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 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.

AI/ML Overview

The provided text describes the 510(k) summary for the SwimCount® Harvester, a device for preparing motile sperm cells. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (from predicate comparison or performance testing)	Reported Device Performance
Endotoxin: < 20 EU/Device (subject device specification)	Meets < 20 EU/device (from Endotoxin testing)
Human Sperm Survival Assay (HSSA): ≥80% of control motility at 24h (subject device specification)	Meets ≥80% of control motility at 24h (from HSSA testing)
Percentage Motile Sperm (1 mL device): Not explicitly stated as criterion, but demonstrated effectiveness	Before separation: 65.4% After separation: 95.1% % change: 45.4%
Percentage Progressive Motile Sperm Cells (PMSC) (1 mL device): Not explicitly stated as criterion, but demonstrated effectiveness	Before separation: 56.8% After separation: 89.6% % change: 57.8%
Percentage Motile Sperm (3 mL device): Not explicitly stated as criterion, but demonstrated effectiveness	Before separation: 64.4% After separation: 94.9% % change: 47.4%
Percentage Progressive Motile Sperm Cells (PMSC) (3 mL device): Not explicitly stated as criterion, but demonstrated effectiveness	Before separation: 54.2% After separation: 89.6% % change: 65.3%
Sterility: Meets SAL of 10-6	Achieved through radiation sterilization validated per ISO 11137-2:2015
Package Integrity & Transportation following accelerated aging: Meets specified ASTM standards	Meets ASTM standards (referencing F1886/F1886M-16, F1929-15, F88/F88M-21, D4169-22)

2. Sample size used for the test set and the data provenance

Performance testing: n=10 for each device variant (1 mL and 3 mL). This means 10 raw semen samples were processed through the 1mL device, and another 10 raw semen samples through the 3mL device.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the performance testing. Quality control or lab personnel would typically perform such assessments.

4. Adjudication method for the test set

The document does not mention any adjudication method for the test set results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sperm separation device, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

This device is a physical sperm separation device. Performance testing was done on the device itself, which is inherently a "standalone" or "algorithm-only" in the sense that it performs its function without a human actively making real-time processing decisions or interpretations during its operation. The human element is in its proper use according to the Instructions for Use.

7. The type of ground truth used

For the performance testing, the "ground truth" implicitly refers to the initial assessment of % motile sperm and % progressive motile sperm cells (PMSC) in the raw semen samples before separation, compared to the same metrics in the harvested (processed) output samples. This is a direct measure of the device's functional performance in enriching motile sperm. The specific methodology for these measurements (e.g., manual count, CASA system) is not detailed.
For the other tests (Endotoxin, HSSA, Sterilization, Package Integrity), the ground truths are defined by recognized standards and laboratory testing protocols.

8. The sample size for the training set

This information is not applicable as the SwimCount® Harvester is a physical medical device, not a software algorithm that requires a training set.

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

This information is not applicable as the SwimCount® Harvester is a physical medical device.

Summary

{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)

K241348

Device Name

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

Indications for Use (Describe)

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

{5}------------------------------------------------

sperm population.

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

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 forSubstantial 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 forpreparing motile spermcells from semen for use inthe treatment of infertilecouples byIntracytoplasmic SpermInjection (ICSI), In VitroFertilization (IVF) andIntrauterine Insemination(IUI) procedures.	The ZyMōt Multi SpermSeparation Device isintended for preparingmotile sperm from semenfor use in the treatment ofinfertile couples byIntracytoplasmic SpermInjection (ICSI), In VitroFertilization (IVF) andIntrauterine Insemination(IUI).	Same intended use
Design	Uses micropore technology(a polycarbonate (PC) filtermembrane) to allow motilesperm cells to migrate fromthe raw sample placed in thelower compartment intosperm separation medium inthe collection compartment.	Uses microporetechnology (apolycarbonate (PC) filtermembrane) to allow motilesperm cells to migratefrom the raw sampleplaced in the lower samplechamber into spermseparation medium in thecollection chamber.	Same
Mechanism of action	The semen is added to theinlet port to fill the lowersample chamber; then, theseparation medium is addedto the upper collectioncompartment through themedium inlet port. Theloaded device is incubated at37°C for 30 min to allowmotile sperm cells to swimup and cross the filtermembrane to migrate intothe over-laying separationmedium in the uppercollection compartment. Themotile sperm cells are thenaspirated with a syringethrough the outlet port.	The semen is added to theinlet port to fill the lowersample chamber; then, theseparation medium isadded to the uppercollection chamber. Theloaded device is incubatedat 37°C for 30 min toallow motile sperm cells toswim up and cross thefilter membrane to migrateinto the over-layingseparation medium in theupper collection chamber.The motile sperm cells arethen aspirated with asyringe through the outletport.	Same
Semen Volume	1 mL and 3 mL	0.85 mL and 3 mL	Similar
Materials	Filter membrane:polycarbonateHousing: TOPAS (cyclo-olefin copolymer)	Filter membrane:polycarbonateHousing: Flash-spunhigh-density polyethylenefiberspolymethylmethacrylate	Differences in devicematerials do not raisedifferent questions ofsafety andeffectiveness.
Human Sperm SurvivalAssay (HSSA)	≥80% of control motility at24h	≥80% of the controlmotility at 24 hours afterexposure for 30 minutes	The differences betweenthe subject and predicatedevice HSSA specificationsdo not raise differentquestions of safety andeffectiveness.
Endotoxin	<20 EU/Device	<2.15 EU/Device	The differences betweenthe subject and predicatedevice endotoxinspecifications do not raisedifferent questions of safetyand effectiveness.
Sterile	Yes (radiation)	Yes (radiation)	Same

{6}------------------------------------------------

{7}------------------------------------------------

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(before/afterseparation)	% change intotal motilty	% progressive motilesperm cells (PMSC)(before/afterseparation)	% change inPMSCs
SwimCount®Harvester 1 mL	65.4% / 95.1%	45.4%	56.8% / 89.6%	57.8%

{8}------------------------------------------------

SwimCount®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

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.