Milli Vaginal Dilator

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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. 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You must comply with all the Act's {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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. {4}------------------------------------------------ ## 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. {5}------------------------------------------------ ## 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. {6}------------------------------------------------ | Device Name | Milli Vaginal Dilator<br>(Subject Device) | Panpac Vaginal Dilator<br>(Primary Predicate) | Amielle Vaginal Dilator<br>(Reference Device) | Rationale for Substantial<br>Equivalence | |-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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: Vaginal<br>stent | 21 CFR§884.3900: Vaginal stent | Same | | Product Code | HDX: Dilator, Vaginal | HDX: Dilator, Vaginal | KXP: Stent, Vaginal | Same as the Panpac Vaginal<br>Dilator, primary predicate. Similar<br>to the Amielle Vaginal Dilator,<br>reference device. | | Indications for Use | The Milli Vaginal Dilator is a<br>tool intended for controlled<br>dilation of the vagina. It can be<br>used for dilation for an<br>examination, in preparation for a<br>surgical procedure, or to help<br>relieve the symptoms of<br>vaginismus and related<br>dyspareunia. | Panpac Vaginal Dilators are<br>indicated for women who<br>need vaginal dilation for an<br>examination, a surgical<br>procedure, or for the relief of<br>vaginismus.<br><br>Panpac Vaginal Dilators has<br>four different size (small,<br>medium, large and extra large)<br>in three family types;<br>Family A, Family B and<br>Family C with variant sizes. | The device is intended to treat<br>women suffering from vaginismus<br>and dyspareunia.<br><br>VAGINISMUS is the involuntary<br>spasm of the muscles in the vaginal<br>wall which then inhibits sexual<br>intercourse by making it painful or<br>impossible. DYSPAREUNIA is the<br>pain experienced during sexual<br>intercourse caused by physical<br>and/or emotional problems.<br>The device comes in varying sizes,<br>the most appropriate is then selected<br>by the physician for use by the<br>patient and the patient's partner as<br>an assistant if appropriate. It is used<br>as a tool to DILATE the vagina in<br>controlled stages.<br><br>The device can be autoclaved or<br>sterilized by normal methods. | Similar; same intended use. | | Single Use | Reusable 5-30 minutes/day | Reusable 5-30 minutes/day | Daily use recommended; dilator is<br>intended to be left in position for up<br>to 5 minutes | Same as the primary predicate.<br>Similar to the reference device. | | Prescription/<br>Over-the-Counter | Prescription Use | Prescription Use | Prescription Use | Same | | Device Name | Milli Vaginal Dilator<br>(Subject Device) | Panpac Vaginal Dilator<br>(Primary Predicate) | Amielle Vaginal Dilator<br>(Reference Device) | Rationale for Substantial<br>Equivalence | | Primary Mode of<br>Action | Passive stretching through<br>electromechanical increase in<br>size | Passive stretching through use<br>of increasingly sized dilators | Passive stretching through use of<br>increasingly sized dilators | Similar; electromechanical size<br>change vs. use of differently sized<br>dilators. The difference in the<br>primary mode of action does not<br>raise different questions of safety<br>or effectiveness; performance is<br>demonstrated by Nonclinical<br>Bench Performance Testing. | | Design | Single dilator (shown fully<br>closed and expanded to display<br>the range of dilation size)<br>Image: Milli Vaginal Dilator | Fixed shape design with<br>different sizes; multiple<br>reusable dilators required<br>Image: Panpac Vaginal Dilator | Fixed shape design with different<br>sizes; multiple reusable dilators<br>required<br>Image: Amielle Vaginal Dilator | Similar; single dilator with gradual<br>size change vs. use of differently<br>sized dilators. | | Dilation Size<br>(Outer Diameter) | 15-40mm | 13-38mm | 15-35mm | Similar, within the dilation range<br>of the primary predicate and<br>reference device. | | Dilation Jumps | 1mm | 1-6mm | 5mm | Similar; more gradual dilation<br>jumps with the Milli Vaginal<br>Dilator. | | Energy Source | Rechargeable lithium-ion battery<br>(3.7V) | None | None | Different. This technological<br>difference does not raise different<br>questions of safety or<br>effectiveness; performance is<br>demonstrated by IEC 60601-1<br>testing. | | Software | The Milli Vaginal Dilator<br>contains basic firmware to<br>dilate/contract and to turn<br>vibration option on/off. | No software | No software | Different. This technological<br>difference does not raise different<br>questions of safety or<br>effectiveness; performance is<br>demonstrated by software<br>verification testing. | | Environment for<br>use | Home or healthcare environment | Home or healthcare<br>environment | Unspecified; likely same | Same | | Device Name | Milli Vaginal Dilator<br>(Subject Device) | Panpac Vaginal Dilator<br>(Primary Predicate) | Amielle Vaginal Dilator<br>(Reference Device) | Rationale for Substantial<br>Equivalence | | Sterility | Nonsterile | Nonsterile | Nonsterile | Same | | Nonclinical Bench<br>Performance<br>Testing/In Vitro<br>Bench Testing | Size and Dilation Testing<br>Charging/Cleaning Testing<br>Reliability Testing<br>Engineering Evaluation<br>Shelf Life Storage and<br>Packaging (Transit) Testing | Testing unknown, not<br>specified in 510(k) summary<br>or marketing materials. | Testing unknown, not specified in<br>510(k) summary or marketing<br>materials. | Testing for the primary predicate<br>and reference device is unknown,<br>as it is not specified in the 510(k)<br>summaries or marketing materials. | | Electrical Safety<br>and EMC Testing | Testing conducted in accordance<br>with 60601-1, 60601-1-6, 60601-<br>1-11 and 60601-1-2. | Testing Not Applicable | Testing Not Applicable | Different. This difference does not<br>raise different questions of safety<br>or effectiveness. | | Biocompatibility<br>Testing | Cytotoxicity, Sensitization,<br>Irritation, Acute Systemic<br>Toxicity, and Biological Risk<br>Assessment Conducted | Testing unknown, not<br>specified in 510(k) summary<br>or marketing materials. | Testing unknown, not specified in<br>510(k) summary or marketing<br>materials. | Testing for the primary predicate<br>and reference device is unknown,<br>not specified in 510(k) summary or<br>marketing materials. Risk<br>management for the proposed<br>device informed the<br>biocompatibility testing. | | Clinical Testing | No clinical testing conducted to<br>support clearance. | No clinical testing conducted<br>to support clearance. | No clinical testing conducted to<br>support clearance. | Same | # Table 1: Substantial Equivalence Table {7}------------------------------------------------ # 510(k) Summary (Cont.) {8}------------------------------------------------ # 510(k) Summary (Cont.)