The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for home use.
The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for over-the-counter (OTC) home use.

Device Description

The Fertell Male Fertility Test measures the concentration of progressively motile sperm in a fresh semen sample. The test is performed between two and seven days after the last ejountion.

Semen is collected directly into a custom design collection container and allowed to liquefy for 30 minutes. A test unit is then positioned onto the liquefied sample and the pressing of a button releases a solution of sodium hyaluronate buffer solution over the semen sample and stats heating the fluid to 37℃. Motile sperm swim-up through the sodium hyaluronate for 30 minutes before a valve is opened, by turning a knob, allowing the buffer solution, and motive 50 mm present, to flow along a capillary channel. Anti-CD59 monoclonal antibody that is conjugated with colloidal gold is released from an absorbent pad in the channel and reacts with the sperm forming an immunocomplex of gold-labeled sperm. The fluid containing this complex flows onto a nitrocellulose strip where the gold-labeled sperm are trapped, forming a realine. Unreacted conjugate is washed from the strip by the flow of excess buffer.

Turning the knob back to its original position closes the valve and reveals the test result. The appearance of a clear red line (test result) indicates motile sperm in the semen sample at a concentration of≥10M/mL. This level is indicative of normally expected motile sperm concentrations.

The device has a microprocessor to control internal fluid temperature at 37° C and provide user prompts by an LED that changes state at the end of each timed activity. A control line is present on the nitrocellulose test strip to confirm to the user that the test has functioned correctly.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Fertell Male Fertility Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Objective	Acceptance Criteria (Implied)	Reported Device Performance
Lay User Performance (Consumer Field Evaluation)	High percentage of correct responses to questionnaire items, indicating ease of use and understanding of instructions.	94.8% correct response level (6160 correct out of 6495 responses from 433 subjects).
Equivalence (Lay User vs. Professional)	High percentage accuracy between lay user and professional results.	95.0% accuracy based on test efficiency (NCCLS GP14-A, June 1996).
Equivalence (Device vs. Predicate Method)	High percentage accuracy between the Fertell Test and predicate methods (CASA, modified Kremer test).	95.7% accuracy against predicate methods based on test efficiency (NCCLS GP14-A, June 1996).

Note: The acceptance criteria are "implied" because specific percentage thresholds for acceptance are not explicitly stated in the provided text. However, the reported performance levels (e.g., 94.8%, 95.0%, 95.7%) are presented as demonstrative of successful validation.

2. Sample Sizes and Data Provenance

Lay User Performance (Consumer Field Evaluation):
- Test Set Sample Size: 433 subjects.
- Data Provenance: Not explicitly stated, but "consumer field evaluation" suggests data collected from actual consumers in their home environment. The mention of "three sites" indicates multiple collection points. It is prospective as it involves subjects performing the test according to instructions.
Lay Users vs. Professionals Study:
- Test Set Sample Size: 121 subjects.
- Data Provenance: Not explicitly stated, but trials were conducted at a "trial site" where lay users provided semen samples. This suggests controlled, prospective data collection.
Method Comparison Study (Device vs. Predicate):
- Test Set Sample Size: 140 subjects.
- Data Provenance: Not explicitly stated, but "trial site" suggests controlled, prospective data collection.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Lay User Performance (Consumer Field Evaluation): No experts were used to establish ground truth for this study. The ground truth was based on the subjects' responses to a questionnaire about their experience and understanding of the instructions.
Lay Users vs. Professionals Study:
- Number of Experts: Not explicitly stated, but the study involved "a professional" who independently read the test result. It is implied there was at least one professional per test.
- Qualifications of Experts: Not specified beyond being referred to as "a professional." It can be inferred that they were trained and experienced in interpreting semen analysis results from such tests.
Method Comparison Study (Device vs. Predicate):
- Number of Experts: Not explicitly stated, but "a laboratory professional" performed testing using the predicate methods and the Fertell Test. It is implied there was at least one professional per test.
- Qualifications of Experts: Not specified beyond being a "laboratory professional." It can be inferred that they were trained and experienced in performing and interpreting laboratory-based semen analysis, including CASA and modified Kremer tests.

4. Adjudication Method for the Test Set

Lay User Performance (Consumer Field Evaluation): No adjudication method was mentioned for this study, as it focused on questionnaire responses and successful task completion directly by the lay user.
Lay Users vs. Professionals Study: The method involved independent interpretation by "the lay user and a professional... without either having knowledge of the other's result." This suggests a non-adjudicated comparison where the professional's reading likely served as the gold standard against which the lay user's reading was compared.
Method Comparison Study (Device vs. Predicate): The specific adjudication method is not described. It states that "testing of the sample by the two predicate methods and by the Fertility Test was performed by a laboratory professional." This suggests the comparison was made between the device's output and the outputs of the predicate methods, likely with the predicate methods serving as the reference standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly mentioned or clearly described. The "Lay Users vs. Professionals study" involved comparing readings, but it focused on the equivalence of reading results between two types of readers (lay vs. professional) rather than measuring the improvement of human readers with AI assistance versus without. The device itself (Fertell Male Fertility Test) is designed as a standalone
test to be read by the user, not an AI or software offering assistance to human readers.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The "Method Comparison Study" evaluated the Fertell Male Fertility Test's performance against established laboratory predicate methods. This measures the device's ability to accurately measure motile sperm concentration independently of a human reader's interpretive assistance, beyond the basic visual interpretation of the result line. The professional performing the test for this study is operating the device and the predicate, not acting as an "assisted reader." Therefore, this study demonstrates the standalone performance of the device against a gold standard.

7. Type of Ground Truth Used

Lay User Performance (Consumer Field Evaluation): The ground truth concerned the correct completion of steps and understanding of instructions, as indicated by questionnaire responses.
Lay Users vs. Professionals Study: The ground truth for interpreting the test result was established by the professional's independent reading of the Fertell Male Fertility Test.
Method Comparison Study (Device vs. Predicate): The ground truth for motile sperm concentration was established by predicate laboratory methods:
- Computer-aided sperm analysis (CASA) using the Hamilton Thorne IVOS system.
- A modified Kremer test (sperm migration test).

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The descriptions focus on the validation (test) sets for clinical and method comparison studies. For medical devices like this, development typically involves internal testing and iterative refinement during the R&D phase, but a formally documented "training set" in the context of machine learning (AI) is not mentioned because the device is not described as a deep learning model requiring such a set. It's a diagnostic test with specific chemical and physical reactions.

9. How Ground Truth for the Training Set Was Established

As no separate training set is explicitly mentioned or described as part of a formal validation, the method for establishing its ground truth is not provided. The device's operation is based on biochemical principles and physical processes rather than learning from data, so the concept of a "training set" in the AI sense wouldn't apply directly.

Summary

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K041039

510(k) SUMMARY

Name of 510(k) sponsor:	Genosis Ltd.
Address:	12-50 Kingsgate RoadKingston Upon ThamesEngland KT2 5AATelephone: (44) 208 408 5232Fax: (44) 208.408 5432
Contact information:	Paul BatemanPresident & CEOGenosis Ltd.Telephone: (44) 208 408 5246Fax: (44) 208 408 5432E-mail: paul_bt@genosis.com
Date summary prepared:	June 25, 2004
Proprietary name of device:	Fertell Male Fertility Test
Generic/classification name:	Device, Semen Analysis

Product code (classification): (7) Z, Class II

Legally Marketed Predicate Devices:

Penetrak Cervical Mucus Penetration Test (K821186) FertilMARQ Test kit (K011679) Hamilton Thorne IVOS (K920179) Humagen Semen Analysis Kit (K915229)

Device Description and Technological Characteristics:

The Fertell Male Fertility Test measures the concentration of progressively motile sperm in a fresh semen sample. The test is performed between two and seven days after the last ejountion.

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Intended Use

The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for home use.

Testing

The following performance evaluations were conducted with the Fertell Male Fertility Test: clinical (i.e., consumer) studies (consumer field evaluations, lay users versus professionals); inhouse method comparison study versus predicate; laboratory evaluations (specificity, reproducibility, result stability, robustness to timings, and influence of ambient temperature); and stability studies.

The objective of the consumer field evaluation was to demonstrate that lay users can reliably perform the test in their home environment following the instructions provided in the package insert and other labeling (box labeling and, for some users, a supplementary instruction sheet), without confusion, complications, or procedural difficulties (i.e., validation of the adequacy of the Instructions for Use). The studies included a questionnaire to obtain feedback from lay users on various aspects of performing the test. A total of 433 questionnaires were received from the three sites. Of the 6495 responses (433 subjects x 15 questions), 6160 were correct, 335 were incorrect or no response. This demonstrate that the Fertell Male Fertility Test could be accurately performed by a general public consumer population in the home environment, the correct response level was 94.8%.

The objective of the Lay Users vs. Professionals study was to demonstrate equivalence between the lay user and professional results. Each lay user was asked to attend the trial site where they provided a semen sample and performed the Fertell Male Fertility Test following the instructions provided in the package insert and other labeling (box labeling and, for some users, a supplementary instruction sheet). On completion of the test, the lay user and a professional read the test result independently, without either having knowledge of the other's result and recorded their interpretation of the result on separate record sheets. The lay users were not given any assistance in the performance of the test. The results from 121 subjects, expressed as precent. accuracy based on test efficiency according to NCCLS guidelines (GP14-A, June 1996). show a percent accuracy between the lay user and the professional of 95.0%.

The objective of the Method Comparison Study was to demonstrate equivalence between the Fertell Male Fertility Test and the predicate method (a laboratory run, computer-aided sperm analysis system, CASA, the Hamilton Thorne IVOS system). A sperm migration test (modified Kremer test) was also used, as a secondary predicate method. Subjects were asked to (fitedd the

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trial site and provide a semen sample into a laboratory collection container. Testing of the sample by the two predicate methods and by the Fertility Test was performed by a laboratory professional. The results from 140 subjects expressed as percent accuracy, based on test efficiency according to NCCLS guidelines (GP14-A, June 1996), show a percent accuracy against the predicate method of 95.7%.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and medicine. The emblem is composed of three curved lines that converge to form a wing-like shape.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Genosis Ltd. c/o Sharon A. Segal, Ph.D., Director, Regulatory Science Morgan, Lewis & Bockius, LLP 1111 Pennsylvania Avenue, NW Washington, DC. 20004

JUN 1 5 2012

Re: K041039

Trade/Device Name: Fertell Male Fertility Test Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: April; 21, 2004 Received: May 11, 2004

Dear Dr. Segal:

This letter corrects our substantially equivalent letter of July 20, 2004.

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth

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Page 2 - Sharon A. Segal, Ph.D.

in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely yours,

ia m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Applicant: Genosis Ltd.

K041039 510(k) Number:

Device Name: Fertell Male Fertility Test

Indications for Use:

The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for over-the-counter (OTC) home use.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or
Over-the Counter Use

Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K041039

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”