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.

AI/ML Overview

The provided document is a 510(k) summary for the Intimate Rose Vaginal Dilators. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study that typically involves human readers or an AI algorithm’s performance.

This document describes a device approval process based on non-clinical performance testing for a physical medical device (vaginal dilators), not an AI/ML-driven device. Therefore, the requested information regarding acceptance criteria, human reader studies, AI assistance, ground truth, and training set details for AI/ML performance is not present in the provided text.

Based on the document, I can only provide information related to the device's physical and biological properties.

Here's what can be extracted from the document regarding the device's evaluation, focusing on the non-clinical tests performed:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that the tests demonstrate the device is "acceptable" or "non-" (e.g., non-cytotoxic). The reported performance is the "test results" and the conclusion.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility:
Non-cytotoxic (per ISO10993-5:2009)	The subject devices were found to be non-cytotoxic.
Non-sensitizing (per ISO10993-10:2010)	The subject devices were found to be non-sensitizing.
Non-irritating (Vaginal irritation testing per ISO10993-10:2010)	The subject devices were found to be non-irritating.
Not causing acute systemic toxicity (per ISO10993-11:2017)	The subject devices were found not to be causing acute systemic toxicity.
Reprocessing:
Adequate reprocessing information provided	Device labeling included reprocessing information per FDA's 2015 guidance document.
Physical Properties:
Acceptable Appearance (No specific threshold given)	Evaluated (Implied satisfactory outcome as no issues raised for substantial equivalence)
Acceptable Diameter (No specific threshold given)	Evaluated (Implied satisfactory outcome as no issues raised for substantial equivalence)
Acceptable Hardness (No specific threshold given)	Evaluated (Implied satisfactory outcome as no issues raised for substantial equivalence)
Acceptable Compression (No specific threshold given)	Evaluated (Implied satisfactory outcome as no issues raised for substantial equivalence)
Acceptable Density (No specific threshold given)	Evaluated (Implied satisfactory outcome as no issues raised for substantial equivalence)

2. Sample size used for the test set and the data provenance:

Sample size: The document states that "all 8 colors of the subject device" were tested for biocompatibility and physical properties. It does not provide a specific number of individual dilator units tested for each characteristic.
Data provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The testing was non-clinical laboratory testing performed to international and FDA guidance standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable. The device is a physical medical device, not an AI/ML diagnostic or interpretive tool that requires expert-established ground truth on clinical data for performance evaluation in the context of this 510(k) submission. The "ground truth" for these tests would be the established biological or physical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, which are not part of this device's non-clinical performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

This question is not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests described:

Biocompatibility: The "ground truth" is defined by the international standards (ISO 10993 series) for toxicity, sensitization, irritation, and systemic effects.
Physical Properties: The "ground truth" for physical characteristics like diameter, hardness, compression, and density would be the device's design specifications and material properties, compared against measured values.

8. The sample size for the training set:

This question is not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

This question is not applicable. This is not an AI/ML device.

Summary

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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.

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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

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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

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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
RegulationNumber	21 CFR§ 884.3900	21 CFR§ 884.3900
RegulationName	Vaginal Stent	Vaginal Stent
Regulatory Class	II	II
Product Code	HDX (Dilator, Vaginal)	HDX (Dilator, Vaginal)
Over theCounter	No	No
Feature	Vaginal dilator, controlled stages	Vaginal dilator, controlled stages
TargetPopulation	Women suffering from vaginismus	Women suffering from vaginismus
Anatomical Site	Vagina	Vagina
Single PatientDevice	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):0.45/2.80.7/3.50.83/3.70.95/4.451.0/5.01.07/5.61.3/6.11.5/6.5	Twelve varying sizes (mm; length, SmallOD, Large OD):150, 30, 38138, 25.5, 32128, 22.5, 28120, 19.5, 2495, 26, 3386, 22.5, 2878, 19.5, 2375, 12.5, 1775, 13.5, 1865, 12, 1660, 10.5, 1450, 9.5, 13
Packaging	Packaged in a cardboard box withinstructions for use.	Packaged in a cardboard box withinstructions for use.
OperatingPrinciple	Dilate the vagina in controlled stages.	Dilate the vagina in controlled stages.
Resistivecomponent	Progressively larger dilators	Progressively larger dilators
Maintenance	Clean with mild soap and warm water.Towel dry.	Clean with mild soap and hot water. Toweldry.
Color	Shades of purple, yellow, blue and green	White
BiocompatibilityTesting	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.

Regulation Number and Section

§ 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).