 6 weights in a | ||
| cardboard box with protective | ||
| foam. It includes a detailed | ||
| instruction guide and travel | ||
| bag. | The FPT device is packaged in a | |
| velveteen bag inside a clear plastic | ||
| tube with instructions and exercise | ||
| chart. | ||
| Color | Shades of white, pink, and purple | Stainless steel |
VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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The indications for use of the subject device and predicate device are similar. The subject device and the predicate device have the same intended use for strengthening pelvic floor muscles.
6
The subject and predicate device have different technological characteristics, including different materials, shapes, dimensions, and weight options. The technological differences between the subject and predicate device do not raise different types of safety and effectiveness questions.
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
The following non-clinical performance information was provided for the subject device
Biocompatibility
- Cytotoxicity testing per ISO 10993-5:2009 O
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 O
- O Vaginal irritation testing per ISO 10993-10:2010
Reprocessing
Information per FDA's 2015 Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
Mechanical Performance
- Joint strength testing
VIII. CONCLUSION
Based on the results of the performance testing described above, the Intimate Rose Kegel Exercise System is as safe and effective as the predicate device and supports a determination of substantial equivalence.