SQA V, SPERM QUALITY ANALYZER

K021746 · Medical Electronic Systems, LLC · POV · Sep 20, 2002 · Hematology

Device Facts

• Record ID: K021746
• Device Name: SQA V, SPERM QUALITY ANALYZER
• Applicant: Medical Electronic Systems, LLC
• Product Code: POV · Hematology
• Decision Date: Sep 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for: - total sperm concentration (TSC, millions/mL) . - percent motility (%MOT) and % progressive motility (%PMOT) . - % normal morphology (%MORPH) . - motile sperm concentration (MSC, millions/mL) and progressive MSC (PMSC) ● - . functional sperm concentration (FSC, millions/mL)

Device Story

SQA V is a point-of-care electro-optical device for semen analysis; utilizes optical sensing to evaluate sperm samples; provides on-screen visualization and image freezing; calculates total sperm concentration, motility percentages, morphology, and functional sperm concentration; operated by clinical staff; output used by healthcare providers to assess male fertility parameters; aids in clinical decision-making regarding reproductive health.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Electro-optical sensing device; provides on-screen visualization and image freezing; performs direct and calculated measurements of sperm parameters; point-of-care form factor.

Indications for Use

Indicated for semen analysis in clinical settings to measure sperm concentration, motility, and morphology parameters.

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.”

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## SEP 2 0 2002

Ms. Erika B. Ammirati Regulatory Consultant Medical Electronic Systems, LLC 269 South Beverly Drive, # 472 Beverly Hills, CA 90212

k021746 Re:

> Trade/Device Name: SQA V, Sperm Quality Analyzer - Visual Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 14, 2002 Received: August 15, 2002

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrlvdsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INTENDED USE

KD21746 510(K) Number (if known):

Device Name: SQA V, Sperm Quality Analyzer - Visual

## Indications for Use:

The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for:

- total sperm concentration (TSC, millions/mL) .
- percent motility (%MOT) and % progressive motility (%PMOT) .
- % normal morphology (%MORPH) .
- motile sperm concentration (MSC, millions/mL) and progressive MSC (PMSC) ●
- . functional sperm concentration (FSC, millions/mL)

Jacqueline Pautrat

(Division Sign-Off)
Division of Clinical Laboratory, Devices
510(k) Number K021746

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over -the-Counter Use