(259 days)
Not Found
No
The device description focuses on a physical separation method based on sperm motility using a chip with chambers and a filter. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance testing measures physical characteristics of the sperm after separation.
Yes.
The device prepares motile sperm for use in the treatment of infertile couples by ICSI, IVF, and IUI procedures, which are therapeutic interventions.
No
The device is intended for "preparing motile sperm from semen" for use in fertility treatments, not for diagnosing a condition or disease. It is a sperm sorting/preparation device, not a diagnostic one.
No
The device description clearly outlines a physical chip with chambers, a porous filter, injection and collection ports, and a sterilization process. This indicates a hardware component, not a software-only device.
Based on the provided information, the SperSort™ Sperm Sorting Chip is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states it's 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." These are procedures performed in vitro (outside the body) using biological samples (semen).
- Device Description: The device processes a biological sample (semen) to isolate a component (motile sperm) for use in in vitro procedures.
- Performance Studies: The performance studies evaluate the device's ability to separate motile sperm from semen samples, measuring metrics like the percentage change in total motility and progressive motile sperm cells. This is a performance evaluation related to the processing of a biological sample for diagnostic or therapeutic purposes.
- Predicate Device: The predicate device listed, K173075 (ZyMot Multi Sperm Separation Device), is also a sperm separation device used in ART procedures, which are typically considered within the scope of IVDs or devices used in conjunction with IVD procedures.
While the device itself doesn't perform a diagnostic test in the traditional sense (like detecting a disease marker), it is a device used to prepare a biological sample for in vitro procedures that are part of the diagnostic and treatment pathway for infertility. Devices used in the preparation of samples for such procedures often fall under the IVD classification or are regulated similarly due to their role in the overall process.
Therefore, the SperSort™ Sperm Sorting Chip fits the definition of a device used in vitro with a biological sample for a purpose related to diagnosis or treatment, making it an IVD.
N/A
Intended Use / 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.
Product codes
MQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Non-Clinical Performance Data
Summary:
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
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 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:
§ 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.
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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
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,
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 Incorporation
4F-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 Chang
iPreg Incorporation
4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist.,
New Taipei City, 221, Taiwan (R.O.C.)
Telephone: +886-8771-3721
Email:
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 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
SperSort™ Sperm Sorting
Chip
K241626 | Predicate Device
ZyMot Multi Sperm
Separation Device
K173075 | Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The ZyMōt Multi 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 | Same |
| | intrauterine insemination (IUI)
procedures. | intrauterine insemination (IUI)
procedures. | |
| Design | The SperŜort™ Sperm
Sorting Chip has a
processing volume of 1.9 mL.
The device consists of upper
and lower case separated by
a porous membrane. The
semen injection port on the
cover connects to the lower
semen chamber, while the
sperm washing buffer loading
and sample collection port
connects to the upper
chamber. | The ZyMōt Multi Sperm
Separation Device has two
processing volumes, 850µl
and 3ml. Each version has a
separation chamber and an
inlet port. The separation
chamber has a lower sample
chamber and an upper
collection chamber. The two
chambers are separated by a
microporous filter. | Different: The subject and
predicate devices have
differences is designs. These
differences in design do not
raise different questions of
safety and effectiveness
(S&E). |
| Mechanism
of action | Liquefied semen is placed in
the lower chamber via the
semen injection port and
cleared sperm washing
medium is placed in the
upper chamber via the sperm
washing buffer loading and
sample collection port. The
loaded device is incubated at
37°C for 30 minutes to allow
motile sperm to swim up and
cross the filter to migrate into
the over-laying separation
medium in the upper
collection chamber. | The semen is added to the
inlet port to fill the lower
sample chamber; then, the
separation medium is added
to the upper collection
chamber. The loaded device
is incubated at 37°C for 30
minutes to allow motile sperm
to swim up and cross the filter
to migrate into the over-laying
separation medium in the
upper collection chamber. | Same |
| Material | Polycarbonate | Polymethylmethacrylate,
polycarbonate, flash-spun
high-density polyethylene
fibers. | Different: The subject device
is comprised of different
materials than the predicate
device. This difference in
materials does not raise
different questions of S&E. |
| Sterilization | Gamma Irradiation
Sterilization (SAL 10-6) | Gamma Irradiation
Sterilization (SAL 10-6) | Same |
| Usage | Single-use only | Single-use only | Same |
| Shelf-Life | 2-Years | 12-Months | Different: The subject device
has a longer shelf-life than
the predicate device. This
difference in shelf-life does
not raise different questions
of S&E. |
| Prescription
Use | Yes | Yes | Same |
| Endotoxin | ≤ 20 EU/device | ≤ 2.15 EU/device | Different: The subject device
has a higher limit for
endotoxin than the predicate |
| | | | device. This difference in
endotoxin limit does not raise
different questions of S&E. |
| Human
sperm
survival
testing | ≥ 80% of the control motility
at 24 hours after exposure for
30 minutes | ≥ 80% of the control motility
at 24 hours after exposure for
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
8
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: