(56 days)
No.
The device description and indications for use explicitly describe a physical medical device (pessaries made of silicone) intended for mechanical support of pelvic organs. There is no mention of any computational or data processing capabilities, nor any terms related to AI, machine learning, or software components.
Yes.
The device is intended to provide support to pelvic organs and treat conditions like pelvic organ prolapse and stress urinary incontinence, which are therapeutic actions.
No
This device is a pessary, which is a supportive device inserted into the vagina to manage pelvic organ prolapse and stress urinary incontinence. Its purpose is therapeutic (support) rather than diagnostic (identifying a condition).
No
The device is a physical, silicone-based pessary that is inserted into the vagina. It is described as being made from silicone and utilizing injection molding. There is no mention of software components, algorithms, or digital processing.
No.
The device is a pessary, which is a physical device inserted into the vagina to provide support to pelvic organs. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina.
The following Indications for Use are associated with each of the following pessary styles:
Milex® Shaatz Folding Pessaries:
Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.
Milex® Gellhorn Pessaries:
Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia.
Milex® Ring Folding Pessaries:
Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.
Product codes (comma separated list FDA assigned to the subject device)
HHW
Device Description
Milex® Pessaries are intended for adult women as Obstetrical and Gynecological medical devices. Milex® Pessaries are distributed in a non-sterile condition made from silicone. The Milex Pessaries are available in a variety of styles, each having a range of sizes that is inserted into the vagina to function as a supportive structure of the uterus, bladder and rectum. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex Pessaries are manufactured in pink for single patient use.
This submission includes the following designs of Milex Pessaries: Shaatz Pessary, Gellhorn Pessary (Short and Long Stem), and Ring Folding Pessaries (Ring without support, Ring with support, Ring with knob without support, Ring with knob with support).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, pelvic organs, uterus, bladder, rectum
Indicated Patient Age Range
adult women
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)
Evidence was submitted to support the following verification activities for the Milex Pessary Devices:
- Shelf Life of Device
- Cleaning and Use Life
- Engineering Rationale for additional sizes of Milex Pessaries
- Biocompatibility
Biocompatibility for the Milex Pessary Devices was performed in accordance with the 2023 FDA biocompatibility guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the and testing performed by CooperSurgical is provided in Table 3.
Table 3: Summary of biological testing
Test Description / Results / ISO Standard
Cytotoxicity / Non-cytotoxic / 10993-5:2009
Sensitization / Non-sensitizer / 10993-10:2021
Irritation or Intracutaneous Reactivity / Non-Irritant / 10993-23:2021
Subacute/Subchronic Toxicity / Non-Subacute/Subchronic Toxic / 10993-11:2017, and 10993-6:2016
Material Mediated Pyrogenicity / Non-Material Mediated Pyrogenic / 10993-11:2017
Acute System Toxicity / Non-Acute Systemic Toxic / 10993-11:2017
Genotoxicity / Non-Mutagenic/Non-Genotoxic / 10993-3:2014, 10993-33:2015, 10993-11:2017
Implantation / Device induced no local response / 10993-6:2016
Chronic Toxicity / Device induced no systemic toxicity / 10993-6:2016, and 10993-11:2017
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
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 11, 2025
CooperSurgical, Inc
Drake Schaffer
Senior Regulatory Affairs Specialist
95 Corporate Drive
Trumbull, Connecticut 06611
Re: K250438
Trade/Device Name: CooperSurgical Milex® Pessaries
Regulation Number: 21 CFR 884.3575
Regulation Name: Vaginal Pessary
Regulatory Class: II
Product Code: HHW
Dated: February 14, 2025
Received: February 14, 2025
Dear Drake Schaffer:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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K250438 - Drake Schaffer
Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
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K250438 - Drake Schaffer
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 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
Page 4
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250438
Device Name: CooperSurgical Milex® Pessaries
Indications for Use (Describe)
The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina.
The following Indications for Use are associated with each of the following pessary styles:
Milex® Shaatz Folding Pessaries:
Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.
Milex® Gellhorn Pessaries:
Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia.
Milex® Ring Folding Pessaries:
Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
Page 5
510(k) Summary
CooperSurgical MILEX Pessaries
I. Submitter Information
Company Name: CooperSurgical Inc.
Company Address: 95 Corporate Drive
Trumbull, CT 06611
Telephone: 203-400-1385
Contact Person: Drake Schaffer
Sr. Regulatory Affairs Specialist
Date Prepared: April 11, 2025
II. Device Information:
Trade Name: CooperSurgical Milex® Pessaries
Common Name: Vaginal pessary
Classification Name: Vaginal pessary
Regulatory Class: Class II
Regulation Medical Specialty: Obstetrics/Gynecology
Regulation Number: 884.3575
Product Code: HHW (pessary, vaginal)
III. Predicate Devices:
| Name | Manufacturer | 510(k) |
|---|---|---|
| Mentor Evacare Vaginal Pessaries (Primary) | Mentor Corp. | K993308 |
Reference Devices:
| Name | Manufacturer | 510(k) |
|---|---|---|
| Gynethotics Gellhorn Pessary | Cosm Medical | K231786 |
| EIS Vaginal Pessaries | EIS Corporation | K132313 |
The predicate device has not been subject to a design related recall.
IV. Device Description:
Milex® Pessaries are intended for adult women as Obstetrical and Gynecological medical devices. Milex® Pessaries are distributed in a non-sterile condition made from silicone. The Milex Pessaries are available in a variety of styles, each having a range of sizes that is inserted
Page 6
into the vagina to function as a supportive structure of the uterus, bladder and rectum. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex Pessaries are manufactured in pink for single patient use.
This submission includes the following designs of Milex Pessaries: Shaatz Pessary, Gellhorn Pessary (Short and Long Stem), and Ring Folding Pessaries (Ring without support, Ring with support, Ring with knob without support, Ring with knob with support).
V. Indications for Use:
The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina.
The following Indications for Use are associated with each of the following pessary styles:
Milex® Shaatz Folding Pessaries
- Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.
Milex® Gellhorn Pessaries
- Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia.
Milex® Ring Folding Pessaries
- Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.
VI. Comparison of Indications for Use and Technological Characteristics with the Predicate Device
The subject Milex Pessary Devices have identical intended use, principles of operation, similar fundamental scientific technology and equivalent or identical Indications for Use with the legally marketed predicate device.
CooperSurgical Milex Pessaries are vaginal pessaries used to function as a supportive structure of the uterus, bladder and/or rectum. Similar to the identified predicate device, CooperSurgical Milex Pessaries are available in multiple shapes and sizes and are manufactured from liquid silicone.
Table 1. Indications for Use Comparison
| Device | Indications for Use |
|---|---|
| Milex Pessaries | The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina. |
The following Indications for Use are associated with each of the following pessary styles:
• Milex® Shaatz Folding Pessaries: Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.
• Milex® Gellhorn Pessaries: |
Page 7
| Device | Indications for Use |
|---|---|
| Milex Pessaries (continued) | Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia. |
| • Milex® Ring Folding Pessaries: Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women. | |
| Predicate Device (K993308) | A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse. The specific indications for use by pessary style is as follows: |
| • Donut Pessary: Support of third degree prolapse, cystocele and rectocele. | |
| • Ring Pessary: Support of first or mild degree prolapse. Ring Pessary with support can also be used on an accompanying cystocele. | |
| • Dish Pessary: Control of stress urinary incontinence and minor degrees of prolapse. | |
| • Oval Pessary: Support of first or second degree prolapse and cystocyle. | |
| • Shaatz Pessary: Support of first or mild second degree prolapse and cystocele. | |
| • Mar-Land Pessary: Control of stress urinary incontinence and minor degrees of prolapse. | |
| • Hodge Pessary: Support of first to second degree prolapse, uterine retroversion or incompetent cervic, stress urinary incontinence. | |
| • Gehrung Pessary: Support of cystocele and rectocele, support of second to third degree prolapse. | |
| • Gellhorn Pessary: Support of second to third degree prolapse or procidentia. | |
| • Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele. |
Fitting Set: Used to determine the proper size of pessary for each patient. |
As shown in the table above, the subject Milex pessaries and the predicate device, Mentor EvaCare™ Vaginal Pessaries, cleared under K993308 share the same intended use: both are removable structures placed in the vagina to provide nonsurgical support to pelvic organs. This intended use is consistent across all pessary styles included in the subject device and aligns with the general use of vaginal pessaries included in the subject device, to manage conditions such as uterine prolapse, cystocele, rectocele, and stress urinary incontinence.
We identify reference device submissions (K231786, K132313) that describe additional pessary shapes and clinical indications similar to those in our submission, but not included in the predicate submission. These reference devices support that the inclusion of other shapes and the broader range of indications included in this CooperSurgical Milex® Pessaries submission do not represent a new intended use and that the bundled shapes and indications included in this submission are consistent with 510k cleared pessaries of the same type.
Therefore, there are no intended use concerns.
Page 8
Table 2: Technological Characteristics Differences
| Technological characteristic | Differences Compared to Predicates |
|---|---|
| Dimensions and sizing (Outer Diameters) | |
| Milex Shaatz Pessaries | 1.50 in. (38 mm) – 3.75 in. (95 mm) |
| The size range for the Milex Shaatz Pessaries is slightly larger than the identified predicate device. The CooperSurgical sizes do not raise different questions of safety or effectiveness. | |
| Milex Gellhorn Pessaries | 1.50 in. (38 mm) – 3.75 in. (95 mm) |
| The size range for the Milex Gellhorn Pessaries is slightly larger than the identified predicate device. The CooperSurgical sizes do not raise different questions of safety or effectiveness. | |
| Milex Ring Pessaries | 1.75 in. (44 mm) – 4.25 in. (108 mm) |
| The size range for the Milex Ring Pessaries is slightly larger than the identified predicate device. The CooperSurgical sizes do not raise different questions of safety or effectiveness. | |
| Materials | The subject device is made of liquid silicone and colorant. The predicate device is also made of silicone and colorant, but silicone and additive formulations may differ. The differences do not raise different questions of safety and effectiveness. |
VII. Performance Data
Evidence was submitted to support the following verification activities for the Milex Pessary Devices:
- Shelf Life of Device
- Cleaning and Use Life
- Engineering Rationale for additional sizes of Milex Pessaries
- Biocompatibility
Biocompatibility for the Milex Pessary Devices was performed in accordance with the 2023 FDA biocompatibility guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the and testing performed by CooperSurgical is provided in Table 3.
Table 3: Summary of biological testing
| Test Description | Results | ISO Standard |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | 10993-5:2009 |
| Sensitization | Non-sensitizer | 10993-10:2021 |
| Irritation or Intracutaneous Reactivity | Non-Irritant | 10993-23:2021 |
Page 9
| Test Description | Results | ISO Standard |
|---|---|---|
| Subacute/Subchronic Toxicity | Non-Subacute/Subchronic Toxic | 10993-11:2017, and 10993-6:2016 |
| Material Mediated Pyrogenicity | Non-Material Mediated Pyrogenic | 10993-11:2017 |
| Acute System Toxicity | Non-Acute Systemic Toxic | 10993-11:2017 |
| Genotoxicity | Non-Mutagenic/Non-Genotoxic | 10993-3:2014, 10993-33:2015, 10993-11:2017 |
| Implantation | Device induced no local response | 10993-6:2016 |
| Chronic Toxicity | Device induced no systemic toxicity | 10993-6:2016, and 10993-11:2017 |
VIII. Conclusion
The subject and predicate device share the same intended use, fundamental scientific technology, principles of operation, and identical or similar Indications for Use. Differences in design sizes or materials between the subject and predicate device do not raise any new questions of safety and effectiveness. Based on the verification evidence activities provided in this pre-market notification application, the subject Milex Pessaries are substantially equivalent to the legally marketed predicate device.