(444 days)
No
The description explicitly states the use of a "proprietary algorithm" based on a "Fertility Awareness Based Method (FABM)". There is no mention of AI, ML, or any related concepts like training or test sets for model development. The performance study references a clinical trial assessing the "same algorithm", further suggesting a deterministic, rule-based approach rather than a learning-based one.
No.
The device is intended to prevent pregnancy, not to treat or cure a disease or condition. While contraception can be considered a health-related intervention, it does not fall under the typical definition of a "therapeutic device" which generally implies treating or mitigating a pre-existing medical condition.
No
The device monitors fertility and prevents pregnancy by identifying "high risk days" and "low risk days" for conception, based on a Fertility Awareness Based Method (FABM) of contraception. It does not diagnose any disease or condition.
Yes
The device is explicitly described as a "software application" and a "feature of the Clue period tracker mobile application." The description focuses solely on the algorithm and user interaction within the software, with no mention of accompanying hardware components required for its primary function.
Based on the provided information, Clue Birth Control is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- Clue Birth Control relies on user-entered data. The software uses information about period start dates and cycle lengths provided by the user. It does not analyze any biological specimens.
- The purpose is fertility monitoring and pregnancy prevention. While this relates to a biological process, the method of operation is based on tracking and predicting cycles using user input, not on analyzing biological markers in a sample.
The device description clearly states that Clue Birth Control is a "software application" that uses a "proprietary algorithm" based on "period start date information entered by the user." This aligns with a software-as-a-medical-device (SaMD) or a digital health tool, rather than an IVD.
N/A
Intended Use / Indications for Use
Clue Birth Control is a software application for women ages 18 - 45 years old, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable 20 - 40 day cycles, who have not recently used hormonal birth control.
Product codes
PYT
Device Description
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control's proprietary algorithm uses period start date information entered by the user to provide predictions of "high risk days" and "low risk days" for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy.
To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 - 45 years old
Intended User / Care Setting
Over-the-counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: The "Dynamic Optical Timing (DOT)" clinical efficacy trial assessed the same algorithm used in the subject device. It was a prospective clinical trial that followed 718 women aged 18 to 39, living in the United States. Each woman participated for up to 13 cycles, providing 6616 cycles in total.
Perfect-use Pearl Index: 0.8
Typical-use Pearl Index: 5.2 (95% CI: 3.4-7.7)
The study involved 718 women, 509 exposure Woman-Years, and 25 (worst-case 58) pregnancies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Perfect-use Pearl Index: 0.8
Typical-use Pearl Index: 5.2
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5370 Software application for contraception.
(a)
Identification. A software application for contraception is a device that provides user-specific fertility information for preventing a pregnancy. This device includes an algorithm that performs analysis of patient-specific data (e.g., temperature, menstrual cycle dates) to distinguish between fertile and non-fertile days, then provides patient-specific recommendations related to contraception.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate the contraceptive effectiveness of the software in the intended use population.
(2) Human factors performance evaluation must be provided to demonstrate that the intended users can self-identify that they are in the intended use population and can correctly use the application, based solely on reading the directions for use for contraception.
(3) Software verification, validation, and hazard analysis must be performed. Documentation must include the following:
(i) A cybersecurity vulnerability and management process to assure software functionality; and
(ii) A description of the technical parameters of the software, including the algorithm used to determine fertility status and alerts for user inputs outside of expected ranges.
(4) Labeling must include:
(i) The following warnings and precautions:
(A) A statement that no contraceptive method is 100% effective.
(B) A statement that another form of contraception (or abstinence) must be used on days specified by the application.
(C) Statements of any factors that may affect the accuracy of the contraceptive information.
(D) A warning that the application cannot protect against sexually transmitted infections.
(ii) Hardware platform and operating system requirements.
(iii) Instructions identifying and explaining how to use the software application, including required user inputs and how to interpret the application outputs.
(iv) A summary of the clinical validation study and results, including effectiveness of the application as a stand-alone contraceptive and how this effectiveness compares to other forms of legally marketed contraceptives.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 18, 2021
BioWink GmbH % Yarmela Pavlovic Partner Manatt, Phelps & Phillips, LLP One Embarcadero Center 30th Floor San Francisco. CA 94111
Re: K193330
Trade/Device Name: Clue Birth Control Regulation Number: 21 CFR§ 884.5370 Regulation Name: Software Application for Contraception Regulatory Class: II Product Code: PYT Dated: January 4, 2021 Received: January 4, 2021
Dear Yarmela Pavlovic:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For 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
Enclosure
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Indications for Use
510(k) Number (if known) K193330
Device Name Clue Birth Control
Indications for Use (Describe)
Clue Birth Control is a software application for women ages 18 - 45 years old, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable 20 - 40 day cycles, who have not recently used hormonal birth control.
Type of Use (Select one or both, as applicable) | |
---|---|
------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for the Clue period tracking app. The logo consists of a red geometric flower-like symbol on the left, followed by the word "Clue" in a red, rounded sans-serif font. A small registration mark is visible to the upper right of the "e" in "Clue."
510(k) Summary BioWink GmbH - Clue Birth Control K193330
Submitter
BioWink GmbH Adalbertstrasse 8 10999 Berlin, Germany
Contact person: Carrie Walter phone: +49 151 62780 364 e-mail: regcontact@helloclue.com
Date prepared: February 16, 2021
Name of Device
Trade name: Clue Birth Control Common name: Software application for contraception Regulation number: 21 CFR 884.5370 Regulation name: Software application for contraception Requlatory Class: II Product Code: PYT (Device, fertility diagnostic, contraceptive, software application)
Predicate Device
Natural Cycles Nordic AB, Natural Cycles (DEN170052)
The predicate device has not been subject to a design-related recall.
Device Description
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control's proprietary algorithm uses period start date information entered by the user to provide predictions of "high risk days" and "low risk days" for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy.
To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between
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18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
Indications for Use
Clue Birth Control is a software application for contraception for women ages 18 - 45 years old, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable 20 - 40 day cycles, who have not recently used hormonal birth control.
Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices
| Description | Subject Device
(Clue Birth Control: K193330) | Predicate Device
(Natural Cycles: DEN170052) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Clue Birth Control is a software
application for contraception for
women ages 18 - 45 years old, to
monitor their fertility and prevent
pregnancy. Clue Birth Control is
suitable for women with predictable
20 - 40 day cycles, who have not
recently used hormonal birth control. | Natural Cycles is a stand-alone software
application, intended for women 18
years and older, to monitor their fertility.
Natural Cycles can be used for
preventing a pregnancy (contraception)
or planning a pregnancy (conception). |
| Prescription /
Over-the-counter
use | Over-the-counter | Over-the-counter |
| Application Type | Mobile-based software supplication | Web and mobile-based software
application |
| User inputs | Period start date | Menstrual cycle information
(period start date and number of
days) Daily basal body temperature
measurements Optional: ovulation or pregnancy
test results |
| Device output | High risk days - Instructs user to abstain
from sex or use a back-up barrier
contraceptive | Use protection - Instructs user to abstain
from sex or use a back-up barrier
contraceptive |
| | Low risk days - States that the risk of
pregnancy is low | Not fertile - States that the user can
have sex without protection |
Table 1. Subject and predicate device comparison
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| Description | Subject Device
(Clue Birth Control: K193330) | Predicate Device
(Natural Cycles: DEN170052) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| User
Requirements | Women aged 18-45 years Women with cycles between 20 and 40 days and vary by $ \le $ 9 days Women who have recently been on hormonal birth control should have at least 3 cycles (4 periods) after the end of their protection period before using the device Women who have been recently pregnant should have at least 3 cycles (4 periods) before using the device | Women 18 years and older |
The subject and predicate device indications for use are not identical. In addition, the subject and predicate device have different use populations, as Clue Birth Control has a narrower population of users based on their cycle length, cycle variability, and prior HBC use as compared to the predicate device. However, the subject and predicate device have the same intended use of predicting fertile and non-fertile days for use in providing patient-specific recommendations related to contraception.
The subject and predicate devices have different technological characteristics, as Clue Birth Control has different device inputs as compared to the predicate device. Also, Clue Birth Control is only for use on mobile platforms, while the predicate can also be used on web-based platforms. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
Performance Data
Non-Clinical Testing
- . Software documentation provided in accordance with the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices to support device software with a major level of concern.
- . Cybersecurity information provided in accordance with the 2014 FDA quidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- . Human factors testing evaluated the potential for user errors when using the device. Testing focused on onboarding (eligibility criteria and understanding of risk), data input, and understanding of messaging (high risk, low risk, ineligible, etc.). Testing demonstrated that device users could safely use the device.
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Clinical Testing
Clinical testing in support of Clue Birth Control came from the Dynamic Optical Timing (DOT) clinical efficacy trial, which assessed the same algorithm used in the subject device.
The clinical trial was performed at the Institute for Reproductive Health at Georgetown University. The study was a prospective clinical trial that followed 718 women aged 18 to 39. who were living in the United States. Each woman participated in the study for a period of up to 13 cycles, providing 6616 cycles in total.
Perfect- vs typical-use
Clue Birth Control has a perfect use Pearl Index of 0.8, which means that 0.8 out of 100 women who use the app perfectly for one year will get pregnant either because:
- They had unprotected sex on a "high risk" day that was incorrectly designated by the app as a "low risk" day (i.e., method failure); or
- They had protected sex on a "high risk" day but became pregnant because the barrier method of protection failed.
Clue Birth Control has a typical use Pearl Index of 5.2, which means that 5.2 women out of 100 get pregnant during one year of use due to all possible reasons (e.g., falsely attributed low risk days, having unprotected intercourse on high risk days, and failure of the contraceptive method used on high risk days).
Study Date Range | # Women | Exposure [Woman-Years] | # Pregnancies [Worst-Case] | Typical-Use PI (95% CI) [Worst-Case] |
---|---|---|---|---|
Feb 2017-Oct 2018 | 718 | 509 | 25 | |
[58] | 5.2 | |||
(3.4-7.7) | ||||
[12] |
Table 2. Summary of clinical data from the efficacy trial
The table above includes worst-case values for the number of pregnancies in addition to the typical use rate. Typical Use Pl includes all pregnancies in the study over all cycles of exposure, including those due to improper use of the app. The worst-case Pl is calculated by assuming pregnancies for all 'possibly pregnant' users lost to follow-up.
Conclusions
A comparison of intended use and technological characteristics combined with performance data demonstrates that Clue Birth Control. for its intended use population, is as safe and effective as the predicate device and supports a determination of substantial equivalence. Clue Birth Control meets the special controls outlined in 21 CFR 884.5370, Software application for contraception.