(158 days)
No
The device description and performance studies focus on the physical characteristics and performance of a cryopreservation storage device, with no mention of AI or ML technologies.
No.
The devices are storage devices used in vitrification procedures to contain and maintain human oocytes and embryos, not to treat a disease or condition in a patient.
No
The devices are described as "cryopreservation storage devices" intended for use in "vitrification procedures to contain and maintain human oocytes (MII) and embryos." They do not perform any diagnostic function; they merely store biological material.
No
The device description clearly outlines physical components made of polypropylene, acrylonitrile butadiene styrene, polyethylene terephthalate, and polystyrene, indicating it is a hardware device for cryopreservation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos." This describes a device used to physically store biological material, not a device used to perform a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description details the physical components and function of the device for holding and sealing oocytes/embryos during vitrification. It does not mention any reagents, assays, or analytical processes typically associated with IVDs.
- Performance Studies: The performance studies focus on the physical properties of the device (cooling/warming rates, dimensions, durability, mechanical strength, sterility, endotoxins, and mouse embryo assay for biocompatibility), not on the accuracy or performance of a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other characteristics commonly found in the description of an IVD.
Therefore, the Cryotop®US-flash and Cryotop®US-scoop are devices for the storage and preservation of biological material, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Cryotop®US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.
Product codes
MQK
Device Description
This 510(k) covers two subject devices, the Cryotop®US-flash and Cryotop®US-scoop that are modified versions of the predicate device (Cryotop®US, K153027). Both devices are cryopreservation storage devices intended for embryo/oocyte vitrification. Cryotop®US-flash and Cryotop®US-scoop are provided sterile and are for single-use only.
The Cryotop®US-flash is composed of a polypropylene straw and an acrylonitrile butadiene styrene handle with a polyethylene terephthalate fine tip where oocytes or embryos are loaded. The fine device is flat with a triangular-shaped area for oocyte/embryo loading. The Cryotop®US-scoop is composed of a polypropylene straw and a polystyrene handle and fine tip where oocytes or embryos are loaded. The fine tip of this device is U-shaped. After oocyte or embryo loading, the handle of the subject devices is inserted into the straw enclosure. A hermetic seal is created via a tapered handle with a stop location integrated into the handle. As the handle is placed into the straw enclosure it creates a closed system keeping the fine tip isolated from the liquid nitrogen. The straw component of both devices also includes a weight at its distal end to aid in maintaining correct device position during storage in liquid nitrogen.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted to support substantial equivalence to the predicate device. Cryotop®US-flash and Cryotop®US-scoop passed all the tests shown below in accordance with internal requirements and applicable standards.
- Cooling Rate Testing - 3,000°C/min
- Warming Rate Testing 44,000°C/min .
- Dimensional Testing - Outer diameter and length per specifications
- . Durability Testing: No burst or liquid nitrogen ingress into straw after 30 second immersion
- Mechanical Tensile Testing – Tensile strength to withstand 5N
- Bacterial Endotoxins – and ANSI/AAMI ST72:2002/(R)2010
- . Mouse Embryo Assay (MEA) – ≥80% of 1-cell embryos developed to blastocysts at 96 hours
- Transportation simulation testing per ASTM D4169-09
- Shelf-life Testing:
- Package integrity testing:
- Dye penetration test per ASTM F1929-15 O
- O Seal strength test per ASTM F88/F88M-15
- Dimensional analysis, mechanical, durability, endotoxin, and MEA testing in accordance with the methods and acceptance criteria mentioned above
- Package integrity testing:
In addition, information regarding sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013 provided in K153027 was leveraged to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the agency's name in a sans-serif font.
November 9, 2018
Kitazato Corporation % Diane Sudduth Senior Consultant, RA Emergo Global Consulting. LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K181469
Trade/Device Name: Cryotop®US-flash and Cryotop®US-scoop Regulation Number: 21 CFR& 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: October 10, 2018 Received: October 11, 2018
Dear Diane Sudduth:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael T. Bailey -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181469
Device Name
Cryotop®US-flash and Cryotop®US-scoop
Indications for Use (Describe)
Cryotop@US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.
| 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 — K181469
1. Submission Sponsor
Kitazato Corporation 81 Nakajima, Fuji-city Shizuoka 416-0907 JAPAN Phone number: +(81) 546-66-2202 Contact: Futoshi Inoue Title: President
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Diane Sudduth Title: Senior Consultant, RA
3. Date Prepared
November 8, 2018
4. Device Identification
| Trade Name: | Cryotop®US-flash and Cryotop®US-scoop |
|---|---|
| Common Name: | Cryopreservation Storage Device |
| Regulation Name: | Assisted Reproduction Labware |
| Regulation Number: | 21 CFR 884.6160 |
| Product Code: | MQK (Labware, Assisted Reproduction) |
| Regulatory Class: | II |
5. Predicate Device
Cryotop®US (K153027) manufactured by Kitazato Corporation (formally KITAZATO BIOPHARMA CO., LTD.) This predicate device has not been subject to any design related recalls.
6. Device Description
This 510(k) covers two subject devices, the Cryotop®US-flash and Cryotop®US-scoop that are modified versions of the predicate device (Cryotop®US, K153027). Both devices are cryopreservation storage devices intended for embryo/oocyte vitrification. Cryotop®US-flash and Cryotop®US-scoop are provided sterile and are for single-use only.
4
The Cryotop®US-flash is composed of a polypropylene straw and an acrylonitrile butadiene styrene handle with a polyethylene terephthalate fine tip where oocytes or embryos are loaded. The fine device is flat with a triangular-shaped area for oocyte/embryo loading. The Cryotop®US-scoop is composed of a polypropylene straw and a polystyrene handle and fine tip where oocytes or embryos are loaded. The fine tip of this device is U-shaped. After oocyte or embryo loading, the handle of the subject devices is inserted into the straw enclosure. A hermetic seal is created via a tapered handle with a stop location integrated into the handle. As the handle is placed into the straw enclosure it creates a closed system keeping the fine tip isolated from the liquid nitrogen. The straw component of both devices also includes a weight at its distal end to aid in maintaining correct device position during storage in liquid nitrogen.
7. Indication for Use
Cryotop®US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.
| Devices | K181469 (subject device) | K153027 (predicate device) |
|---|---|---|
| Indications for | ||
| Use | Cryotop®US-flash and Cryotop®US-scoop are | |
| cryopreservation storage devices that are | ||
| intended for use in vitrification procedures to | ||
| contain and maintain human oocytes (MII) and | ||
| embryos. | The Cryotop®US is a cryopreservation | |
| storage device that is intended for use in | ||
| vitrification procedures to contain and | ||
| maintain human 4-8 cell and blastocyst | ||
| stage embryos. | ||
| Fundamental | ||
| design | Same as the predicate | A handle incorporating a sample-loading |
| tip, and a cap (straw) to close the device. | ||
| Film tip shape | Cryotop®US-flash - Flat | |
| Cryotop®US-scoop - U-shape | Flat | |
| Dimensions | Cryotop®US-flash: | |
| • Total length - 116 mm | ||
| • Film tip length - 18 mm | ||
| • Handle length - 98 mm | ||
| • Straw length - 90 mm | ||
| • Straw diameter - 3 mm | ||
| Cryotop®US-scoop: | ||
| • Total length - 113 mm | ||
| • Film tip length - 15 mm | ||
| • Handle length - 98 mm | ||
| • Straw length - 90 mm | ||
| • Straw diameter - 3 mm | • Total length - 105 mm | |
| • Film tip length - 20 mm | ||
| • Handle length - 85 mm | ||
| • Straw length - 100 mm | ||
| • Straw diameter - 2.9 mm | ||
| Mode of action | Same as the predicate | Vitrification method - The loaded, closed |
| device is placed in liquid nitrogen | ||
| Cooling rate | Same as the predicate | 3000 °C/min |
| Warming rate | Same as the predicate | 44000 °C/min |
| Materials | Cryotop®US-flash: | |
| • Handle – acrylonitrile butadiene styrene | ||
| • Fine tip – polyethylene terephthalate | ||
| • Straw – polypropylene/stainless steel | ||
| Cryotop®US-scoop: | ||
| • Handle and fine tip – polystyrene | ||
| • Straw - polypropylene/stainless steel | • Handle – acrylonitrile butadiene styrene | |
| Film sheet – polyethylene terephthalate | ||
| • Straw – polypropylene/stainless steel |
8. Substantial Equivalence Discussion
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The subject devices are indicated to contain, vitrify and maintain MII oocytes and all stages of embryo development (2 PN-blastocyst stage), whereas the predicate device is only indicated for cleavage and blastocyst stage embryos. Inclusion of MII oocytes and earlier stage embryos (2 PN) in the subject devices indications does not represent a new intended use because processing of the embryos or oocytes is applicable to same patient population with same clinical needs – infertility preservation. Therefore, the subject and predicate devices have the same intended use.
Cryotop®US-flash and the predicate device have technological characteristics including design, mode of action, materials and cooling/warming rates; however, they have differences in dimensions. Cryotop®USscoop and the predicate device have the same fundamental design, mode of action and cooling/warming rates; however, they have differences in dimensions and materials. The differences noted do not raise different questions of safety and effectiveness.
9. Summary of Non-Clinical Performance Data
Non-clinical performance testing was conducted to support substantial equivalence to the predicate device. Cryotop®US-flash and Cryotop®US-scoop passed all the tests shown below in accordance with internal requirements and applicable standards.
- . Cooling Rate Testing - 3,000°C/min
- Warming Rate Testing 44,000°C/min .
- Dimensional Testing - Outer diameter and length per specifications
- . Durability Testing: No burst or liquid nitrogen ingress into straw after 30 second immersion
- Mechanical Tensile Testing – Tensile strength to withstand 5N
- Bacterial Endotoxins – and ANSI/AAMI ST72:2002/(R)2010
- . Mouse Embryo Assay (MEA) – ≥80% of 1-cell embryos developed to blastocysts at 96 hours
- Transportation simulation testing per ASTM D4169-09
- Shelf-life Testing: ●
- Package integrity testing:
- Dye penetration test per ASTM F1929-15 O
- O Seal strength test per ASTM F88/F88M-15
- Dimensional analysis, mechanical, durability, endotoxin, and MEA testing in accordance with the methods and acceptance criteria mentioned above
- Package integrity testing:
In addition, information regarding sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013 provided in K153027 was leveraged to support substantial equivalence.
10. Clinical Performance Data
Clinical information provided in K171748 (Kitazato Corporation Vitrification Kit and Thawing Kit) that incorporates the predicate Cryotop®US device was leveraged in supporting the additional uses of the Cryotop®US-flash and Cryotop®US-scoop for oocyte an 2 PN embryo vitrification procedures.
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11. Conclusion
The subject and predicate devices have intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.