(268 days)
Not Found
No
The summary mentions a "proprietary algorithm" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML like training sets or complex model architectures. The description focuses on rule-based processing of user-entered data.
Yes
The device is intended for preventing a pregnancy (contraception) or planning a pregnancy (conception), which are therapeutic uses by definition.
No.
The device provides information about fertility status for preventing or planning pregnancy, which is a monitoring and informative function, not a diagnosis of a disease or condition. While it identifies ovulation, it doesn't diagnose a medical state.
No
While the core of the device is software, the description explicitly mentions the ability to receive automatic temperature input from the Oura ring, a wearable temperature monitor. This indicates a dependency on external hardware for data input, which is integrated into the device's functionality.
Based on the provided information, Natural Cycles is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze specimens from the human body. The core function of an IVD is to examine biological samples (like blood, urine, tissue) to provide information about a person's health or condition.
- Natural Cycles relies on user-entered data and external device readings. The primary inputs for Natural Cycles are daily body temperature measurements (from an oral thermometer or Oura ring), menstruation information, and optional test results. It does not directly analyze biological specimens from the user.
- The purpose is fertility monitoring and prediction. While the data used relates to physiological processes, the device's function is to interpret this data to predict fertility status, not to diagnose a condition or analyze a biological sample.
Therefore, Natural Cycles falls under a different regulatory category than IVDs. It is classified as a medical device, specifically a software application used for fertility monitoring and contraception/conception planning.
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 (comma separated list FDA assigned to the subject device)
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, and Pregnancy. For Contraception 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 device allows automatic temperature input from the Oura ring, a wearable temperature monitor.
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 preqnant 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 Oura ring, to a two decimal place oral thermometer for use by the NaturalCycles algorithm. The study included 40 women who were experienced users of both Natural Cycles and entering their daily temperature using an oral thermometer but did not have experience using the Oura ring with Natural Cycles. The mean age of the study participants was 31.3 ± 4.9 years, and the mean menstrual cycle length for complete cycles during the study was 28.6 ± 4.4 days. The majority (38) of the women were located in Sweden, with one each in the US and Switzerland.
The women wore the Oura ring nightly, with the user's temperature information automatically synced to the Oura Cloud each morning, and also recorded their temperature each morning as taken using a two-decimal place oral thermometer. Data were collected over a total of 223 menstrual cycles, 155 of which were considered complete cycles 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 87 of the complete study cycles.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was conducted to compare the daily temperatures generated by a wearable temperature monitor, the Oura ring, to a two decimal place oral thermometer for use by the NaturalCycles algorithm. The study included 40 women. The results of the clinical study demonstrated that when temperature was inputted from either the Oura ring 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 87 positive LH test results. Compared to the two-decimal place oral thermometer, the Natural Cycles algorithm provides additional 1.6 green days (not fertile) in the luteal phase of the menstrual cycle when the input temperature was from the Oura ring, without increasing the risk of unintended pregnancy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
June 24, 2021
Natural Cycles Nordic AB % Sheila Hemeon-Heyer, JD, RAC President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002
Re: K202897
Trade/Device Name: Natural Cycles Regulation Number: 21 CFR§ 884.5370 Regulation Name: Software Application for Contraception Regulatory Class: II Product Code: PYT Dated: May 17, 2021 Received: May 17, 2021
Dear Sheila 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,
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
2
Indications for Use
510(k) Number (if known) K202897
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).
Type of Use (Select one or both, as applicable)
| Registration Use (Part 21 CFR 201.321 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201.66 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K202897 - Natural Cycles
-
A. Submitter: NaturalCycles 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: June 23, 2021
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): DEN170052 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, and Pregnancy. For Contraception mode, the device provides predictions of "not fertile," shown as green days, and
4
"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 device allows automatic temperature input from the Oura ring, a wearable temperature monitor.
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 preqnant 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 preqnancy (conception).
H. Comparison with Predicate Device
A detailed comparison of the intended use and technological features of the subject and predicate device are described in the table below:
5
| Parameter | Subject Device
Natural Cycles
K202897 | Predicate Device
Natural Cycles
DEN 170052 | 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 |
| Input
Information | • 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. | • Manual input of two-
decimal daily basal
body temperature
(BBT) measurements.
• 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. |
6
| Output
Information | • 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. | • 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. | Identical |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | • 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
users. | • 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
users. | |
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.
Summary of Non-Clinical Performance Testing l.
- . 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.
J. Summary of Clinical Performance Testing
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 Oura ring, a wearable temperature monitor. 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
7
temperature monitor, the Oura ring, to a two decimal place oral thermometer for use by the NaturalCycles algorithm. The study included 40 women who were experienced users of both Natural Cycles and entering their daily temperature using an oral thermometer but did not have experience using the Oura ring with Natural Cycles. The mean age of the study participants was 31.3 ± 4.9 years, and the mean menstrual cycle length for complete cycles during the study was 28.6 ± 4.4 days. The majority (38) of the women were located in Sweden, with one each in the US and Switzerland.
The women wore the Oura ring nightly, with the user's temperature information automatically synced to the Oura Cloud each morning, and also recorded their temperature each morning as taken using a two-decimal place oral thermometer. Data were collected over a total of 223 menstrual cycles, 155 of which were considered complete cycles 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 87 of the complete study cycles.
The results of the clinical study demonstrated that when temperature was inputted from either the Oura ring 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 87 positive LH test results. Compared to the two-decimal place oral thermometer, the Natural Cycles algorithm provides additional 1.6 green days (not fertile) in the luteal phase of the menstrual cycle when the input temperature was from the Oura ring, without increasing the risk of unintended pregnancy.
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. Natural Cycles meets the special controls outlined in 21 CFR 884.5370, Software application for contraception.