(90 days)
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No
The summary describes a biosensor that provides digital data points related to electron flow. There is no mention of AI, ML, or any algorithms that would process this data using such techniques to provide interpretations or predictions beyond simple data display.
No.
The device is intended as an aid to conception by helping to define the fertile window and as an independent information aid, not to treat or cure a disease or condition.
No
The device is described as a "fertility aid" that provides "digital information (data points) relative to electron flow" to help "define the fertile window." It is explicitly stated that it "serves as an independent information aid" and is "not to be used for contraception." While it can provide data for a physician, its primary purpose is to inform timing for conception, not to diagnose a medical condition or disease.
No
The device description explicitly states it is an "electronic biosensor" designed for home use, which is a hardware component.
Based on the provided information, the Ovulon Monitor is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to provide information about a woman's fertile window by measuring electron flow in the vaginal extracellular milieu. This information is used to aid in conception by helping to time intercourse or other fertility treatments.
- Nature of the Measurement: It measures a biological parameter (electron flow in extracellular fluid) from a sample (vaginal fluid/tissue).
- Purpose: The information derived from this measurement is used for a medical purpose – aiding in achieving pregnancy.
While it's for home use and over-the-counter purchase, and the user is the primary interpreter of the data, the fundamental nature of the device is to perform a test on a biological sample to provide information relevant to a physiological state (fertility). This aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques.
The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception.
After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.
Product codes
85 LHD
Device Description
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
posterior fornix and paracervical region of the vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, over-the-counter purchase. May be used by a physician for fertility treatment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Image /page/0/Picture/17 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 1998.
Terry R. Knapp, M.D. President and Medical Director Conception Technology, Inc. 214 S. College Avenue Ft. Collins, CO 80524
Re: K973860
Ovulon Monitor Dated: October 7, 1997 Received: October 9, 1997 Regulatory Class: I Unclassified/Procode: 85 LHD
Dear Dr. Knapp:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begine 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 question 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/dsmamain.html".
Sincerely yours
htliau
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
1
INDICATIONS FOR USE SECTION II:
510(k) Number (if known): _ K973860
Device Name: Ovulon Monitor
Indications for Use:
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques.
The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception.
After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Dolun R Satting | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973860 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |
Conception Technology, Inc.