(214 days)
Not Found
No
The device primarily uses signal processing technology and proprietary algorithms to interpret electrical signals from light disturbances as sperm move. There is no mention of AI, machine learning, or deep learning models being employed for analysis or interpretation of results. The "proprietary algorithms" are not described as AI.
No.
The SQA-iOw Sperm Quality Analyzer is an in-vitro diagnostic device intended to analyze semen parameters, not to treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the SQA-iOw is "intended for in-vitro diagnostic use" to determine various semen parameters, which are used to evaluate male fertility status.
No
The device is not a software-only medical device because it explicitly states it is a "PC-based analytical medical device" and the "SQA-iOw Sperm Quality Analyzer package provides the SQA-iOw device and USB cable," indicating a hardware component. It describes an "SQA-iO optical block" and the aspiration of samples into a "disposable SQA capillary sample delivery system" which is then "inserted into the SQA-iOw measurement chamber," all pointing to a physical, non-software component of the system. While software is critical for analysis, it functions alongside dedicated hardware for data acquisition.
Yes.
The "Intended Use / Indications for Use" section explicitly states "intended for in-vitro diagnostic use".
N/A
Intended Use / Indications for Use
The SQA-iOw Sperm Quality Analyzer is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen:
Measured parameters:
- Sperm Concentration/ Total Sperm Concentration, millions/mL
- Motile Sperm Concentration (MSC), millions/mL
- Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL)
- Normal Forms (% Normal Morphology), %
Derived parameters:
- Total Motility / Total Motile (PR + NP), %
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
- Non-Progressive (NP), %
- Immotile (IM), %
The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.
Product codes
POV
Device Description
The SQA-iOw Sperm Quality Analyzer is a PC-based analytical medical device that tests human semen samples. The device works with a computer application that manages the device, and information related to the patient, the sample, the test results and the facility.
After collection and preparation, 0.6 mL of semen sample is aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iOw measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run.
The SQA-iOw Sperm Quality Analyzer utilizes proprietary software code to both perform analysis of semen parameters and present those results on the user interface. This software is installed on a PC as a cloud-based application ("app") and is designed to perform all functions and features of the SQA-iO device, controlled by the user through a proprietary graphical user interface (GUI).
The SQA-iOw Sperm Quality Analyzer software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iOw software. The SQA-iOw software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters.
The SQA-iOw Sperm Quality Analyzer package provides the SQA-iOw device and USB cable. SQA disposable capillaries, cleaning kits and related testing supplies and test kits are supplied individually.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
CLIA Waived settings
Healthcare professionals (CLIA waived, moderate, and high complexity settings)
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
Not Found
Summary of Performance Studies
Clinical Precision (Precision using control material):
- Study Type: Precision/repeatability study based on CLSI EP05-A3 standard.
- Sample Size: 3 sites x 9 users (3 per site) over 3 days per site x 3 levels x 10 replicates of each level = 270 measurements in total. Three levels of bead controls and three lots of capillaries were used.
- Key Results: The StDev and %CV met the acceptance criteria for the three levels.
Clinical Precision (Precision using native samples):
- Study Type: Precision study based on CLSI EP05-A3 guidance.
- Sample Size: 9 total native semen samples x 2 reps per sample x 3 users/site x 4 time points = 216 measurements total, 24 results per sample.
- Key Results: The StDev and %CV met the acceptance criteria for all reported parameters for the samples.
Method Comparison Study:
- Study Type: Clinical equivalence study comparing SQA-iOw operated by WAIVED USERS vs. SQA-V performed by TRAINED USERS.
- Sites: Three U.S. sites.
- Waived testing: 9 WAIVED USERS (3 per site).
- Comparative testing: One or more TRAINED OPERATORS per site.
- Sample Size: A total of 380 donor semen samples distributed approximately equally across 3 sites and 9 operators and assayed in singleton and in a blinded fashion using both methods.
- Key Results:
- CONCENTRATION, M/mL: Slope 0.98 (0.9718 to 0.9836), Correlation 1.0 (0.9974 to 0.9982)
- MOTILITY, %: Slope 0.9 (0.9189 to 0.9565), Correlation 0.96 (0.9493 to 0.9659)
- PROGRESSIVE MOTILITY, %: Slope 1.0 (0.9286 to 0.9677), Correlation 1.0 (0.9683 to 0.9787)
- NON-PROGRESSIVE MOTILITY, %: Slope 1.3 (1.2500 to 1.4000), Correlation 0.7 (0.6944 to 0.7850)
- IMMOTILE, %: Slope 0.9 (0.9200 to 0.9583), Correlation 0.9 (0.9130 to 0.9411)
- MORPHOLOGY, %: Slope 1.0 (0.9091 to 1.0000), Correlation 1.0 (0.9563 to 0.9706)
- MSC, %: Slope 0.9 (0.9344 to 0.9571), Correlation 1.0 (0.9889 to 0.9925)
- PMSC, %: Slope 0.9 (0.9149 to 0.9364), Correlation 1.0 (0.9894 to 0.9929)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.”
FDA 510(k) Clearance Letter - SQA-iOw Sperm Quality Analyzer
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 2, 2025
Medical Electronic Systems Ltd.
Taly Vider Cohen
Regulatory Affairs and IP Director
Alon Hatavor St. 20
Caesarea, 3088900
Israel
Re: K243114
Trade/Device Name: SQA-iOw Sperm Quality Analyzer
Regulation Number: 21 CFR 864.5220
Regulation Name: Automated differential cell counter
Regulatory Class: Class II
Product Code: POV
Dated: January 30, 2025
Received: January 30, 2025
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.
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K243114 - Taly Vider Cohen Page 2
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 (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-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243114 - Taly Vider Cohen Page 3
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,
Min Wu -S
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K243114
Device Name: SQA-iOw Sperm Quality Analyzer
Indications for Use (Describe)
The SQA-iOw Sperm Quality Analyzer is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen:
Measured parameters:
- Sperm Concentration/ Total Sperm Concentration, millions/mL
- Motile Sperm Concentration (MSC), millions/mL
- Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL)
- Normal Forms (% Normal Morphology), %
Derived parameters:
- Total Motility / Total Motile (PR + NP), %
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
- Non-Progressive (NP), %
- Immotile (IM), %
The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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."
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Medical Electronic Systems
SQA-iOw Sperm Quality Analyzer
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Date: 02.MAY.2025
SQA-iOw 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
807.92 (a)(1):
Name: Medical Electronic Systems, LTD
Address: ALON HATAVOR ST. 20 ZONE 6
CAESAREA INDUSTRIAL PARK
CAESAREA, 38900, ISRAEL
Phone: 972 54 209-1712
Contact: Ms. Taly Vider Cohen
807.92 (a)(2): Device name, trade name and common name, and Classification
Trade Name: SQA-iOw Sperm Quality Analyzer
Common Name: SQA-iOw Sperm Quality Analyzer
Classification: Class II, POV
21 CFR 864.5220
807.92 (a)(3): Identification of the legally marketed predicate devices
SQA-iOw Sperm Quality Analyzer is substantially equivalent to a predicate device, the SQA-V sperm analyzer, (MES Ltd., Israel), cleared under K021746, September 20, 2002. Both of these testing devices utilize human sperm to measure a variety of male fertility factors.
807.92 (a)(4): Device Description
The SQA-iOw Sperm Quality Analyzer is a PC-based analytical medical device that tests human semen samples. The device works with a computer application that manages the device, and information related to the patient, the sample, the test results and the facility.
After collection and preparation, 0.6 mL of semen sample is aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iOw measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run.
The SQA-iOw Sperm Quality Analyzer utilizes proprietary software code to both perform analysis of semen parameters and present those results on the user interface. This software is installed on a PC as a cloud-based application ("app") and is designed to perform all functions and features of the SQA-iO device, controlled by the user through a proprietary graphical user interface (GUI).
The SQA-iOw Sperm Quality Analyzer software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iOw software. The SQA-iOw software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters.
The SQA-iOw Sperm Quality Analyzer package provides the SQA-iOw device and USB cable. SQA disposable capillaries, cleaning kits and related testing supplies and test kits are supplied individually.
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Medical Electronic Systems
SQA-iOw Sperm Quality Analyzer
Page 2 of 8
807.92 (a)(5): Intended Use
The SQA-iOw Sperm Quality Analyzer is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen:
Measured parameters:
- Sperm Concentration/ Total Sperm Concentration, millions/mL
- Motile Sperm Concentration (MSC), millions/mL
- Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL)
- Normal Forms (% Normal Morphology), %
Derived parameters:
- Total Motility / Total Motile (PR + NP), %
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
- Non-Progressive (NP), %
- Immotile (IM), %
The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
SQA-iOw Sperm Quality Analyzer is substantially equivalent to the predicate device; SQA-V Sperm Quality Analyzer, (MES Ltd., Israel), cleared under K021746. The SQA-iOw is substantially equivalent in terms of general intended use, sample type, male fertility factor measurements, and in vitro use. The various device features are compared in the table below.
SQA-iOw vs. SQA-V Predicate
| Element | New product SQA-iOw Sperm Quality Analyzer | Predicate SQA-V: 510(k) K021746 |
|---|---|---|
| Intended use | See "intended use" section above. | The SQA-V is a point-of-care, in vitro use, electro-optical medical device with on-screen visualization for semen analysis performed by healthcare professionals (trained lab technicians- device is CLIA moderate). The SQA-V does not provide a comprehensive evaluation of a male's fertility status. |
| Intended User | Healthcare professionals (CLIA waived, moderate, and high complexity settings) | Healthcare professionals (trained lab technicians, CLIA moderate or high complexity) |
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| Element | New product SQA-iOw Sperm Quality Analyzer | Predicate SQA-V: 510(k) K021746 |
|---|---|---|
| Semen parameters | The SQA-iOw reports the following directly measured quantitative semen parameters: |
- Sperm Concentration/ Total Sperm Concentration, millions/mL
- Motile Sperm Concentration (MSC), millions/mL
- Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL)
- Normal Forms (% Normal Morphology), %
The SQA-iOw also reports the following derived semen parameters:
5. Total Motility / Total Motile (PR + NP), %
6. Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
7. Non-Progressive (NP), %
8. Immotile (IM), % | The SQA-V reports the same Semen Parameters |
| WHO compliance | WHO 6 | WHO 4/ WHO 5 |
| Sample type | Human semen | Same |
| Male fertility factor | Yes | Same |
| Technology | Desk-top unit consists of a light source and optical sensors, connected to a PC that runs the software containing algorithms for the assessment of semen parameters. This software is installed on the user's PC as a cloud-based application. See additional explanations in the discussion section below. | Desk-top unit consists of a light source, optical sensors, built-in video microscopy and an internal computer containing algorithms for the assessment of semen parameters. |
| Testing capillary | SQA-V testing capillary | Same |
| External controls | Use of QwikCheck Beads (cleared under K041600) for performing quality control | Same |
(b)(1): Brief Description of Nonclinical Data
- Linearity/dynamic ranges (Assay measuring range)- See K220828.
- Analytical specificity (interference)- See K220828.
- Sample stability- see K220828.
- Analytical sensitivity (detection limits: limits of blank and detection/quantitation)- See K220828.
807.92 (b)(2): Brief Description of Clinical Data
Clinical Precision
MES performed two waived-user precision studies as follows:
- Precision using control material
- Precision using native samples.
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1. CLIA Waived user Precision study using control material
Objective and Study Design
To estimate precision/repeatability of the SQA-iOw device based on the CLSI EP05-A3 standard, a study was designed as follows: 3 sites x 9 users (3 per site) over 3 days per site x 3 levels x 10 replicates of each level (5 runs in duplicate) = 270 measurements in total. Three levels of bead controls (same lots across sites) and three lots of capillaries (different lots across sites) were used. Data analyses included ANOVA analysis with the following components: within-run, between-operator, between-day, and between-site repeatability using standard deviations (SDs) and Coefficients of Variation (CV, %).
Table 1: Controls Level 1
| Site | N | Mean | Repeatability (Within-run) | Between-day | Between-run/ Operator | Between site / instrument | Total |
|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | |||
| All sites combined | 90 | 47.8 | 0.12 | 0.24% | 0.40 | 0.83% | 0.35 |
Table 2: Controls Level 2
| Site | N | Mean | Repeatability (Within-run) | Between-day | Between-run/ Operator | Between site / instrument | Total |
|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | |||
| All sites combined | 90 | 24.9 | 0.06 | 0.23% | 0.57 | 2.28% | 0.45 |
Table 3: Negative Control
| Site | N | Mean | Repeatability (Within-run) | Between-day | Between-run/ Operator | Between site / instrument | Total |
|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | |||
| All sites combined | 90 | 0.0 | 0.00 | 0.00% | 0.00 | 0.00% | 0.00 |
Conclusion
The StDev and %CV met the acceptance criteria for the three levels.
2. CLIA Waived user Precision study using native samples
Objective and Study Design
To determine precision of the SQA-iOw device based on CLSI EP05-A3 guidance, as follows, across two sites: 9 total native semen samples x 2 reps per sample x 3 users/site x 4 time points = 216 measurements total, 24 results per sample. Precision analysis included within-run, between-operator standard deviations (SD) and Coefficients of Variation (CV, %), and total imprecision (reproducibility) using the estimated components.
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Results
The following precision results were obtained by the waived users testing native semen samples using SQA-iOw Waiver devices:
Table 4: SQA-iOw Sperm Concentration Precision
*Note: SDs are used for low-level samples (