(160 days)
No
The description focuses on electromechanical expansion and user-controlled operation with no mention of AI or ML algorithms for decision-making, data analysis, or adaptive control.
Yes
The device is specifically intended to "help relieve the symptoms of vaginismus and related dyspareunia" through "distention of the vaginal tissue under electromechanical expansion." This description clearly indicates a therapeutic purpose rather than just diagnostic or general wellness.
No
The device is described as a "tool intended for controlled dilation of the vagina" and for "therapy through distention of the vaginal tissue." Its purpose is to facilitate examination, prepare for surgery, or relieve symptoms, all of which are therapeutic or assistive functions, not diagnostic.
No
The device description clearly details a physical, electromechanical device with buttons, a battery, and a charging case, indicating it is not software-only.
Based on the provided information, the Milli Vaginal Dilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Milli Vaginal Dilator's Function: The Milli Vaginal Dilator is a physical tool used for the mechanical dilation of the vagina. It directly interacts with the body and does not analyze any biological specimens.
- Intended Use: The intended uses described (dilation for examination, surgical preparation, relief of vaginismus/dyspareunia) are all related to physical manipulation and therapy, not diagnostic testing of samples.
Therefore, the Milli Vaginal Dilator falls under the category of a medical device used for treatment and physical intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HDX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
adult women (≥18 years)
Intended User / Care Setting
Home or healthcare environment. The device is intended for prescription (Rx) use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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. 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
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
(Subject Device) | Panpac Vaginal Dilator
(Primary Predicate) | Amielle Vaginal Dilator
(Reference Device) | Rationale for Substantial
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
stent | 21 CFR§884.3900: Vaginal stent | Same |
| Product Code | HDX: Dilator, Vaginal | HDX: Dilator, Vaginal | KXP: Stent, Vaginal | Same as the Panpac Vaginal
Dilator, primary predicate. Similar
to the Amielle Vaginal Dilator,
reference device. |
| Indications for Use | 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. | 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 A, Family B and
Family C with variant sizes. | The device is intended to treat
women suffering from vaginismus
and 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 comes in varying sizes,
the most appropriate is then selected
by the physician for use by the
patient and the patient's partner as
an assistant if appropriate. It is used
as a tool to DILATE the vagina in
controlled stages.
The device can be autoclaved or
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
intended to be left in position for up
to 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 Substantial
Equivalence |
| Primary Mode of
Action | Passive stretching through
electromechanical increase in
size | Passive stretching through use
of increasingly sized dilators | Passive stretching through use of
increasingly sized dilators | Similar; electromechanical size
change vs. use of differently sized
dilators. The difference in the
primary mode of action does not
raise different questions of safety
or effectiveness; performance is
demonstrated by Nonclinical
Bench Performance Testing. |
| Design | Single dilator (shown fully
closed and expanded to display
the range of dilation size)
Image: Milli Vaginal Dilator | Fixed shape design with
different sizes; multiple
reusable dilators required
Image: Panpac Vaginal Dilator | Fixed shape design with different
sizes; multiple reusable dilators
required
Image: Amielle Vaginal Dilator | Similar; single dilator with gradual
size change vs. use of differently
sized dilators. |
| Dilation Size
(Outer Diameter) | 15-40mm | 13-38mm | 15-35mm | Similar, within the dilation range
of the primary predicate and
reference device. |
| Dilation Jumps | 1mm | 1-6mm | 5mm | Similar; more gradual dilation
jumps with the Milli Vaginal
Dilator. |
| Energy Source | Rechargeable lithium-ion battery
(3.7V) | None | None | Different. This technological
difference does not raise different
questions of safety or
effectiveness; performance is
demonstrated by IEC 60601-1
testing. |
| Software | The Milli Vaginal Dilator
contains basic firmware to
dilate/contract and to turn
vibration option on/off. | No software | No software | Different. This technological
difference does not raise different
questions of safety or
effectiveness; performance is
demonstrated by software
verification testing. |
| Environment for
use | Home or healthcare environment | Home or healthcare
environment | Unspecified; likely same | Same |
| Device Name | Milli Vaginal Dilator
(Subject Device) | Panpac Vaginal Dilator
(Primary Predicate) | Amielle Vaginal Dilator
(Reference Device) | Rationale for Substantial
Equivalence |
| Sterility | Nonsterile | Nonsterile | Nonsterile | Same |
| Nonclinical Bench
Performance
Testing/In Vitro
Bench Testing | Size and Dilation Testing
Charging/Cleaning Testing
Reliability Testing
Engineering Evaluation
Shelf Life Storage and
Packaging (Transit) Testing | Testing unknown, not
specified in 510(k) summary
or marketing materials. | Testing unknown, not specified in
510(k) summary or marketing
materials. | Testing for the primary predicate
and reference device is unknown,
as it is not specified in the 510(k)
summaries or marketing materials. |
| Electrical Safety
and EMC Testing | Testing conducted in accordance
with 60601-1, 60601-1-6, 60601-
1-11 and 60601-1-2. | Testing Not Applicable | Testing Not Applicable | Different. This difference does not
raise different questions of safety
or effectiveness. |
| Biocompatibility
Testing | Cytotoxicity, Sensitization,
Irritation, Acute Systemic
Toxicity, and Biological Risk
Assessment Conducted | Testing unknown, not
specified in 510(k) summary
or marketing materials. | Testing unknown, not specified in
510(k) summary or marketing
materials. | Testing for the primary predicate
and reference device is unknown,
not specified in 510(k) summary or
marketing materials. Risk
management for the proposed
device informed the
biocompatibility testing. |
| Clinical Testing | No clinical testing conducted to
support clearance. | No clinical testing conducted
to support clearance. | No clinical testing conducted to
support clearance. | Same |
Table 1: Substantial Equivalence Table
7
510(k) Summary (Cont.)
8