(160 days)
The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia.
The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion. The device is intended for use for adult women (>=18 years) who need controlled vaginal dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia. 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 are completed by 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. 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. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The Milli Vaginal Dilator is intended for use in a home or healthcare environment. The device is intended for prescription (Rx) use, and the treatment duration, frequency, and length are specified in the Instructions for Use and/or at the discretion of the physician.
The provided text does not contain acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for a medical device.
This document is a 510(k) Premarket Notification for the Milli Vaginal Dilator, which is a process to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific performance criteria against a predefined standard in a clinical setting.
Here's a breakdown of why the requested information is largely absent and what is provided:
-
A table of acceptance criteria and the reported device performance:
The document extensively compares the Milli Vaginal Dilator to two predicate devices (Panpac Vaginal Dilator and Amielle Vaginal Dilator) in "Table 1: Substantial Equivalence Table" (page 6). This table highlights similarities and differences in:- Classification, Product Code, Indications for Use, Single Use, Prescription/OTC, Primary Mode of Action, Design, Dilation Size (Outer Diameter), Dilation Jumps, Energy Source, Software, Environment for Use, Sterility.
- For performance, it lists various nonclinical bench testing performed for the Milli Vaginal Dilator:
- 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
- Crucially, it states for each of these nonclinical tests that "All Nonclinical Bench Performance Testing performed for the Milli Vaginal Dilator passed the prespecified acceptance criteria/design inputs."
- However, the specific acceptance criteria values (e.g., what constitutes a pass for "Size and Dilation Design Verification") are not provided nor are the quantitative results of these tests. The table only states that the tests were performed and passed.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical "test set" in the context of human subjects is mentioned for performance evaluation. The testing described is primarily nonclinical bench testing.
- For bench testing, the sample sizes of units tested are not provided.
- The "data provenance" (country of origin, retrospective/prospective) is not applicable or provided for the bench tests.
-
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 is not applicable as no clinical study with "ground truth" established by experts for performance evaluation was conducted or presented in this 510(k). The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." (page 5).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical performance "test set" requiring adjudication by experts was presented.
-
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:
- Not applicable. The Milli Vaginal Dilator is a physical medical device, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is not an AI algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the nonclinical bench testing, the "ground truth" would be the device's own design specifications and engineering standards. The document states that tests passed "prespecified acceptance criteria/design inputs." The specifics of these are not detailed.
-
The sample size for the training set:
- Not applicable. There is no mention of a "training set" for an algorithm.
-
How the ground truth for the training set was established:
- Not applicable.
In summary:
The document describes a 510(k) submission, where the primary goal is a finding of "substantial equivalence" to existing predicate devices. This typically relies heavily on nonclinical (bench) performance testing to show that any differences in technological characteristics do not raise different questions of safety or effectiveness.
The document indicates that all necessary bench testing was conducted, and the results "passed the prespecified acceptance criteria/design inputs." However, the specific quantitative acceptance criteria and the detailed results of these tests that would demonstrate "device performance" in terms of those criteria are not provided in this summary document. The "study" itself is the battery of nonclinical bench tests listed, which collectively demonstrated that the device meets its established specifications, allowing the FDA to conclude substantial equivalence.
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December 1, 2021
Materna Medical % Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose. California 95110
Re: K211959
Trade/Device Name: Milli Vaginal Dilator Regulation Number: 21 CFR 884.3900 Regulation Name: Vaginal Stent Regulatory Class: II Product Code: HDX Dated: October 29, 2021 Received: November 1, 2021
Dear Valerie Defiesta-Ng:
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. You must comply with all the Act's
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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 (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 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) K211959
Device Name
Milli Vaginal Dilator
Indications for Use (Describe)
The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia.
| 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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510(k) Notification K211959
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Materna Medical, Inc. 2495 Hospital Drive, Suite 300 Mountain View, CA 94040 U.S.A. Phone: 866-433-6933
Contact Person:
Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110
Date Prepared:
November 30, 2021
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Milli Vaginal Dilator
Generic/Common Name:
Vaginal Dilator
Regulation Number:
21 CFR§884.3900
Regulation Name:
Vaginal Stent
Regulatory Class:
II
Product Code:
HDX
PREDICATE DEVICE [807.92(a)(3)]
Primary Predicate Device: Panpac Vaginal Dilators (K130273) Reference Device: Amielle Vaginal Dilator (K983045) The predicate device has not been subject to a design-related recall.
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DEVICE DESCRIPTION [807.92(a)(4)]
The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion. The device is intended for use for adult women (≥18 years) who need controlled vaginal dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia. 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 are completed by 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. 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. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging.
The Milli Vaginal Dilator is intended for use in a home or healthcare environment. The device is intended for prescription (Rx) use, and the treatment duration, frequency, and length are specified in the Instructions for Use and/or at the discretion of the physician.
INDICATIONS FOR USE [807.92(a)(5)]
The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(a)(6)]
The proposed device and the predicate device have the same Intended Use and similar Indications for Use. The Milli Vaginal Dilator, the primary predicate device, the Panpac Vaginal Dilator, and the reference device, the Amielle Vaginal Dilator, are intended for gradual dilation of the vaginal tissue for vaginismus and related dyspareunia.
The proposed and predicate device share key technological similarities, as they are each intended for gradual dilation of the vaginal tissue in the home or healthcare environment. Please see Table 1 below for a detailed technological comparison. The differences in technology of the Milli Vaginal Dilator as compared to the predicate do not raise different questions of safety or effectiveness, and can be evaluated through performance testing, as summarized below.
PERFORMANCE DATA [807.92(b)]
All necessary bench testing was conducted on the Milli Vaginal Dilator to support a determination of substantial equivalence to the predicate device. All Nonclinical Bench Performance Testing performed for the Milli Vaginal Dilator passed the prespecified acceptance criteria/design inputs.
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NONCLINICAL BENCH PERFORMANCE TESTING SUMMARY [807.92(B)(1)]
The Nonclinical Bench Performance Testing included:
- 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 Bench 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 results of performance testing demonstrate that differences in technological characteristics between the Milli Vaginal Dilator and the Panpac Vaginal Dilator do not raise any different questions of safety and effectiveness.
CLINICAL TESTING SUMMARY [807.92(B)(2)]
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
CONCLUSIONS [807.92(b)(3)]
The proposed device and the predicate device have the same Intended Use and similar Indications for Use. Furthermore, the proposed and predicate device share key technological similarities. The technological differences presented with the proposed device do not raise different questions of safety or effectiveness as compared to the predicate, and the performance testing on the proposed device demonstrate it is as safe and as effective as the predicate device.
SUMMARY
The Milli Vaginal Dilator is substantially equivalent to the predicate device.
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| Device Name | Milli Vaginal Dilator(Subject Device) | Panpac Vaginal Dilator(Primary Predicate) | Amielle Vaginal Dilator(Reference Device) | Rationale for SubstantialEquivalence |
|---|---|---|---|---|
| 510(k) Number | K211959 | K130273 | K983045 | - |
| Company | Materna Medical, Inc. | Panpac Medical Corporation | Owen Mumford, Ltd. | - |
| Classification | 21 CFR§884.3900: Vaginal stent | 21 CFR§884.3900: Vaginalstent | 21 CFR§884.3900: Vaginal stent | Same |
| Product Code | HDX: Dilator, Vaginal | HDX: Dilator, Vaginal | KXP: Stent, Vaginal | Same as the Panpac VaginalDilator, primary predicate. Similarto the Amielle Vaginal Dilator,reference device. |
| Indications for Use | The Milli Vaginal Dilator is atool intended for controlleddilation of the vagina. It can beused for dilation for anexamination, in preparation for asurgical procedure, or to helprelieve the symptoms ofvaginismus and relateddyspareunia. | Panpac Vaginal Dilators areindicated for women whoneed vaginal dilation for anexamination, a surgicalprocedure, or for the relief ofvaginismus.Panpac Vaginal Dilators hasfour different size (small,medium, large and extra large)in three family types;Family A, Family B andFamily C with variant sizes. | The device is intended to treatwomen suffering from vaginismusand dyspareunia.VAGINISMUS is the involuntaryspasm of the muscles in the vaginalwall which then inhibits sexualintercourse by making it painful orimpossible. DYSPAREUNIA is thepain experienced during sexualintercourse caused by physicaland/or emotional problems.The device comes in varying sizes,the most appropriate is then selectedby the physician for use by thepatient and the patient's partner asan assistant if appropriate. It is usedas a tool to DILATE the vagina incontrolled stages.The device can be autoclaved orsterilized by normal methods. | Similar; same intended use. |
| Single Use | Reusable 5-30 minutes/day | Reusable 5-30 minutes/day | Daily use recommended; dilator isintended to be left in position for upto 5 minutes | Same as the primary predicate.Similar to the reference device. |
| Prescription/Over-the-Counter | Prescription Use | Prescription Use | Prescription Use | Same |
| Device Name | Milli Vaginal Dilator(Subject Device) | Panpac Vaginal Dilator(Primary Predicate) | Amielle Vaginal Dilator(Reference Device) | Rationale for SubstantialEquivalence |
| Primary Mode ofAction | Passive stretching throughelectromechanical increase insize | Passive stretching through useof increasingly sized dilators | Passive stretching through use ofincreasingly sized dilators | Similar; electromechanical sizechange vs. use of differently sizeddilators. The difference in theprimary mode of action does notraise different questions of safetyor effectiveness; performance isdemonstrated by NonclinicalBench Performance Testing. |
| Design | Single dilator (shown fullyclosed and expanded to displaythe range of dilation size)Image: Milli Vaginal Dilator | Fixed shape design withdifferent sizes; multiplereusable dilators requiredImage: Panpac Vaginal Dilator | Fixed shape design with differentsizes; multiple reusable dilatorsrequiredImage: Amielle Vaginal Dilator | Similar; single dilator with gradualsize change vs. use of differentlysized dilators. |
| Dilation Size(Outer Diameter) | 15-40mm | 13-38mm | 15-35mm | Similar, within the dilation rangeof the primary predicate andreference device. |
| Dilation Jumps | 1mm | 1-6mm | 5mm | Similar; more gradual dilationjumps with the Milli VaginalDilator. |
| Energy Source | Rechargeable lithium-ion battery(3.7V) | None | None | Different. This technologicaldifference does not raise differentquestions of safety oreffectiveness; performance isdemonstrated by IEC 60601-1testing. |
| Software | The Milli Vaginal Dilatorcontains basic firmware todilate/contract and to turnvibration option on/off. | No software | No software | Different. This technologicaldifference does not raise differentquestions of safety oreffectiveness; performance isdemonstrated by softwareverification testing. |
| Environment foruse | Home or healthcare environment | Home or healthcareenvironment | Unspecified; likely same | Same |
| Device Name | Milli Vaginal Dilator(Subject Device) | Panpac Vaginal Dilator(Primary Predicate) | Amielle Vaginal Dilator(Reference Device) | Rationale for SubstantialEquivalence |
| Sterility | Nonsterile | Nonsterile | Nonsterile | Same |
| Nonclinical BenchPerformanceTesting/In VitroBench Testing | Size and Dilation TestingCharging/Cleaning TestingReliability TestingEngineering EvaluationShelf Life Storage andPackaging (Transit) Testing | Testing unknown, notspecified in 510(k) summaryor marketing materials. | Testing unknown, not specified in510(k) summary or marketingmaterials. | Testing for the primary predicateand reference device is unknown,as it is not specified in the 510(k)summaries or marketing materials. |
| Electrical Safetyand EMC Testing | Testing conducted in accordancewith 60601-1, 60601-1-6, 60601-1-11 and 60601-1-2. | Testing Not Applicable | Testing Not Applicable | Different. This difference does notraise different questions of safetyor effectiveness. |
| BiocompatibilityTesting | Cytotoxicity, Sensitization,Irritation, Acute SystemicToxicity, and Biological RiskAssessment Conducted | Testing unknown, notspecified in 510(k) summaryor marketing materials. | Testing unknown, not specified in510(k) summary or marketingmaterials. | Testing for the primary predicateand reference device is unknown,not specified in 510(k) summary ormarketing materials. Riskmanagement for the proposeddevice informed thebiocompatibility testing. |
| Clinical Testing | No clinical testing conducted tosupport clearance. | No clinical testing conductedto support clearance. | No clinical testing conducted tosupport clearance. | Same |
Table 1: Substantial Equivalence Table
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510(k) Summary (Cont.)
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510(k) Summary (Cont.)
§ 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).