The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

Device Description

The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy for vaginal tightness through stretching of the vaginal tissue under electromechanical expansion, one millimeter at a time. The Milli Vaginal Dilator expands electronically in increments of 1mm from a baseline of 15mm to 40mm in diameter. Dilation and contraction of the Milli Vaginal Dilator is at the control of the user with a simple button push of either the + or - buttons. The Milli Vaginal Dilator is a single vaginal dilator tool that encompasses the diameter range of many commercially available dilator sets, allowing the user to increase the diameter in smaller increments while the device remains inserted, eliminating the need for removal and insertion of larger sizes. The dilation setting is provided on the user interface to allow the user to easily track dilation progress. The Milli Vaginal Dilator also incorporates a vibration feature that may be used as desired to promote relaxation. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The subject device is intended to be sold over the counter (OTC), to be purchased online without the support of a healthcare provider.

AI/ML Overview

The Milli Vaginal Dilator (K220035) does not meet the specified input requirement of being an AI/ML device, as it is a physical medical device. Therefore, a comprehensive analysis of AI/ML-specific acceptance criteria, test sets, ground truth establishment, and comparative effectiveness against human readers is not applicable.

However, based on the provided text, I can extract the following information regarding the device's performance assessment and criteria for its clearance:

The device, Milli Vaginal Dilator, is intended for "controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex." The current 510(k) submission (K220035) is for Over-The-Counter (OTC) use, whereas its predicate (K211959) was for Prescription (Rx) use. The primary study presented aims to demonstrate that users can self-select appropriately for the OTC version.

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

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance and Summary of Evidence
Nonclinical Performance (Technical)	Established specifications necessary for consistent performance for its intended use. This broadly covers various aspects of device design, manufacturing, and safety. Specific tests included: Shelf-Life Storage and Packaging (Transit) TestingBiocompatibility TestingSoftware Verification TestingElectromagnetic Compatibility and Electrical Safety TestingSize and Dilation Design VerificationCharging/Cleaning VerificationReliability TestingEngineering Evaluation	The collective results of the nonclinical performance testing demonstrate that the materials chosen, the manufacturing processes, and design of the Milli Vaginal Dilator meet the established specifications necessary for consistent performance for its intended use. (The document states that the proposed and predicate device are technologically identical, so all nonclinical tests from K211959 apply.)
Clinical Performance (OTC Self-Selection)	Prospective users of the Milli Vaginal Dilator can accurately determine if they are appropriate candidates for use of the device, based on review of the device labeling (website), without the support of a Health Care Professional (HCP). This aimed to establish that OTC use is as effective as prescription use in terms of appropriate patient selection.	96% (24 of 25) of the potential users of the Milli Vaginal Dilator could correctly determine whether they are appropriate candidates for use of the device, based on review of the Milli ordering webpage prior to purchase. This was determined by comparing the subject's unaided self-assessment with an assessment by a healthcare professional (blinded to the self-assessment).
Risk Analysis	No new risks introduced by the OTC indication.	A risk analysis concluded that there were no new risks for the OTC indication.

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

Sample Size for Clinical (Self-Selection) Study: 25 subjects.
Data Provenance: Prospective, multi-center study. The text does not specify the country of origin, but generally, FDA submissions involve studies conducted in the US unless otherwise stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: The ground truth for the self-selection study was established by one healthcare professional (HCP) for each subject.
Qualifications of Experts: The text refers to them generally as "healthcare professional," but does not provide specific qualifications (e.g., "radiologist with 10 years of experience"). However, for a vaginal dilator, it would typically imply a gynecologist, family physician, or similar medical practitioner.

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

Adjudication Method: The study used a comparison method where each subject's "unaided self-assessment" was compared against "the assessment by the healthcare professional, after an in-person evaluation of the subject and blinded to the subject's prior self-assessment." This is a direct comparison against a single blinded expert's assessment for each subject, rather than a multi-expert consensus or adjudication model.

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:

No MRMC comparative effectiveness study was done. This device is a physical medical device, not an AI/ML diagnostic tool meant to assist human readers. Therefore, this question is not applicable.

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

No standalone (algorithm-only) performance study was done. This is a physical device, not an algorithm. The "standalone" performance closest to this concept would be the device's technical performance (e.g., dilation accuracy, reliability), which was assessed through nonclinical testing.

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

For the self-selection clinical study, the ground truth for appropriate candidacy was the assessment by a healthcare professional (HCP) after an in-person evaluation.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As the "training set" concept is not relevant for this physical device.

Summary

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February 27, 2023

Materna Medical % Cindy Domecus, R.A.C. Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010

Re: K220035

Trade/Device Name: Milli Vaginal Dilator Regulation Number: 21 CFR§ 884.3900 Regulation Name: Vaginal Stent Regulatory Class: II Product Code: HDX Dated: January 27, 2023 Received: January 30, 2023

Dear Cindy Domecus:

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,

Jason Roberts -S

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) K220035

Device Name Milli Vaginal Dilator

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K220035 Page 1 of 4

510(k) SUMMARY: K220035

SUBMITTER I.

Submitter:

Materna Medical, Inc. 2495 Hospital Drive, Suite 300 Mountain View, CA 94040 Phone: 866-433-6933

Contact: Kelly Ashfield

Submission Correspondent:

Cindy Domecus, R.A.C. (US & EU) Principal Domecus Consulting Services LLC Cindy(@)DomecusConsulting.com

Date Prepared:

February 24, 2023

II. DEVICE INFORMATION

Name of Device: Milli Vaginal Dilator

Common or Usual Name: Vaginal Dilator

Classification Name: Vaginal Stent (21 CFR 884.3900)

Regulatory Class: II

Product Code: HDX

PREDICATE DEVICE III.

The predicate device is the Milli Vaginal Dilator cleared under K211959. The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION IV.

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Dilation and contraction of the Milli Vaginal Dilator is at the control of the user with a simple button push of either the + or - buttons. The Milli Vaginal Dilator is a single vaginal dilator tool that encompasses the diameter range of many commercially available dilator sets, allowing the user to increase the diameter in smaller increments while the device remains inserted, eliminating the need for removal and insertion of larger sizes. The dilation setting is provided on the user interface to allow the user to easily track dilation progress. The Milli Vaginal Dilator also incorporates a vibration feature that may be used as desired to promote relaxation. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The subject device is intended to be sold over the counter (OTC), to be purchased online without the support of a healthcare provider.

V. INDICATIONS FOR USE

The intended use of the subject device is identical to the predicate device. They are both intended for controlled dilation of the vaginal tissue for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia. The Indications for Use of the subject and predicate device are shown below. The only modification to the language cleared in the Indications for Use for the Milli Vaginal Dilator (Rx) is to include some lay terms in the OTC indication.

Milli Vaginal Dilator (OTC)	Milli Vaginal Dilator (Rx)
Subject Device	Predicate Device
K220035	K211959
The Milli Vaginal Dilator is a tool intendedfor controlled dilation of the vagina. It can beused for dilation for an examination (by yourdoctor), in preparation for a surgicalprocedure, or to help relieve the symptoms ofvaginismus (condition that involvestightening of the vaginal muscles) and relatedpainful sex.	The Milli Vaginal Dilator is a tool intendedfor controlled dilation of the vagina. It can beused for dilation for an examination, inpreparation for a surgical procedure, or tohelp relieve the symptoms of vaginismus andrelated dyspareunia.

VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the predicate device are unchanged. Therefore, the technological characteristics of the subject device are substantially equivalent to the predicate Milli Vaginal Dilator (Rx) cleared under K211959.

PERFORMANCE DATA VII.

The proposed and predicate device are technologically identical. As such, all necessary nonclinical performance testing conducted to support the clearance of the predicate Milli Vaginal Dilator (Rx) (K211959) are applicable to the subject 510(k).

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Nonclinical Testing Summary:

The nonclinical performance testing that supports the clearance of the subject device included the following:

. Shelf-Life Storage and Packaging (Transit) Testing
Biocompatibility Testing
Software Verification Testing ●
Electromagnetic Compatibility and Electrical Safety Testing ●
Size and Dilation Design Verification ●
Charging/Cleaning Verification ●
Reliability Testing ●
Engineering Evaluation ●

The collective results of the nonclinical performance testing demonstrate that the materials chosen, the manufacturing processes, and design of the Milli Vaginal Dilator meet the established specifications necessary for consistent performance for its intended use.

Clinical Testing Summary:

A self-selection study was conducted to assess whether potential users of the Milli Vaginal Dilator could accurately determine if they were indicated for use of the Milli Vaginal Dilator based on the device labeling (website).

The study was a prospective, single-arm, multi-center, single-blinded study enrolling subjects who were prospective users of the Milli Vaginal Dilator. The study enrolled 25 subjects, all of whom completed the study per protocol.

The study assessed, via independent review of a mock Milli ordering website, and follow up questionnaires, whether prospective users of the Milli Vaginal Dilator could accurately determine if they were indicated for the Milli Vaginal Dilator without the support of a Health Care Professional (HCP). This was determined by a comparison of the subject's unaided selfassessment with the assessment by the healthcare professional, after an in-person evaluation of the subject and blinded to the subject's prior self-assessment.

The results demonstrated that 96% (24 of 25) of the potential users of the Milli Vaginal Dilator could correctly determine whether they are appropriate candidates for use of the device, based on review of the Milli ordering webpage prior to purchase, and therefore provides sufficient information to support that OTC use of the Milli Vaginal Dilator is as effective as prescription use of the device.

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VII. CONCLUSIONS

The subject device and the predicate device have the same intended use and technological characteristics. The differences in the Indications for Use statement do not raise different questions of safety and effectiveness. A self-selection study was conducted to support substantial equivalence of device effectiveness by evaluating self-diagnosis in the OTC population as compared to diagnosis by an HCP for the OTC indication of the subject device; in addition, a risk analysis concluded that there were no new risks for the OTC indication. Therefore, the Milli Vaginal Dilator for OTC use is substantially equivalent to the predicate Milli Vaginal Dilator for Rx use cleared under K211959.

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).