(175 days)
None
No
The device description and performance studies focus on a fluid-based mechanical separation process, with no mention of AI or ML.
No.
The device is intended for preparing motile sperm for assisted reproductive technology procedures and does not directly treat a disease or condition in a patient.
No
The device description clearly states it is a "sperm separation device used to prepare motile sperm for assisted reproductive technology (ART) procedures," and its intended use is for "preparing motile sperm from semen." It does not mention diagnosing any condition or disease.
No
The device description clearly outlines a physical device with a fluid-filled microstructure, wells, and a collection outlet, which is sterilized and individually packaged. This indicates a hardware component, not a software-only device.
Based on the provided information, the SpermAlign Sperm Separation Device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is 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." This preparation of a biological sample (semen) for subsequent medical procedures falls under the scope of in vitro diagnostics.
- Device Description: The device description details how it processes a biological sample (semen) to isolate a specific component (motile sperm) for use in ART procedures. This manipulation and preparation of a biological sample outside of the body is characteristic of an IVD.
- Performance Studies: The performance studies include testing like "Human Sperm Survival Assay" and "Sperm Separation Performance," which evaluate the device's ability to process and prepare a biological sample (sperm) for its intended use. These types of studies are typical for IVDs that interact with biological materials.
- Predicate Devices: The predicate devices listed (ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device) are also sperm separation devices used in ART procedures, and these types of devices are generally classified as IVDs.
While the device doesn't perform a diagnostic test in the traditional sense (like detecting a disease marker), it is a device used in vitro (outside the body) to prepare a biological sample for a medical procedure aimed at treating infertility. This function aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MQK
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 IVF procedures.
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.
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
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:
- Visual inspection (ASTM F1886/F1886M)
- Bubble leak (ASTM F2096-11 (2019)) o
- Seal strength (ASTM F88/F88M-16) O
- Endotoxin testing per USP and ANSI/AAMI ST72:2019:
§ 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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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.
1
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
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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)
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.
| 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
-
- Submitter
| Applicant: | CytoSwim Ltd |
|---|---|
| Address: | Unit 34, The Venture Centre |
| University of Warwick Science Park, | |
| Coventry, | |
| CV4 7EZ | |
| UK | |
| Telephone: | Tel: +44 (0) 7833254489 |
| Date Prepared: | March 11, 2024 |
2. Correspondent Information
| Contact Person: | Zennia Paniwnyk |
|---|---|
| Contact Title: | Senior Regulatory and Quality Consultant |
| Insight 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 Multi | |
| Sperm Separation Device (850µl, 3ml) | K173075 |
The predicate device has not been subject to a design-related recall.
5
ട. Description of Device
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 106. The devices are individually packaged and for single use only.
Indications for Use 6.
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.
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 Sperm
Separation Device (subject
device) - K232980 | ZyMot Multi Sperm
Separation Device (850µl,
3ml) (predicate device) –
K173075 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | 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. | The ZyMōt Multi Sperm Separation
Device 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. |
| Design | SpermAlign is a disposable,
circular device. The lid has 6
identical outer wells and a central
well. A microstructure covers the
inside surface of the base to
direct the motile sperm to the
central outlet. | A disposable culture dish
containing 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. |
| Mechanism of
Action | Media is added via the central
well to cover the microstructure.
Liquefied semen is added to each
of the 6 inlet ports and media
further added to the central well.
The device is incubated for 30
minutes allowing the motile
sperm to swim against the
microstructure pillars to the
central well for collection. | 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 min to allow
motile sperm to swim up and
cross the filter to migrate into
the over-laying separation
medium in the upper
collection chamber. |
| Material | Polypropylene and silicone
adhesive | Polymethylmethacrylate,
polycarbonate, flash-spun
high-density |
| 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 |
| Endotoxin | and ANSI/AAMI ST72:2019: