(363 days)
The Ava Fertility Tracker is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
The Ava Fertility Tracker aids women in ovulation prediction and to facilitate conception. The Ava Fertility Tracker is a non-invasive device made up of the following components:
The Ava bracelet incorporating hardware with electronics and embedded software
A mobile application running on smartphones (iOS and Android)
A backend server software, including algorithms running on remote servers
The Ava bracelet is worn by women at night and tracks the following physiological parameters with built-in sensors:
Temperature sensor - provides information on skin temperature
Photoplethysmography (PPG) sensor – measures the interbeat interval (IBI) providing information on pulse rate (HR), heart rate variability (HRV), breathing rate (BR) and perfusion. Only HR, HRV, and BR are used by the algorithms for prediction of the fertile window. Perfusion information is used to assess the quality of the PPG sensor data.
Accelerometer provides information on movement and sleep duration and phases
The user synchronizes the bracelet to the mobile app each morning. The mobile app receives the raw datasets via Bluetooth Low Energy (BLE) and transfers this data to the backend server. The algorithm is run on the physiological parameters collected and the prediction of ovulation and the fertile window is determined. This information is transferred and displayed in the mobile app. The mobile app will also display a single mean value for HR, temperature, HRV ratio, BR, and sleep duration from the prior night.
The mobile application has three modes:
Trying to Conceive Mode - The application shows the user the predicted day of ovulation plus five predicted fertile days leading up to the predicted day of ovulation. Users receive the prior night summary of measured parameters displayed in graphs. Users can track additional information on their cycle, such as sexual intercourse or cervical fluid (this information does not feed into the algorithm).
Cycle Tracking Mode– For users not wanting to conceive but wanting to track their cycle. These users receive the same information provided to Trying to Conceive Mode users.
Pregnancy Mode - Users receive the prior night summary of measured parameters displayed on graphs. They can also track additional information as relates to their pregnancy, such as their weight or their daily water intake. For each week of their pregnancy, a different piece of informational content gets displayed in the application, such as typical height and weight of a baby at this stage of their pregnancy.
Here's a breakdown of the acceptance criteria and study information for the Ava Fertility Tracker, based on the provided document:
Acceptance Criteria and Device Performance
| Test Name | Specification | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Transportation test | D.U.T. functional and no visual damage | Pass |
| Connector mating test | >1460 cycles | Pass |
| Battery Test 1 | Battery retains >50% capacity after 730 charging/discharging cycles | Pass |
| Battery Test 2 | Valid physiological data transferred to app after one night of data collection (at end of life with aged D.U.T.) | Pass |
| Cyclic strap elongation | Maximum 10% of straps break completely after 730 cycles of elongation and relaxation by 15% | Pass |
| Drop Test | D.U.T. functional and no visual damage after dropping from 1.5 m onto a hard surface (10 drops) | Pass |
| Shock test | D.U.T. functional and no visual damage after 15g acceleration applied (54 shocks) | Pass |
| Vibration test | D.U.T. functional and no visual damage after broad band random vibration excitation for 4.5h | Pass |
| Load Test | D.U.T. functional and no visual damage after 250N mechanical load for 1 hour | Pass |
| Perfume / insect repellent test | D.U.T. functional and no visual damage after 30-day exposure to perfume and insect repellent housing | Partial pass - Labeling to avoid exposure to ethanol-containing products. |
| Cosmetic cream test | D.U.T. functional and no visual damage after 30-day exposure to cosmetic cream housing | Pass |
| Sweat test | D.U.T. functional and no visual damage after 30-day exposure to artificial sweat housing | Pass |
| Temperature sensor validation | Precision: ± 0.2°C, Accuracy: ± 0.8°C (accelerated aging test) | Pass |
| Accelerometer sensor validation | Accuracy < ± 0.02 g, Precision < ± 0.001g (accelerated aging test) | Partial Pass – Precision met at all timepoints, while accuracy passed in aged devices. Justification provided in support of precision as the more important factor as the device only uses relative acceleration changes that are used in the sleep state computation. |
| PPG sensor Validation | PPG sensor signal ± 3% error for IBI and HR, and < 2.5% signal error for BR and HRV | Pass |
| Clinical Performance (Primary Endpoint) | ||
| Ovulation Day Prediction Error | Equivalence bounds of ±2 days compared to urinary LH tests as a reference. | Mean error of 0.315 days (95% Cl -0.029 to 0.698) (p-value for equivalence <0.001). This shows the device can predict the time of ovulation within the specified limits. |
| Clinical Performance (Secondary Endpoint) | ||
| Detection of Post-Ovulation Temperature Shifts | Comparison of temperature shifts detected by Ava Fertility Tracker (wrist skin temperature) vs. Lady-Comp (basal-body temperature). | The Ava Fertility Tracker detected significantly more post-ovulation temperature shifts compared to Lady-Comp (p<0.001). |
Study Details for Clinical Performance:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: The final analysis was performed on data from 61 women and 154 cycles.
- Data Provenance: The study was a single center, prospective clinical study. The country of origin is not explicitly stated, but Ava AG is based in Zürich, Switzerland, and Ava Science Inc. in San Francisco, USA. The study design ("single center, prospective") indicates primary data collection for this purpose.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study involving human readers (as typically seen in image-based diagnostics) was not performed.
- The study compared the device's performance against a reference method (urinary LH tests) and a predicate device (Lady-Comp). It was not structured to assess human improvement with or without AI assistance in interpretation.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical study essentially assessed the standalone performance of the Ava Fertility Tracker algorithm in predicting ovulation day, using "urinary LH tests as a reference." The device runs its algorithms on collected physiological parameters to determine predictions which are then displayed to the user.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for ovulation prediction was urinary LH tests.
- For the secondary endpoint (temperature shifts), the comparison was against the Lady-Comp device's basal-body temperature readings.
-
The sample size for the training set:
- The document does not provide information regarding the sample size for the training set used for the Ava Fertility Tracker's algorithms.
-
How the ground truth for the training set was established:
- The document does not provide information on how the ground truth for the training set was established.
{0}------------------------------------------------
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
January 15, 2021
Ava AG Blathnaid Feldman Director Quality and Regulatory Affairs Gustrasse 73 Zürich 8055 Switzerland
Re: K200163 Trade/Device Name: Ava Fertility Tracker Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LHD Dated: December 4, 2020 Received: December 7, 2020
Dear Blathnaid Feldman:
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,
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) K200163
Device Name Ava Fertility Tracker
Indications for Use (Describe)
The Ava Fertility Tracker is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Type of Use (Select one or both, as applicable)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}------------------------------------------------
avaco
510(k) Summary K200163 Ava Fertility Tracker
| Date Prepared | January 14, 2020 |
|---|---|
| Applicant | Ava AGGutstrasse 73CH-8055 ZurichSwitzerland |
| Contact Person | Agata Sroka, Senior Regulatory Affairs ManagerAgata.Sroka@avawomen.com |
| US Contact Person | Stephen La Barbera, VP Marketing & SalesAva Science Inc.77 Geary Street, 5th FloorSan Francisco, CA 94108USAStephen.LaBarbera@avawomen.com |
| Proprietary Name | Ava Fertility Tracker |
| Common Name | Proceptive Fertility Tracker |
| Device Classification | Unclassified |
| Product Code | LHD (Device, Fertility Diagnostic, Proceptive) |
| Predicate Device | Lady-Comp® USA (K050094)The predicate device has not been subject to a design-related recall. |
| Device Description | The Ava Fertility Tracker aids women in ovulation prediction and to facilitateconception. The Ava Fertility Tracker is a non-invasive device made up of thefollowing components:The Ava bracelet incorporating hardware with electronics and embedded software A mobile application running on smartphones (iOS and Android) A backend server software, including algorithms running on remote servers The Ava bracelet is worn by women at night and tracks the following physiologicalparameters with built-in sensors:Temperature sensor - provides information on skin temperature Photoplethysmography (PPG) sensor – measures the interbeat interval (IBI)providing information on pulse rate (HR), heart rate variability (HRV),breathing rate (BR) and perfusion. Only HR, HRV, and BR are used by thealgorithms for prediction of the fertile window. Perfusion information is usedto assess the quality of the PPG sensor data. |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc. 77 Geary Street – 5th Floo San Francisco, CA 94108 United States
{4}------------------------------------------------
- Accelerometer provides information on movement and sleep duration ● and phases
The user synchronizes the bracelet to the mobile app each morning. The mobile app receives the raw datasets via Bluetooth Low Energy (BLE) and transfers this data to the backend server. The algorithm is run on the physiological parameters collected and the prediction of ovulation and the fertile window is determined. This information is transferred and displayed in the mobile app. The mobile app will also display a single mean value for HR, temperature, HRV ratio, BR, and sleep duration from the prior night.
The mobile application has three modes:
- . Trying to Conceive Mode - The application shows the user the predicted day of ovulation plus five predicted fertile days leading up to the predicted day of ovulation. Users receive the prior night summary of measured parameters displayed in graphs. Users can track additional information on their cycle, such as sexual intercourse or cervical fluid (this information does not feed into the algorithm).
- Cycle Tracking Mode– For users not wanting to conceive but wanting to track . their cycle. These users receive the same information provided to Trying to Conceive Mode users.
- . Pregnancy Mode - Users receive the prior night summary of measured parameters displayed on graphs. They can also track additional information as relates to their pregnancy, such as their weight or their daily water intake. For each week of their pregnancy, a different piece of informational content gets displayed in the application, such as typical height and weight of a baby at this stage of their pregnancy.
- Indications for The Ava Fertility Tracker is intended to measure and display physiological Use parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Comparison of The table below includes a comparison of intended use and technological characteristics of the subject and predicate devices: Subject and Predicate Device Intended Use and Technological Characteristics
| Parameter | Subject DeviceK200163Ava Fertility Tracker | Predicate DeviceK050094Lady-CompFertility Monitor | Comparison |
|---|---|---|---|
| Indications for Use | The Ava FertilityTracker is intended tomeasure anddisplay physiologicalparameters (bodytemperature, restingpulse rate, heart ratevariability, and | Lady-Comp USAis intended formeasuring andrecording basalbody temperature(BBT) as an aid inovulationprediction tofacilitate | Although there aredifferences in theindications for usestatements, the intendeduses for both devices arethe same (i.e., an aid inovulation prediction and tofacilitate conception). |
| breathing rate) as anaid in ovulationprediction to facilitateconception (not to beused forcontraception). | conception (not tobe used forcontraception). | ||
| General Design | Watch-style sensorbracelet, phone app,backend server | Oral temperaturesensor attachedto reader by acable | Different: The predicatedevice has a temperaturesensor connected to areader loaded with theprediction algorithm thatprovides information onthe fertility status of theuser. The subject deviceincludes a wrist-wornsensor that wirelesslytransmits data to an appthat connects to a serverwhere the fertilityalgorithms analyze theinformation collected andtransfer the prediction tothe app for display to theuser. These differencesdo not raise differentquestions of safety andeffectiveness (S&E). |
| Sensors | TemperaturePPG SensorAccelerometer | Temperature | Different: The subjectdevice includes additionalsensors to collectadditional information thatis used in by the fertilityprediction algorithm. Theaddition of differentsensors does not raisedifferent questions ofS&E. |
| ParametersMeasured | Skin temperatureResting pulse rateBreathing rateHeart rate variability(HRV)Sleep duration/ sleepphasesMovementPerfusion | Temperature | Different: The subjectdevice collects additionalphysiological informationbeyond that of thepredicate for use by thefertility algorithm and fordata integrity purposes.The collection of theseadditional parametersdoes not raise differentquestions of S&E |
| Number ofMeasurementsTaken | Periodically each nightwhile sleeping | Singlemeasurementupon waking | Different: The subjectdevice collects datathroughout the night, whilethe predicate is only usedonce per day uponwaking. Collecting dataover a longer period doesnot raise differentquestions of S&E. |
| Location ofTemperatureMeasurement | Wrist - skin | Oral | Different: The subjectdevice incorporates awrist-worn sensor, while |
| TemperatureSensorAccuracy/Precision | ±0.8°C/ ±0.2°C | ± 0.05°C/unknown | the predicate uses an oraltemperature probe. Useof a wrist-worn sensordoes not raise differentquestions of S&E.Different: The accuracyof the temperature sensoris higher for the predicatedevice than the subjectdevice. This differencedoes not raise differentquestions of S&E. |
| User Inputs | User can input:• Period/flowinformation• Cervical fluidconsistency• Sexual intercourse• Pregnancy testresults• Mood• 10 user definedfunctions | Not reported inpredicate 510(k)Summary | Different: The specificuser inputs for thepredicate device are notknown. However, theability to input additionalinformation for trackingdoes not raise differentquestions of S&E. |
| User Interface | Smartphone appshowing graphicaldisplay of thefertility status (5-6days)• Fertile Days• Ovulation day• Additionalparametersmeasured (e.g.,HRV) for generalwellnessinformation• User inputs | Per predicate510(k) Summarythe user interactswith the displayon the physicaldevice displayingthe measuredtemperature. | Different: The subjectdevice providesinformation via asmartphone app, while thepredicate device displaysinformation on the screenof the device. Differencesin user interfaces do notraise different questions ofS&E. |
| Power Source | Rechargeable battery | Not reported inpredicate 510(k)Summary | Different: Information onthe specific power sourcesfor the predicate deviceare not known. However,differences in in powersources do not raisedifferent questions ofS&E. |
| Data TransmissionMethod fromSensor to Reader | Bluetooth Wireless(wrist sensor to appon phone)Wi-Fi (phone tobackend server) | None | Different: The predicatedevice transfersinformation from the probeto the reader using anattached cable. Thesubject device useswireless technology totransfer informationbetween devicecomponents. Thisdifference does not raisedifferent questions of S&E |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
{5}------------------------------------------------
OVACO
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
{6}------------------------------------------------
Image /page/6/Picture/8 description: The image shows the word "avac" in a stylized font. The first three letters, "ava", are in black, while the last two letters, "co", are in a light purple color. The letters are connected and have a flowing, cursive appearance. The image is simple and clean, with a white background.
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
As shown in the table above, there are differences in the subject and predicate device indications for use statements. However, the intended uses of both devices are the same as they are both for aiding in ovulation prediction to facilitate conception and not to be used for contraception.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows a logo with the letters "AVACO" in a stylized font. The first three letters, "AVA," are in black, while the last two letters, "CO," are in a light purple color. The letters are connected and have a smooth, flowing design. The logo appears to be for a company or organization with the name AVACO.
The subject and predicate devices have different technological characteristics as shown in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Data
| BiocompatibilityTesting | Biocompatibility testing for the Ava Fertility Tracker device was conducted inaccordance with the 2020 FDA guidance document Use of InternationalStandard ISO 10993-1, "Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process" as follows:Cytotoxicity: ISO 10993-5:2009 Skin Irritation: ISO 10993-10:2010 Sensitization (Guinea Pig Maximization Model): ISO 10993-10:2010 Testing confirmed that the subject device materials are biocompatible. |
|---|---|
| Software andCybersecurity | Software documentation provided in accordance with the 2005 FDA guidancedocument Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices to support device software with a minor level ofconcern.Cybersecurity information provided in accordance with the 2014 FDA guidancedocument Content of Premarket Submissions for Management ofCybersecurity in Medical Devices. |
| Electrical Safetyand EMC Testing | Electrical safety of the Ava Fertility Tracker was tested in accordance with:AAMI/ANSI ES 60601-1:2005/A2:2010 (Medical electrical equipment -Part 1: General requirements for basic safety and essential performance) IEC 60601-1-11:2015 (Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance -- Collateralstandard: Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment) Photobiological safety was conducted in accordance with IEC 62471:2006(Photobiological safety of lamps and lamp systems)Battery testing conducted in accordance with IEC 62133-1:2012 (Secondarycells and batteries containing alkaline or other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells, and for batteries made fromthem, for use in portable applications)Electromagnetic compatibility of the Ava Fertility Tracker was tested inaccordance with IEC 60601-1-2:2014 (Medical electrical equipment - Part 1:General requirements for basic safety and essential performance -- Collateralstandard: Electromagnetic compatibility - Requirements and tests) |
| WirelessTechnology | Wireless technology information provided in accordance with the 2013 FDAguidance document Radio Frequency Wireless Technology in Medical DevicesGuidance for Industry and Food and Drug Administration Staff. |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc. 77 Geary Street – 5th Floor San Francisco, CA 94108 United States
avawomen.com
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows a logo with the letters "ava" in black and the letters "co" in purple. The letters are stylized and connected. The letters are all lowercase.
Performance
Testing - Bench
Bench testing shown in the table below was conducted to demonstrate that the Ava Fertility Tracker device meets its predetermined performance specifications.
| Test name | Summary | Specification | Pass / Fail |
|---|---|---|---|
| Transportation test | Drop test ofDevice UnderTest (D.U.T.) intransportationbox | D.U.T. functionaland no visualdamage | Pass |
| Connectormating test | Check expectedmating cycles ofchargingconnector withincomponentspecification | >1460 cycles | Pass |
| Battery Test 1 | Lifetime testafter 730charging /dischargingcycles | Battery retains>50% capacity | Pass |
| Battery Test 2 | Sufficient batterycapacity at endof life with agedD.U.T. | Validphysiologicaldata transferredto app after onenight of datacollection | Pass |
| Cyclic strapelongation | Cyclic elongationof strap following730 cycles ofelongation andrelaxation by15% | Maximum 10%of straps breakcompletely | Pass |
| Drop Test | Drop D.U.T.from 1.5 m ontohard surface (10drops) | D.U.T. functionaland no visualdamage | Pass |
| Shock test | Acceleration of15g is applied toD.U.T. (54shocks) | D.U.T. functionaland no visualdamage | Pass |
| Vibration test | Broad bandrandom vibrationexcitation isapplied to D.U.T.for 4.5h | D.U.T. functionaland no visualdamage | Pass |
| Load Test | Mechanical loadof 250N isapplied to D.U.T.for 1 hour | D.U.T. functionaland no visualdamage | Pass |
| Perfume / insectrepellent test | Perfume andinsect repellentapplied to D.U.T. | D.U.T. functionaland no visualdamage | Partial pass -Labeling toavoid exposure |
| housing (30-dayexposure) | to ethanol-containingproducts | ||
| Cosmetic creamtest | Cosmetic creamapplied to D.U.T.housing (30-dayexposure) | D.U.T. functionaland no visualdamage | Pass |
| Sweat test | Artificial sweatapplied to D.U.T.housing (30-dayexposure) | D.U.T. functionaland no visualdamage | Pass |
| Temperaturesensor validation | Acceleratedaging test toassesstemperaturesensor functionover time | The temperaturesensor chipstays withinspecification:Precision:$\pm$ 0.2°CAccuracy:$\pm$ 0.8°C | Pass |
| Accelerometersensor validation | Acceleratedaging test toassessaccelerometerfunction overtime | Accuracy $\lt\pm$0.02 gPrecision $\lt\pm$0.001g | Partial Pass –Precision met atall timepoints,while accuracypassed in ageddevices.Justificationprovided insupport ofprecision as themore importantfactor as thedevice only usesrelativeaccelerationchanges that areused in thesleep statecomputation. |
| PPG sensorValidation | Assessed theability of thedevice tomeasure IBI,HR, BR, andHRV | PPG sensorsignal $\pm$ 3% errorfor IBI and HR,and $\lt$ 2.5%signal error forBR and HRV | Pass |
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
{9}------------------------------------------------
avo
Summary of Clinical Data
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Performance Testing - Clinical
Ava Science Inc.
77 Geary Street – 5th Floor San Francisco, CA 94108 United States
A single center, prospective clinical study was conducted to support the subject device. The study enrolled 66 women between the ages of 18 and 45 years of age that were not planning to become pregnant in the following three to six months. Also, the women enrolled in the study were not on hormonal birth control, breastfeeding or taking medications that could affect the menstrual cycle. They also did not have any health issues, frequently travel between time
{10}------------------------------------------------
zones or have a sleeping disorder. The final analysis was performed on data from 61 women and 154 cycles.
Each woman in the study collected data in each cycle using subject device, Clearblue Digital Ovulation Test, and the Lady-Comp device (predicate).
The primary endpoint assessed the error in detecting the ovulation day using the Ava Fertility Tracker compared to urinary LH tests as a reference. In addition, the difference in the number of temperature shifts detected using basal-body temperature (Lady-Comp) compared to wrist skin temperature (Ava Fertility Tracker) was assessed as a secondary endpoint.
The study demonstrated that the Ava Fertility Tracker was able to accurately predict the day of ovulation. With a mean error of 0.315 days (95% Cl -0.029 to 0.698) the Ava Fertility Tracker was within the limits of the equivalence bounds of ±2 days, showing that the device can predict the time ovulation as compared to the LH reference test (p-value for equivalence <0.001). Furthermore, the secondary endpoint outcome showed that the Ava Fertility Tracker detected significantly more post-ovulation temperature shifts compared to Lady-Comp (p<0.001).
Conclusion Based on the non-clinical verification performance testing and the clinical validation provided with the submission, it can be concluded that the Ava Fertility Tracker is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Ava AG Gutstrasse 73 8055 Zürich Switzerland
Ava Science Inc. 77 Geary Street – 5th Floor San Francisco, CA 94108 United States
avawomen.com
N/A