The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

(1) Sperm concentration (10^6 per ml)

(2) Total motility (PR+NP, %)

Progressive motility (%)
Non-Progressive motility (%)

(3) Sperm morphology (normal forms, %)

(4) pH value

The LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.

The LensHooke X1 PRO SE Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

-Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value

The LensHooke X1 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a seff-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared.

Device Description

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

AI/ML Overview

The provided text describes the 510(k) summary for the LensHooke X1 PRO Semen Quality Analyzer and LensHooke X1 PRO SE Semen Quality Analyzer. Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. It states that "Verification and validation of test results were evaluated to establish the performance, functionality and reliability of LensHooke X1 PRO SE Semen Quality Analyzer and LensHooke X1 PRO Semen Quality Analyzer. The evaluation included Repeatability, Reproducibility, LoB/LoD/LoQ and linearity, sample volume, operating conditions and stability." However, specific numerical targets for acceptance criteria and the corresponding device performance results are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify the exact sample size used for the system accuracy study. It mentions a "user performance study" which involved English-speaking and reading lay users across educational backgrounds, and also Point-of-Care professionals or licensed registered nurses. However, the number of participants for these studies is not provided.
Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the studies were retrospective or prospective, though "user performance study" typically implies a prospective design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document indicates that for the "System Accuracy Study and Layuser Performance study," the "SQA-V Analyzer performed by POC personnel was used as a reference method." This implies that the ground truth was established by the SQA-V Analyzer, and its performance was managed by Point-of-Care (POC) personnel. The text does not specify the number of individual experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") beyond "Point-of-Care professionals or licensed registered nurses."

4. Adjudication Method

The document does not mention an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It states that the SQA-V Analyzer was used as the reference method, implying a direct comparison rather than a consensus-based adjudication process among multiple human experts.

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

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on the device's accuracy against a reference method and lay user performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "System Accuracy Study" implicitly describes the algorithm's performance (as part of the LensHooke X1 PRO/PRO SE Analyzer) against a reference method (SQA-V Analyzer). The device is an "optical device... which provides direct and calculated quantitative measurements," meaning it operates autonomously to produce these measurements. The "Layuser Performance study" also evaluates the standalone device's accuracy when used by laypersons.

7. Type of Ground Truth Used

The ground truth for the system accuracy study was established using a "SQA-V Analyzer performed by POC personnel" as a reference method. This suggests a comparative reference method or known standard approach, rather than solely expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the AI image processing algorithm.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. It only mentions that the device uses "artificial intelligence image processing method" for analysis.

Summary

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Image /page/0/Picture/0 description: The image shows 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 the FDA logo, which 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.

October 28, 2020

Bonraybio Co., Ltd. % Feng-Yu Lee Principal Consultant Dynamic Biotech, Inc dba. IVDD Regulatory Consultant 29122 Rancho Viejo Rd., Suite 212 San Juan Capistrano, California 92675

Re: K202089

Trade/Device Name: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: POV, GKZ Dated: July 21, 2020 Received: July 28, 2020

Dear Feng-Yu Lee:

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. 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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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-regulatoryassistance/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.

Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202089

Device Name

LensHooke X1 PRO Semen Quality Analyzer

Indications for Use (Describe)

The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

(1) Sperm concentration (10^6 per ml)

(2) Total motility (PR+NP, %)

Progressive motility (%)
Non-Progressive motility (%)

(3) Sperm morphology (normal forms, %)

(4) pH value

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:

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Indications for Use

510(k) Number (if known) K202089

Device Name LensHooke X1 PRO SE Semen Quality Analyzer

Indications for Use (Describe)

-Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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.

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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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:

1 Submitter's Identification:

1.1 BonrayBio Co., Ltd. 4F., No.118, Gongye 9th Rd., Dali Dist., Taichung City 41280, Taiwan(R.O.C) Contact Person: Clare Huang TEL: +886-4-24912385 FAX: +886-4-24912885
1.2 c/o IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212, San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee TEL: 1-949-218-0929 FAX: 1-949-218-0928
1.3 Date Summary Prepared: July 17th, 2020

2 Name of the device:

LensHooke Semen Test Cassette LensHooke X1 PRO Semen Quality Analyzer LensHooke X1 PRO SE Semen Quality Analyze

3 Common or Usual Name: Semen Analysis Device

Product Code	Classification	Regulation Section	Panel
POV;Semen AnalysisDevice	Class II	21 CFR 864.5220	Hematology80

4 Device Description

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Product Information

For Over-the-Counter Setting: 4.1 LensHooke X1 PRO SE Semen System, consist of the following devices: LensHooke X1 PRO SE Semen Quality Analyzer LensHooke Semen Test Cassette LensHooke X QC Beads (For Semen) LensHooke X QC Reticle (For Semen) C-KUP Liquefaction Test Cup LensHooke Cleaning Wipe
The LensHooke X1 PRO § Semen Quality Analyzer and LensHooke Semen Test Cassette are manufactured by Bonraybio.
4.2 For Point-of-Care Professional Setting: LensHooke X1 PRO Semen System, consist of the following devices: LensHooke X1 PRO Semen Quality Analyzer LensHooke Semen Test Cassette LensHooke X QC Beads (For Semen) LensHooke X QC Reticle (For Semen) C-KUP Liquefaction Test Cup LensHooke Cleaning Wipe
The LensHooke X1 PRO Semen Quality Analyzer and LensHooke Semen Test Cassette are manufactured by Bonraybio.
4.3 Consumables Description
LensHooke Semen Test Cassette

LensHooke Semen Test Cassette is a well-designed microscopic slide for the optical analyzer, LensHooke Semen Quality Analyzer. Top and bottom plastic case and pH paper are the components of LensHooke Semen Test Cassette. There are two polished windows which analyzed concentration, motility and morphology of the semen and the pH of semen respectively.

LensHooke X QC Beads (For Semen)

LensHooke X QC Beads is the quality control material for semen analysis. The LensHooke X QC Beads (For Semen) are supplied as three different levels of control and it has been developed as a tool to assess the accuracy and precision of sperm counting and pH test methods by providing a known target value and +/- range.

LensHooke X QC Reticle (For Semen)

LensHooke X QC Beads is the quality control material for semen analysis. The LensHooke X QC Reticle (For Semen) are supplied as three different levels of control and it has been developed as a tool to assess the accuracy and precision of sperm counting method by providing a known target value and +/- range.

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Image /page/6/Picture/0 description: The image shows the logo for Bonraybio. The logo consists of a teal circle with a stylized wheat stalk inside, followed by the word "bonraybio" in a modern, sans-serif font. The color scheme is simple, with teal and white dominating the design.

C-KUP Liquefaction Test Cup

C-KUP Liquefaction Test Cup is used to collecting semen samples to liquefaction and volume testing. Collected semen samples are applicable for semen quality analysis. Cup, cup cover and drip cover are the components of C-KUP Liquefaction Test Cup. The V-Stick on cup cover is used to check the liquefaction's status. The Scale on cup is used to check the volume of the semen sample.

LensHooke Cleaning Wipe

LensHooke Cleaning Wipe is a plastic stick with lens cotton. Using LensHooke Cleaning Wipe to clean the Test Cassette Insert Slot of LensHooke Semen Quality Analyzer. This is the cleaning and maintenance procedures usually used for microscopic analyzers.

5 Indications for Use

5.1 For Over-the-Counter Setting:
The LensHooke X1 PRO §E Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

-Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value

The LensHooke X1 PRO § Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared.

5.2 For Point-of-Care Professional Setting:

The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

(1) Sperm concentration (10^6 per ml)
(2) Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
(3) Sperm morphology (normal forms, %)
(4) pH value

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Image /page/7/Picture/0 description: The image shows the logo for Bonraybio. The logo consists of a teal-colored circle with a white plant-like design inside, followed by the word "bonraybio" in a simple, sans-serif font, also in teal. The logo is clean and modern, suggesting a company focused on biotechnology or related fields.

6 Predicate Device Information

LensHooke X1 PRO and X1 PRO § Semen Quality Analyzer are substantially equivalent to : LensHooke X1 PRO and X1 Semen Quality Analyzer Device Company: Bonraybio Co., LTD. 510(k) Number: K180343

7 Comparison to Predicate Device:

7.1 LensHooke X1 PRO Semen Quality Analyzer:

Product Name	LensHooke X1 PROSemen Quality Analyzer(Candidate Device)	LensHooke X1 PROSemen Quality Analyzer(Predicate Device)
Intended Use	The LensHooke X1 PRO Semen QualityAnalyzer used with LensHooke Semen TestCassette is an optical device for humansemen analysis which provides direct andcalculated quantitative measurements for:(1) Sperm concentration (10^6 per ml)(2) Total motility (PR+NP, %)- Progressive motility (%)- Non-Progressive motility (%)(3) Sperm morphology (normal forms, %)(4) pH valueThe LensHooke X1 PRO Semen QualityAnalyzer does not provide a comprehensiveevaluation of a male's fertility status. It is anin-vitro diagnostic system intended forhuman semen analysis of individuals inhealthcare professional setting to evaluatemale fertility.	Same
Male FertilityFactor	Yes	Same
Technology	Desk-top unit consists of light sources, built-in video microscopy and an internalcomputer containing algorithms for theassessment of semen parameters.	Same
Transmissioninterface	HDMI/USB	Same

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Image /page/8/Picture/0 description: The image contains the logo for Bonraybio. The logo consists of a teal-colored circle with a stylized plant inside, followed by the company name "bonraybio" in a lowercase, sans-serif font. The text is in a dark gray or black color.

Intended User	Point-of-Care professional	Same
Compatible SemenTest CassetteModel	CS0, CS1	CS0
Control Material	X QC Beads, X QC Reticle	Quality control by blank cassette

7.2 LensHooke X1 PRO § Semen Quality Analyzer:

Product Name	LensHooke X1 PROSESemen Quality Analyzer(Candidate Device)	LensHooke X1Semen Quality Analyzer(Predicate Device)
Intended Use	The LensHooke X1 PROSE Semen QualityAnalyzer used with LensHooke SemenTest Cassette is an optical device forhuman semen analysis which providesdirect and calculated quantitativemeasurements for:-Sperm concentration (10^6 per ml)-Total motility (PR+NP, %)-Sperm morphology (normal forms, %)-pH valueThe LensHooke X1 PROSE Semen QualityAnalyzer does not provide acomprehensive evaluation of a male'sfertility status. It is a self-testing, in-vitrodiagnostic system intended for humansemen analysis of individuals at home toevaluate male fertility. The systems areintended for single person use only andshould not be shared.	Same
Male Fertility Factor	Yes	Same
Technology	Desk-top unit consists of light sources,built-in video microscopy and aninternal computer containing algorithmsfor the assessment of semenparameters.	Same
Transmission interface	HDMI/USB	Bluetooth/Wi-Fi
Intended User	Over-the-Counter	Same
Compatible SemenTest Cassette Model	CS0, CS1	CS0
Control Material	X QC Beads, X QC Reticle	Quality control by blank cassette

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Image /page/9/Picture/0 description: The image contains the logo for Bonraybio. The logo consists of a circular icon on the left and the company name "bonraybio" on the right. The icon is a light blue circle with a white wheat stalk inside. The company name is written in a simple, sans-serif font in a dark gray color.

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as 8 follows:

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of LensHooke X1 PRO §5 Semen Quality Analyzer and LensHooke X1 PRO Semen Quality Analyzer. The evaluation included Repeatability, Reproducibility, LoB/LoD/LoQ and linearity, sample volume, operating conditions and stability.

9 Discussion of Clinical Tests Performed

System Accuracy Study and Layuser Performance study

The user performance study was performed to demonstrate that English speaking and reading lay users across all educational backgrounds can easily understand and follow the labeling/user instructions to obtain accurate results while using Candidate device. The study was also performed using Point-of-Care professionals or licensed registered nurses to obtain POC test findings. SQA-V Analyzer performed by POC personnel was used as a reference method. The study results demonstrate that the layperson user accuracy and ease of use (via participant questionnaire scoring) of Candidate device.

10 Conclusions

Results of performance evaluation of LensHooke X1 PRO SE Semen Quality Analyzer and LensHooke X1 PRO Semen Quality Analyzer demonstrate that the candidate devises are substantial equivalence to the predicate device, LensHooke X1 Semen Quality Analyzer and LensHooke X1 PRO Semen Quality Analyzer.

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.”