(319 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological effects of the preservation media, with no mention of AI or ML technologies.
No.
Explanation: Therapeutic devices are generally used to treat, cure, or prevent disease. This device is a preservation medium for human semen samples used in assisted reproductive technology procedures, which is not a direct therapeutic intervention for a disease in the traditional sense. It aids in a reproductive process rather than treating an illness.
No
Explanation: The device description and intended use clearly state that Sperm Freeze and Sperm Fridge are preservation media for semen samples, not devices used for diagnosis. Their purpose is to protect and store sperm for ART procedures.
No
The device description clearly states that the devices are "preservation media" which are liquid solutions, not software. The performance studies also focus on chemical and biological properties of the media.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cryopreservation and refrigerated storage of human semen samples prior to use in assisted reproductive technology procedures. These procedures involve manipulating biological samples outside of the body for diagnostic or therapeutic purposes.
- Device Description: The device is described as "preservation media intended for preserving sperm... for in vitro fertilization (IVF) and assisted reproduction technologies (ART)". "In vitro" literally means "in glass" and refers to procedures performed outside of a living organism. IVF and ART are classic examples of in vitro procedures.
- Laboratory Environment: The device is intended to be used exclusively in a laboratory environment by trained professionals, which is typical for IVD products.
- Performance Studies: The performance studies focus on metrics like "Sperm cryo-survival" and "Sperm refrigeration survival," which are measurements of the biological sample's viability after being treated with the device. This is consistent with evaluating the performance of a reagent or media used in an in vitro process.
- Predicate Device: The predicate device is also described as "Freezing Medium TEST Yolk Buffer (TYB) with Glycerol, Refrigeration Medium TEST Yolk Buffer (TYB)", which are also media used in in vitro procedures.
While the device itself isn't performing a diagnostic test on the sperm (like identifying a disease), it is a critical component used in preparation for in vitro procedures that are part of the diagnostic and therapeutic process of assisted reproduction. The preservation media directly interacts with the biological sample outside the body to maintain its viability for subsequent in vitro use.
Therefore, it fits the definition of an IVD as a product intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the information is about the viability of the sperm for use in ART procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQL
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).
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
intended to be used exclusively in a laboratory environment by trained professionals.
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, sample size, AUC, MRMC, standalone performance, key results)
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
- Osmolality
- pH per USP
- Sperm cryo-survival
- . Sperm refrigeration survival
- Sterility per USP ●
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sperm Fridge-survival ≥ 80% (45 min)
Sperm Cryo-survival ≥ 80% (45 min)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
-
- 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
- Osmolality
- pH per USP
- Sperm cryo-survival
- . Sperm refrigeration survival
- Sterility per USP ●
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.