LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer

K202089 · Bonraybio Co., Ltd. · POV · Oct 28, 2020 · Hematology

Device Facts

Record IDK202089
Device NameLensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
ApplicantBonraybio Co., Ltd.
Product CodePOV · Hematology
Decision DateOct 28, 2020
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 864.5220
Device ClassClass 2
AttributesAI/ML

AI Performance

OutputAcceptanceObservedDev DSTest DS
Sperm concentrationNot specifiedNot specifiedNot specifiedSystem Accuracy Study and Layuser Performance study comparing candidate device results to SQA-V Analyzer reference method
Total sperm motilityNot specifiedNot specifiedNot specifiedSystem Accuracy Study and Layuser Performance study comparing candidate device results to SQA-V Analyzer reference method
Sperm morphologyNot specifiedNot specifiedNot specifiedSystem Accuracy Study and Layuser Performance study comparing candidate device results to SQA-V Analyzer reference method
Semen pHNot specifiedNot specifiedNot specifiedSystem Accuracy Study and Layuser Performance study comparing candidate device results to SQA-V Analyzer reference method

Indications for Use

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 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.

Device Story

LensHooke X1 PRO and X1 PRO SE Semen Quality Analyzers are automated systems for semen analysis. Device utilizes test cassettes to process semen samples; optical imaging captures sperm characteristics. System performs automated analysis to quantify semen quality parameters. Used in clinical settings by trained personnel. Output provided to healthcare providers to assist in fertility assessment and clinical decision-making regarding male reproductive health.

Clinical Evidence

System accuracy and lay-user performance study conducted. Compared candidate device results against SQA-V Analyzer (reference method) using point-of-care professionals and lay users. Study confirmed lay users across educational backgrounds could follow instructions to obtain accurate results. Questionnaire scoring demonstrated ease of use.

Technological Characteristics

Desktop unit; light sources; built-in video microscopy; internal computer. Connectivity: HDMI/USB. Consumables: LensHooke Semen Test Cassette (plastic case with pH paper). Control materials: X QC Beads and X QC Reticle. Software: AI-based image processing for sperm detection and parameter calculation.

Indications for Use

Indicated for human semen analysis to evaluate male fertility. Used in healthcare professional settings (X1 PRO) or home settings (X1 PRO SE) for adult males. Not for comprehensive fertility evaluation.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: A 510(k) Number K202089 B Applicant Bonraybio Co., Ltd. C Proprietary and Established Names LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | POV, GKZ | Class II | 21 CFR 864.5220 - Automated Differential Cell Counter | HE - Hematology | ## II Review Summary: This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable. 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. 2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials. 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} The change was for the addition of a new Test Cassette model that has a different external design. 4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device. K202089 - Page 2 of 2
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