The SperSort™ Sperm Sorting Chip 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 Description

The SperSort™ Sperm Sorting Chip is used to prepare motile sperm for assisted reproductive technology (ART) procedures. The device separates motile sperm from the semen based on the mobility (i.e., swim-up nature) of motile sperm. The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber. The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port. The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.

AI/ML Overview

The FDA 510(k) summary for the SperSort™ Sperm Sorting Chip (IPG02) provides information on its acceptance criteria and non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a single table, but can be inferred from the performance testing section and comparison with the predicate device.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (SperSort™ Sperm Sorting Chip)
Sterility Assurance Level (SAL)	10⁻⁶ (as per predicate device and FDA guidance)	10⁻⁶
Package Integrity	Maintain sterile barrier after simulated transport and aging	Passed (Can withstand shipping, sterile barrier maintained)
Shelf-Life Performance (HSSA)	≥ 80% of the control motility at 24 hours after exposure for 30 minutes	Maintained performance after two years accelerated aging and passed HSSA (≥ 80% control motility)
Endotoxin	≤ 20 EU/device (device specific)	< 20 EU/device
% Motile Sperm (after separation)	Significantly increased compared to input (demonstrating efficacy)	95.89% (from 57.50% before separation)
% Progressive Motile Sperm Cells (PMSC) (after separation)	Significantly increased compared to input (demonstrating efficacy)	92.97% (from 47.07% before separation)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set used in the performance testing.
The data provenance is not specified. It is unclear if the data is from a particular country or if it's retrospective or prospective. The study is described as "Performance Testing" using "donor semen samples," implying a prospective study, but details are lacking.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The performance testing primarily focuses on device output measurements (% motile sperm, % progressive motile sperm) rather than expert-adjudicated ground truth for a diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not provided as the testing described focuses on quantitative measurements of sperm characteristics rather than qualitative assessments requiring adjudication.

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

The SperSort™ Sperm Sorting Chip is a physical device for processing semen samples, not an AI software/algorithm for interpretation. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers assisting AI or vice-versa is not applicable and was not performed.

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

The SperSort™ Sperm Sorting Chip is a physical device, not an algorithm or AI. Therefore, a standalone algorithm performance study is not applicable and was not performed. The "standalone" performance in this context refers to the device's ability to separate sperm effectively on its own, which is what the performance testing describes.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" for the effectiveness of sperm separation was established through quantitative measurement of sperm parameters (percentage of total motile sperm and progressively motile sperm cells) in both the input (before separation) and output (after separation) samples. These measurements serve as an objective ground truth for the device's performance in improving sperm quality.

8. The Sample Size for the Training Set

The document describes a physical medical device, not an AI or machine learning algorithm that requires a "training set." Therefore, information about a training set size is not applicable and not provided.

9. How the Ground Truth for the Training Set was Established

As this is a physical device and not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it is not applicable.

Summary

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February 20, 2025

iPreg Incorporation Ching-Wen Chang R&D Head 4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist. New Taipei City, 221 TAIWAN

Re: K241626

Trade/Device Name: SperSort™ Sperm Sorting Chip (IPG02) Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Received: January 24, 2025

Dear Ching-Wen Chang:

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" (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).

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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 Rule"). 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the text "Michael T. Bailey -S" in a large, sans-serif font. The text is black and appears to be centered. The background is white. The text is clear and easy to read.

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

510(k) Number (if known) K241626

Device Name SperSort™ Sperm Sorting Chip (IPG02)

Indications for Use (Describe)

The SperSort™ Sperm Sorting Chip 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 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart G)
☑	☐

|X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K241626

Submitter/Address	iPreg Incorporation4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist.,New Taipei City, 221, Taiwan (R.O.C.)Telephone: +886-8771-3721
Contact Person:	Ching-Wen ChangiPreg Incorporation4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist.,New Taipei City, 221, Taiwan (R.O.C.)Telephone: +886-8771-3721Email:cwchang@ipreginc.com
Date Prepared:	February 20, 2025
Trade Name:	SperSort™ Sperm Sorting Chip (IPG02)
Common Name:	Sperm Separation Device
Regulation Name:	Assisted Reproduction Labware
Regulation Number:	21 CFR 884.6160
Regulatory Class:	Class II
Product Code:	MQK (Labware, Assisted Reproduction)
Predicate Device:	ZyMot Multi Sperm Separation Device (K173075)

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

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Device Description:

The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber.

The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port.

The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.

Indication for Use:

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.

	Subject DeviceSperSort™ Sperm SortingChipK241626	Predicate DeviceZyMot Multi SpermSeparation DeviceK173075	Comparison
Indicationsfor Use	The SperSort™ SpermSorting Chip is intended forpreparing motile sperm fromsemen for use in thetreatment of infertile couplesby intracytoplasmic sperminjection (ICSI), in vitrofertilization (IVF) and	The ZyMōt Multi is intendedfor preparing motile spermfrom semen for use in thetreatment of infertile couplesby intracytoplasmic sperminjection (ICSI), in vitrofertilization (IVF) and	Same
	intrauterine insemination (IUI)procedures.	intrauterine insemination (IUI)procedures.
Design	The SperŜort™ SpermSorting Chip has aprocessing volume of 1.9 mL.The device consists of upperand lower case separated bya porous membrane. Thesemen injection port on thecover connects to the lowersemen chamber, while thesperm washing buffer loadingand sample collection portconnects to the upperchamber.	The ZyMōt Multi SpermSeparation Device has twoprocessing volumes, 850µland 3ml. Each version has aseparation chamber and aninlet port. The separationchamber has a lower samplechamber and an uppercollection chamber. The twochambers are separated by amicroporous filter.	Different: The subject andpredicate devices havedifferences is designs. Thesedifferences in design do notraise different questions ofsafety and effectiveness(S&E).
Mechanismof action	Liquefied semen is placed inthe lower chamber via thesemen injection port andcleared sperm washingmedium is placed in theupper chamber via the spermwashing buffer loading andsample collection port. Theloaded device is incubated at37°C for 30 minutes to allowmotile sperm to swim up andcross the filter to migrate intothe over-laying separationmedium in the uppercollection chamber.	The semen is added to theinlet port to fill the lowersample chamber; then, theseparation medium is addedto the upper collectionchamber. The loaded deviceis incubated at 37°C for 30minutes to allow motile spermto swim up and cross the filterto migrate into the over-layingseparation medium in theupper collection chamber.	Same
Material	Polycarbonate	Polymethylmethacrylate,polycarbonate, flash-spunhigh-density polyethylenefibers.	Different: The subject deviceis comprised of differentmaterials than the predicatedevice. This difference inmaterials does not raisedifferent questions of S&E.
Sterilization	Gamma IrradiationSterilization (SAL 10-6)	Gamma IrradiationSterilization (SAL 10-6)	Same
Usage	Single-use only	Single-use only	Same
Shelf-Life	2-Years	12-Months	Different: The subject devicehas a longer shelf-life thanthe predicate device. Thisdifference in shelf-life doesnot raise different questionsof S&E.
PrescriptionUse	Yes	Yes	Same
Endotoxin	≤ 20 EU/device	≤ 2.15 EU/device	Different: The subject devicehas a higher limit forendotoxin than the predicate
			device. This difference inendotoxin limit does not raisedifferent questions of S&E.
Humanspermsurvivaltesting	≥ 80% of the control motilityat 24 hours after exposure for30 minutes	≥ 80% of the control motilityat 24 hours after exposure for30 minutes	Same

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As shown in the table above, the subject and predicate devices have the same indications for use and 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.

Non-Clinical Performance Data

The following studies have been performed to support substantial equivalence to the predicate device:

Sterilization Testing:

Radiation sterilization and validation was conducted in accordance with ISO 11137-1:2018, 11137-2:2015, and the 2024 FDA Guidance Document, Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile. The subject devices have a Sterility Assurance Level (SAL) of 10-°.

Simulated Transportation/Package Integrity:

Simulated transportation and package integrity testing was performed after accelerated aging to the end of the stated two-year shelf-life per ASTM F1980-21. The simulated transportation and package integrity assessments conducted are shown below:

Simulated transportation conditioning per ASTM D4169-22
Visual inspection of packaging per ASTM F1886/F1886M-16 ●
Dye penetration testing per ASTM F1929-23 ●
Seal strength (peel) testing per ASTM F88/F88M-23

The testing above demonstrated that devices can withstand the rigors of shipping and maintain the sterile barrier over the stated shelf-life duration.

Shelf Life:

The following tests were completed and demonstrated that the subject devices maintained their performance in newly manufactured devices and after two years of

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accelerated aging per ASTM F1980-21:

. Human sperm survival (HSSA) testing: ≥ 80% of the control motility at 24 hours after exposure for 30 minutes

Endotoxin Testing:

Testing conducted in accordance with USP<85>: <20 EU/device.

Performance Testing:

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 total 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:

	% motile sperm(before/after separation)	% change intotal motility	% progressive motilesperm cells (PMSC)(before/after separation)	% change inPMSC
SperŜort™ SpermSorting Chip	57.50 / 95.89%	38.39%	47.07 / 92.97%	45.90%

Conclusion:

The results of the performance testing described above demonstrate that the SperSort™ Sperm Sorting Chip is as safe and effective as the predicate device and supports the 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.