QUALIS

K133295 · Menicon Co., Ltd. New Business Division · MQK · Jun 18, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K133295
• Device Name: QUALIS
• Applicant: Menicon Co., Ltd. New Business Division
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Jun 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

The Qualis is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.

Device Story

Qualis is a sterile, disposable, plastic laboratory dish featuring four chambers connected by micro-channels. It is used in clinical laboratory settings to isolate motile human spermatozoa from semen samples containing non-motile sperm and cellular debris. The device operates via laminar flow: semen is placed in one chamber and separation medium in another; fluids flow through micro-channels side-by-side. Motile sperm naturally swim across the laminar interface into the separation medium stream, while non-motile components remain in the original flow. Motile sperm are then collected from a designated chamber for use in ICSI. This process replaces traditional gravity-based migration-sedimentation methods. The device benefits patients by providing a refined, motile sperm sample for assisted reproduction, potentially improving fertilization outcomes.

Clinical Evidence

No clinical data. Bench testing only. Performance was verified using human sperm survival assay (HSSA) and human sperm motility/morphology testing to confirm device effectiveness and safety.

Technological Characteristics

Sterile, disposable culture dish made of cyclo-olefin polymer. Features four chambers connected by micro-channels. Operates via passive laminar flow separation of motile sperm. Standalone laboratory device; no energy source or software.

Indications for Use

Indicated for preparing motile human sperm for use in the treatment of infertile couples undergoing intracytoplasmic sperm insertion (ICSI) fertilization.

Regulatory Classification

Identification

Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• Research Instruments Migration Sedimentation Chamber (K112413)

Submission Summary (Full Text)

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### 510(k) Summary

| Submitter: | Menicon Co., Ltd. New Business Division<br>5-1-10, Takamoridai, Kasugai, Aichi 487-0032 JAPAN |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Marcia Palma<br>Senior Principal Consultant, NAMSA<br>4050 Olson Memorial Hwy, Suite 450 Minneapolis, MN 55422<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date<br>Prepared: | June 6, 2014 |
| Trade Name: | Qualis |
| Classification: | Class II<br>21 CFR § 884.6160, Assisted Reproduction Labware |
| Product<br>Code: | MQK |
| Predicate<br>Device(s): | The subject device is equivalent to the following devices:<br>K112413, Research Instruments Migration Sedimentation Chamber |
| Device<br>Description: | The Qualis is a sterile, disposable, plastic laboratory dish that contains four<br>chambers connected through micro-channels and is designed to be used in<br>conjunction with commercially available culture medium to selectively separate<br>motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris. |
| Intended Use: | The Qualis is intended for preparing motile human sperm for use in the treatment of<br>infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization. |
| Functional<br>and Safety<br>Testing: | To verify that device design met its functional performance and safety<br>requirements, representative sample of the device underwent testing including<br>human sperm survival assay (HSSA) and human sperm motility/morphology. |
| Conclusion: | Menicon Co., Ltd. New Business Division considers the Qualis to be equivalent<br>to the predicate device listed above. This conclusion is based upon the devices'<br>similarities in principles of operation, technology, materials and indications for<br>use. |
| | Substantial Equivalence Discussion<br>• The subject and predicate devices have the same intended use, although<br>different indications. The predicate device is intended to prepare motile<br>sperm for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF)<br>and intrauterine insemination (IUI), whereas the subject device is intended<br>for separating motile sperm for ICSI only. The difference does not raise any |

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concerns because the indication claimed for the subject device falls within the indications covered by the predicate device.

- · The subject and predicate devices are based on the same fundamental technological characteristics - natural swimming of sperm, although they have different designs and mechanisms of action. The subject device is designed to separate the motile sperm via laminar flows, whereas the predicate device is designed to separate the motile sperm by gravity drop. However, both devices rely on natural swimming of motile sperm from suspension media into separation media where the motile sperm are collected.
Effectiveness of the subject device with new design is a concern but can be evaluated by performance testing. The final design validation study demonstrated that the subject device is effective.

- · · The subject and predicate devices are also different in materials. The subject device is manufactured with cyclo-olefin polymer whereas the predicate device is made of polystyrene. The difference raises a safety concern; however, safety of the subject device can be evaluated by Human Sperm Survival Assay (HSSA). The result of HSSA testing demonstrated that the subject device is safe.

| Parameter | Subject device -- Qualis (K133295) | Predicate device -- RI MSC (K112413) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Intended for preparing motile human<br>sperm for use in the treatment of<br>infertile couples by intracytoplasmic<br>sperm insertion (ICSI) fertilization | Intended to prepare sperm by migration-<br>sedimentation method for the assisted<br>reproductive techniques of<br>intracytoplasmic sperm injection (ICSI),<br>in vitro fertilization (IVF), and<br>intrauterine insemination (IUI) |
| Design | A disposable culture dish with four<br>chambers connected by micro-channels | A cylindrical container with internal<br>gallery and well. Optically clear, flat base |
| Mechanism of<br>action | The semen sample is placed in<br>Chamber A and separation medium is<br>placed in Chamber B. Fluids from<br>both chambers flow via the micro-<br>channels into the central micro-channel<br>where the two fluids pass side-by-side<br>in laminar flow. Motile sperm are able<br>to swim across the interface of the<br>laminar flow streams and pass into the<br>separation medium stream but non-<br>motile sperm and debris cannot.<br>Motile sperm that cross into the<br>separation medium flow are carried<br>into Chamber C where they are<br>collected. Non-motile sperm and<br>debris remain in the semen sample<br>flow from Chamber A into Chamber<br>D. | The chamber is pre-loaded with culture<br>medium into which unprepared (raw)<br>sperm is pipetted. During incubation.<br>sperm migrate to the over-laying medium<br>based on their nature swimming nature<br>and fall by gravity into the central well of<br>the chamber for collection. |
| Material | Cyclo-olefin polymer | Polystyrene |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 18, 2014

Menicon Life Science % Marcia Palma Medical Research Regulatory Specialist NAMSA 4050 Olson Memorial Hwy. Suite 450 Minneapolis, MN 55422

K133295 Re:

> Trade/Device Name: Qualis Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproductive Labware Regulatory Class: Class II Product Code: MQK Dated: May 20, 2014 Received: May 22, 2014

Dear Marcia Palma,

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 (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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#### Page 2 - Marcia Palma

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) 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), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K133295

Device Name

Qualis

Indications for Use (Describe)

The Oualis is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Herbert P. Lerner -S 2014.06.18 15:28:03 -04

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