SperSort™ Sperm Sorting Chip (IPG02)

K241626 · Ipreg Incorporation · MQK · Feb 20, 2025 · Obstetrics/Gynecology

Device Facts

• Record ID: K241626
• Device Name: SperSort™ Sperm Sorting Chip (IPG02)
• Applicant: Ipreg Incorporation
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Feb 20, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

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 Story

SperSort™ Sperm Sorting Chip is a single-use, radiation-sterilized labware device for assisted reproduction. It consists of an upper collection chamber and a lower semen sample chamber separated by a porous filter. Operation: 1.9 mL of liquefied semen is loaded into the lower chamber; 1.5 mL of sperm washing medium is added to the upper chamber. After 30 minutes of incubation at 37°C, motile sperm migrate through the filter into the upper chamber. The device is used in clinical laboratories by embryologists or technicians. The output is a concentrated sample of motile sperm, which is then used by clinicians for ICSI, IVF, or IUI procedures. The device benefits patients by isolating high-quality, motile sperm from semen samples, potentially improving the success rates of fertility treatments.

Clinical Evidence

Bench testing only. Performance evaluated using donor semen samples. Results showed an increase in total motile sperm from 57.50% to 95.89% (+38.39%) and progressive motile sperm cells (PMSC) from 47.07% to 92.97% (+45.90%). Human sperm survival assay (HSSA) confirmed ≥80% of control motility at 24 hours post-exposure. Sterility validated per ISO 11137; package integrity and shelf-life (2 years) validated per ASTM F1980, F4169, F1886, F1929, and F88.

Technological Characteristics

Polycarbonate construction; porous membrane filter; 1.9 mL processing volume. Energy source: passive incubation at 37°C. Sterilization: Gamma irradiation (SAL 10^-6). Connectivity: None (standalone). Standards: ISO 11137-1:2018, 11137-2:2015, ASTM F1980-21, ASTM D4169-22, ASTM F1886/F1886M-16, ASTM F1929-23, ASTM F88/F88M-23, USP <85>.

Indications for Use

Indicated for infertile couples undergoing ICSI, IVF, or IUI procedures requiring preparation of motile sperm from semen.

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 Sperm Separation Device (K173075)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|----------------------------------------------|---------------------------------------------|
| <span style="font-size: 20px;">☑</span> | <span style="font-size: 20px;">☐</span> |

|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 Incorporation<br>4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist.,<br>New Taipei City, 221, Taiwan (R.O.C.)<br>Telephone: [phone] |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ching-Wen Chang<br>iPreg Incorporation<br>4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist.,<br>New Taipei City, 221, Taiwan (R.O.C.)<br>Telephone: [phone]<br>Email:<br>[e-mail] |
| 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 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.

# Indication for Use:

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.

# 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 Device<br>SperSort™ Sperm Sorting<br>Chip<br>K241626 | Predicate Device<br>ZyMot Multi Sperm<br>Separation Device<br>K173075 | Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The SperSort™ Sperm<br>Sorting Chip is intended for<br>preparing motile sperm from<br>semen for use in the<br>treatment of infertile couples<br>by intracytoplasmic sperm<br>injection (ICSI), in vitro<br>fertilization (IVF) and | The ZyMōt Multi is intended<br>for preparing motile sperm<br>from semen for use in the<br>treatment of infertile couples<br>by intracytoplasmic sperm<br>injection (ICSI), in vitro<br>fertilization (IVF) and | Same |
| | intrauterine insemination (IUI)<br>procedures. | intrauterine insemination (IUI)<br>procedures. | |
| Design | The SperŜort™ Sperm<br>Sorting Chip has a<br>processing volume of 1.9 mL.<br>The device consists of upper<br>and lower case separated by<br>a porous membrane. The<br>semen injection port on the<br>cover connects to the lower<br>semen chamber, while the<br>sperm washing buffer loading<br>and sample collection port<br>connects to the upper<br>chamber. | The ZyMōt Multi Sperm<br>Separation Device has two<br>processing volumes, 850µl<br>and 3ml. Each version has a<br>separation chamber and an<br>inlet port. The separation<br>chamber has a lower sample<br>chamber and an upper<br>collection chamber. The two<br>chambers are separated by a<br>microporous filter. | Different: The subject and<br>predicate devices have<br>differences is designs. These<br>differences in design do not<br>raise different questions of<br>safety and effectiveness<br>(S&E). |
| Mechanism<br>of action | Liquefied semen is placed in<br>the lower chamber via the<br>semen injection port and<br>cleared sperm washing<br>medium is placed in the<br>upper chamber via the sperm<br>washing buffer loading and<br>sample collection port. The<br>loaded device is incubated at<br>37°C for 30 minutes to allow<br>motile sperm to swim up and<br>cross the filter to migrate into<br>the over-laying separation<br>medium in the upper<br>collection chamber. | 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>chamber. The loaded device<br>is incubated at 37°C for 30<br>minutes to allow motile sperm<br>to swim up and cross the filter<br>to migrate into the over-laying<br>separation medium in the<br>upper collection chamber. | Same |
| Material | Polycarbonate | Polymethylmethacrylate,<br>polycarbonate, flash-spun<br>high-density polyethylene<br>fibers. | Different: The subject device<br>is comprised of different<br>materials than the predicate<br>device. This difference in<br>materials does not raise<br>different questions of S&E. |
| Sterilization | Gamma Irradiation<br>Sterilization (SAL 10-6) | Gamma Irradiation<br>Sterilization (SAL 10-6) | Same |
| Usage | Single-use only | Single-use only | Same |
| Shelf-Life | 2-Years | 12-Months | Different: The subject device<br>has a longer shelf-life than<br>the predicate device. This<br>difference in shelf-life does<br>not raise different questions<br>of S&E. |
| Prescription<br>Use | Yes | Yes | Same |
| Endotoxin | ≤ 20 EU/device | ≤ 2.15 EU/device | Different: The subject device<br>has a higher limit for<br>endotoxin than the predicate |
| | | | device. This difference in<br>endotoxin limit does not raise<br>different questions of S&E. |
| Human<br>sperm<br>survival<br>testing | ≥ 80% of the control motility<br>at 24 hours after exposure for<br>30 minutes | ≥ 80% of the control motility<br>at 24 hours after exposure for<br>30 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<br>(before/after separation) | % change in<br>total motility | % progressive motile<br>sperm cells (PMSC)<br>(before/after separation) | % change in<br>PMSC |
|---------------------------------|---------------------------------------------|-------------------------------|-------------------------------------------------------------------------|---------------------|
| SperŜort™ Sperm<br>Sorting 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.