The SpermAlign Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) procedures.

Device Description

SpermAlign is a sperm separation device used to prepare motile sperm for assisted reproductive technology (ART) procedures. Separation is achieved through a fluid filled microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilizes a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and sperm washing media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in intracytoplasmic sperm injection (ICSI) or in vitro fertilization (IVF) procedures.

SpermAlign is sterilized using X-Ray irradiation and has a sterility assurance level (SAL) of 10-6. The devices are individually packaged and for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the SpermAlign Sperm Separation Device, indicating substantial equivalence to a predicate device. While it details several non-clinical performance tests, it does NOT contain the specific information requested about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML medical device, particularly regarding test sets, expert adjudication, MRMC studies, or standalone algorithm performance. The device described appears to be a physical labware device, not an AI/ML software device.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML performance, sample sizes for AI/ML test/training data, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document.

However, I can extract information regarding the non-clinical performance studies conducted for this physical device:

A table of acceptance criteria and the reported device performance (for physical device tests):

Test	Acceptance Criterion	Reported Performance
Sterilization Validation	Sterility Assurance Level (SAL) of 10⁻⁶	Met SAL of 10⁻⁶
Endotoxin Testing	< 20 EU/device	< 20 EU/device
Human Sperm Survival Assay (HSSA)	≥80% of the control motility at 24 hours after 30 minutes exposure to SpermAlign	Met (before and after accelerated aging to support 12-month shelf life)
Sperm Separation Performance (Motility)	Not explicitly stated as an "acceptance criterion" but reported as performance metric	Average percent of progressively motile sperm: Input 57.4% / Output 91.9%
Transportation Simulation	Not explicitly stated (implied to meet a standard)	Performed per ASTM D4169-22
Package Integrity (after accelerated aging to support 12-month shelf-life)	Visual inspection, Bubble leak, Seal strength (implied to meet standards)	Performed per ASTM F1886/F1886M, ASTM F2096-11 (2019), ASTM F88/F88M-16. (Results implied to be successful as device was cleared.)

The document does NOT provide information for the following AI/ML specific questions:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

Summary

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March 14, 2024

CytoSwim Ltd. % Zennia Paniwnyk Senior Regulatory and Quality Consultant Insight Regulatory Consultancy Ltd. Unit A, Wixford Park, Georges Elm Lane, Alcester, Warwickshire B50 4JS United Kingdom

Re: K232980

Trade/Device Name: SpermAlign Sperm Separation Device Regulation Number: 21 CFR$ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: February 20, 2024 Received: February 20, 2024

Dear Zennia Paniwnyk:

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.

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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" (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 QS 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.

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.

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Page

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 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,

Monica D. Garcia -S

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

510(k) Number (if known) K232980

Device Name SpermAlign Sperm Separation Device

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)

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510(k) Summary K232980

1. Submitter

Applicant:	CytoSwim Ltd
Address:	Unit 34, The Venture CentreUniversity of Warwick Science Park,Coventry,CV4 7EZUK
Telephone:	Tel: +44 (0) 7833254489
Date Prepared:	March 11, 2024

2. Correspondent Information

Contact Person:	Zennia Paniwnyk
Contact Title:	Senior Regulatory and Quality ConsultantInsight Regulatory Consultancy Ltd.
Phone:	44 (203) 954-3606
Email:	zennia@insightregulatory.com

3. Device Information

Proprietary Name:	SpermAlign Sperm Separation Device
Common Name:	Sperm Separation Device
Regulation Name:	Assisted reproduction labware
Regulation Number	21 CFR 884.6160
Regulatory Class:	II
Product Code:	MQK (Labware, assisted reproduction)

4. Predicate Device

Predicate Device	510(k) Number
ZyMot ICSI Sperm Separation Device, ZyMot MultiSperm Separation Device (850µl, 3ml)	K173075

The predicate device has not been subject to a design-related recall.

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ട. Description of Device

SpermAlign is sterilized using X-Ray irradiation and has a sterility assurance level (SAL) of 106. The devices are individually packaged and for single use only.

Indications for Use 6.

7. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The following table compares the intended use and key technological characteristics of the subject and predicate device:

Characteristic /Feature	SpermAlign SpermSeparation Device (subjectdevice) - K232980	ZyMot Multi SpermSeparation Device (850µl,3ml) (predicate device) –K173075
Indication for use	The SpermAlign SpermSeparation Device is intended forpreparing motile sperm fromsemen for use in the treatment ofinfertile couples byintracytoplasmic sperm injection(ICSI) and in vitro fertilization(IVF) procedures.	The ZyMōt Multi Sperm SeparationDevice is intended for preparingmotile sperm from semen for use inthe treatment of infertile couples byintracytoplasmic sperm injection(ICSI), in vitro fertilization (IVF)and intrauterine insemination (IUI)procedures.
Design	SpermAlign is a disposable,circular device. The lid has 6identical outer wells and a centralwell. A microstructure covers theinside surface of the base todirect the motile sperm to thecentral outlet.	A disposable culture dishcontaining a separationchamber and aninlet port. The separationchamber has a lower samplechamber and an uppercollection chamber. Thetwo chambers are separated bya microporous filter.
Mechanism ofAction	Media is added via the centralwell to cover the microstructure.Liquefied semen is added to eachof the 6 inlet ports and mediafurther added to the central well.The device is incubated for 30minutes allowing the motilesperm to swim against themicrostructure pillars to thecentral well for collection.	Semen is added to the inletport to fill the lower samplechamber; then, the separationmedium is added to the uppercollection chamber. Theloaded device is incubated at37°C for 30 min to allowmotile sperm to swim up andcross the filter to migrate intothe over-laying separationmedium in the uppercollection chamber.
Material	Polypropylene and siliconeadhesive	Polymethylmethacrylate,polycarbonate, flash-spunhigh-density
Human SpermSurvival Testing	≥80% of the control motility at24 hours after exposure for 30minutes	≥80% of the control motilityat 24 hours after exposure for30 minutes
Endotoxin	<20 EU/device	<2.15 EU/device
Sterile	Radiation sterilized	Radiation sterilized
Shelf-Life	12 months	12 months

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The subject and predicate devices have similar indications for use and same intended use. The subject device and predicate device have similar mechanisms of action, incorporating a chamber for loading semen, structure enabling 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 differences in the design, materials and endotoxin specifications. These differences do not raise different questions of safety and effectiveness as compared to the predicate device.

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8. Summary of Non-Clinical Performance Testing

The following testing has been performed on the Sperm Separation Device:

Sterilization Validation per ISO 11137-1:2006(R)2015 [Including: Amendment 1 (2013) and Amendment 2 (2018)] & ISO 11137-2:2013/Amd 1:2022, to meet Sterility Assurance Level of 10-6.
. Transportation Simulation per ASTM D4169-22
Package integrity testing following accelerated aging per ASTM F1980-21 to ● support a 12-month shelf-life:
- o Visual inspection (ASTM F1886/F1886M)
- Bubble leak (ASTM F2096-11 (2019)) o
- Seal strength (ASTM F88/F88M-16) O
Endotoxin testing per USP<85> and ANSI/AAMI ST72:2019: <20 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 device 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 30 minutes exposure to SpermAlign.

Sperm Separation Performance:
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 (see table below for a summary of the results).

Device	Average percent of progressively motile sperm(before/after separation)
SpermAlign	57.4%/91.9%

9. Conclusion

The results of the performance testing described above demonstrate that the SpermAlign Sperm Separation Device is 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.