(21 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of silicone dilators, with no mention of AI or ML.
Yes
The device is described as a tool intended to dilate the vagina to help relieve symptoms of vaginismus, which is a medical condition. It directly addresses a health problem, fulfilling the definition of a therapeutic device.
No
The device is described as a tool to dilate the vagina to relieve symptoms of vaginismus, which is a treatment or therapy, not a diagnostic procedure to identify a disease or condition.
No
The device description clearly states the device is comprised of physical, medical-grade silicone dilators, which are hardware components.
Based on the provided information, the Intimate Rose Vaginal Dilators are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body ("in vitro").
- Intended Use and Device Description: The provided text clearly states the intended use is to "dilate the vagina in controlled stages to help relieve symptoms of vaginismus." The device description details its physical form (silicone dilators) and how it is used within the body to address a physical condition.
- Lack of Testing on Samples: There is no mention of the device being used to test samples from the body. Its function is mechanical and therapeutic, not diagnostic.
- Biocompatibility and Physical Properties: The performance studies described focus on the device's safety for contact with the body (biocompatibility) and its physical characteristics, which are relevant for a medical device used internally, but not for an IVD.
In summary, the Intimate Rose Vaginal Dilators are a medical device used for treatment and physical therapy within the body, not for performing diagnostic tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.
Product codes (comma separated list FDA assigned to the subject device)
HDX
Device Description
The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to
§ 884.3900 Vaginal stent.
(a)
Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
June 7, 2023
Plus EV Holdings dba Intimate Rose % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. Warren, NJ 07059
Re: K231430
Trade/Device Name: Intimate Rose Vaginal Dilators Regulation Number: 21 CFR§ 884.3900 Regulation Name: Vaginal stent Regulatory Class: II Product Code: HDX Dated: April 9, 2023 Received: May 17, 2023
Dear Dave Yungvirt:
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 (OS) 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,
Reginald K. Avery -S
for
Jason R. Roberts, 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) K231430
Device Name
Intimate Rose Vaginal Dilators
Indications for Use (Describe)
The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Intimate Rose. The logo features a stylized flower with six petals in shades of purple and pink on the left. To the right of the flower is the text "Intimate Rose" in a light gray sans-serif font.
510(k) Summary
I. SUBMITTER
Plus EV Holdings dba Intimate Rose 1419 Murray Street North Kansas City, MO 64116 Phone: 816-805-6722
Contact Person: Aaron Wilt
Date Prepared: June 5, 2023
II. DEVICE
| Name of Device: | Intimate Rose Vaginal Dilators |
|---|---|
| Common or Usual Name: | Vaginal Dilators |
| Classification Number: | 21 CFR 884.3900 |
| Classification Name: | Vaginal Stent |
| Regulatory Class: | II |
| Product Code: | HDX (Dilator, Vaginal) |
| Classification Panel: | Obstetrics/Gynecology |
III. PREDICATE DEVICE
| 510(k) Number | Trade or Proprietary Name | Manufacturer |
|---|---|---|
| K130273 | Vaginal Dilators | Panpac |
This predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to ≤ 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.
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Image /page/4/Picture/0 description: The image shows the logo for Intimate Rose. The logo features a stylized flower with six petals in shades of purple and pink on the left. To the right of the flower is the text "Intimate Rose" in a light purple, sans-serif font.
Image /page/4/Figure/2 description: The image shows the logo for Intimate Rose. The logo features a stylized flower with six petals in shades of purple and pink. To the right of the flower is the text "Intimate Rose" in a light gray, sans-serif font.
ators Dimensions & Circumference
Image /page/4/Figure/4 description: The image shows a collection of eight different sizes of sex toys. Each toy is labeled with a size number from 1 to 8, and each toy has measurements indicating its dimensions. The toys vary in height and width, with the smallest toy being size 1 and the largest being size 8. The measurements are in inches, and the toys are arranged in a row.
V. INDICATIONS FOR USE
The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.
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Image /page/5/Picture/0 description: The image shows the logo for "Intimate Rose". The logo consists of a flower with six petals on the left side and the text "Intimate Rose" on the right side. The flower petals are colored in shades of pink and purple, while the text is in a light purple color.
Differences in indications for use:
SUBJECT DEVICE INDICATIONS FOR USE: "The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus."
PREDICATE DEVICE INDICATIONS FOR USE: "Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus. Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family B and Family C with variant sizes."
The difference between the subject and predicate device indications for use is that the predicate device includes 2 additional indications: vaginal dilation for examination and vaginal dilation for surgical procedure. The subject device is not intended for these uses; it is intended solely for use to provide dilation to help relieve the symptoms of vaginismus.
As the subject device indications are a subset of the predicate device indications, this difference does not raise intended use concerns.
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Device Name | Intimate Rose Vaginal Dilators | Panpac Vaginal Dilators |
| 510(k) Number | K231430 | K130273 |
| Regulation | ||
| Number | 21 CFR§ 884.3900 | 21 CFR§ 884.3900 |
| Regulation | ||
| Name | Vaginal Stent | Vaginal Stent |
| Regulatory Class | II | II |
| Product Code | HDX (Dilator, Vaginal) | HDX (Dilator, Vaginal) |
| Over the | ||
| Counter | No | No |
| Feature | Vaginal dilator, controlled stages | Vaginal dilator, controlled stages |
| Target | ||
| Population | Women suffering from vaginismus | Women suffering from vaginismus |
| Anatomical Site | Vagina | Vagina |
| Single Patient | ||
| Device | Yes | Yes |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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Image /page/6/Picture/1 description: The image shows the logo for "Intimate Rose". The logo features a stylized flower with six petals in shades of purple and pink on the left. To the right of the flower is the company name, "Intimate Rose", in a light purple sans-serif font. The overall design is clean and modern.
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Sterile | Non-sterile | Non-sterile |
| Device Design | Conical | Conical |
| Materials | Medical Grade Silicone | Medical Grade Silicone |
| Dimensions | Eight varying sizes (Inches; | |
| diameter/length): | ||
| 0.45/2.8 | ||
| 0.7/3.5 | ||
| 0.83/3.7 | ||
| 0.95/4.45 | ||
| 1.0/5.0 | ||
| 1.07/5.6 | ||
| 1.3/6.1 | ||
| 1.5/6.5 | Twelve varying sizes (mm; length, Small | |
| OD, Large OD): | ||
| 150, 30, 38 | ||
| 138, 25.5, 32 | ||
| 128, 22.5, 28 | ||
| 120, 19.5, 24 | ||
| 95, 26, 33 | ||
| 86, 22.5, 28 | ||
| 78, 19.5, 23 | ||
| 75, 12.5, 17 | ||
| 75, 13.5, 18 | ||
| 65, 12, 16 | ||
| 60, 10.5, 14 | ||
| 50, 9.5, 13 | ||
| Packaging | Packaged in a cardboard box with | |
| instructions for use. | Packaged in a cardboard box with | |
| instructions for use. | ||
| Operating | ||
| Principle | Dilate the vagina in controlled stages. | Dilate the vagina in controlled stages. |
| Resistive | ||
| component | Progressively larger dilators | Progressively larger dilators |
| Maintenance | Clean with mild soap and warm water. | |
| Towel dry. | Clean with mild soap and hot water. Towel | |
| dry. | ||
| Color | Shades of purple, yellow, blue and green | White |
| Biocompatibility | ||
| Testing | Yes | Yes |
As noted in the table above, the subject device and predicate device are similar in all aspects, except for the following:
Differences in available sizes: The predicate device provides 12 total progressively sized dilators as compared to 8 for the subject device. The smallest diameter of the subject device is 0.45" (11.4 mm) while the smallest diameter for the predicate is 9.5 mm. The largest diameter of the subject device is 1.5" (38.1 mm) while the largest diameter for the predicate is 38 mm.
Differences in color: The subject device comprises 8 different sizes of dilators. Each of the 8 varying sizes is produced in one of 8 colors. The predicate device comprises 12 different sizes of dilators, all colored white.
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Image /page/7/Picture/0 description: The image shows the logo for Intimate Rose. The logo consists of a flower with six petals in shades of pink and purple on the left, followed by the text "Intimate Rose" in a light purple sans-serif font. The flower is stylized and the text is clean and modern.
These differences do not raise different questions of safety or effectiveness and can be evaluated through performance testing.
VII. NON-CLINICAL PERFORMANCE TESTING
Biocompatibility:
The following biocompatibility testing was performed for all 8 colors of the subject device, as recommended in the FDA's 2020 guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"":
-
Cytotoxicity testing per ISO10993-5:2009
- A Guinea pig maximization sensitization testing per ISO10993-10:2010
-
Vaginal irritation testing per ISO10993-10:2010
-
Acute systemic toxicity testing per ISO10993-11:2017
The test results demonstrate that the subject devices (8 various colors) are acceptable regarding all 4 of the above biocompatibility test standards. The subject devices were found to be non-cytotoxic, non-irritating, non-sensitizing, and not causing acute systemic toxicity.
Reprocessing:
The device labeling included reprocessing information per FDA's 2015 guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
Physical Properties:
The following device characteristics were evaluated for all 8 colors of the subject device:
- ▶ Appearance
-
Diameter
- � Hardness
-
Compression
-
Density
VIII. CONCLUSION
Based on the results of the performance testing described above, the Intimate Rose Vaginal Dilators are as safe and effective as the predicate device and supports a determination of substantial equivalence.