SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reprocedures. SepaSperm Washing Solution is not intended for use in intrauterine insemination procedures.

SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.

Device Description

SepaSperm is used for preparation and washing of sperm and for separation of motile sperm from semen in assisted reproductive techniques.

The device includes two types of solutions used for density-gradient centrifugation:

. SepaSperm Solution for sperm preparation and separation from semen, and
. SepaSperm Washing Solution for sperm washing and preparation

Both solutions are provided in two sizes (100mL and 50mL bottles). This product is single-use only and includes no accessories. The provided sterile-filtered into a container that is sterilized by gamma irradiation.

SepaSperm Solution is offered in four different densities, determined by the amount of silica present:

SepaSperm Solution 100% -
-Lower laver solution 80%
Middle layer solution 60% -
-Upper layer solution 40%

SepaSperm Solution is composed of silica particles diluted with modified human tubal fluid (m-HTF) medium, with dextran and polyvinylpyrrolidone added. The m-HTF medium is a HEPES-buffered solution which is suitable for use in ambient conditions. All SepaSperm Solutions are provided with and without gentamicin. SepaSperm Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.

The SepaSperm Washing Solution consists of m-HTF medium supplemented with dextran and polyvinylpyrrolidone. It contains no silica. SepaSperm Washing Solution is used to wash the prepared sperm and suspend the final pellet. SepaSperm Washing Solutions are provided with and without gentamicin. SepaSperm Washing Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.

AI/ML Overview

The provided text describes the acceptance criteria and a "Summary of Non-Clinical Performance Testing" for the SepaSperm Washing Solution and SepaSperm Solution, which are reproductive media. This document is a 510(k) summary for a medical device submitted to the FDA, indicating a comparison to a predicate device.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Specification)	Reported Device Performance (Summary of Non-Clinical Performance Testing)
Appearance	Met (implicitly, as it's part of "Shelf Life Performance Testing" and results confirm specifications are met)
Specific gravity: 1.0600-1.1200	Met (implicitly, as results confirm specifications are met)
pH, per USP <791>: 7.2 - 7.6	Met (implicitly, as results confirm specifications are met)
Osmolality, per USP <785>: 270-300 mOsm/Kg	Met (implicitly, as results confirm specifications are met)
Endotoxin, per USP <85>: < 0.25 EU/mL	Met (implicitly, as results confirm specifications are met)
HSSA (Sperm Survival Assay): ≥80% of control motility at 24h	Met (implicitly, as results confirm specifications are met)
Sterility, per USP <71>: No microbial growth	Met (implicitly, as results confirm specifications are met)
Sterile filtration and Aseptic fill validation, per ISO 13408-1:2008(R2013) and ISO 13408-2:2003(R)2013)	Met (implicitly, as results confirm specifications are met)
Transportation testing per ASTM D4169-16	Met (implicitly, as results confirm specifications are met)
Bottle seal strength testing and containers performance testing per <USP 671>	Met (implicitly, as results confirm specifications are met)
Effectiveness of device in three separation modes (sperm assessment for motility, morphology, viability, purity, and integrity before and after separation)	Met (implicitly, as results confirm specifications are met)

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size for individual tests (e.g., how many batches for shelf-life, how many sperm samples for HSSA or separation effectiveness) or the provenance (country of origin, retrospective/prospective nature) of the non-clinical performance test data. It only states that "The following studies have been performed to support substantial equivalence to the predicate devices."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies listed are laboratory performance tests for the media itself, not clinical studies involving expert interpretation of medical images or patient data.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided, as the studies are described as non-clinical performance testing of a medical device (media), not human-read clinical data 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:

This information is not applicable and therefore not provided. This is a 510(k) submission for reproductive media, not an AI-powered diagnostic device.

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

This information is not applicable and therefore not provided. This is a medical device (culture media), not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance testing of these media solutions is based on established laboratory standards and specifications (e.g., USP <791> for pH, USP <785> for osmolality, USP <85> for endotoxin, USP <71> for sterility, ISO 13408 standards for sterile filtration, ASTM D4169 for transportation, USP <671> for container performance). For sperm assessment, the "ground truth" would be the initial characteristics of the sperm samples and their characteristics after processing, compared against expected physiological ranges and performance standards.

8. The sample size for the training set:

This information is not applicable and therefore not provided. This is not a machine learning or AI-based device, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

This information is not applicable and therefore not provided for the reason stated in point 8.

Summary

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September 26, 2019

Kitazato Corporation % Audrey Swearingen Regulatory Affairs Manager Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746

Re: K190199

Trade/Device Name: SepaSperm Washing Solution, SepaSperm Solution Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: August 26, 2019 Received: August 27, 2019

Dear Audrey Swearingen:

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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

For Sharon M. Andrews 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) K190199

Device Name

SepaSperm Washing Solution, SepaSperm Solution

Indications for Use (Describe)

SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reprocedures. SepaSperm Washing Solution is not intended for use in intrauterine insemination procedures.

SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction 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 - K190199

1. Submitter Information

Applicant:	Kitazato Corporation
Contact:	Mr. Futoshi InouePresident and Representative Director
Address:	81 Nakajima, Fuji-shiShizuoka 416-0907Japan

2. Correspondent Information

Contact:	Audrey SwearingenManager, Regulatory Affairs
Address:	Emergo Global Consulting, LLC 2500 BeeCave RoadBuilding 1, Suite 300Austin, TX 78746 USA
Phone:	(512) 327-9997
Fax:	(512) 327-9998
Email:	lst.aus.projectmanagement@ul.com

3. Date prepared: September 23, 2019

4. Device Information

Device Name:	SepaSperm Washing Solution, SepaSperm Solution
Common Name:	Sperm processing media
Regulation Number:	21 CFR 884.6180
Regulation Name:	Reproductive media and supplements
Regulatory Class:	Class II
Product Code:	MQL (media, reproductive)

5. Predicate Device Information

Device Name:	Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit, Sydney IVF Spermient
510(k) Number:	K152782
Manufacturer:	William A. Cook Australia Pty Ltd.
Regulatory Class:	Class II
Product Code:	MQL (media, reproductive)

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

6. Device Description

SepaSperm is used for preparation and washing of sperm and for separation of motile sperm from semen in assisted reproductive techniques.

The device includes two types of solutions used for density-gradient centrifugation:

. SepaSperm Solution for sperm preparation and separation from semen, and
. SepaSperm Washing Solution for sperm washing and preparation

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SepaSperm Solution is offered in four different densities, determined by the amount of silica present:

SepaSperm Solution 100% -
-Lower laver solution 80%
Middle layer solution 60% -
-Upper layer solution 40%

7. Indications for Use

SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reproduction

procedures. SepaSperm Washing Solution is not intrauterine insemination procedures.

SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction

procedures.

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

The table below lists the comparison of the indications for use and technological characteristics of the subject and predicate device.

Manufacturer	Kitazato Corporation	William A. Cook Australia Pty Ltd.
Trade Name	SepaSperm Solution andSepaSperm Washing Solution	Sydney IVF Spermient, Sydney IVFSperm Gradient Kit, and Sydney IVFSperm Medium
510(k) Number	K190199	K152782

Table 1: Comparison of Characteristics

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Indications for Use	SepaSperm Washing Solution isused for preparation and washingof sperm for use in assistedreproduction procedures.SepaSperm Washing Solution isnot intended for use inintrauterine inseminationprocedures.SepaSperm Solution is used forseparation of motilesperm from seminal fluid for usein assisted reproductionprocedures.	Sydney IVF Sperm Gradient Kit andSydney IVF Spermient are intended foruse during in vitro fertilizationprocedures to separate motile sperm fromseminal plasma.Sydney IVF Sperm Medium is intendedfor use during in vitro fertilizationprocedures to process sperm.
Materials ofSpermSeparationSolution	Silica, HEPES buffered saltsolution, D-glucose, water,dextran, polyvinylpyrrolidone;includes options with andwithout gentamicin.	Not known
Materials ofSpermWashingComponent	Same as those of the SepaSpermSolution (above), except that itdoes not contain silica.	Not known
Volume	50mL, 100mL	Sydney IVF Sperm Medium: 20 mL, 50mL, and 100 mLSydney IVF Sperm Gradient Kit: 20 mLand 50 mLSydney IVF Spermient: 200 mL and 100mL
Solutiondensity (%silica)	SepaSperm Solution: 40%,60%, 80%, 100%	Sperm Gradient Kit: 40% and 80%;Sydney IVF Spermient: 100%
Osmolality	270-300 mOsm/kg	285-295 mOsm/kg
pH	7.2 - 7.6	Sydney IVF Sperm Medium: 7.5-7.8Sydney IVF Sperm Gradient Kit /SydneyIVF Spermient: 7.3-7.5
SpermSurvivalAssay(HSSA)	≥80% of control motility at 24h	Performed, specification not known
Endotoxin	≤0.25 EU/mL	<0.4 EU/mL
Sterility	Sterile filtration	Sterile filtration

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Storagetemperature	2 - 8°C	2 - 8°C
Shelf Life	6 months (without gentamicin);1 year (with gentamicin)	20 weeks

The subject and predicate device have similar indications for use and have the same intended use (preparation, separation, and washing of sperm for use in assisted reproduction procedures). The subject and predicate device have similar technological characteristics as shown in the table above (e.g., design, gradient concentrations, osmolality, pH, sterilization method, etc.). The different technological characteristics of the subject device (e.g., formulation, shelf-life, endotoxin specifications, etc.) do not raise different types of safety and effectiveness questions.

9. Summary of Non-Clinical Performance Testing

The following studies have been performed to support substantial equivalence to the predicate devices. Results confirm that the design inputs and performance specifications for the device are met.

Shelf Life Performance Testing (Time 0 and end of shelf-life):
- o Appearance
- Specific gravity: 1.0600-1.1200 о
- pH, per USP <791>: 7.2 7.6 o
- Osmolality, per USP <785>: 270-300 mOsm/Kg o
- Endotoxin, per USP <85>: < 0.25 EU/mL o
- HSSA: ≥80% of control motility at 24h o
- Sterility, per USP <71>: No microbial growth o
Sterile filtration and Aseptic fill validation, per ISO 13408-1:2008(R2013) and ISO 13408-● 2:2003(R)2013)
Transportation testing per ASTM D4169-16
Bottle seal strength testing and containers performance testing per <USP 671> ●
Sperm assessment for motility, morphology, viability, purity, and integrity before and after ● separation procedures to assess the effectiveness of the device when used in the three separation modes stated in device labeling.

10. Conclusion

The results of the performance testing described above demonstrate that the SepaSperm Washing Solution and SepaSperm Solution are as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.