(236 days)
Not Found
No
The device description and performance studies focus on a physical separation method using micro-channels and do not mention any computational or algorithmic processes indicative of AI/ML.
No
The device is intended for preparing sperm, which is a step in a medical procedure, but it does not directly treat a disease or condition itself.
No
Explanation: The device description clearly states its purpose is to "selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris" for use in ICSI. This is a preparatory, therapeutic, or assistive function, not a diagnostic one. Diagnostic devices are used to identify or characterize medical conditions.
No
The device description explicitly states it is a "sterile, disposable, plastic laboratory dish," indicating it is a physical hardware device, not software only.
Based on the provided information, the Qualis device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization." This process involves analyzing and preparing biological samples (sperm) outside of the body to provide information for medical treatment.
- Device Description: The device is a "laboratory dish" designed to "selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris." This is a process performed on a biological sample in a laboratory setting.
- Performance Studies: The performance studies involve "human sperm survival assay (HSSA)" and "human sperm motility/morphology," which are tests performed on biological samples to assess the device's function in preparing those samples.
While the device itself is a physical tool, its intended use and function are directly related to the in vitro examination of a human biological sample (sperm) to provide information for a medical purpose (treatment of infertility). This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The final design validation study demonstrated that the subject device is effective. The result of HSSA testing demonstrated that the subject device is safe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
:
.
510(k) Summary
| Submitter: | Menicon Co., Ltd. New Business Division
5-1-10, Takamoridai, Kasugai, Aichi 487-0032 JAPAN |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Marcia Palma
Senior Principal Consultant, NAMSA
4050 Olson Memorial Hwy, Suite 450 Minneapolis, MN 55422
Telephone: 763.588.9847
Fax: 763-287-3836
Email: mpalma@namsa.com |
| Date
Prepared: | June 6, 2014 |
| Trade Name: | Qualis |
| Classification: | Class II
21 CFR § 884.6160, Assisted Reproduction Labware |
| Product
Code: | MQK |
| Predicate
Device(s): | The subject device is equivalent to the following devices:
K112413, Research Instruments Migration Sedimentation Chamber |
| 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. |
| Intended Use: | The Qualis is intended for preparing motile human sperm for use in the treatment of
infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization. |
| Functional
and Safety
Testing: | 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. |
| Conclusion: | Menicon Co., Ltd. New Business Division considers the Qualis to be equivalent
to the predicate device listed above. This conclusion is based upon the devices'
similarities in principles of operation, technology, materials and indications for
use. |
| | Substantial Equivalence Discussion
• The subject and predicate devices have the same intended use, although
different indications. The predicate device is intended to prepare motile
sperm for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF)
and intrauterine insemination (IUI), whereas the subject device is intended
for separating motile sperm for ICSI only. The difference does not raise any |
·
1
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 | |
| sperm for use in the treatment of | ||
| infertile couples by intracytoplasmic | ||
| sperm insertion (ICSI) fertilization | Intended to prepare sperm by migration- | |
| sedimentation method for the assisted | ||
| reproductive techniques of | ||
| intracytoplasmic sperm injection (ICSI), | ||
| in vitro fertilization (IVF), and | ||
| intrauterine insemination (IUI) | ||
| Design | A disposable culture dish with four | |
| chambers connected by micro-channels | A cylindrical container with internal | |
| gallery and well. Optically clear, flat base | ||
| Mechanism of | ||
| action | The semen sample is placed in | |
| Chamber A and separation medium is | ||
| placed in Chamber B. Fluids from | ||
| both chambers flow via the micro- | ||
| channels into the central micro-channel | ||
| where the two fluids pass side-by-side | ||
| in laminar flow. Motile sperm are able | ||
| to swim across the interface of the | ||
| laminar flow streams and pass into the | ||
| separation medium stream but non- | ||
| motile sperm and debris cannot. | ||
| Motile sperm that cross into the | ||
| separation medium flow are carried | ||
| into Chamber C where they are | ||
| collected. Non-motile sperm and | ||
| debris remain in the semen sample | ||
| flow from Chamber A into Chamber | ||
| D. | The chamber is pre-loaded with culture | |
| medium into which unprepared (raw) | ||
| sperm is pipetted. During incubation. | ||
| sperm migrate to the over-laying medium | ||
| based on their nature swimming nature | ||
| and fall by gravity into the central well of | ||
| the chamber for collection. | ||
| Material | Cyclo-olefin polymer | Polystyrene |
2
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
3
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
4
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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