(314 days)
Not Found
No
The device description and performance studies focus on physical properties and biocompatibility, with no mention of AI or ML.
Yes
The device is used for the relief of vaginismus, which is a medical condition, making it a therapeutic device.
No
The device, Hope&Her Vaginal Dilators, is used for vaginal dilation for examination, surgical preparation, or relief of vaginismus. Its function is to provide passive distention of vaginal tissues, not to diagnose a condition.
No
The device description explicitly states it is a series of reusable, non-sterile, single-user vaginal dilators made of polyester and polyamide, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Hope&Her Vaginal Dilators are physical devices used to mechanically distend vaginal tissues. They are used for examination, surgical preparation, or relief of vaginismus. They do not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use clearly describes a physical intervention, not a diagnostic test.
Therefore, the Hope&Her Vaginal Dilators fall under the category of a medical device used for therapeutic or procedural purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.
Product codes
HDX
Device Description
Hope&Her Vaginal Dilators is a series of reusable, non-sterile, single user vaginal dilators that are used by patients to provide passive distention of the vaginal tissues using various sized dilators. The subject device has various sized rigid dilators that range from 15 mm to 38 mm in diameter (15, 22, 26, 30, 34, and 38 mm) and a handle to hold the dilator. The subject device is prescription-only. The subject device is composed polyester and polyamide. The subject device is distributed in heat-seal plastic bags.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility
Biocompatibility testing on the vaginal dilators was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009/(R)2014)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
- Vaginal Irritation (ISO 10993-23: 2021)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrate that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
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 the subject device:
- Appearance
- Diameter
- Tensile strength
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 5, 2023
Lujena, Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108
Re: K222492 Trade/Device Name: Hope&Her Vaginal Dilators Regulation Number: 21 CFR§ 884.3900 Regulation Name: Vaginal Stent Regulatory Class: II Product Code: HDX
Dear Alan Donald:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 27, 2023. Specifically, FDA is updating this SE Letter to correct the contact information in the 510(k) Summary as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jason Roberts, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (240) 402-6400, Jason.Roberts@fda.hhs.gov.
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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, followed by the word "ADMINISTRATION" in a smaller font size.
June 27, 2023
Lujena, Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108
Re: K222492
Trade/Device Name: Hope&Her Vaginal Dilators Regulation Number: 21 CFR§ 884.3900 Regulation Name: Vaginal Stent Regulatory Class: II Product Code: HDX Dated: Mav 24, 2023 Received: May 24, 2023
Dear Alan Donald:
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.
2
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 (QS) 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
Monica D. Garcia, 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
3
Indications for Use
510(k) Number (if known) K22492
Device Name Hope&Her Vaginal Dilators
Indications for Use (Describe)
Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary – K222492 Hope&Her Vaginal Dilators
General Information on Submitter l.
| Applicant: | Lujena, Inc. |
|---|---|
| Address: | 772 Jamacha Road. #80 |
| El Cajon, CA 92019 | |
| Telephone: | 1 619 449 1200 |
| Contact Person: | Troy Gemmer |
| Contact Title: | President |
| Email: | lujena@icloud.com |
| Date Prepared: | June 15, 2023 |
II. General Information on Device
| Name of Device: | Hope&Her Vaginal Dilators |
|---|---|
| Dilators Common of Usual Name: | Vaginal Dilators |
| Regulation Number: | 21 CFR 884.3900 |
| Classification Name: | Vaginal Stent |
| Regulatory Class: | II |
| Product Code: | HDX (Dilator, Vaginal) |
| Classification Panel: | Obstetrics/Gynecology |
lll. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| Amielle | K983045 |
This predicate device has not been subject to a design-related recall.
IV. Description of Device
Hope&Her Vaginal Dilators is a series of reusable, non-sterile, single user vaginal dilators that are used by patients to provide passive distention of the vaginal tissues using various sized dilators. The subject device has various sized rigid dilators that range from 15 mm to 38 mm in diameter (15, 22, 26, 30, 34, and 38 mm) and a handle to hold the dilator. The subject device is prescription-only. The subject device is composed polyester and polyamide. The subject device is distributed in heat-seal plastic bags.
V. Indications for Use
5
Hope&Her Vaqinal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.
Differences in Indications for Use:
Subject device: "Hope&Her Vaqinal Dilators are indicated for women who need vaqinal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus."
Predicate device: "The device is intended to treat women suffering from vaginismus and dyspareunia. Vaginismus is the involuntary spasm of the muscles in the vaqinal 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 vaqina in controlled stages. The device can be autoclaved or sterilized by normal methods."
The difference between the subject and predicate device indications for use is that the predicate device includes additional indications for dyspareunia and also includes technological description of the device. As the subject device indications are a subset of the predicate device indications, this difference does not raise intended use concerns.
| | SUBJECT DEVICE
K222492 | PREDICATE DEVICE
K983045 |
|-----------------------------|------------------------------------|----------------------------------------------------|
| Device Name | Hope&Her Vaginal Dilators | Amielle |
| Regulation
Number | 21 CFR§ 884.3900 | 21 CFR§ 884.3900 |
| Regulation
Name | Vaginal Stent | Vaginal Stent |
| Regulatory Class | II | II |
| Over
the
Counter | No | No |
| Feature | Vaginal dilator, controlled stages | Vaginal dilator, controlled stages |
| Target
Population | Women suffering from vaginismus | Women suffering from vaginismus and
dyspareunia |
| Anatomical Site | Vagina | Vagina |
| Single
Patient
Device | Yes | Yes |
| Reusable | Yes | Yes |
VI. Comparison of Technological Characteristics with the Predicate Device
6
| Sterile | Non-sterile | Non-sterile |
|---|---|---|
| Device Design | Conical | Conical |
| Materials | Polyester and polyamide | Polybutylene terephthalate dilator |
| Diameter | Available from 15 - 38 mm; | |
| increases diameter in metrics of 4 - 7 mm | Available from 15 - 35 mm; | |
| increases diameter in metrics of 5 mm | ||
| Packaging | Packaged in heat-sealed bag with | |
| instructions for use. | Packaged in a cardboard box with | |
| instructions for use. | ||
| Operating | ||
| Principle | Dilate the vagina in controlled stages | Dilate the vagina in controlled stages |
| Resistive | ||
| component | Progressively larger dilators | Progressively larger dilators |
| Maintenance | Clean with mild soap and boiling water. | |
| Towel dry. | Clean with mild soap and hot water. Towel dry. | |
| Color | White and turquoise | White |
| Biocompatibility | ||
| Testing | Yes | Yes |
As noted in the table above, the subject device and predicate device are similar in all aspects, except for differences in target population, materials, dimensions, packaging, maintenance, and color. These differences do not raise different questions of safety or effectiveness and can be evaluated through performance testing.
VII. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility testing on the vaginal dilators was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009/(R)2014) ●
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ●
- Vaginal Irritation (ISO 10993-23: 2021) ●
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
The results of this testing demonstrate that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Reprocessing
7
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 the subject device:
- Appearance
- Diameter
- Tensile strength ●
VIII. Conclusion
Based on the results of the performance testing described above, the Hope&Her Vaginal Dilators are as safe and effective as the predicate device and supports a determination of substantial equivalence.