Who is the manufacturer of Sperm Freeze, Sperm Fridge?

Kitazato Corporation filed the 510(k) submission for Sperm Freeze, Sperm Fridge (K192845).

What is the FDA product code for Sperm Freeze, Sperm Fridge?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Sperm Freeze, Sperm Fridge?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Sperm Freeze, Sperm Fridge?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sperm Freeze, Sperm Fridge

K192845 · Kitazato Corporation · MQL · Aug 17, 2020 · Obstetrics/Gynecology

Device Facts

Record ID	K192845
Device Name	Sperm Freeze, Sperm Fridge
Applicant	Kitazato Corporation
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Aug 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended 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.

Device Story

Sperm Freeze and Sperm Fridge are preservation media for human semen samples used in ART. Sperm Freeze, a Tris-buffered solution containing glycerol and trehalose, facilitates long-term cryopreservation. Sperm Fridge, a TES and Tris-buffered solution containing dextrose, facilitates short-term refrigerated storage. Both products are intended for laboratory use by trained professionals. The media protect sperm viability during storage, mitigating the negative effects of freezing or refrigeration on sperm motility and survival. Healthcare providers use these media to prepare samples for IVF or other ART treatments, potentially improving patient outcomes by maintaining sample quality prior to clinical use.

Clinical Evidence

Bench testing only. Performance testing included appearance, osmolality, pH (USP <791>), endotoxin (USP <85>), sterility (USP <71>), and sperm survival rates (cryo-survival and refrigeration survival). Shelf-life testing was conducted at Time 0 and beyond 12 months to verify specifications.

Technological Characteristics

Buffered solutions (Tris/TES). Sperm Freeze contains glycerol, trehalose, and recombinant human albumin. Sperm Fridge contains dextrose and recombinant human albumin. Sterilization via aseptic filtration. pH 7.2–7.6. Endotoxin ≤ 0.25 EU/mL. Storage at -20°C.

Indications for Use

Indicated for human semen sample preservation (cryopreservation or refrigerated storage) prior to assisted reproductive technology (ART) procedures. Prescription use only.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

Freezing Medium TEST Yolk Buffer (TYB) with Glycerol, Refrigeration Medium (K991421)

Related Devices

K113786 — SPERMFREEZE SOLUTION · Vitrolife Sweden AB · Oct 26, 2012
K991421 — FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) · Irvine Scientific Sales Co., Inc. · Jul 2, 1999
K991333 — MEDI-CULT SPERM FREEZE MEDIUM · Medicult A/S · Feb 28, 2000
K030117 — ENHANCE SPERM FREEZE · Conception Technology, Inc. · Mar 20, 2003
K070689 — LG SPERM FREEZING · Genx Intl., Inc. · Jul 3, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | --- #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## K192845 - Sperm Freeze, Sperm Fridge ### 1. Submitter Information | Applicant: | Kitazato Corporation | |------------|------------------------------------------------------------| | Contact: | Mr. Futoshi Inoue President and Representative Director | | Address: | 81 Nakajima Fuji Shizuoka JAPAN 416-0907 | | Phone: | +81 545 66 2202 | #### 2. Correspondent Information | Contact: | Michael A. Siano Regulatory Affairs Consultant | |----------|---------------------------------------------------------------------------------------------------------| | Address: | Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 USA | | Phone: | (512) 327-9997 | - 3. 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. {4}------------------------------------------------ #### 6. Device Description 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). 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 | K191485 Subject Device: Sperm Fridge | K991421 Predicate Device: Refrigeration Medium- TEST Yolk Buffer (TYB) | Comparison | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Kitazato | Irvine Scientific | Different | | Product Code | MQL | MQL | Same | | Indications for use | Sperm Fridge is intended to protect human semen samples during refrigerated storage prior to use in assisted reproductive technology procedures. | Refrigeration Medium -Test Yolk Buffer and Freezing Medium - Test Yolk Buffer with Glycerol are intended for use in assisted reproductive technology procedures that involve the manipulation and storage of semen samples prior to use in in vitro fertilization and other similar treatments. Refrigeration Medium - Test Yolk Buffer is specifically designed for to protect semen samples during refrigerated storage, while Freezing | Different | {5}------------------------------------------------ | | | Medium - Test Yolk Buffer with Glycerol is intended to be used as a cryopreservative of semen samples. | | |---------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------| | Rx/OTC | Rx | Rx | Same | | Ingredients | TES; Tris; Dextrose; Gentamicin Sulfate; Recombinant Human Albumin | 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 | K191485 Subject Device: Sperm Freeze | K991421 Predicate Device: Freezing Medium-TEST Yolk Buffer(TYB) with Glycerol | Comparison | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Kitazato | Irvine Scientific | Different | | Product Code | MQL | MQL | Same | | Indications for Use | Sperm Freeze is intended for the cryopreservation of human semen samples prior to use in assisted reproductive technology procedures. | Refrigeration Medium -Test Yolk Buffer and Freezing Medium - Test Yolk Buffer with Glycerol are intended for use in assisted reproductive technology procedures that involve the manipulation and storage of semen samples prior to use in in vitro fertilization and other similar treatments. Refrigeration Medium - Test Yolk Buffer is specifically designed for to protect semen samples during refrigerated storage, while Freezing Medium - Test Yolk Buffer with Glycerol is intended to be used as a cryopreservative of semen samples. | Different | | Rx/OTC | Rx | Rx | Same | | Ingredients | Water; Calcium DL-Lactate; Disodium Hydrogenphosphate; Gentamicin; Glycerol; Glycine; Lauryl Alcohol; Magnesium Sulfate; Potassium Chloride; Recombinant Human Albumin; | Water; TES; Tris; Sodium Citrate; Fructose; Glycerol; Egg Yolk; Penicillin-G; Streptomycin Sulfate | Different | {6}------------------------------------------------ | | Sodium Bicarbonate; Sodium Chloride; 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.