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

Device Description

The Qualis is a sterile, disposable, plastic laboratory dish that contains four chambers connected through micro-channels and is designed to be used in conjunction with commercially available culture medium to selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris.

AI/ML Overview

The provided text describes the "Qualis" device, a sterile, disposable, plastic laboratory dish designed to separate motile spermatozoa from non-motile spermatozoa and cellular debris for use in intracytoplasmic sperm insertion (ICSI) fertilization. The document evaluates the device's substantial equivalence to a predicate device, the "Research Instruments Migration Sedimentation Chamber."

The acceptance criteria are not explicitly listed in a table format within the provided text. However, the functional and safety testing paragraph and the substantial equivalence discussion highlight key performance and safety aspects that were evaluated.

Here's an attempt to parse the acceptance criteria and performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Performance: Effectiveness in separating motile sperm (presumably for ICSI fertilization)	"The final design validation study demonstrated that the subject device is effective." (This suggests the device successfully achieved its intended function, likely assessed by the quality and quantity of separated motile sperm.)
Safety: Biocompatibility with human sperm	"The result of HSSA testing demonstrated that the subject device is safe." (Indicates the device does not adversely affect sperm viability or function.)
Human Sperm Survival Assay (HSSA) Requirement	Passed HSSA testing.
Human Sperm Motility/Morphology Assessment	Testing included human sperm motility/morphology. (While a specific pass/fail isn't stated, the overall conclusion of "functional performance and safety requirements" implies satisfactory results.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "To verify that device design met its functional performance and safety requirements, representative sample of the device underwent testing including human sperm survival assay (HSSA) and human sperm motility/morphology."

Sample Size: The exact sample size used for the test set (i.e., the number of Qualis devices tested, or the number of sperm samples used for testing each device) is not specified in the provided text. It mentions "representative sample of the device."
Data Provenance: The provenance of the data (country of origin, retrospective or prospective) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for the test set in the context of the device's functional or safety testing. The evaluation primarily relies on laboratory assays (HSSA, motility/morphology) which typically have objective measures. The ground truth for these assays would generally be the predetermined laboratory standards or comparison to controls, rather than expert consensus on interpretation of complex data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not mention any adjudication method, as the tests described (HSSA, motility/morphology) are typically objective laboratory measurements rather than subjective assessments requiring multiple reviewers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the Qualis device is for sperm preparation in assisted reproduction, not an AI-assisted diagnostic imaging device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable as the Qualis device is a physical laboratory instrument for sperm processing, not an algorithm or software. It is a standalone device in the sense that its functional performance and safety were evaluated independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the functional and safety testing appears to be based on objective laboratory measurements and established biological assays.

For "functional performance" in sperm separation, the ground truth would likely be the quantitative analysis of enriched motile sperm populations (e.g., count, motility percentage, morphology) compared to established benchmarks or predicate device performance.
For "safety" (HSSA), the ground truth is the survival and viability of human sperm after exposure to the device, measured against controls and established safety limits for cell viability.

8. The sample size for the training set

This section is not applicable. The Qualis device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development and validation.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as above (no training set for a physical device).

Summary

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510(k) Summary

Submitter:	Menicon Co., Ltd. New Business Division5-1-10, Takamoridai, Kasugai, Aichi 487-0032 JAPAN
ContactPerson:	Marcia PalmaSenior Principal Consultant, NAMSA4050 Olson Memorial Hwy, Suite 450 Minneapolis, MN 55422Telephone: 763.588.9847Fax: 763-287-3836Email: mpalma@namsa.com
DatePrepared:	June 6, 2014
Trade Name:	Qualis
Classification:	Class II21 CFR § 884.6160, Assisted Reproduction Labware
ProductCode:	MQK
PredicateDevice(s):	The subject device is equivalent to the following devices:K112413, Research Instruments Migration Sedimentation Chamber
DeviceDescription:	The Qualis is a sterile, disposable, plastic laboratory dish that contains fourchambers connected through micro-channels and is designed to be used inconjunction with commercially available culture medium to selectively separatemotile 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 ofinfertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.
Functionaland SafetyTesting:	To verify that device design met its functional performance and safetyrequirements, representative sample of the device underwent testing includinghuman sperm survival assay (HSSA) and human sperm motility/morphology.
Conclusion:	Menicon Co., Ltd. New Business Division considers the Qualis to be equivalentto the predicate device listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indications foruse.
	Substantial Equivalence Discussion• The subject and predicate devices have the same intended use, althoughdifferent indications. The predicate device is intended to prepare motilesperm for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF)and intrauterine insemination (IUI), whereas the subject device is intendedfor 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 humansperm for use in the treatment ofinfertile couples by intracytoplasmicsperm insertion (ICSI) fertilization	Intended to prepare sperm by migration-sedimentation method for the assistedreproductive techniques ofintracytoplasmic sperm injection (ICSI),in vitro fertilization (IVF), andintrauterine insemination (IUI)
Design	A disposable culture dish with fourchambers connected by micro-channels	A cylindrical container with internalgallery and well. Optically clear, flat base
Mechanism ofaction	The semen sample is placed inChamber A and separation medium isplaced in Chamber B. Fluids fromboth chambers flow via the micro-channels into the central micro-channelwhere the two fluids pass side-by-sidein laminar flow. Motile sperm are ableto swim across the interface of thelaminar flow streams and pass into theseparation medium stream but non-motile sperm and debris cannot.Motile sperm that cross into theseparation medium flow are carriedinto Chamber C where they arecollected. Non-motile sperm anddebris remain in the semen sampleflow from Chamber A into ChamberD.	The chamber is pre-loaded with culturemedium into which unprepared (raw)sperm is pipetted. During incubation.sperm migrate to the over-laying mediumbased on their nature swimming natureand fall by gravity into the central well ofthe 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301)796-7100 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.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FDA USE ONLY ...

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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Regulation Number and Section

§ 884.6160 Assisted reproduction labware.

(a)
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.(b)
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.