(209 days)
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No
The description focuses on hormone detection and an adaptive testing strategy, but there is no mention of AI, ML, or related terms. The adaptation likely refers to adjusting the testing schedule based on individual cycle length or hormone levels, which can be achieved with traditional algorithms.
No.
The device identifies fertile days to help achieve conception but does not treat a disease or condition; it is a diagnostic tool for fertility.
Yes
The device identifies days for conception based on hormone levels. While not diagnosing a disease, it provides information to achieve a specific health outcome (pregnancy), which aligns with the broad definition of diagnostic devices that aid in making medical decisions or guiding treatments.
No
The device description explicitly states it detects hormone levels in urine, implying the use of a physical component (likely a test strip or reader) to analyze the urine sample, which is not a software-only function.
Yes, the CLEARPLAN EASY FERTILITY MONITOR is an In Vitro Diagnostic (IVD) device.
Here's why:
- It analyzes biological samples: The device measures the levels of luteinizing hormone (LH) and estrone-3-glucuronide (E3G) in urine, which is a biological sample taken from the human body.
- It provides information about a physiological state: The analysis of these hormones provides information about a woman's fertility status and helps identify the most fertile days of her cycle. This is information about a physiological state (fertility).
- It is used for diagnostic purposes (in a broad sense): While not diagnosing a disease, it is used to provide information that helps individuals understand their reproductive health and make decisions related to achieving pregnancy. The term "diagnostic" in IVD encompasses tests that provide information about physiological states, not just diseases.
The intended use clearly states that it is designed to identify days when intercourse is most likely to lead to conception, based on the analysis of urine samples. This aligns with the definition of an IVD device.
N/A
Intended Use / Indications for Use
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy.
The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility.
CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.
CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.
Product codes
LHD, CEP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The bird is oriented towards the right. Surrounding the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 28 1998
Louise Roberts . Requlatory Affairs Manager UniPath Limited Priory Business Park Bedford, MK44 3UP United Kingdom
K981207 Re : Clearplan Easy Fertility Monitor Requlatory Class: I Product Code: LHD, CEP Dated: August 26, 1998 Received: August 28, 1998
Dear Ms. Roberts:
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 The general controls provisions of the Act 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 (Special Controls) or 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 Requlations, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 vour 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) 594-4588. 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/dsmamain.html".
Sincerely yours,
Steven Bitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy .
The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility.
CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.
CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Clinical Laboratory Devices | |
| 510(k) Number | K981207 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use |
(Optional Format 1-2-96)