SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

K241348 · Motilitycount Aps · MQK · Jan 31, 2025 · Obstetrics/Gynecology

Device Facts

• Record ID: K241348
• Device Name: SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
• Applicant: Motilitycount Aps
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Jan 31, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Sperm separation device; utilizes motility of sperm cells to isolate motile sperm from raw semen. Device consists of 3 compartments: lower sample compartment, upper collection compartment, and 10 um microporous polycarbonate filter membrane. Semen added to lower compartment; separation medium added to upper compartment. Device incubated at 37°C for 30 minutes; motile sperm swim through membrane into upper compartment. Separated sperm aspirated via syringe from harvest outlet for use in ART procedures. Used in clinical laboratory settings by trained personnel. Benefits patient by providing concentrated motile sperm for fertilization procedures.

Clinical Evidence

Bench testing only. Performance testing (n=10 per variant) demonstrated successful separation of motile sperm. 1 mL variant: motility increased from 65.4% to 95.1%; progressive motile sperm cells (PMSC) increased from 56.8% to 89.6%. 3 mL variant: motility increased from 64.4% to 94.9%; PMSC increased from 54.2% to 89.6%. Human Sperm Survival Assay (HSSA) confirmed ≥80% of control motility at 24h. Sterilization, package integrity, and endotoxin (<20 EU/device) testing performed.

Technological Characteristics

Materials: Polycarbonate (filter membrane), TOPAS cyclo-olefin copolymer (housing). Dimensions: 1 mL and 3 mL sample volumes. Principle: Passive migration of motile sperm through 10 um microporous membrane. Energy: None (passive). Connectivity: None. Sterilization: Radiation (SAL 10^-6). Single-use.

Indications for Use

Indicated for preparing motile sperm cells from semen for use in the treatment of infertile couples undergoing ICSI, IVF, or IUI procedures.

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

• ZyMot Multi (K173075)

Submission Summary (Full Text)

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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"

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(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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

Submission Number (if known)

K241348

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)

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# 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: [e-mail] Telephone Number: [phone]

#### 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

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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<br>(Subject Device) | ZyMōt Multi<br>(Predicate Device) | Rationale for<br>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-<br>the-Counter | Prescription | Prescription | Same |
| Indication for use | The SwimCount®<br>Harvester is intended for<br>preparing motile sperm<br>cells from semen for use in<br>the treatment of infertile<br>couples by<br>Intracytoplasmic Sperm<br>Injection (ICSI), In Vitro<br>Fertilization (IVF) and<br>Intrauterine Insemination<br>(IUI) procedures. | The ZyMōt Multi Sperm<br>Separation Device is<br>intended for preparing<br>motile sperm from semen<br>for use in the treatment of<br>infertile couples by<br>Intracytoplasmic Sperm<br>Injection (ICSI), In Vitro<br>Fertilization (IVF) and<br>Intrauterine Insemination<br>(IUI). | Same intended use |
| Design | Uses micropore technology<br>(a polycarbonate (PC) filter<br>membrane) to allow motile<br>sperm cells to migrate from<br>the raw sample placed in the<br>lower compartment into<br>sperm separation medium in<br>the collection compartment. | Uses micropore<br>technology (a<br>polycarbonate (PC) filter<br>membrane) to allow motile<br>sperm cells to migrate<br>from the raw sample<br>placed in the lower sample<br>chamber into sperm<br>separation medium in the<br>collection chamber. | Same |
| Mechanism of action | The semen is added to the<br>inlet port to fill the lower<br>sample chamber; then, the<br>separation medium is added<br>to the upper collection<br>compartment through the<br>medium inlet port. The<br>loaded device is incubated at<br>37°C for 30 min to allow<br>motile sperm cells to swim<br>up and cross the filter<br>membrane to migrate into<br>the over-laying separation<br>medium in the upper<br>collection compartment. The<br>motile sperm cells are then<br>aspirated with a syringe<br>through the outlet port. | The semen is added to the<br>inlet port to fill the lower<br>sample chamber; then, the<br>separation medium is<br>added to the upper<br>collection chamber. The<br>loaded device is incubated<br>at 37°C for 30 min to<br>allow motile sperm cells to<br>swim up and cross the<br>filter membrane to migrate<br>into the over-laying<br>separation medium in the<br>upper collection chamber.<br>The motile sperm cells are<br>then aspirated with a<br>syringe through the outlet<br>port. | Same |
| Semen Volume | 1 mL and 3 mL | 0.85 mL and 3 mL | Similar |
| Materials | Filter membrane:<br>polycarbonate<br>Housing: TOPAS (cyclo-<br>olefin copolymer) | Filter membrane:<br>polycarbonate<br>Housing: Flash-spun<br>high-density polyethylene<br>fibers<br>polymethylmethacrylate | Differences in device<br>materials do not raise<br>different questions of<br>safety and<br>effectiveness. |
| Human Sperm Survival<br>Assay (HSSA) | ≥80% of control motility at<br>24h | ≥80% of the control<br>motility at 24 hours after<br>exposure for 30 minutes | The differences between<br>the subject and predicate<br>device HSSA specifications<br>do not raise different<br>questions of safety and<br>effectiveness. |
| Endotoxin | <20 EU/Device | <2.15 EU/Device | The differences between<br>the subject and predicate<br>device endotoxin<br>specifications do not raise<br>different questions of safety<br>and effectiveness. |
| Sterile | Yes (radiation) | Yes (radiation) | Same |

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The subject and predicate devices have comparable indications for use and the same intended use. The subject device and predicate device have the same fundamental design incorporating a chamber for loading semen, a filter for motile sperm to migrate through, and a port for collection of motile sperm. However, there are technological differences between the subject and predicate devices, including device materials, device volumes, and device specifications. These differences do not raise different questions of safety and effectiveness.

# 9. Summary of Non-Clinical Performance Testing

The following tests were conducted on the subject device to support a determination of substantial equivalence to the predicate device:

- Sterilization validation study per ISO 11137-2:2015 ●
- Package integrity and transportation testing after accelerated aging to the end of the 24-month . shelf-life duration. Testing included the following:
- Transportation simulation study per /ASTM D4169-22, DC13 O
- Package integrity testing on aged devices and following transportation simulation per O ASTM D4169-22:
- Visual inspection per ASTM F1886/F1886M-16
- I Dye penetration testing per ASTM F1929-15
- I Seal strength testing per ASTM F88/F88M-21
- Endotoxin testing per USP<85>: <20 EU/device
- Human Sperm Survival Assay (HSSA) before and after accelerated aging to support a 24-● month shelf-life: ≥80% of control motility at 24h
- 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. A summary of the results is provided in Table 2 below:

Table 2: Performance testing of subject device variants (1 mL and 3 mL) n=10:

| Device variant | % motile sperm<br>(before/after<br>separation) | % change in<br>total motilty | % progressive motile<br>sperm cells (PMSC)<br>(before/after<br>separation) | % change in<br>PMSCs |
|------------------------------|------------------------------------------------|------------------------------|----------------------------------------------------------------------------|----------------------|
| SwimCount®<br>Harvester 1 mL | 65.4% / 95.1% | 45.4% | 56.8% / 89.6% | 57.8% |

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| SwimCount®<br>Harvester 3 mL | 64.4% / 94.9% | 47.4% | 54.2% / 89.6% | 65.3% |
|------------------------------|---------------|-------|---------------|-------|
|------------------------------|---------------|-------|---------------|-------|

### 10. Conclusion

The results of the performance testing described above demonstrate that SwimCount® Harvester (1 mL and 3 mL) are as safe and effective as the predicate device and supports a determination of substantial equivalence