(114 days)
Not Found
Unknown
The document mentions a "proprietary algorithm" but does not explicitly state whether this algorithm utilizes AI or ML techniques. The focus of the summary is on the data inputs and the clinical study validating the use of different temperature sources, not the internal workings of the algorithm itself.
No
- Intended Use: The device aims to prevent or plan pregnancy, which are lifestyle choices or reproductive goals, not treatment of a disease or condition.
- Device Description: The core function is to monitor fertility and provide information, not to directly treat or mitigate a medical condition. While avoiding pregnancy can be part of a health plan, the device itself doesn't offer therapeutic intervention.
No
The device is intended to monitor fertility for contraception or conception, not to diagnose a disease or condition. While it identifies fertility status, this is a physiological state rather than a diagnosis of illness.
Yes
The device is explicitly described as a "stand-alone software application" and "web and mobile-based standalone software application." While it utilizes temperature data from external hardware (oral thermometer, Oura Ring, Apple Watch), the device itself is the software that processes this data and provides fertility status information. The submission focuses on the software's algorithm and its performance with different data inputs, not on the hardware itself.
Based on the provided text, Natural Cycles is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Natural Cycles' Function: Natural Cycles primarily relies on physiological measurements (body temperature) and user-reported information (menstruation dates, optional test results). It analyzes this data to predict fertility status.
- Lack of Specimen Analysis: The core function of Natural Cycles does not involve the analysis of biological specimens in vitro. While it can incorporate optional ovulation or pregnancy test results, the device itself is not performing the in vitro diagnostic test. It's using the results of those tests as input data.
Therefore, Natural Cycles falls under the category of a medical device, specifically a software application used for fertility monitoring and contraception/conception planning, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes
PYT
Device Description
Natural Cycles is an over-the-counter web and mobile-based standalone software application that monitors a woman's menstrual cycle using information entered by the user and informs the user about her past, current, and future fertility status. The following information is used by the Natural Cycles software:
- daily body temperature measurements
- information about the user's menstruation cycle (i.e., start date, number of days)
- optional ovulation or pregnancy test results
A proprietary algorithm evaluates the data and returns the user's fertility status.
Natural Cycles is available in three modes: Contraception (NC° Birth Control), Conception (NC° Plan Pregnancy), and Pregnancy (NCº Follow Pregnancy). For NCº Birth Control mode, the device provides predictions of "not fertile," shown as green days, and "use protection," shown as red days, that allow 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.
In addition to measuring daily basal body temperature with an oral thermometer with two decimal points, the predicate submission cleared the Oura Ring for automatic temperature input to the Natural Cycles algorithm, and the current submission expands to allow the device to utilize automatic temperature inputs from the Apple Watch.
Natural Cycles can be used by women 18 years and older. Women who have been on hormonal birth control within 60 days prior to using Natural Cycles have a higher risk of becoming pregnant when compared to women who have not been on hormonal birth control within the 12 months prior to using the device may not be right for women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus.
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 years and older
Intended User / Care Setting
Home environment
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
A clinical study was conducted to compare the daily temperatures generated by a wearable temperature monitor, the Apple Watch, to a two decimal place oral thermometer for use by the Natural Cycles algorithm. The study included data of de-identified information from 272 users after all applied criteria were met. A subset of the data, 104 users, was assessed for the ovulation key performance indicator (KPI), which required a positive result from a luteinizing hormone (LH) test. The mean age of the study participants was 30.5 ± 5.1 years, and the mean menstrual cycle length for complete cycles during the study was 28.8 ± 5.5 days. The majority (58%) of the women were located in the European Union and the United Kingdom, with the remainder located in the US (42%).
The women wore the Apple Watch nightly, with the user's temperature information being transferred to the subject device each morning and recorded their temperature each morning as taken using a two-decimal place oral thermometer. Data were collected over a total of 1918 menstrual cycles, 505 of which were considered complete cycles and met the applied criteria, per the study definition. The participants were also asked to record the results of luteinizing hormone (LH) tests each cycle. At least one positive LH test was submitted in 153 of the complete study cycles.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study. The results of the clinical study demonstrated that when temperature was inputted from either the Apple Watch or the two-decimal place oral thermometer, the Natural Cycles algorithm was able to identify that ovulation had occurred, which was confirmed in the study by comparison to the 153 positive LH test results. Compared to the two-decimal place oral thermometer, the Natural Cycles algorithm provided 0.6 fewer green days (not fertile) in the luteal phase of the menstrual cycle when the input temperature was from the Apple Watch without increasing the risk of unintended pregnancy. This is in contrast with the predicate device, which provided an additional 1.6 green days when the input temperature was from the Oura Ring; however, this difference does not impact the safety and effectiveness of Natural Cycles for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2023
Natural Cycles Nordic AB % Shelia Hemeon-Heyer, MS, JD, FRAPS President Heyer Regulatory Solutions, LLC 125 Cherry Lane Amherst, MA 01002
Re: K231274
Trade/Device Name: Natural Cycles Regulation Number: 21 CFR§ 884.5370 Regulation Name: Software Application for Contraception Regulatory Class: II Product Code: PYT Dated: July 27, 2023 Received: July 27, 2023
Dear Shelia Hemeon-Heyer:
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.
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.
1
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 (QS) 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 mediation-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,
Michael T. Bailey -S
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
2
Indications for Use
510(k) Number (if known) K231274
Device Name Natural Cycles
Indications for Use (Describe)
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 Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K231274 - Natural Cycles
-
A. Submitter: Natural Cycles Nordic AB St Eriksqatan 63B 112 34 Stockholm, Sweden Contact: Raoul Scherwitzl, PhD, CEO and Co-Founder
Phone: +46 707174866 E-mail: Raoul.scherwitzl@naturalcycles.com -
B. Correspondent: Hever Requlatory Solutions LLC 125 Cherry Lane Amherst, MA 01002
Contact: Sheila Hemeon-Heyer E-mail: Sheila@heyer-requlatory.com -
C. Date Prepared: August 23, 2023
Device Name and Classification Information: D.
| Trade Name: | Natural Cycles |
|---|---|
| Common Name: | Software application for contraception |
| Regulation Name: | Software application for contraception |
| Regulation Number: | 21 CFR 884.5370 |
| Regulatory Class: | II |
| Product Code: | PYT (Device, fertility diagnostic, contraceptive, software application) |
E. Predicate Device(s): K202897 Natural Cycles
The predicate device has not been subject to a design-related recall.
F. Device Description:
Natural Cycles is an over-the-counter web and mobile-based standalone software application that monitors a woman's menstrual cycle using information entered by the user and informs the user about her past, current, and future fertility status. The following information is used by the Natural Cycles software:
- daily body temperature measurements
- information about the user's menstruation cycle (i.e., start date, number of days)
- optional ovulation or pregnancy test results ●
A proprietary algorithm evaluates the data and returns the user's fertility status.
Natural Cycles is available in three modes: Contraception (NC° Birth Control), Conception (NC° Plan Pregnancy), and Pregnancy (NCº Follow Pregnancy). For NCº Birth Control mode, the
4
device provides predictions of "not fertile," shown as green days, and "use protection," shown as red days, that allow 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.
In addition to measuring daily basal body temperature with an oral thermometer with two decimal points, the predicate submission cleared the Oura Ring for automatic temperature input to the Natural Cycles algorithm, and the current submission expands to allow the device to utilize automatic temperature inputs from the Apple Watch.
Natural Cycles can be used by women 18 years and older. Women who have been on hormonal birth control within 60 days prior to using Natural Cycles have a higher risk of becoming pregnant when compared to women who have not been on hormonal birth control within the 12 months prior to using the device may not be right for women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus.
G. Indications for Use Statement
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).
Comparison with Predicate Device H.
A detailed comparison of the intended use and technological features of the subject and predicate device are described in the table below:
| Parameter | Subject Device
Natural Cycles
K231274 | Predicate Device
Natural Cycles
K202897 | Comparison |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Indications for
Use Statement | 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). | 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). | Identical |
| Use
Environment | App is downloaded to
user's smartphone and
used in the home
environment | App is downloaded to
user's smartphone and
used in the home
environment | Identical |
| Parameter | Subject Device
Natural Cycles
K231274 | Predicate Device
Natural Cycles
K202897 | Comparison |
| Input
Information | • Manual input of two-
decimal daily basal body
temperature (BBT)
measurements, or
automatic input from the
Oura ring or Apple Watch.
• Manual input of
information about the
user's menstruation
cycle, i.e., start date,
number of days.
• Optional manual input of
ovulation or pregnancy
test results. | • Manual input of two-
decimal daily basal
body temperature
(BBT) measurements
or automatic input from
the Oura ring.
• Manual input of
information about the
user's menstruation
cycle, i.e., start date,
number of days.
• Optional manual input of
ovulation or pregnancy
test results. | Expanded
option for a
new source of
daily basal
body
temperature
information. |
| Output
Information | • NC° Birth Control: For
each day, whether the
woman is fertile (red) or
non- fertile (green), with
descriptive texts.
• NC° Plan Pregnancy:
Fertility status results are
displayed as a scale for
fertile days, and green for
non-fertile days, together
with description texts.
• NC° Follow
Pregnancy: Provides
educational
information about the
progress of the
pregnancy.
• All uses in Prevent
mode or Plan mode
receive the ovulation
date for the month and
daily statement of
fertility status. Historic
data is available for all | • Prevent mode: For each
day, whether the woman
is fertile (red) or non-
fertile (green), with
descriptive texts.
• Plan mode: Fertility
status results are
displayed as a scale for
fertile days, and green
for non-fertile days,
together with
description texts.
• Pregnancy mode:
Provides educational
information about the
progress of the
pregnancy.
• All uses in Prevent
mode or Plan mode
receive the ovulation
date for the month and
daily statement of
fertility status. Historic
data is available for all | Identical; titles
for the modes
have been
changed |
5
The subject and predicate device have identical indications for use statements and have the same intended use - to predict fertile and non-fertile days for use in providing patient-specific recommendations related to contraception. The subject and predicate device have different technological characteristics (i.e., temperature data input sources). This difference does not raise different questions of safety and effectiveness as compared to the predicate device.
6
l. Summary of Non-Clinical Performance 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 guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- . Human factors testing in DEN170052 was used to support that device users could safely use the device.
Summary of Clinical Performance Testing J.
The purpose of this 510(k) is to add the option for the user to obtain the daily basal body temperature information used by the Natural Cycles fertility algorithm from the Apple Watch. There have been no changes to how the Natural Cycles algorithm determines the daily fertility status.
A clinical study was conducted to compare the daily temperatures generated by a wearable temperature monitor, the Apple Watch, to a two decimal place oral thermometer for use by the Natural Cycles algorithm. The study included data of de-identified information from 272 users after all applied criteria were met. A subset of the data, 104 users, was assessed for the ovulation key performance indicator (KPI), which required a positive result from a luteinizing hormone (LH) test. The mean age of the study participants was 30.5 ± 5.1 years, and the mean menstrual cycle length for complete cycles during the study was 28.8 ± 5.5 days. The majority (58%) of the women were located in the European Union and the United Kingdom, with the remainder located in the US (42%).
The women wore the Apple Watch nightly, with the user's temperature information being transferred to the subject device each morning and recorded their temperature each morning as taken using a two-decimal place oral thermometer. Data were collected over a total of 1918 menstrual cycles, 505 of which were considered complete cycles and met the applied criteria, per the study definition. The participants were also asked to record the results of luteinizing hormone (LH) tests each cycle. At least one positive LH test was submitted in 153 of the complete study cycles.
The results of the clinical study demonstrated that when temperature was inputted from either the Apple Watch or the two-decimal place oral thermometer, the Natural Cycles algorithm was able to identify that ovulation had occurred, which was confirmed in the study by comparison to the 153 positive LH test results. Compared to the two-decimal place oral thermometer, the Natural Cycles algorithm provided 0.6 fewer green days (not fertile) in the luteal phase of the menstrual cycle when the input temperature was from the Apple Watch without increasing the risk of unintended pregnancy. This is in contrast with the predicate device, which provided an additional 1.6 green days when the input temperature was from the Oura Ring; however, this difference does not impact the safety and effectiveness of Natural Cycles for its intended use.
7
K. Conclusion
A comparison of intended use and technological characteristics combined with performance data demonstrates that Natural Cycles is as safe and effective as the predicate device and supports a determination of substantial equivalence.