(263 days)
Not Found
No
The device description and performance studies focus on a physical separation method based on sperm motility and a microporous membrane, with no mention of computational analysis, algorithms, or learning processes.
Yes
The device is used to prepare sperm cells for use in fertility treatments (ICSI, IVF, and IUI procedures), which are therapeutic interventions aimed at treating infertility.
No
Explanation: The device is designed to separate motile sperm cells from semen for use in assisted reproductive technology procedures. It processes the sample rather than providing a diagnosis of a condition.
No
The device description clearly outlines physical components (compartments, membrane, ports) and a physical mechanism of action (sperm motility and a filter membrane) for separating sperm, indicating it is a hardware device, not software-only.
Based on the provided information, the SwimCount® Harvester is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to prepare motile sperm cells from semen for use in ART procedures (ICSI, IVF, IUI). It is a sample preparation device, not a device that performs a diagnostic test on the sample to provide information about a patient's health or condition.
- Device Description: The device physically separates motile sperm based on their ability to swim through a membrane. It does not analyze the sample or provide any diagnostic results.
- Performance Studies: The performance studies evaluate the device's ability to enrich the sample with motile sperm, not its ability to diagnose a condition or provide a diagnostic measurement. The metrics are related to the quality of the separated sample for subsequent procedures.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SwimCount® Harvester's function is to process a sample for a subsequent medical procedure, not to provide diagnostic information.
N/A
Intended Use / Indications for Use
The SwimCount® Harvester is intended for preparing motile sperm cells from semen for use in the treatment of infertile couples by Intracytoplasmic Sperm Injection (ICSI), In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI) procedures.
Product codes
MQK
Device Description
The SwimCount® Harvester (1 mL and 3 mL) is a sperm separation device used to prepare sperm samples for Assisted Reproductive Technology (ART) procedures. The SwimCount® Harvester separates the sperm sample by allowing motile sperm cells to pass the SwimCount® Harvester's membrane system. The SwimCount® Harvester has a design/technology that utilizes the motility of the sperm cells (i.e. swim-up nature) to separate the motile sperm cells from the rest of the sperm population.
The SwimCount® Harvester has two processing volumes, 1 mL and 3 mL. The device consists of 3 compartments: 1) Sample compartment (1 mL or 3 mL), 2) Medium/Harvest compartment (0.8 mL for both device versions), and 3) Microporous polycarbonate (PC) filter membrane (10 um pore size).
Each device version has a Semen Inlet port that communicates with the lower sample compartment. The sample compartment is separated from the upper collection compartment by the microporous filter membrane. Semen is added to the lower compartment through the sample inlet port and cleared sperm separation medium (not provided) is added to the upper collection compartment through the Medium Inlet port. After incubation, the separated motile sperm cells are collected from the upper collection compartment through the Harvest Outlet port and used for subsequent assisted reproduction fertilization procedures.
The SwimCount® Harvester is supplied to the user as sterile (radiation), with a sterility assurance level of (SAL) of 10 6. The devices are individually packed 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
Performance testing: Each version of the subject device (1 mL and 3 mL) was used to separate motile sperm cells from raw semen samples. The separation procedures followed the Instructions for Use, and the % motile sperm cells in the harvested output samples were compared to those of the input samples.
Key Metrics
% motile sperm (before/after separation), % change in total motilty, % progressive motile sperm cells (PMSC) (before/after separation), % change in PMSCs.
SwimCount® Harvester 1 mL: 65.4% / 95.1% motile sperm, 45.4% change in total motilty, 56.8% / 89.6% PMSC, 57.8% change in PMSCs.
SwimCount® Harvester 3 mL: 64.4% / 94.9% motile sperm, 47.4% change in total motilty, 54.2% / 89.6% PMSC, 65.3% change in PMSCs.
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 31, 2025
MotilityCount ApS Jacob Møllenbach Co-Founder Gl. Køge Landevej 57, 2. Valby, DK-2500 DENMARK
Re: K241348
Trade/Device Name: SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: January 3, 2025 Received: January 3, 2025
Dear Jacob Møllenbach:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael T. Bailey -S
For
Monica D Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
Indications for Use (Describe)
The SwimCount® Harvester is intended for preparing motile sperm cells from semen for use in the treatment of infertile couples by Intracytoplasmic Sperm Injection (ICSI), In Vitro Fertilization (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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
SwimCount® Harvester
1. Submitter
MotilityCount ApS Gl. Køge Landevej 57, 2. DK-2500 Valby Denmark
2. Contact
Jacob Møllenbach Co-Founder, MotilityCount ApS Email: jm@motilitycount.com Telephone Number: +4521445919
3. Summary Preparation Date: January 30, 2025
4. Device Identification
| Trade Name: | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) |
|---|---|
| Common Name: | Sperm Separation Device |
| Regulation Name: | Assisted Reproduction Labware |
| Regulation Number: | 24 CFR 884.6160 |
| Product Code: | MQK (Labware, Assisted Reproduction) |
| Regulatory Class: | Class II |
5. Predicate Device
ZyMot Multi (K173075). The predicate device has not been subject to a design-related recall.
6. Device Description
The SwimCount® Harvester (1 mL and 3 mL) is a sperm separation device used to prepare sperm samples for Assisted Reproductive Technology (ART) procedures. The SwimCount® Harvester separates the sperm sample by allowing motile sperm cells to pass the SwimCount® Harvester's membrane system. The SwimCount® Harvester has a design/technology that utilizes the motility of the sperm cells (i.e. swim-up nature) to separate the motile sperm cells from the rest of the
5
sperm population.
The SwimCount® Harvester has two processing volumes, 1 mL and 3 mL. The device consists of 3 compartments: 1) Sample compartment (1 mL or 3 mL), 2) Medium/Harvest compartment (0.8 mL for both device versions), and 3) Microporous polycarbonate (PC) filter membrane (10 um pore size).
Each device version has a Semen Inlet port that communicates with the lower sample compartment. The sample compartment is separated from the upper collection compartment by the microporous filter membrane. Semen is added to the lower compartment through the sample inlet port and cleared sperm separation medium (not provided) is added to the upper collection compartment through the Medium Inlet port. After incubation, the separated motile sperm cells are collected from the upper collection compartment through the Harvest Outlet port and used for subsequent assisted reproduction fertilization procedures.
The SwimCount® Harvester is supplied to the user as sterile (radiation), with a sterility assurance level of (SAL) of 10 6. The devices are individually packed and for single use only.
7. Indications for use
The SwimCount® Harvester is intended for preparing motile sperm cells from semen for use in the treatment of infertile couples by Intracytoplasmic Sperm Injection (ICSI), In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI) procedures.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
Comparison of Intended Use and Technological Characteristics are outlined in Table 1. Table 1. Comparison between Subject Device (SwimCount® Harvester) and Predicate Device (ZyMōt Multi)
| Device name | SwimCount® Harvester
(Subject Device) | ZyMōt Multi
(Predicate Device) | Rationale for
Substantial Equivalence |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K241348 | K173075 | N/A |
| Company | MotilityCount ApS | DxNow, Inc. | N/A |
| Classification | II | II | Same |
| Product code | MQK | MQK | Same |
| Prescription/ Over-
the-Counter | Prescription | Prescription | Same |
| Indication for use | The SwimCount®
Harvester is intended for
preparing motile sperm
cells 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 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). | Same intended use |
| Design | Uses micropore technology
(a polycarbonate (PC) filter
membrane) to allow motile
sperm cells to migrate from
the raw sample placed in the
lower compartment into
sperm separation medium in
the collection compartment. | Uses micropore
technology (a
polycarbonate (PC) filter
membrane) to allow motile
sperm cells to migrate
from the raw sample
placed in the lower sample
chamber into sperm
separation medium in the
collection chamber. | Same |
| Mechanism of action | The semen is added to the
inlet port to fill the lower
sample chamber; then, the
separation medium is added
to the upper collection
compartment through the
medium inlet port. The
loaded device is incubated at
37°C for 30 min to allow
motile sperm cells to swim
up and cross the filter
membrane to migrate into
the over-laying separation
medium in the upper
collection compartment. The
motile sperm cells are then
aspirated with a syringe
through the outlet port. | 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 cells to
swim up and cross the
filter membrane to migrate
into the over-laying
separation medium in the
upper collection chamber.
The motile sperm cells are
then aspirated with a
syringe through the outlet
port. | Same |
| Semen Volume | 1 mL and 3 mL | 0.85 mL and 3 mL | Similar |
| Materials | Filter membrane:
polycarbonate
Housing: TOPAS (cyclo-
olefin copolymer) | Filter membrane:
polycarbonate
Housing: Flash-spun
high-density polyethylene
fibers
polymethylmethacrylate | Differences in device
materials do not raise
different questions of
safety and
effectiveness. |
| Human Sperm Survival
Assay (HSSA) | ≥80% of control motility at
24h | ≥80% of the control
motility at 24 hours after
exposure for 30 minutes | The differences between
the subject and predicate
device HSSA specifications
do not raise different
questions of safety and
effectiveness. |
| Endotoxin | :