PELVX DONUT, PELVX CUBE

K974117 · Deschutes Medical Products, Inc. · HHW · Apr 27, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K974117
• Device Name: PELVX DONUT, PELVX CUBE
• Applicant: Deschutes Medical Products, Inc.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Apr 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse. The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.

Device Story

PelvX Donut and Cube Vaginal Pessaries are medical devices designed for the support of pelvic organ prolapse. The Donut model provides support for 310 degree prolapse, while the Cube model is indicated for 314 degree prolapse, often in conjunction with rectocele or cystocele. These devices are inserted into the vagina to provide mechanical support to pelvic structures, alleviating symptoms associated with prolapse. They are intended for prescription use by healthcare professionals. The devices function as physical supports to maintain anatomical positioning, thereby improving patient comfort and quality of life.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vaginal pessaries; mechanical support devices. Materials and specific technical dimensions are not detailed in the provided documentation.

Indications for Use

Indicated for patients with 310 degree prolapse (Donut model) or 314 degree prolapse combined with rectocele and/or cystocele (Cube model).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 7 1998

Mr. Matthew Hoskins Vice President of Research and Development DesChutes Medical Products, Inc. 1011 SW Emkay Drive, #104 Bend, OR 97702

Re: K974117

PelyX Donut and PelvX Cube Vaginal Pessaries Dated: January 29, 1998 Received: February 5, 1998 Regulatory Class: II 21 CFR \$884.3575/Procode: 85 HHW

Dear Mr. Hoskins:

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 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). 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 II (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 vito 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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

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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## Indications for Use Statement

510(k) Number (if known): K97417

Device name: PelvX Donut Vaginal Pessary and PelvX Cube Vaginal Pessary

Indications for Use:

The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse.

The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.

(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Satlung/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K974112

Prescription Use ✓

OR

Over-The-Counter Use