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 Description

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.

AI/ML Overview

The provided 510(k) summary for the PelvX Incontinence Dish does not contain information about specific acceptance criteria related to a performance study for the device's intended use (treating stress urinary incontinence and mild prolapse/cystocele).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Milex Incontinence Dish) and safety testing of the materials used in the device. This type of 510(k) submission typically does not include a clinical performance study with acceptance criteria in the same way modern AI/software-as-a-medical-device (SaMD) submissions do. For a physical device like a pessary, substantial equivalence is often based on design, materials, and intended use comparison.

Therefore, I cannot populate the requested table and sections with specific acceptance criteria and a performance study demonstrating the device meets those criteria, as that information is not present in the provided document.

However, I can extract information related to the safety testing and the comparison to the predicate device, which serves as the basis for marketing clearance in this context.

Summary of Available Information (Not a Performance Study against Acceptance Criteria):

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria for Performance: Not explicitly stated as this device's clearance relied on substantial equivalence, not a direct performance study against a predefined efficacy metric.
Reported Device Performance (Implicit): The device is considered substantially equivalent to the Milex Incontinence Dish, which implies it performs similarly for its intended use. No specific efficacy rates (e.g., reduction in incontinence episodes) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Clinical Performance Study: No clinical performance study data provided.
Safety Testing: Material testing was performed by NamSA, without specifying a "sample size" in the context of device performance on patients. It refers to testing on the silicone material itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical performance study involving expert assessment or ground truth establishment for patient outcomes was conducted or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical performance study involving expert assessment or adjudication was conducted or reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable; this is a physical medical device, not an AI/software device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable; this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no clinical performance study requiring ground truth was conducted or reported. The "ground truth" for clearance in this case is the established safety and efficacy of the predicate device.

8. The sample size for the training set

Not applicable as there is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable as there is no mention of a training set for an algorithm.

Information on Safety Testing (as provided in the document):

The submission highlights material safety testing conducted on the medical-grade silicone used in the device. 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.

Tests Performed:
- Acute Systemic Toxicity
- Cytotoxicity
- Muscle Implantation (1 week)
- Muscle Implantation (4 weeks)
- Muscle Implantation (12 weeks)
- ISO Sensitization Study
- Pyrogenicity
- Vaginal Irritation (14 days)
Conclusion: The test results supported the position that this material is substantially equivalent to other materials used for similar purposes (specifically, the material in DesChutes Donut Pessary (510(k) #974117)).

In summary, for K990593, the acceptance criteria for market clearance were primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Milex Incontinence Dish) in terms of intended use, materials, design, and contraindications, along with demonstrating the safety of the specific materials used. There was no clinical performance study reported in this 510(k) summary that established specific performance acceptance criteria for treating stress urinary incontinence or prolapse directly for this device.

Summary

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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
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Phone	: (541) 385-0350
Fax	: (541) 382-2079

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.

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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 ProductsPelvX Incontinence Dish	Milex ProductsIncontinence Dish withSupport
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 ProductsPelvX Incontinence Dish	Milex ProductsIncontinence Dishwith 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 bymedical personnel	yes	yes
Requires regular visits tomedical personnel forchecking	yes	yes
Contraindications	1) pelvic infections orlacerations2) non-compliant patients3) endometriosis4) pregnancy	1) pelvic infections orlacerations2) non-compliant patients3) endometriosis4) 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
MaterialOuter	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",3.5"	55mm, 60mm, 65mm, 70mm,75mm, 80mm, 85mm
Instructions	physician and patientinstructions	physician/nurse and patientinstructions
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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 _

Regulation Number and Section

§ 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).