OVULATION CALCULATOR/CONCEPTION CALCULATOR

K954183 · Hector Vides · MPT · Feb 29, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K954183
• Device Name: OVULATION CALCULATOR/CONCEPTION CALCULATOR
• Applicant: Hector Vides
• Product Code: MPT · Obstetrics/Gynecology
• Decision Date: Feb 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5350
• Device Class: Class 2

Intended Use

This is not a stand-alone device. It should be used in conjunction with your present contraceptive method.

Device Story

Ovurite is an ovulation calculator used as an accessory to existing contraceptive methods. It functions as a tool to assist users in tracking ovulation cycles. The device is intended for use by individuals managing their fertility in conjunction with other contraceptive measures. It is not a stand-alone contraceptive device. The output provides information to the user to aid in fertility awareness and decision-making regarding contraceptive use.

Clinical Evidence

No clinical data provided.

Indications for Use

Indicated for use as an accessory to a legally marketed contraceptive method to assist in ovulation calculation.

Regulatory Classification

Identification

A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

July 11, 2022

HVR
Hector Vides
3652 N. Richmond
Chicago, IL 60618

Re: K954183
Trade/Device Name: Ovurite, Ovulation Calculator
Regulation Number: 21 CFR§ 884.5350
Regulation Name: Contraceptive diaphragm and accessories.
Regulatory Class: II
Product Code: MPT

Dear Hector Vides:

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 February 29, 1996. Specifically, because FDA has better categorized your device technology under regulation 884.5350.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Monica D. Garcia, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, [phone], [e-mail].

Sincerely,

Monica D. Garcia -S
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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 29 1996

Mr. Hector Vides
HVR
3552 N. Richmond
Chicago, Illinois 60618

Re: K954183
Ovurite, Ovulation Calculator
Regulatory Class: Unclassified
Product Code: 85 MPT
Dated: January 20, 1996
Received: January 24, 1996

Dear Mr. Vides:

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 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 as an accessory to a legally marketed contraceptive, 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. The following statement must be prominently located on the front panel of the device:

"This is not a stand-alone device. It should be used in conjunction with your present contraceptive method".

If your device is classified (see above) into either class II (Special Controls) or class III (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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),

{2}

Page 2 - Mr. Hector Vides

promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at [phone]. 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 at [phone].

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