(160 days)
Not Found
No
The device description and performance studies focus on physical separation methods based on sperm motility, with no mention of AI or ML.
No
The device is intended for separating motile sperm from semen for use in assisted reproductive technology (ART) procedures, not for directly treating a disease or condition in a patient.
No
This device is intended for preparing motile sperm for assisted reproductive technology (ART) procedures, not for diagnosing a medical condition.
No
The device description clearly details physical components like micro-channels, inlet/outlet ports, a sample chamber, a collection chamber, and a microporous filter, indicating it is a hardware device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures." These procedures are diagnostic and therapeutic interventions related to human health and fertility.
- Device Description: The device is designed to "prepare motile sperm from semen," which is a biological sample. The process involves separating components of the semen sample based on biological characteristics (sperm motility).
- Performance Testing: The performance testing described involves analyzing the "percentage of motile sperm and progressively motile sperm in the output samples" compared to the input samples. This is a measurement of a biological characteristic of the semen sample.
While the device itself is a physical separation tool and doesn't perform a chemical reaction or analysis in the traditional sense of some IVDs, its purpose is to process a biological sample (semen) for use in diagnostic and therapeutic procedures related to human health. The preparation of the sample is a crucial step in these downstream procedures, and the device's performance is measured by its ability to isolate a specific component (motile sperm) from the biological sample.
Therefore, the ZyMōt Sperm Separation Devices fit the definition of an In Vitro Diagnostic device as they are intended for use in the examination of specimens derived from the human body (semen) to provide information for diagnostic and therapeutic purposes.
N/A
Intended Use / Indications for Use
The ZyMot ICSI Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) procedures.
The ZyMot Multi Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (IVF) and intrauterine insemination (IUI) procedures.
Product codes
MQK
Device Description
The ZyMōt ICSI Sperm Separation Device and ZyMōt Multi Sperm Separation Device (850μl, 3ml) are used to prepare motile sperm for assisted reproductive technology (ART) procedures. They separate motile sperm from the semen based on the mobility (i.e., swimup nature) of motile sperm.
The ZyMōt ICSI Sperm Separation Device has five micro-channels, each accommodating 2ul of semen and processes up to five separations from one semen sample. Each channel has an inlet port for applying the semen sample and an outlet port for collecting the motile sperm. The ports are connected by a fluid-filled micro-channel in which separation occurs.
The ZyMōt Multi Sperm Separation Device has two processing volumes, 850µl and 3ml. Each version has an inlet port that communicates with the lower sample chamber. The sample chamber is separated from the upper collection chamber by a microporous filter. Untreated semen is added through the inlet port. After incubation, the separated motile sperm are collected from the upper chamber through the outlet port.
The subject devices are radiation-sterilized devices with a sterility assurance level (SAL) of 10-6. They are individually packaged and for single-use only.
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
The following studies have been performed to support substantial equivalence to the predicate devices:
- Sterilization validation study per ISO 11137-2:2012
- Transportation simulation study per ASTM D5276-98
- Package integrity testing following accelerated aging per ASTM F1980-07 to support a 12-month shelf-life:
- Dye penetration testing per ASTM F1929-98
- Seal strength testing per ASTM F88/F88M-15
- Endotoxin testing per USP: ≤2.15 EU/device.
- Human sperm survival assay (HSSA) before and after accelerated aging to support a 12-month shelf-life:
Donor sperm were exposed to the subject devices for 30 minutes and then, incubated at room temperature for 24 hours. The rate of motile sperm after incubation was compared to that of the control (no exposure to the subject device). The acceptance criterion is ≥80% of the control motility at 24 hours after exposure for 30 minutes. - Performance testing:
Each version of the subject device was used to separate motile sperm from donor semen samples. The separation procedures followed the Instructions for Use, and the percentage of motile sperm and progressively motile sperm in the output samples were compared to those of the input samples.
Key Metrics
Percentage of motile sperm (before/after separation):
ZyMōt ICSI: 29.7% / 87%
ZyMōt Multi 850µl: 67% / 83.6%
ZyMōt Multi 3ml: 67% / 86.5%
Percentage of progressively motile sperm (before/after separation):
ZyMōt ICSI: 26.3% / 74.2%
ZyMōt Multi 850µl: 44.7% / 68.6%
ZyMōt Multi 3ml: 44.7% / 75.4%
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2018
DxNow, Inc. Kevin Sly Senior Advisor to DxNow, Inc. 401 Professional Drive, Suite 130 Gaithersburg, Maryland 20879-3429
Re: K173075
Trade/Device Name: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: Class II Product Code: MQK Dated: February 6, 2018 Received: February 6, 2018
Dear Kevin Sly:
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 (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Benjamin R. Fisher -S
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
2
Indications for Use
510(k) Number (if known) K173075
Device Name ZyMōt ICSI Sperm Separation Device ZyMot Multi Sperm Separation Device (850ul, 3ml)
Indications for Use (Describe)
The ZyMot ICSI Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) procedures.
The ZyMot Multi Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (IVF) and intrauterine insemination (IUI) procedures.
| 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) |
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3
510(k) Summary K173075
1. Submitter
DxNow, Inc. 401 Professional Drive, Suite 130 Gaithersburg, MD 20879-3429 Contact: Bill Sharp, CEO Email: bsharp@dxnowinc.com Phone: 240-454-9893
2. Correspondent
Kevin Sly Senior Advisor, DxNow, Inc. Email: ksly@dxnowinc.com Phone: 240-751-6521
3. Date Prepared: March 6, 2018
4. Device Identification:
| Trade name: | ZyMōt ICSI Sperm Separation Device
ZyMōt Multi Sperm Separation Device (850µl, 3ml) |
|----------------------|----------------------------------------------------------------------------------------|
| Common name: | Sperm Separation Device |
| Classification name: | Assisted Reproduction Labware (21 CFR 884.6160) |
| Product code: | MQK (Labware, Assisted Reproduction) |
| Regulatory class: | II |
ട. Predicate Device
Qualis (K133295). This predicate device has not been subject to any design related recalls.
6. Device Description
The ZyMōt ICSI Sperm Separation Device and ZyMōt Multi Sperm Separation Device (850μl, 3ml) are used to prepare motile sperm for assisted reproductive technology (ART) procedures. They separate motile sperm from the semen based on the mobility (i.e., swimup nature) of motile sperm.
4
The ZyMōt ICSI Sperm Separation Device has five micro-channels, each accommodating 2ul of semen and processes up to five separations from one semen sample. Each channel has an inlet port for applying the semen sample and an outlet port for collecting the motile sperm. The ports are connected by a fluid-filled micro-channel in which separation occurs.
The ZyMōt Multi Sperm Separation Device has two processing volumes, 850µl and 3ml. Each version has an inlet port that communicates with the lower sample chamber. The sample chamber is separated from the upper collection chamber by a microporous filter. Untreated semen is added through the inlet port. After incubation, the separated motile sperm are collected from the upper chamber through the outlet port.
The subject devices are radiation-sterilized devices with a sterility assurance level (SAL) of 10-6. They are individually packaged and for single-use only.
7. Indications for Use
The ZyMōt ICSI Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) procedures.
The ZyMōt Multi Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
| Device/Predicate
| Device(s): | K173075 (subject devices) | K133295 (predicate device) |
|---|---|---|
| Indications for | ||
| Use | The ZyMōt ICSI is intended for preparing | |
| motile sperm from semen for use in the | ||
| treatment of infertile couples by | ||
| intracytoplasmic sperm injection (ICSI) | ||
| procedures. | ||
| The ZyMōt Multi is intended for preparing | ||
| motile sperm from semen for use in the | ||
| treatment of infertile couples by | ||
| intracytoplasmic sperm injection (ICSI), in | ||
| vitro fertilization (IVF) and intrauterine | ||
| insemination (IUI) procedures. | The Qualis is intended for preparing | |
| motile human sperm for use in the | ||
| treatment of infertile couples by | ||
| intracytoplasmic sperm insertion | ||
| (ICSI) fertilization. | ||
| Design | ZyMōt ICSI – A disposable culture dish | |
| containing five micro-channels, each | ||
| connected to an inlet port and an outlet | ||
| port | ||
| ZyMōt Multi – A disposable culture dish | ||
| containing a separation chamber and an | ||
| inlet port. The separation chamber has a | ||
| lower sample chamber and an upper | A disposable culture dish with four | |
| chambers connected by micro- | ||
| channels |
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
5
| | collection chamber. The two chambers
are separated by a microporous filter. | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism of
action | ZyMōt ICSI — The inlet port is preloaded
with sperm separation medium and then
loaded with semen. After incubation at
37°C for 30 min, the motile sperm are
collected from the outlet port.
ZyMōt Multi – The semen is added to the
inlet port to fill the lower sample
chamber; then, the separation medium is
added to the upper collection chamber.
The loaded device is incubated at 37°C for
30 min to allow motile sperm to swim up
and cross the filter to migrate into the
over-laying separation medium in the
upper collection chamber. | 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 can 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. |
| Material | ZyMōt ICSI – Polymethylmethacrylate,
borosilicate glass, flash-spun high-density
polyethylene fibers
ZyMōt Multi - Polymethylmethacrylate,
polycarbonate, flash-spun high-density
polyethylene fibers | Cyclo-olefin polymer |
The subject and predicate devices have different Indications for Use statements; however, they have the same intended use – preparing motile sperm from semen for use in ART procedures.
The subject and predicate devices have the same fundamental design incorporating a culture dish with an inlet port/chamber for loading of semen and an outlet port/chamber for collection of motile sperm. Both devices rely on sperm motility to separate motile sperm from non-motile sperm or non-sperm cells. The predicate device incorporates microfluidic technology, whereas the subject devices do not. However, this difference does not raise different questions of safety and effectiveness as compared to the predicate device, as both devices (and other cleared devices) have the same fundamental mode of action (i.e., using motility of sperm to prepare pools of motile sperm for use in ART procedures). In addition, the subject and predicate devices have different materials. However, differences in materials do not raise different questions of safety and effectiveness as compared to the predicate device.
g. Summary of Non-Clinical Performance Testing:
The following studies have been performed to support substantial equivalence to the predicate devices:
6
- . Sterilization validation study per ISO 11137-2:2012
- . Transportation simulation study per ASTM D5276-98
- . Package integrity testing following accelerated aging per ASTM F1980-07 to support a 12-month shelf-life:
-
- Dye penetration testing per ASTM F1929-98
-
- Seal strength testing per ASTM F88/F88M-15
-
- Endotoxin testing per USP: ≤2.15 EU/device .
- . Human sperm survival assay (HSSA) before and after accelerated aging to support a 12-month shelf-life:
Donor sperm were exposed to the subject devices for 30 minutes and then, incubated at room temperature for 24 hours. The rate of motile sperm after incubation was compared to that of the control (no exposure to the subject device). The acceptance criterion is ≥80% of the control motility at 24 hours after exposure for 30 minutes.
- Performance testing: .
Each version of the subject device was used to separate motile sperm from donor semen samples. The separation procedures followed the Instructions for Use, and the percentage of motile sperm and progressively motile sperm in the output samples were compared to those of the input samples. A summary of the results is provided in the table below:
| Device | Percentage of motile sperm
(before/after separation) | Percentage of progressively motile
sperm (before/after separation) |
|-------------------|---------------------------------------------------------|-----------------------------------------------------------------------|
| ZyMōt ICSI | 29.7% / 87% | 26.3% / 74.2% |
| ZyMōt Multi 850µl | 67% / 83.6% | 44.7% / 68.6% |
| ZyMōt Multi 3ml | 67% / 86.5% | 44.7% / 75.4% |
10. Conclusion
The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.