PELVX INCONTINENCE DISH, MODEL 301-306

K990593 · Deschutes Medical Products, Inc. · HHW · May 24, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K990593
• Device Name: PELVX INCONTINENCE DISH, MODEL 301-306
• Applicant: Deschutes Medical Products, Inc.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: May 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PelvX Incontinence Dish Vaginal Pessary is intended for treatment of stress urinary incontinence combined with a mild 1st or 2nd degree uterine prolapse and/or a mild cystocele.

Device Story

PelvX Incontinence Dish is a reusable vaginal pessary; constructed of medical-grade silicone; dish-shaped to support cervical and bladder areas. Features a bulbous portion on the circumference to support and elevate the bladder neck, improving urethral sphincter control. Device is fitted by medical personnel; requires regular clinical visits for monitoring and fit checks. Patient removes device before coitus; cleans with soap and water. Intended to treat stress urinary incontinence and mild prolapse/cystocele by providing mechanical support to pelvic structures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed by NamSA included acute systemic toxicity, cytotoxicity, muscle implantation (1, 4, and 12 weeks), ISO sensitization, pyrogenicity, and vaginal irritation (14 days). Testing followed ISO-10993 requirements for mucosal membrane contact devices.

Technological Characteristics

Material: medical grade silicone. Form factor: dish-shaped with bulbous support and drainage holes. Dimensions: 6 sizes ranging from 2.25" to 3.5". Sterilization: supplied clean, non-sterile. Reusable. Mechanical support principle.

Indications for Use

Indicated for patients with stress urinary incontinence combined with mild 1st or 2nd degree uterine prolapse and/or mild cystocele. Contraindicated in patients with pelvic infections, lacerations, endometriosis, pregnancy, or non-compliant patients.

Regulatory Classification

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.

Predicate Devices

• Milex Incontinence Dish with Support

Reference Devices

• DesChutes Donut Pessary (K974117)

Submission Summary (Full Text)

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PelvX 510(k)

02/22/99
K90593

MAY 2 4 1999

# 510(k) SUMMARY PelvX Incontinence Dish

DesChutes Medical Products, Inc. 1011 SW Emkay Drive, Suite 104 Bend, OR 97702 Date Prepared: 2/19/99

## 1. CONTACT PERSON

| Denise Bestwick |
|-----------------|
|-----------------|

| Phone | : [phone] |
|-------|------------------|
| Fax | : [phone] |

#### 2. NAME OF THE MEDICAL DEVICE

| Classification name | : Vaginal Pessary |
|---------------------|---------------------------|
| Common/usual name | : Vaginal Pessary |
| Proprietary name | : PelvX Incontinence Dish |

#### 3. DEVICE CLASSIFICATION

PelvX Incontinence Dish Vaginal Pessary is classified by the FDA under the heading of Vaginal Pessary (21 CFR Section 884.3575) as a Class II device with Product Code: 85HHW.

#### STATEMENT OF SUBSTANTIAL EQUIVALENCE 4.

PelvX Incontinence Dish Vaginal Pessary is substantially equivalent to the Milex Incontinence Dish pessary, manufactured by Milex Products, Inc., Chicago, IL 60631.

A comparison of the PelvX Devices versus the Milex Devices is presented in Tables 1 and 2.

### 5. INTENDED USE

The PelvX Incontinence Dish Vaginal Pessary is intended for treatment of stress urinary incontinence combined with a mild 1st or 2nd degree uterine prolapse and/or a mild cystocele.

#### DESCRIPTION OF DEVICE 6.

The PelvX Incontinence Dish Vaginal Pessary is a pessary intended for the treatment of stress urinary incontinence. It is made of medical grade silicone and is shaped like a dish to surround and support the cervical area and bladder areas. Holes in the dish allow drainage of vaginal fluids. It features a bulbous portion at one location on its circumference designed to support and elevate the bladder neck, thereby providing improved urethral sphincter control. Figure 1 shows a diagram of the PelvX Incontinence Dish.

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### 7. SUBSTANTIAL EQUIVALENCE COMPARISON

Tables 1 and 2 demonstrate the regulatory classifications and features of the DesChutes Incontinence Ring compared to the Milex Incontinence Ring.

The common and classification names for these products are identical. In addition, both of these devices are prescription devices.

These vaginal pessaries are reusable devices which must be fitted, checked for continuing fit, and monitored for developing problems by medical personnel. The DesChutes and Milex Dishes have identical intended uses. The contraindications for their use are also the same. The pessaries are supplied clean but not sterile. Cleaning procedures are also the same. Both devices come in a variety of sizes for fitting.

There are several differences between the DesChutes and Milex products. First, DesChutes explicitly states that these are single patient devices while Milex is silent on this point. Second, DesChutes adds a precaution that the pessary should be removed before coitus. Finally the pessaries are packaged differently which does not affect the intended use or performance of the product.

| Category | DesChutes Medical Products<br>PelvX Incontinence Dish | Milex Products<br>Incontinence Dish with<br>Support |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Common or usual name | vaginal pessary | vaginal pessary |
| Classification name | 884.3575 Vaginal pessary | 884.3575 Vaginal pessary |
| Product Code | 85HHW | 85HHW |
| Prescription device | Yes | Yes |
| Feature | DesChutes Medical Products<br>PelvX Incontinence Dish | Milex Products<br>Incontinence Dish<br>with Support |
| Intended Use | treatment of stress urinary incontinence combined with 1st or 2nd degree prolapse and/or a mild cystocele | stress urinary incontinence coupled with a mild 1st or 2nd degree prolapse and/or a mild cystocele |
| Single patient device | yes | implied but not specifically stated |
| Single use or reusable | reusable | reusable |
| Must be initially fitted by<br>medical personnel | yes | yes |
| Requires regular visits to<br>medical personnel for<br>checking | yes | yes |
| Contraindications | 1) pelvic infections or<br>lacerations<br>2) non-compliant patients<br>3) endometriosis<br>4) pregnancy | 1) pelvic infections or<br>lacerations<br>2) non-compliant patients<br>3) endometriosis<br>4) pregnancy |
| Cautions | 1) pessary should be removed before coitus | |
| Sterilization status | clean, but not sterile | clean, but not sterile |
| Foldable | yes | yes |
| Maintenance | clean with warm water and soap when removed | clean with water and mild soap when removed |
| Material<br>Outer | medical grade silicone | medical grade silicone |
| Color additives | yes | yes |
| Number of models | 6 | 6 |
| Sizes | 2.25", 2.5", 2.75", 3", 3.25",<br>3.5" | 55mm, 60mm, 65mm, 70mm,<br>75mm, 80mm, 85mm |
| Instructions | physician and patient<br>instructions | physician/nurse and patient<br>instructions |
| Packaging | plastic bag inside paperboard box with label | plastic clamshell with instructions for use visible |

### Table 1-Comparison of Regulatory Classifications

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## Table 2 -Comparison of Device Features

#### 8. SUMMARY OF SAFETY TESTING

The DesChutes PelvX Incontinence Dish is made of a known medical grade silicone. Extensive testing of this silicone was performed for DesChutes Medical Products by NamSA. The following tests were performed:

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Acute Systemic Toxicity Cytotoxicity Muscle Implantation (1 week) Muscle Implantation (4 weeks) Muscle Implantation (12 weeks) ISO Sensitization Study Pyrogenicity Vaginal Irritation (14 days)

The material used is the same as for the DesChutes Donut Pessary (510(k) #974117). This testing regime was compared to requirements in "General Purpose Memorandum G95-1 Use of International Standard ISO-10993" for devices in contact with mucosal membranes for between 24 hours and 30 days. The test results support the position that this material is substantially equivalent to the other materials used for similar purposes.

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Image /page/4/Figure/0 description: This image shows a technical drawing of a pessary incontinence dish. The drawing includes multiple views of the dish, with dimensions labeled such as 1.100, 2.750, 1.000, 0.651, and 1.600. The scale of the drawing is 1:1, and notes indicate the finish is DHE C-3 and parts should be furnished clean and dry. The drawing also includes a part number 110303 and specifies that dimensions are in inches.

### DesChutes Medical Products, Inc. PelvX 510(k) FIGURE 1. DIAGRAM OF PELVX INCONTINENCE DISH

02/22/99

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and vigilance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 1999

Ms. Denise Bestwick Director, Quality Assurance and Regulatory Affairs DesChutes Medical Products, Inc. 1011 S.W. Emkay Drive, Suite 104 Bend, OR 97702

Re: K990593 PelvX Incontinence Dish Vaginal Pessary Dated: February 22, 1999 Received: February 24,1999 Regulatory Class: II 21 CFR §884.3575/Procode: 85 HHW

Dear Ms. Bestwick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Statement of Indications for Use

510(K) Number (if known): 长990593

Device name: PelvX Incontinence Dish Vaginal Pessary

Indications for Use:

.. -

The PelvX Incontinence Dish Vaginal Pessary is a vaginal pessary intended for the treatment of stress urinary incontinence combined with mild 1st or 2nd degree uterine prolapse and/or a mild cystocele.

(Please do not write below this line) 营款电信维修在发展或者的优质量是是是是最高品质量和用品质量和产品 Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number Prescription Use_ OR Over-The-Counter Use _