(160 days)
SQA-V
No
The document does not mention AI, ML, or image processing, and the performance studies focus on traditional analytical and clinical metrics.
No.
The device is for in vitro diagnostic use to provide a qualitative assessment of motile sperm concentration, not for treating any condition.
Yes
The device provides a qualitative assessment of motile sperm concentration (MSC) in human semen, reporting results as "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE." This assessment provides information about a male's fertility status, which falls under the definition of a diagnostic device. The "Intended Use" explicitly states it provides a "qualitative assessment of motile sperm concentration (MSC) in human semen."
No
The device description explicitly states that the YO™ kit includes physical components such as collection cups, liquefying powder, pipettes, slides, a QC slide, and a YOT™ Clip that attaches to the smartphone. While the software is a crucial part of the system, it is not the sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the YO™ Home Sperm Test is an "in vitro use only" device.
- Device Description: The description details that the device provides a qualitative assessment of motile sperm concentration in human semen, which is a biological sample tested in vitro (outside the body).
- Over-The-Counter Use: While it's an over-the-counter device, this doesn't preclude it from being an IVD. Many IVDs are designed for home use.
- Performance Studies: The document describes performance studies conducted on human semen samples, which is typical for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Devices: The listed predicate devices (SpermCheck® Fertility and SQA-V sperm analyzer) are also IVD devices used for semen analysis.
Therefore, based on the provided information, the YO™ Home Sperm Test clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The YO™ Home Sperm Test is a smartphone based home test which provides a qualitative assessment of motile sperm concentration (MSC) in human semen. MSC is one aspect of a male semen examination. The 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.
Product codes
POV
Device Description
YO™ is an over-the-counter device that provides a qualitative assessment of motile sperm concentration (MSC) in human semen. Results are reported as "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE," requiring no user interpretation. The YO™ software application is downloaded onto the users' own smartphone and on-screen menus and instructions are shown on the phone's display so that the user is taken through the process step by step. The YO™ kit (purchased on the website) provides all the supplies necessary to evaluate two semen samples: two semen collection cups, two vials of liquefying powder (chymotrypsin), two pipettes for sample aspiration, two fixed coverslip slides for sample testing, one QC slide, and one YOT™ Clip that attaches to the smartphone and houses the fixed coverslip slide.
The YO™ software recommends seeking medical advice if both YO™ test results report LOW MSC RANGE. The LOW cutoff has been established at 8 M/mL).
- Key Results: Intra-device (iPhone and Galaxy separately), inter-phone type (iPhone vs. Galaxy), and inter-operator/Clip/slide lot repeatability, calculated via percents coefficients of variation (%CVs), were 90% against SQA-V.
Clinical Data (3-site study):
- Study type: Cross-sectional, multi-site clinical investigation.
- Sample size: 316 samples evaluated across three sites (82, 136, and 98 subjects/samples per site).
- Data source: Male subjects (self-reporting no known fertility issues, partner in a couple having difficulty conceiving, diagnosed with male factor infertility, post-vasectomy patients, post-vasectomy reversal patients) and "tester" lay-persons. Semen specimens collected and tested by lay users, trained healthcare professionals (HCPs), and SQA-V systems.
- Key Metrics: Percent agreements between Lay Users (YO™) and SQA-V (A vs. C), Lay Users (YO™) and Trained Users (YO™) (A vs. B), and Trained Users (YO™) and SQA-V (B vs. C).
- Key Results:
- Agreement: A vs. B (YO™ by Lay User vs. YO™ by Trained User): PPA = 96.7%, NPA = 98.7%.
- Agreement: A vs. C (YO™ by Lay User vs. SQA-V): PPA = 95.3%, NPA = 96.1%.
- Agreement: B vs. C (YO™ by Trained User vs. SQA-V): PPA = 97.6%, NPA = 97.0%.
- Questionnaire (User Comprehension and Satisfaction): Descriptive summary of responses to 5-point Likert scale questions. High percentages for "Very clear and easy to follow" for all aspects of the instructions (YO™ TEST PROCEDURE, SAMPLE PREPARATION, ATTACHING THE YO SPERM CLIP TO THE PHONE, FILLING THE YO SLIDE WITH SAMPLE, YO ANIMATIONS AND VIDEOS).
Key Metrics
- Reproducibility/Repeatability: Intra-device, inter-phone type, and inter-operator/Clip/slide lot repeatability (%CVs) were
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 8, 2016
Medical Electronic Systems, Ltd. c/o Erika B. Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022
Re: K161493
Trade/Device Name: YOTM Home Sperm Test Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: POV Dated: October 28, 2016 Received: October 31, 2016
Dear Ms. Ammirati:
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. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); 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 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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.
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161493
Device Name YOTM Home Sperm Test
Indications for Use (Describe)
The YO™ Home Sperm Test is a smartphone based home test which provides a qualitative assessment of motile sperm concentration (MSC) in human semen. MSC is one aspect of a male semen examination. The 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.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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. The assigned 510(k) number is K161493.
807.92 (a)(1):
Name: Medical Electronic Systems, LTD
- ALON HATAVOR ST. 20 ZONE 6 Address: CAESAREA INDUSTRIAL PARK CAESAREA, 38900, ISRAEL
| Phone: | 011 972 4 637-3981 |
|---|---|
| FAX: | 011 972 4 637-3984 |
| Contact: | Ms. Marcia Deutsch |
807.92 (a)(2): Device name- trade name and common name, and classification
Trade name:
YO™ Home Sperm Test
Common Name: YO™ Home Sperm Test for qualitative assessment of motile sperm concentration (MSC) using the user's smartphone, the YO™ software application, and the YO™ test kit.
Classification: Class II, POV 21 CFR 864.5220
807.92 (a)(3): Identification of the legally marketed predicate devices
YO™ Home Sperm Test (YO™) is substantially equivalent to an amalgam of two existing predicate devices, namely SpermCheck® Fertility (Princeton BioMeditech Corporation, Princeton, NJ), cleared under K100341, May 4, 2010, and the SQA-V sperm analyzer, (MES Ltd., Israel), cleared under K021746, September 20, 2002. All three test systems utilize fresh human sperm to measure various aspects of male fertility factors.
807.92 (a)(4): Device Description
YO™ is an over-the-counter device that provides a qualitative assessment of motile sperm concentration (MSC) in human semen. Results are reported as "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE," requiring no user interpretation. The YO™ software application is downloaded onto the users' own smartphone and on-screen menus and instructions are shown on the phone's display so that the user is taken through the process step by step. The YO™ kit (purchased on the website) provides all the supplies necessary to evaluate two semen samples: two semen collection cups, two vials of liquefying powder (chymotrypsin), two pipettes for sample aspiration, two fixed coverslip slides for sample testing, one QC slide, and one YOT™ Clip that attaches to the smartphone and houses the fixed coverslip slide.
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The YO™ software recommends seeking medical advice if both YO™ test results report LOW MSC RANGE. The LOW cutoff has been established at 8 M/mL)
| Site 1: MES | Positive | Negative | Total | % Positive | % Negative |
|---|---|---|---|---|---|
| Positive (8 M/mL) | 0 | 60 | 30x2 phone | ||
| types = 60 | 0 | 100 |
| Site 2: Ruppin
| College | Positive | Negative | Total | % Positive | % Negative |
|---|---|---|---|---|---|
| Positive (8 M/mL) | 0 | 42 | 21x2 phone types | ||
| = 42 | 0 | 100 |
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| Overall | Positive | Negative | Total | % Positive | % Negative |
|---|---|---|---|---|---|
| Positive (8 M/mL) | 0 | 102 | 51x2 phone types | ||
| = 102 | 0 | 100 |
It was demonstrated that the intra-device (iPhone and Galaxy separately), inter-phone type (iPhone vs. Galaxy), and inter-operator/Clip/slide lot repeatability, calculated via percents coefficients of variation (%CVs), were = 6 M/mL)
The YO™ and SQA-V results were compared based on the following categories: Positive (below cut-off) and Negative (equal to or greater than the cut-off). The comparison results were presented as positive and negative percents agreement (PPA & NPA).
| iPhone | Galaxy | ||||||
|---|---|---|---|---|---|---|---|
| Candidate | |||||||
| Method | Comparative Method | Candidate | Comparative Method | ||||
| Positive | Negative | Total | Method | Positive | Negative | Total | |
| Positive | 51 | 52 | Positive | 50 | 2 | 52 | |
| Negative | 3 | 45 | 48 | Negative | ব | 44 | 48 |
| Total | 54 | 46 | 100 | Total | 54 | 46 | 100 |
| 11 | |||||||
| A / Ph Ph A | |||||||
| 1 A A | |||||||
| A 1 101 | |||||||
| A / Ph Ph A | |||||||
| 100 | |||||||
| AA AAI |
% PPA = 100 x a/(a+c) = 94.4%
% NPA = 100 x d/(b+d) = 97.8%
% PPA = 100 x a/(a+c) = 92.6%
% NPA = 100 x d/(b+d) = 95.7%
| Candidate
| Method | Comparative Method | ||
|---|---|---|---|
| Positive | Negative | Total | |
| Positive | 101 | 3 | 104 |
| Negative | 7 | 89 | 96 |
| Total | 108 | 92 | 200 |
iPhone and Galaxy Combined
| $% PPA = 100 x a/(a+c) = 93.5%$ |
|---|
| $% NPA = 100 x b/(b+d) = 93.7%$ |
% NPA = 100 x d/(b+d) = 96.7%
The results of the MSC cutoff study demonstrated that both the iPhone and Galaxy YO™ device platforms can discriminate MSC levels of fresh semen samples above and below 6 M/mL cutoff with PPA and NPA levels greater than 90% vs. the SQA-V comparative method.
807.92 (b)(2): Brief Description of Clinical Data
YO™ was clinically validated via a clinical study. The study was a cross-sectional, multi-site investigation conducted at three clinical sites, one in Israel and two in the US. All labeling was provided in English, and age and education levels across the sites were similar. Male subjects who provided the semen specimens comprised the groupings of: no known fertility issues (by self-reporting), a partner in a couple having difficulty conceiving, had been diagnosed with male factor infertility, post-vasectomy patients, or post-vasectomy reversal patients. The primary purpose of including subjects with fertility issues was to enrich the numbers of low MSC levels so that both positive and negative MSC samples were well represented. Additionally, "tester" lay-persons (men and women) were included to test semen specimens provided by a subset of the male subjects.
Following collection of the specimen by the subject either the subject and/or the tester analyzed the sample with the YOT™ system using only the instructions provided in the kit. A trained health care professional (HCP, trained user) performed a separate YOT™ test using the same ejaculate, phone type and lot of materials, and a third aliquot of the sample was assayed by two SQA-V systems where results were averaged and converted to the qualitative outcomes (see
11
below). All comparative testing was carried out within 10 minutes. A total of 316 samples were evaluated across the three sites, with a range of 82 to 136 samples at each site.
Samples were collected per instructions based on WHO 5" edition manual guidelines and maintained at room temperature until tested. All lav users (subjects and testers) provided demographic information and signed the informed consent form prior to study participation. Results were expressed as "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE" by YO™, and the reference (SQA-V) results were translated to these two categories using the 6M/mL MSC cutoff; SQA-V results of >6M/mL were interpreted as "MODERATE/NORMAL MSC RANGE," and SQA-V results