Sperm Freeze and Sperm Fridge are preservation media intended for preserving sperm (short-term and long-term) for in vitro fertilization (IVF) and assisted reproduction technologies (ART). There are two methods for sperm preservation; freezing and refrigeration. Freezing is necessary for long-term sperm preservation, but may have disadvantages such as reduced survival rate and/or sperm motility after thawing. Refrigeration makes it possible to preserve sperm for several days without freezing and may be preferable for short-term preservation. Both products are intended to be used exclusively in a laboratory environment by trained professionals.

Sperm Freeze is a is a Tris-buffered solution containing the cryoprotectants glycerol and trehalose that is used for long-term sperm cryopreservation procedures. Sperm Fridge is a buffered solution (TES and Tris) that includes a nutrient source for sperm (dextrose) that is used for short-term sperm preservation procedures. Sperm Freeze and Sperm Fridge are offered in two volumes (0.5 mL and 10 mL, and 0.5 mL is sold in a pack of 5).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Sperm Freeze, Sperm Fridge" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method	Acceptance Criteria (Sperm Fridge)	Reported Performance (Sperm Fridge)	Acceptance Criteria (Sperm Freeze)	Reported Performance (Sperm Freeze)
Appearance	Not specified in table	Passed	Not specified in table	Passed
Endotoxin (per USP <85>)	≤ 0.25 EU/mL	Met Criteria	≤ 0.25 EU/mL	Met Criteria
Osmolality	Not specified in table	Passed	Not specified in table	Passed
pH (per USP <791>)	7.2–7.6	Met Criteria	7.2–7.6	Met Criteria
Sperm Refrigeration Survival	≥ 80% (45 min)	Met Criteria	N/A (for Sperm Freeze)	N/A
Sperm Cryo-survival	N/A (for Sperm Fridge)	N/A	≥ 80% (45 min)	Met Criteria
Sterility (per USP <71>)	No growth	Met Criteria	No growth	Met Criteria
Shelf-life performance testing	Met product specifications	Met Criteria	Met product specifications	Met Criteria

Note: The "Reported Performance" column indicates that the device "passed" or "met criteria" based on the general statement in section 9: "Results confirm that the design inputs and performance specifications for the devices are met." Specific numerical results for each test (e.g., the exact percentage for sperm survival) are not provided in this summary.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Kitazato completed the following non-clinical tests" and refers to "internal requirements, national standards, and international standards."

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 studies described are non-clinical (laboratory testing of the media itself), not clinical studies involving human samples and expert evaluation of outcomes in the way one might see for an AI diagnostic device.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests described are non-clinical and do not involve human interpretation or adjudication of results.

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 is not applicable. The device (Sperm Freeze, Sperm Fridge) is a reproductive media product, not an AI or imaging device that would involve human readers or AI assistance in interpretation. No MRMC study was conducted.

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

This is not applicable. The device is a chemical medium, not an algorithm or software. No standalone performance testing in this context was performed.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests appears to be laboratory measurements against established specifications and standards. For example, the pH measurement would be compared to the specified pH range (7.2-7.6), endotoxin levels compared to the maximum allowed (≤ 0.25 EU/mL), and sperm survival rates compared to the minimum required (≥ 80%). The "ground truth" is essentially the predefined acceptable range or threshold for each physical/chemical/biological property of the media.

8. The Sample Size for the Training Set:

This is not applicable. The device is a manufactured product, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 17, 2020

Kitazato Corporation % Michael A. Siano, MA Regulatory Affairs Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746

K192845 Re:

Trade/Device Name: Sperm Freeze, Sperm Fridge Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: July 6, 2020 Received: July 9, 2020

Dear Michael A. Siano:

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.

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.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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, Ph.D. Acting 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) K192845

Device Name Sperm Freeze Sperm Fridge

Indications for Use (Describe)

Sperm Freeze is intended for the cryopreservation of human semen samples prior to use in assisted reproductive technology procedures.

Sperm Fridge is intended to protect human semen samples during refrigerated storage prior to use in assisted reproductive technology 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

K192845 - Sperm Freeze, Sperm Fridge

1. Submitter Information

Applicant:	Kitazato Corporation
Contact:	Mr. Futoshi InouePresident and Representative Director
Address:	81 NakajimaFuji ShizuokaJAPAN 416-0907
Phone:	+81 545 66 2202

2. Correspondent Information

Contact:	Michael A. SianoRegulatory Affairs Consultant
Address:	Emergo Global Consulting, LLC2500 Bee Cave RoadBuilding 1, Suite 300Austin, TX 78746USA
Phone:	(512) 327-9997

1. Date Prepared: August 17, 2020

Device Information 4.

Device Name:	Sperm Freeze, Sperm Fridge
Common Name:	Cryopreservation/refrigeration media
Regulation Number:	21 CFR 884.6180
Regulation Name:	Reproductive media and supplements
Product Code:	MQL (Media, Reproductive)
Regulatory Class:	Class II

5. Predicate Device(s)

Device Name:	Freezing Medium TEST Yolk Buffer (TYB) with Glycerol, Refrigeration Medium
	TEST Yolk Buffer (TYB)
510(k) Number:	K991421
Manufacturer:	Irvine Scientific

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

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6. Device Description

Device specifications for Sperm Freeze and Sperm Fridge are detailed in Tables 1 and 2 below.

7. Indications for Use

Sperm Freeze is intended for the cryopreservation of human semen samples prior to use in assisted reproductive technology procedures.

Sperm Fridge is intended to protect human semen samples during refrigerated storage prior to use in assisted reproductive technology procedures.

8. Substantial Equivalence Discussion

A detailed comparison of the intended use and technological features of the subject and predicate device are described in the tables below:

Table 1: Comparison of Characteristics, Sperm Fridge

Attribute	K191485Subject Device:Sperm Fridge	K991421Predicate Device:Refrigeration Medium- TEST YolkBuffer (TYB)	Comparison
Manufacturer	Kitazato	Irvine Scientific	Different
Product Code	MQL	MQL	Same
Indications for use	Sperm Fridge is intended to protecthuman semen samples duringrefrigerated storage prior to use inassisted reproductive technologyprocedures.	Refrigeration Medium -Test Yolk Bufferand Freezing Medium - Test YolkBuffer with Glycerol are intended foruse in assisted reproductivetechnology procedures that involve themanipulation and storage of semensamples prior to use in in vitrofertilization and other similartreatments. Refrigeration Medium -Test Yolk Buffer is specifically designedfor to protect semen samples duringrefrigerated storage, while Freezing	Different

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		Medium - Test Yolk Buffer withGlycerol is intended to be used as acryopreservative of semen samples.
Rx/OTC	Rx	Rx	Same
Ingredients	TES; Tris; Dextrose; GentamicinSulfate; Recombinant HumanAlbumin	TES; Tris; Dextrose; Egg Yolk; Penicillin-G; Streptomycin Sulfate	Different
pH	7.2–7.6	7.2 ± 0.2	Different
Endotoxin	≤ 0.25 EU/mL	≤ 3 EU/mL	Different
Sterility	No growth	No growth	Same
Sperm Fridge-survival	≥ 80% (45 min)	N/A	Different
Storage Conditions	-20°C	-10°C	Different
Shelf-life	1 year	2 years	Different
Sterilization	Aseptic Filtration	Aseptic Filtration	Same

Table 2: Comparison of Characteristics, Sperm Freeze

Attribute	K191485Subject Device:Sperm Freeze	K991421Predicate Device:Freezing Medium-TEST YolkBuffer(TYB) with Glycerol	Comparison
Manufacturer	Kitazato	Irvine Scientific	Different
Product Code	MQL	MQL	Same
Indications for Use	Sperm Freeze is intended for thecryopreservation of human semensamples prior to use in assistedreproductive technologyprocedures.	Refrigeration Medium -Test Yolk Bufferand Freezing Medium - Test YolkBuffer with Glycerol are intended foruse in assisted reproductivetechnology procedures that involve themanipulation and storage of semensamples prior to use in in vitrofertilization and other similartreatments. Refrigeration Medium -Test Yolk Buffer is specifically designedfor to protect semen samples duringrefrigerated storage, while FreezingMedium - Test Yolk Buffer withGlycerol is intended to be used as acryopreservative of semen samples.	Different
Rx/OTC	Rx	Rx	Same
Ingredients	Water; Calcium DL-Lactate;Disodium Hydrogenphosphate;Gentamicin; Glycerol; Glycine;Lauryl Alcohol; MagnesiumSulfate; Potassium Chloride;Recombinant Human Albumin;	Water; TES; Tris; Sodium Citrate;Fructose; Glycerol; Egg Yolk;Penicillin-G; Streptomycin Sulfate	Different

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	Sodium Bicarbonate; SodiumChloride; Sodium Phosphate;Tocopherol; Trehalose; Tris
pH	7.2–7.6	7.0-7.4	Different
Endotoxin	$≤$ 0.25 EU/mL	$≤$ 3 EU/mL	Different
Sterility	No growth	No growth	Same
Sperm Cryo-survival	$≥$ 80% (45 min)	N/A	Different
Storage Conditions	-20 °C	-10 °C	Different
Shelf-Life	1 year	2 years	Different
Sterilization	Aseptic Filtration	Aseptic Filtration	Same

The subject and predicate device have similar indications for use statements and have the same intended use - to cryopreserve or refrigerate human semen samples prior to use in assisted reproductive technology procedures. The subject and predicate device have different technological characteristics, including differences in formulation, pH, endotoxin, storage conditions, and shelf-life. These differences do not raise different questions of safety and effectiveness as compared to the predicate device.

9. Summary of Non-Clinical Performance Testing

To demonstrate safety and effectiveness of Sperm Freeze and Sperm Fridge and to show substantial equivalence to the predicate device, Kitazato completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the devices are met.

The device passed all testing in accordance with internal requirements, national standards, and international standards shown below:

Appearance
Endotoxin per USP <85>
Osmolality
pH per USP <791>
Sperm cryo-survival
. Sperm refrigeration survival
Sterility per USP <71> ●

Shelf-life performance testing was conducted at Time 0 and beyond the shelf-life (>12 months) to ensure that the product specifications listed above were met.

10. Conclusions

The results of the performance testing described above demonstrate that Sperm Freeze and Sperm Fridge 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.