K Number

Device Name

Manufacturer

FERTILITY FOCUS LTD

Date Cleared

2013-08-06

(369 days)

Product Code

LHD

Regulation Number

N/A

Type

Traditional

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

K102499,K904211

Predicate For

N/A

Intended Use

The Fertility Focus OvuSense Fertility Monitor (Fertility Focus OvuSense Fertility Monitor Starter Kit M009-US, which includes Reader M010-US and Personal Sensor M011) is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).

Device Description

The Fertility Focus OvuSense Fertility Monitor is intended for measuring and recording core body temperature intra-vaginally on a nightly basis during the non-menstruating phases of the monthly female reproductive cycle. The Fertility Focus OvuSense Fertility Monitor consists of two components made of silicone - a Personal Sensor, which collects the data, and a Reader (with LCD display), which establishes a communication link to the Personal Sensor whereupon the data is transferred to the Reader. Electromagnetic induction communications hardware transmits the stored temperature data from the Personal Sensor to the receiving device, the Reader, activated when the Sensor is placed on the Reader cradle and the Reader's dedicated download button is pressed. The microprocessor based Reader filters the overnight data, then calculates and stores the 25th percentile value, representative of the average basal (lowest) overnight temperature. The Reader then displays these nightly temperature readings on a graph using a relative scale - the kev information for necessary calculations being the temperature changes relative to other recorded temperatures within a cycle for a particular user, and not absolute temperature value. At the start of the next cycle, indicated by the User inputting first day of the bleeding in the cycle, the Reader algorithm calculates the date of ovulation in the prior cycle, and uses this to predict the fertile period for the cycle which has just started. The Reader then displays fertility information in a verbal summary, including: An indication of the day ovulation occurred in the prior cycle, or if ovulation was not detected it displays this information instead. An indication whether the cycle length was within the expected normal parameters.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Fertility Focus OvuSense Fertility Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining specific, quantifiable acceptance criteria. However, it does state an overall conclusion regarding the device's performance relative to the gold standard.

Acceptance Criteria (Implied)	Reported Device Performance
Ovulation Detection	The OvuSense Fertility Monitor system provided a biological and statistically significant improvement in ovulation detection compared with the traditional method of oral temperature measurement. It demonstrated good linear agreement with the gold standard detection of ovulation using ultrasound and an improved 95% confidence interval for the agreement.
Safety & Effectiveness	The Fertility Focus OvuSense Fertility Monitor has been demonstrated to be as safe, as effective, and performs as well as or better than the predicates.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 19 women, measuring 81 cycles.
- Data Provenance: Prospective study. The country of origin is not explicitly stated, but the applicant and official correspondent are based in the UK and USA respectively, suggesting the study likely took place in one of these regions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that "ultrasound" was used as the gold standard for ovulation detection. It does not specify the number or qualifications of experts involved in interpreting the ultrasound results and establishing this ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method for the ground truth.
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 MRMC comparative effectiveness study was done. This device is a standalone monitor for ovulation prediction, not an AI-assisted tool for human readers.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was conducted. The clinical investigation directly assessed the performance of the OvuSense Fertility Monitor system (algorithm only) in detecting ovulation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was ultrasound detection of ovulation ("gold standard detection of ovulation using ultrasound").
The sample size for the training set:
- The text does not explicitly mention a separate "training set" or its sample size. The clinical investigation appears to be a validation study (test set) for the established algorithm.
How the ground truth for the training set was established:
- Since a separate training set is not described, the method for establishing its ground truth is not provided. The algorithm's development or initial training phase is not detailed in this 510(k) summary.

Summary

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K122337 pg 1 of 5

fertility focus

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

DATE:	July 30, 2013
APPLICANT:	Fertility Focus Ltd.Robert Milnes, CEOUnit 19D, University of Warwick Science ParkWarwick Technology Park, Gallows HillWarwick, United Kingdom CV34 6UWTel: 044-1494-510272Email: robert.milnes@fertility-focus.com	AUG 0 6 2013
OFFICIALCORRESPONDENTFOR THISSUBMISSION:	Penny Northcutt, RAC, FRAPS, CQARegulatory Consultant for Fertility FocusREGSolutions, LLCTel: 678-428-6978Fax: 678-513-0937Email: pennynorthcutt@theregsolutions.com
TRADE NAME:	Fertility Focus OvuSense Fertility Monitor
CLASSIFICATIONNAME:	Device, fertility diagnostic, proceptive
DEVICECLASSIFICATIONAND PRODUCTCODE:	Pre-amendment, UnclassifiedProduct Code: LHD
PREDICATEDEVICE NAME:	DuoFertility Monitor, K102499Bioself 2000 Fertility Indicator, K904211

SUBSTANTIAL EQUIVALENCE:

The Fertility Focus OvuSense Fertility Monitor is substantially equivalent to the legally marketed DuoFertility Monitor (K102499) and the Bioself 2000 Fertility Indicator (K904211). The Fertility Focus OvuSense Fertility Monitor has similar indications for use statements, principles of operation, and technological characteristics as the predicate devices.

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DESCRIPTION OF THE DEVICE:

Electromagnetic induction communications hardware transmits the stored temperature data from the Personal Sensor to the receiving device, the Reader, activated when the Sensor is placed on the Reader cradle and the Reader's dedicated download button is pressed. The microprocessor based Reader filters the overnight data, then calculates and stores the 25th percentile value, representative of the average basal (lowest) overnight temperature.

The Reader then displays these nightly temperature readings on a graph using a relative scale - the kev information for necessary calculations being the temperature changes relative to other recorded temperatures within a cycle for a particular user, and not absolute temperature value. At the start of the next cycle, indicated by the User inputting first day of the bleeding in the cycle, the Reader algorithm calculates the date of ovulation in the prior cycle, and uses this to predict the fertile period for the cycle which has just started. The Reader then displays fertility information in a verbal summary, including:

An indication of the day ovulation occurred in the prior cycle, or if ovulation was not detected it displays this information instead.
An indication whether the cycle length was within the expected normal parameters. -

INTENDED USE/INDICATIONS FOR USE:

TECHNOLOGICAL CHARACTERISTICS:

OvuSense Fertility Monitor and DuoFertility Monitor have the following similar and substantially equivalent technological characteristics:

Operating Principle Both devices assess Basal Body Temperature. .
. Temperature Sensor - Both devices use a thermistor sensor.
Sensor Accuracy The DuoFertility device has a quoted accuracy of +/- 0.05 degrees . Centigrade, and of +/- 0.1 decrees Celsius; OvuSense Fertility Monitor has an accuracy of +/- 0.05 degrees Centigrade. Any potential difference in the accuracy of temperature measurements is not believed to raise any issues of safety, and is a function of the requirements of each devices' algorithms.
. User Inputs - Both devices have the facility for user input of relevant data.
Display of Graphs Both devices have the facility for the display of temperature graphs. . The DuoFertility device uses a computer for this display and uses an absolute temperature scale, whilst OvuSense Fertility Monitor uses the OvuSense Reader for

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K122337

pg 3 of 5

display and a relative temperature scale. The different display methodologies do not raise any safety issues, with the relative temperature scale allowing the OvuSense Fertility Monitor user a graph view optimized to their particular temperature readings.

Number of Measurements Both devices record multiple temperatures. The difference . in any relative number of temperature measurements is not believed to raise any issues of safety, and is simply a function of the requirements of each devices' algorithms.
Automatic measurements Both devices take measurements automatically. .
Wireless transfer of data Both devices involve the transfer of data from the Sensor to a . receiving unit.
Algorithm Both devices use an algorithm to calculate the date of ovulation. The . additional information provided by the OvuSense Fertility Monitor device in respect of absence of ovulation and fertile period prediction is not believed to raise any direct issues of safety, and is employed for increased effectiveness.

The following differences between DuoFertility and OvuSense Fertility Monitor are noted and thus a secondary predicate or reference device - Bioself 2000 is used for substantial equivalence purposes.

Number of Thermistors The DuoFertility device uses two thermistors plus an . accelerometer/movement Sensor: the OvuSense Fertility Monitor device uses a single thermistor. The Bioself 2000 device uses a single thermistor.
Location of Thermistor -- The DuoFertility device is worn on the skin: the OvySense . device is placed intravaginally by means of a Personal Sensor. The Bioself 2000 device can be used intravaginally or orally.

The use of two thermistors and an accelerometer (in DuoFertility) versus the use of a single thermistor (OvuSense Fertility Monitor and Bioself 2000) is not believed to raise any direct issues of safety or effectiveness, and the relative location of vaginal versus skin placement is employed by OvuSense Fertility Monitor and Bioself 2000.

NONCLINICAL PERFORMANCE TESTING:

A series of performance tests was conducted in support of the design verification of the Fertility Focus OvuSense Fertility Monitor.

	Summary of Performance Testing Conducted on OvuSense
Biocompatibility	In Vitro Cytotoxicity MEM Elution Assay
	Mucosal (Vaginal) Irritation Test
	Guinea Pig Maximization Sensitization Test
	USP Physicochemical Extraction Parameters
	ISO Acute Systemic Toxicity Test
	In Vitro Mouse Micronucleus Assay – 2 Extracts (ISO)
	In Vivo Mouse Micronucleus Assay – 2 Extracts
	Bacterial Mutagenicity Test (Ames Assay)
Summary of Performance Testing Conducted on OvuSense
	Subchronic (14 day) Intravenous Toxicity Study in Non-Swiss Webster Mice(14 Repeat Dose Exposure)(GLP)
	Subacute (14 day) Intraperitoneal Toxicity Study in Non-Swiss Webster Mice(14 Repeat Dose Exposure) (GLP)
	Exhaustive Extractables
Electrical Testing	EN60601-1-4:2000 Medical electrical equipment. General requirements forsafety. Collateral standard. General requirements for electrical programmablemedical systems.
	EN60601-1-2:2007 Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance - Collateralstandard: Electromagnetic compatibility - Requirements and tests
	EN301 489-3 v1.4.1 Electromagnetic Compatibility and Radio SpectrumMatters (ERM); ElectroMagnetic Compatibility (EMC) Standard for RadioEquipment and Services; Part 3: Specific Conditions for Short-Range Devices(SRD) Operating on Frequencies between 9 KHz and 40 GHz
	IEC60601-1:2006 Medical equipment. Medical electrical equipment - Part 1:General requirements for basic safety and essential performance
	EN302 291 v1.1.1 Electromagnetic compatibility and Radio spectrum Matters(ERM); Short Range Devices (SRD); Close Range Inductive DataCommunication equipment operating at 13,56 MHz; Part 2: Harmonized ENunder article 3.2 of the R&TTE Directive
MechanicalTesting	Tensile (Pull Test)
DesignVerification& Validation	Physical Dimensions, User Cleaning, Reliability for Operating Life, HumanFactors-Machine Interface
CleaningValidation	Cleaning Validation of Personal Sensor

Fertility Focus OvuSense Fertility Monitor

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K122337

CLINICAL TESTING:

Clinical investigation was conducted of the Fertility Focus OvuSense Fertility Monitor from 19 women who participated in a prospective study measuring 81 cycles over 3 months participation.

Traditional 510(k) Fertility Focus

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K122337

pg 5 of 5

The data from the primary endpoint of the trial described in the CIP demonstrated that the OvuSense Fertility Monitor system of ovulation detection provided a biological and statistically significant improvement in ovulation detection compared with the traditional method of oral temperature measurement. It demonstrated good linear agreement with the gold standard detection of ovulation using ultra-sound and an improved 95% confidence interval for the agreement.

CONCLUSION:

Based on the nonclinical verification performance testing and clinical validation, it can be concluded that the Fertility Focus OvuSense Fertility Monitor is equivalent to the DuoFertility Monitor (K102499) and Bioself 2000 (K904211) with respect to intended use, principles of operation, and technological characteristics. The Fertility Focus OvuSense Fertility Monitor has been demonstrated to be as safe, as effective, and performs as well as or better than the predicates.

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Image /page/5/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with three stylized lines and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the emblem. The text is in uppercase letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MIJ 20993-0002

August 6, 2013

Fertility Focus, Ltd. % Penny Northcutt, RAC, FRAPS, CQA President/CEO REGSolutions, LLC 717 Lakeglen Drive Suwanee, GA 30024

Re: K122337

Trade/Device Name: Fertility Focus OvuSense Fertility Monitor Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LHD Dated: July 30, 2013 Received: July 31, 2013

Dear Penny Northcutt,

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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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Page 2 - Penny Northcutt, RAC, FRAPS, CQA

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Glenn Bell -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122337

Device Name: Fertility Focus OvuSense Fertility Monitor

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ___X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Glenn B. Bell -S

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122337 510(k) Number _

Traditional 510(k) Fertility Focus

Fertility Focus OvuSense Fertility Monitor

Regulation Number and Section

N/A