(176 days)
No
The document mentions "proprietary algorithms" for image analysis and reporting, but does not explicitly mention or describe the use of AI or ML techniques. The focus is on traditional image processing and algorithmic analysis of sperm movement.
No.
The device is used for semen analysis (diagnosis), not for treating any condition.
Yes
The device analyzes semen parameters (sperm concentration, motility, etc.) to provide information about male fertility status, which is a diagnostic purpose. The Intended Use section states it is a "smartphone-based test for semen analysis."
No
The device description explicitly states that the YO Home Sperm Test (YO 3.0) includes a physical "YO device" which contains hardware components such as a magnification lens, WiFi camera, and LED. While it utilizes software for analysis and presentation, it is not solely software.
Based on the provided information, the YO Home Sperm Test (YO 3.0) is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a "smartphone-based test for semen analysis performed by lay users" and is "intended for in vitro, over the counter only." This clearly indicates that the device is used to examine specimens (semen) taken from the human body to provide information for diagnostic purposes (in this case, related to semen parameters which are indicators of fertility).
- Device Description: The description details how the device analyzes semen samples in vitro (outside the body) using a combination of hardware (device, slide, camera) and software to measure specific parameters of the semen.
- Over-the-Counter (OTC) Use: The indication for "over the counter only" further reinforces its classification as an IVD intended for use by lay users without the direct supervision of a healthcare professional.
- Analysis of Human Specimens: The core function of the device is to analyze human semen samples.
- Providing Information for Diagnostic Purposes: While it doesn't provide a comprehensive fertility diagnosis, the parameters it measures (sperm concentration, motility) are key indicators used in the evaluation of male fertility, which falls under the umbrella of diagnostic information.
- Clinical Validation: The summary of performance studies describes a clinical validation study comparing the device's results to a predicate device (SQA-V sperm quality analyzer), which is a common requirement for IVDs to demonstrate their accuracy and reliability.
Therefore, the YO Home Sperm Test (YO 3.0) fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users.
The parameters reported by the YO Home Sperm Test (YO 3.0) are:
- Total Sperm Concentration / Sperm Concentration, M/mL
- Total Motile / Motility (PR + Non Progressive [NP]), %
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
- Motile Sperm Concentration (MSC), M/mL
- Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL)
The YO Home Sperm Test (YO 3.0) does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro, over the counter only.
Product codes
POV
Device Description
The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users.
The parameters reported by the YO Home Sperm Test (YO 3.0) are:
-
- Total Sperm Concentration / Sperm Concentration, M/mL
-
- Total Motile / Motility (PR + NP), %
-
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
-
- Motile Sperm Concentration (MSC), M/mL
-
- Proqressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL)
The YO Home Sperm Test (YO 3.0) utilizes proprietary algorithms to both conduct semen analysis, and present and store the results and videos on the user's smartphone and in the YO application ("app") is downloaded onto the user's own smartphone (iPhone/Android) and is controlled by the user through a proprietary graphical interface (GUI). The GUI quides the user through the process step by step on the App's screen and operates with the YO device.
The YO kit provides the supplies necessary to test up to six semen collection cups, pipettes for sample aspiration, fixed coverslip slides, liquefaction powder and a YO device that connects via WiFi to a smartphone and houses the YO slide. The YO software app guides the user through the sample preparation and testing process step-by-step with mandatory confirmation by the user of each completed step. The app also operates the YO device's camera and processor to provide a semen video.
The plastic YO device contains a fixed coverslip slide insertion channel, magnification lens, lens holder, WiFi camera and an LED that lights up the optical path. The YO software captures a video in HD (high definition) mode and implements a unique software algorithm to identify sperm and analyze the light fluctuations resulting from sperm movement to report semen values. The algorithm recognizes when the YO autofocus function has the best image and then defines the optimal area of the video for analysis.
When YO reports any semen value below the cut-off for normal, YO recommends performing an additional test with a new sample and to seek medical advice. YO cut-offs are based on WHO 6th ed. reference values for semen parameters, statistical modeling, and expert publications. The user is not required to perform any interpretation of the test results and YO does not review, verify, or interpret the video provided to the operator. The user can only observe and archive his test results and sperm video. YO does not provide a comprehensive evaluation of a male's fertility status and is intended for over-the-counter ), for in vitro use only.
The YO software quides the user through the testing process step by step on the smartphone's screen and operates in conjunction with the: YO device, smartphone's built-in camera, flash, and man-machine interface to report and store the results of 5 sperm parameters and a video of the user's semen samples. After analyzing the operator's semen video, the YO software reports both the quantitative results and an explanation about the 5 Semen parameters which are visually presented in the YO app directly following testing. In addition, the operator's sperm video is also presented in the test results section directly following the testing phase of the app.
Mentions image processing
Yes, "utilization of signal/image processing" and "The YO software captures a video in HD (high definition) mode and implements a unique software algorithm to identify sperm and analyze the light fluctuations resulting from sperm movement to report semen values."
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Optical (magnified video of semen)
Anatomical Site
Not Found
Indicated Patient Age Range
18 years and above, based on the age range of tested users.
Intended User / Care Setting
Lay Users (over-the-counter)
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
Clinical Validation Sample Size: 309 comparative data sets overall, with a minimum of 100 semen samples per site.
Data Source: Human semen samples collected from lay users and donor semen samples tested by female lay users, performed at three US sites.
Annotation Protocol: Each semen sample was tested in singleton in a blinded fashion by each method (YO 3.0 Home Sperm Test and SQA-V comparator device) using split aliquots. Lay users analyzed their own samples (or donor samples for female users) using the YO 3.0 device, following Instructions for Use and a "HOW YO WORKS" video. The SQA-V comparator device was operated by trained operators.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Analytical (bench) studies and a clinical validation (method comparison study).
Analytical Studies:
- Precision (user repeatability): 3-site study, approximately 20 users per site, tested in triplicate. Directly measured parameters were sperm concentration, motile sperm concentration (MSC), and progressively motile sperm concentration (PMSC). Results showed within-run repeatability (%CV) ranges: Concentration (6.7%-9.7%), MSC (4.6%-9.6%), PMSC (7.4%-11.8%). Between-run repeatability showed SDs for sperm concentration 0.9 and slope > 1.0 +/- 0.2. Supports linear concentration results from 2 to 150 M/mL.
- Interference Study: Used two concentration levels of semen samples and 11 potentially interfering substances. Results of assessed semen parameters were within 15% of controls, meeting CLSI EP07, 3rd ed. acceptance criteria.
Clinical Data:
- Study Type: Method comparison study comparing YO 3.0 (intended users) vs. SQA-V (trained operators).
- Sample Size: 309 comparative data sets.
- Key Results (Passing-Bablok Regression Data):
- Concentration: Slope 0.86 (CI: 0.82-0.91), Y-intercept 2.29 (CI: 1.29-3.25), Correlation (r) 0.93 (CI: 0.92-0.95).
- Motility, %: Slope 1.05 (CI: 1.00-1.11), Y-intercept 0.00 (CI: 0.00-3.00), Correlation (r) 0.90 (CI: 0.88-0.92).
- Progressive Motility, %: Slope 1.24 (CI: 1.16-1.31), Y-intercept -0.47 (CI: -2.78 to 0.00), Correlation (r) 0.88 (CI: 0.85-0.90).
- Motile Sperm Concentration, M/mL: Slope 0.92 (CI: 0.88-0.95), Y-intercept 1.84 (CI: 1.50-2.20), Correlation (r) 0.94 (CI: 0.93-0.95).
- Progressively Motile Sperm Concentration, M/mL: Slope 1.03 (CI: 0.98-1.07), Y-intercept -0.04 (CI: -0.44 to 0.00), Correlation (r) 0.94 (CI: 0.92-0.95).
- Post-Test Questionnaire: Demonstrated high user comprehension of reported parameters and appropriate actions based on results (e.g., 90% correct on sperm concentration definition, 99% correct on actions for low results, 99% correct on actions for normal results after 1 year of trying to conceive).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. The study focused on correlation and agreement with a predicate device.
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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 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.
November 29, 2024
Medical Electronic Systems Ltd. Taly Vider Cohen Regulatory Affairs and IP Director Alon Hatavor St. 20 Caesarea, 3088900 Israel
Re: K241628
Trade/Device Name: YO Home Sperm Test Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: POV Dated: June 6, 2024 Received: June 6, 2024
Dear Taly Vider Cohen:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows the text "Min Wu-S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. The background is white, with a faint watermark or design visible behind the text.
Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241628
Device Name YO Home Sperm Test
Indications for Use (Describe)
The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users.
The parameters reported by the YO Home Sperm Test (YO 3.0) are:
-
Total Sperm Concentration / Sperm Concentration, M/mL
-
Total Motile / Motility (PR + Non Progressive [NP]), %
-
Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
-
Motile Sperm Concentration (MSC), M/mL
-
Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL)
The YO Home Sperm Test (YO 3.0) does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro, over the counter only.
| 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."
4
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
807.92 (a)(1): Name: Medical Electronic Systems, LTD
ALON HATAVOR ST. 20 ZONE 6 Address: CAESAREA INDUSTRIAL PARK CAESAREA, 38900, ISRAEL
972 54 209-1712 Phone: FAX: NA Contact: Ms. Taly Vider Cohen
October 14th, 2024 Date Created:
807.92 (a)(2): Device name- trade name and common name, and
ClassificationTrade Name:
YO Home Sperm Test
Common Name: YO Home Sperm Test
Classification: Class II, POV 21 CFR 864.5220
807.92 (a)(3): Identification of the legally marketed predicate devices
The YO Home Sperm Test (YO 3.0) is substantially equivalent to two FDA-cleared predicate devicesthe initial YO Home Sperm Test cleared under K161493, and the SQA-V sperm quality analyzer (SQA-V), cleared under K021746.
The YO Home Sperm Test (YO 3.0) is substantially equivalent to both devices in terms of general intended use (assessment of semen parameters), general optical technology, sample type, male fertility factor, and in vitro use.
Specifically, the YO Home Sperm Test (YO 3.0) is substantially equivalent to the initial YO Home Sperm Test in terms of intended users: Lay Users (over-the-counter) and utilization of signal/image processing. The YO Home Sperm Test is substantially equivalent to the SQA-V in terms of comparative data for the various measured and calculated parameters.
807.92 (a)(4): Device Description
The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users.
The parameters reported by the YO Home Sperm Test (YO 3.0) are:
-
- Total Sperm Concentration / Sperm Concentration, M/mL
-
- Total Motile / Motility (PR + NP), %
-
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
-
- Motile Sperm Concentration (MSC), M/mL
-
- Proqressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL)
5
The YO Home Sperm Test (YO 3.0) utilizes proprietary algorithms to both conduct semen analysis, and present and store the results and videos on the user's smartphone and in the YO application ("app") is downloaded onto the user's own smartphone (iPhone/Android) and is controlled by the user through a proprietary graphical interface (GUI). The GUI quides the user through the process step by step on the App's screen and operates with the YO device.
The YO kit provides the supplies necessary to test up to six semen collection cups, pipettes for sample aspiration, fixed coverslip slides, liquefaction powder and a YO device that connects via WiFi to a smartphone and houses the YO slide. The YO software app guides the user through the sample preparation and testing process step-by-step with mandatory confirmation by the user of each completed step. The app also operates the YO device's camera and processor to provide a semen video.
The plastic YO device contains a fixed coverslip slide insertion channel, magnification lens, lens holder, WiFi camera and an LED that lights up the optical path. The YO software captures a video in HD (high definition) mode and implements a unique software algorithm to identify sperm and analyze the light fluctuations resulting from sperm movement to report semen values. The algorithm recognizes when the YO autofocus function has the best image and then defines the optimal area of the video for analysis.
When YO reports any semen value below the cut-off for normal, YO recommends performing an additional test with a new sample and to seek medical advice. YO cut-offs are based on WHO 6th ed. reference values for semen parameters, statistical modeling, and expert publications. The user is not required to perform any interpretation of the test results and YO does not review, verify, or interpret the video provided to the operator. The user can only observe and archive his test results and sperm video. YO does not provide a comprehensive evaluation of a male's fertility status and is intended for over-thecounter ), for in vitro use only.
The YO software quides the user through the testing process step by step on the smartphone's screen and operates in conjunction with the: YO device, smartphone's built-in camera, flash, and man-machine interface to report and store the results of 5 sperm parameters and a video of the user's semen samples. After analyzing the operator's semen video, the YO software reports both the quantitative results and an explanation about the 5 Semen parameters which are visually presented in the YO app directly following testing. In addition, the operator's sperm video is also presented in the test results section directly following the testing phase of the app.
807.92 (a)(5): Intended Use/Indications for Use
The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users.
The parameters reported by the YO Home Sperm Test (YO 3.0) are:
-
- Total Sperm Concentration / Sperm Concentration, M/mL
-
- Total Motile / Motility (PR + Non Progressive [NP]), %
-
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
-
- Motile Sperm Concentration (MSC), M/mL
- Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL)
The YO Home Sperm Test (YO 3.0) does not provide a comprehensive evaluation of a male's fertility i status and is intended for in vitro, over the counter only.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
The YO Home Sperm Test (YO 3.0) is substantially equivalent to two FDA-cleared predicate devicesthe initial YO Home Sperm Test cleared under K161493, and the SOA-V sperm quality analyzer, cleared under K021746.
The YO Home Sperm Test (YO 3.0) is substantially equivalent to both devices in terms of general intended use (assessment of semen parameters), qeneral optical technology, sample type, male fertility
6
factor, and in vitro use. Specifically, the YO Home Sperm Test (YO 3.0) is substantially equivalent to the initial YO Home Sperm Test in terms of intended users: Lay Users (over-the-counter) and utilization of signal/image processing. The YO Home Sperm Test is substantially equivalent to the SQA-V in terms of comparative data for the various measured and calculated parameters.
| Element | New product | Legal Predicate | Functional Predicate/
Comparative Method |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | YO Home Sperm Test (YO 3.0) | YO Home Sperm Test: 510(k) K161493 | SQA-V: 510(k) K021746 |
| Intended
use | The YO Home Sperm Test (YO
3.0) is a smartphone-based test
for semen analysis performed by
lay users.
The YO Home Sperm Test (YO
3.0) does not provide a
comprehensive evaluation of a
male's fertility status and is
intended for over-the-counter in
vitro use only. | The initial YO Home Sperm Test is a
smartphone-based test that provides a
qualitative assessment of motile sperm
concentration (MSC) in human semen.
MSC is one aspect of a male semen
examination.
The initial YO Home Sperm Test does
not provide a comprehensive evaluation
of a male's fertility status and is
intended for over-the-counter in vitro
use only. | The SQA-V is an, in vitro use,
electro-optical medical device
with on-screen visualization
for semen analysis performed
by healthcare professionals
(trained lab technicians). |
| Intended
User | Lay Users (over-the-counter). | Same | Healthcare Professionals
(trained lab technicians) |
| WHO
compliance | WHO 6th | WHO 5th | WHO 5th and WHO 6th |
| Sample
type | Human semen | Same | Same |
| Male
fertility
factor | Yes | Same | Same |
| Sample
delivery
method | YO Fixed Cover Slip Slide which
is inserted into the YO device | Same | SQA-V testing capillary which
is inserted into the SQA-V
device |
| Semen
parameters | Parameters measured/
Reported:
• Total Sperm Concentration /
Sperm Concentration, M/mL
• Percent Motility/ Total Motile
(PR + NP), %
• Motile Sperm Concentration
(MSC), M/mL
• Progressive Motility (PR), %
(combines Rapidly and Slowly
Progressive, %)
• Progressively Motile Sperm
Concentration (PMSC), M/mL
(combines Rapidly and Slowly
Motile Sperm Concentration,
M/mL) | Parameters Measured/
Reported:
• Motile Sperm Concentration (MSC),
millions/mL above and below the
6M/ml cut-off for normal/abnormal.
Results are presented as LOW or
Moderate/Normal Range. | The Parameters
measured/ reported
that overlap with the
YO Home Sperm
Test (YO 3.0):
• Sperm Concentration / Total
Sperm Concentration, M/mL
• Percent Motility/ Total
Motile (PR + NP), %
• Motile Sperm Concentration
(MSC), M/mL
The SQA-V also reports other
parameters. |
| Test Type | Quantitative | Qualitative | Quantitative |
| Element | New product
YO Home Sperm Test (YO 3.0) | Legal Predicate
YO Home Sperm Test: 510(k) K161493 | Functional Predicate/
Comparative Method
SQA-V: 510(k) K021746 |
| Technology | Desktop unit consists of a light
source, and image sensors
(camera), wirelessly connected
to a smartphone, onto which the
cloud-based software is
downloaded. The software is
used to capture and analyze
magnified sperm videos using a
proprietary algorithm to produce
results.
A specimen-filled slide is
inserted into the OTC device unit
and illuminated by the light
source.
The image is magnified by a
magnification lens in the YO
device and projected to the
image sensors (YO camera).
The camera transmits the video
to the smartphone. | Magnification "Clip" which slides over the
top of the Smartphone.
Software downloaded onto the phone is
used to capture and analyze magnified
sperm videos using a proprietary
algorithm to produce results.
A specimen-filled slide is inserted into
the "Clip" and illuminated by the
smartphone's light source.
In addition, the "Clip" utilizes the
smartphone's lens and image sensors
(camera) to assess semen parameters.
The image is magnified by the
magnification lens in the "Clip", and
using mirrors projected back to the
smartphone's lens and to the
smartphone's image sensors (camera). | Desktop unit consists of a
light source, optical sensors,
built-in video microscopy and
an internal computer
containing algorithms for the
assessment of semen
parameters.
A specimen-filled capillary is
inserted into the desktop unit
and illuminated by the light
source. |
7
807.92 (b)(1) Brief Description of Nonclinical Data
Medical Electronic Systems (MES) has conducted a series of analytical (bench) studies in support of the analytical claims of the YO Home Sperm Test (YO 3.0). These studies were all performed in-house and included evaluations for:
- Precision (user repeatability and laboratory reproducibility) ●
- Detection limits (LOB/LOD [LOD = LOQ]) ●
- . Linearity
- Specificity/Interference ●
All the studies utilized native human semen samples being manually prepared (diluted or spiked) to achieve the necessary quantitation ranges. Semen samples were collected following WHO 6th ed. manual guidance for sample handling from consented donors and were assayed in a blinded fashion on the SQA-iO, and in parallel on the SQA-V comparator device, as applicable.
Precision (user repeatability)
In a 3-site study, approximately 20 users per site collected their own semen samples and tested the samples in triplicate. The study included three batches (lots) of slides- one per site. After the initial test, the users tested their sample two more times using a new slide.
This study only reported the directly measured parameters of sperm concentration, motile sperm concentration (MSC), progressively motile sperm concentration (PMSC).
The statistical analyses calculated means, standard deviations (SDs) and percent coefficients of variation (%CVs) per sample. Then, group SDs and %CVs were calculated from samples where the means were categorized as arbitrary low, middle, and high for sperm concentrations.
Note: Native samples were analyzed in a prospective manner without the requirement to obtain full dynamic range representation for each parameter.
8
Within-run Repeatability Summary (in %CV) is presented in the table below, for all three sites:
| Site | Concentration | MSC | PMSC |
|---|---|---|---|
| VN | 6.7% | 4.6% | 7.4% |
| NH | 9.7 | 9.6 | 11.8 |
| EN | 7.9% | 5.9% | 7.7% |
For between-run repeatability, it was demonstrated that SDs for sperm concentration were 0.9 for all three directly measured parameters. For the calculated parameters (%motility and %progressive motility), the slopes were 1.05 and 1.24, respectively, and the y-intercepts were 0.00 and -0.47. The "r"s were 0.9 and 0.88.
YO Intended User vs. SOA-V Expert User (n = 309)
| CONCENTRATION | ||||||
|---|---|---|---|---|---|---|
| Intercept | 95% CI | Slope | 95% CI | Correlation | 95% CI | |
| 2.29 | 1.29 to 3.25 | 0.86 | 0.82 to 0.91 | 0.93 | 0.92 to 0.95 |
| MOTILITY, % | |||||
|---|---|---|---|---|---|
| Intercept | 95% CI | Slope | 95% CI | Correlation | 95% CI |
| 0.00 | 0.00 to 3.00 | 1.05 | 1.00 to 1.11 | 0.90 | 0.88 to 0.92 |
| PROGRESSIVE MOTILITY, % | |||||
|---|---|---|---|---|---|
| Intercept | 95% CI | Slope | 95% CI | Correlation | 95% CI |
| -0.47 | -2.78 to 0.00 | 1.24 | 1.16 to 1.31 | 0.88 | 0.85 to 0.90 |
| MOTILE SPERM CONCENTRATION, M/ml | |||||
|---|---|---|---|---|---|
| Intercept | 95% CI | Slope | 95% CI | Correlation | 95% CI |
| 1.84 | 1.50 to 2.20 | 0.92 | 0.88 to 0.95 | 0.94 | 0.93 to 0.95 |
| PROGRESSIVELY MOTILE SPERM CONCENTRATION, M/ml | |||||
|---|---|---|---|---|---|
| Intercept | 95% CI | Slope | 95% CI | Correlation | 95% CI |
| -0.04 | -0.44 to 0.00 | 1.03 | 0.98 to 1.07 | 0.94 | 0.92 to 0.95 |
Intended User Overall Demographics (n = 315)
The diversity of the United States intended use population was reflected in the study. The following information was requested of each subject enrolled in the study: gender, age, ethnicity and educational level. Overall demographics is summarized in the table below:
| Site 1 | Site 2 | Site 3 | All sites | |
|---|---|---|---|---|
| Gender (Testers) | 115 | 115 | 85 | 315 |
| Male | 108 (93.9%) | 104 (90.4%) | 85 (100%) | 297 (94.2%) |
| Female | 6 (5%) | 7 (6%) | 0 | 13 (4.1%) |
11
| Other | 1 (The number of sperm in 1mL of your sample | 90% |
| C. | The number of live sperm | 5% |
| D. | The number of abnormally shaped sperm | 0% |
| Question #2:
| Sperm MOTILITY (%) is: | ||
|---|---|---|
| ANSWER | RESPONSE % | |
| A. | The % of all moving sperm in your sample, even | |
| those wiggling in place and moving in all directions | 87% | |
| B. | The % of sperm moving in only one direction | 13% |
| C. | The % of sperm moving backwards | 0% |
| D. | The % of sperm that are not moving | 0% |
| Question #3: | ||
|---|---|---|
| Sperm PROGRESSIVE MOTILITY (%) is: | ||
| ANSWER | RESPONSE % | |
| A. | The % of sperm with multiple heads | 4% |
| B. | The % of only forward moving sperm in your sample | 96% |
| C. | The % of sperm that are not moving | 0% |
12
D. | The % of sperm moving backwards
| Question #4: | ||
|---|---|---|
| MOTILE SPERM CONCENTRATION (MSC) M/mL is: | ||
| ANSWER | RESPONSE % | |
| A. | The number of sperm with abnormal shapes | 0% |
| B. | The number of moving sperm in the collection cup | 6% |
| C. | The number of sperm moving backwards | 0% |
| D. | The number of moving sperm in 1mL of your sample | 94% |
| Question #5: | ||
|---|---|---|
| PROGRESSIVELY MOTILE SPERM CONCENTRATION (PMSC) M/mL is: | ||
| ANSWER | RESPONSE % | |
| A. | The number of sperm moving forward in 1ml of your sample | 97% |
| B. | The number of sperm with abnormal shapes in 1 mL of your sample | 1% |
| C. | The number of sperm moving backwards in 1 mL of your sample | 0% |
| D. | The number of sperm moving forward in the collection cup | 2% |
| Question #6: | ||
|---|---|---|
| What factors may cause semen quality to change from time to time? | ||
| ANSWER | RESPONSE % | |
| A. | My lifestyle habits such as smoking, drinking, | |
| overeating resulting in obesity | 12% | |
| B. | Taking hormones such as testosterone or body | |
| enhancing steroids | 0% | |
| C. | A recent illness with high fevers or requiring | |
| chemotherapy | 0% | |
| D. | All of the above are correct | 88% |
Note: Only answer D is considered as correct
| Question #7:
| If all of your results are NORMAL and you've been trying to conceive for over a year, what should you do? | ||
|---|---|---|
| ANSWER | RESPONSE % | |
| A. | Consider talking to your doctor or a fertility expert with your partner | 12% |
| B. | There is nothing to do | 1% |
| C. | Understand that YO is a screening device, and a more extensive semen analysis might be useful | 0% |
| D. | Both A and C are correct | 87% |
| Question #8: | ||
|---|---|---|
| Your first YO Home Sperm Test shows all test results are LOW, what should you do? | ||
| ANSWER | RESPONSE % | |
| A. | Consider repeating your YO test in 2-4 weeks | |
| and modifying your lifestyle habits such as: | ||
| Smoking, alcohol and recreational drug use. | 99% | |
| B. | Do nothing | 0% |
13
| C. | Share results with friends who have had fertility
problems for advice. | 0% |
|----|---------------------------------------------------------------------------|----|
| D. | Repeat your YO test the next day. | 1% |
| Question #9:
| Your second YO Home Sperm Test shows all test results as NORMAL, but you have not | ||
|---|---|---|
| conceived in a year. What should you do? | ||
| ANSWER | RESPONSE % | |
| A. | Repeat your YO test the next day | 0% |
| B. | There is nothing you can do but keep trying | 1% |
| C. | Consider talking to your doctor or a fertility | |
| expert, because infertility can be a male and a | ||
| female problem | 99% | |
| D. | Share results with friends who have had fertility | |
| problems for their advice | 0% |
807.92 (b)(3) Conclusions from Nonclinical and Clinical Testing
The YO Home Sperm Test (YO 3.0) testing confirms that the device can be used according to its intended use. The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues for this device type. Therefore, the YO Home Sperm Test (YO 3.0) is safe and performs effectively based on its intended use.