(80 days)
Not Found
No
The device description and performance testing focus on the physical properties and biological compatibility of a cryopreservation storage device, with no mention of AI or ML.
No.
The device is a cryopreservation storage device for maintaining human embryos and does not directly treat a disease or condition.
No
The device is described as a cryopreservation storage device intended to contain and maintain human embryos during vitrification procedures. Its function is to store and preserve, not to diagnose.
No
The device description explicitly details physical components (ABS handle shaft, PET fine tip, straw enclosure, straw cap, weight) and mentions an accompanying physical device (Aluminum Block). It also describes physical testing (tensile strength, dimensions).
Based on the provided information, the Cryotop®SC device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "contain and maintain human 4-8 cell and blastocyst stage embryos" during vitrification procedures. This is a storage and handling function, not a diagnostic test performed in vitro on a specimen to provide information about a patient's health.
- Device Description: The description focuses on the physical components and how it's used to hold and protect embryos during freezing and thawing. It doesn't describe any reagents, assays, or analytical processes typically associated with IVDs.
- Performance Studies: The performance studies evaluate the device's physical properties (cooling/warming rates, dimensions, tensile strength), sterility, and lack of toxicity to mouse embryos. These are tests to ensure the device functions correctly for its intended purpose of preserving embryos, not to assess its ability to diagnose a condition.
- Lack of Diagnostic Metrics: There are no mentions of typical IVD performance metrics like sensitivity, specificity, PPV, or NPV.
The Cryotop®SC is a medical device used in assisted reproductive technology (ART) procedures for the preservation of embryos. It facilitates a process (vitrification) but does not perform a diagnostic test.
N/A
Intended Use / Indications for Use
The Cryotop®SC 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.
Product codes
MQK
Device Description
CryotopSC 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. Extracting embryos from the body can be costly and burdensome process for the patient to go through multiple extraction procedures. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopSC device for subsequent storage.
The CryotopSC device is composed of an ABS handle shaft with a PET fine tip and a straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopSC device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The straw cap is designed to be heat sealed by the user. The straw cap has a weight at the distal end to place the straw cap and the shaft inside of the cap in a correct position in the liquid nitrogen. The CryotopSC device is provided sterile and is for single use only. The CryotopSC device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.
The Aluminum Block is required for use with the CryotopSC device for the vitrification and thawing process and is sold separately. The Aluminum Block is to be used with the CryotopSC device to prevent liquid nitrogen from entering the straw and to assist in stabilizing the manipulation of the straw.
The CryotopSC device conforms to product quality test specifications of our company: appearance, dimension, durability, tensile strength, colorfastness, endotoxin and Mouse Embryo Assay. The sterilization dose of CryotopSC is validated by sterilization to maintain the sterility of the device through anticipated storage and handling.
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
Performance Testing
- Cooling Rate Testing: Cooling rate of 3,000 °C/min passed.
- Warming Rate Testing: Warming rate of 44,000 °C/min passed.
- Dimensional Testing: Passes outer diameter and length according to specifications.
- Mechanical Tensile Testing: Tensile strength to withstand 5N.
- Endotoxin Testing: Endotoxin values conform to the value ≤0.5 EU/device.
- Sterility Testing: No microbial growth from sterility testing.
- Mouse Embryo Assay: ≥80% of 1-cell control embryos develop at 96 hours.
Note: The performance testing, Mouse Embryo Assay (MEA), and sterility test are all performed on samples from routine manufactured lots; a Certificate of Analysis is provided with each lot of CryotopSC device.
The CryotopSC device passed all testing and supports the claims of substantial equivalence. The CryotopSC meets all the requirements for overall design, sterilization, functional, and mouse embryo assay testing confirms that the output meets the design inputs and specifications. The CryotopSC passed all testing stated above as shown by the acceptable results obtained.
The CryotopSC device complies with the applicable voluntary standards for sterilization. The device passed all the testing in accordance with national and international standards.
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The validation testing of sterility testing and mouse embryo testing was found to acceptable and supports the claims of substantial equivalence.
Key Metrics
Cooling Rate: 3,000°C/min
Rewarming Rate: 44,000°C/min
Mechanical Tensile Testing: Tensile strength to withstand 5N
Endotoxin Testing: Endotoxin values conform to the value ≤0.5 EU/device
Mouse Embryo Assay: ≥80% of 1-cell control embryos develop at 96 hours
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.
0
510(k) Summary
for
CRYOTOP®SC
1. Submission Sponsor
KITAZATO BioPharma Co., Ltd. 81 Nakajima, Fuji Shizuoka 416-0907 JAPAN Phone: +(81) 545-66-2202 Fax: +(81) 545-60-5772 Contact: Futoshi INOUE, President
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (508) 838.9139 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard VINCINS, Vice President, QA Email: project.management@emergogroup.com
3. Date Prepared
1 April 2014
4. Device Identification
Cryotop®SC Trade/Proprietary Name: Cryopreservation storage device Common/Usual Name: Assisted Reproduction Labware Classification Name: 884.6160 Classification Regulation: MQK Product Code: Device Class: Class II Classification Panel: Obstetrics/Gynecology
5. Legally Marketed Predicate Device(s)
Cryo Bio System, HSV Straw, K092398
..............................................................................................................................................................................
APR 0 3 2014
1
6. Device Description
CryotopSC 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. Extracting embryos from the body can be costly and burdensome process for the patient to go through multiple extraction procedures. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopSC device for subsequent storage.
The CryotopSC device is composed of an ABS handle shaft with a PET fine tip and a straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopSC device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The straw cap is designed to be heat sealed by the user. The straw cap has a weight at the distal end to place the straw cap and the shaft inside of the cap in a correct position in the liquid nitrogen. The CryotopSC device is provided sterile and is for single use only. The CryotopSC device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.
The Aluminum Block is required for use with the CryotopSC device for the vitrification and thawing process and is sold separately. The Aluminum Block is to be used with the CryotopSC device to prevent liquid nitrogen from entering the straw and to assist in stabilizing the manipulation of the straw.
The CryotopSC device conforms to product quality test specifications of our company: appearance, dimension, durability, tensile strength, colorfastness, endotoxin and Mouse Embryo Assay. The sterilization dose of CryotopSC is validated by sterilization to maintain the sterility of the device through anticipated storage and handling.
7. Indication for Use Statement
The Cryotop®SC 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.
Substantial Equivalence Discussion 8.
The following table compares the CryotopSC to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer
Trade Name | KITAZATO BioPharma Co., Ltd.
Cryotop®SC | Cryo Bio System
HSV Straw |
|----------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Not assigned | K092398 |
| Product Code | MQK | MQK |
| Regulation Number | 884.6160 | 884.6160 |
| Regulation Name | Assisted Reproduction Labware | Assisted Reproduction Labware |
| Indications for Use: | The CryotopSC is a
cryopreservation storage device
that is intended for use in | The HSV Straw is a cryopreservation
storage device that is intended for
use in vitrification procedures to |
| Table 5A - Comparison of Characteristics | |
|---|---|
2
| Manufacturer | KITAZATO BioPharma Co., Ltd. | Cryo Bio System |
|---|---|---|
| Trade Name | Cryotop ® SC | HSV Straw |
| vitrification procedures to contain | ||
| and maintain human 4-8 cell and | ||
| blastocyst stage embryos. | contain and maintain human 4-8 cell | |
| and blastocyst stage embryos. | ||
| Overall Design | The CryotopSC is designed to | |
| contain, freeze and maintain | ||
| embryos. The device consists of a | ||
| two piece assembly comprised of | ||
| the main part containing the fine | ||
| tip film area and the "straw." The | ||
| straw is designed to be sealed. The | ||
| straw is weighted to allow proper | ||
| alignment in the storage container. | ||
| The CryotopSC device is packaged | ||
| in a single barrier sterilization | ||
| pouch. | The HSV Straw is designed to | |
| contain, vitrify and maintain | ||
| embryos. | ||
| The device consists of 3 parts: a resin | ||
| straw, a capillary tube with a pre- | ||
| formed gutter attached to a colored | ||
| handling rod, and a blue plastic | ||
| insertion device. | ||
| The straw is designed to be sealed. | ||
| The HSV Straw is packaged in a peel | ||
| off blister pack. | ||
| Method of Action | Vitrification Method | Vitrification Method |
| Sterile | Radiation | Radiation |
| Cooling Rate | 3,000°C/min | 2,900°C/min |
| Rewarming Rate | 44,000°C/min | 25,000°C/min |
| Material Composition | PET, ABS, Polypropylene | Medical Grade Styrene-Butadiene |
| Copolymer, Ionomeric resin | ||
| Contact with Warming | ||
| Medium | The tip (film) and the shaft of | |
| CryotopSC are taken out from the | ||
| straw. Directly immerse the tip | ||
| (film) into thawing solution. | The curved spatula, containing the | |
| cryopreserved embryo, is immersed | ||
| in thawing solution where thawing | ||
| and dilution in the thawing solution | ||
| occur simultaneously. | ||
| Performance Testing of | ||
| Device | Passed | Passed |
| Mouse Embryo Test | ||
| Passed | Yes | Yes |
| Sterility Validation | ||
| Passed | Yes | Yes |
Non-Clinical Performance Data 9.
The CryotopSC device has been evaluated for the cooling/warming rate, mechanically tested, sterility tested, and mouse embryo assay supporting that all the specifications have met the acceptance criteria for the device. The following testing has been performed to support substantial equivalence:
Performance Testing
- Cooling Rate Testing: Cooling rate of 3,000 °C/min passed .
- Warming Rate Testing: Warming rate of 44,000 °C/min passed .
- Dimensional Testing: Passes outer diameter and length according to specifications .
- Mechanical Tensile Testing: Tensile strength to withstand 5N .
- Endotoxin Testing: Endotoxin values conform to the value ≤0.5 EU/device .
- Sterility Testing: No microbial growth from sterility testing .
- Mouse Embryo Assay: ≥80% of 1-cell control embryos develop at 96 hours .
3
Note: The performance testing, Mouse Embryo Assay (MEA), and sterility test are all performed on samples from routine manufactured lots; a Certificate of Analysis is provided with each lot of CryotopSC device.
The CryotopSC device passed all testing and supports the claims of substantial equivalence. The CryotopSC meets all the requirements for overall design, sterilization, functional, and mouse embryo assay testing confirms that the output meets the design inputs and specifications. The CryotopSC passed all testing stated above as shown by the acceptable results obtained.
The CryotopSC device complies with the applicable voluntary standards for sterilization. The device passed all the testing in accordance with national and international standards.
10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The validation testing of sterility testing and mouse embryo testing was found to acceptable and supports the claims of substantial equivalence.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
KITAZATO BioPharma's Cryotop®SC, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring a staff with a snake winding around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
KITAZATO BioPharma Co., Ltd. % Richard A. VINCINS, CQA, CBA, RAC (US, EU) Vice President, QA Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701
K140072 Re:
Trade/Device Name: Cryotop®SC Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: January 10, 2014 Received: January 13, 2014
Dear Richard A. VINCINS,
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. 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 I loast of 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.
5
Page 2 - Richard A. VINCINS, CQA, CBA, RAC (US, EU)
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/6 description: The image shows the name "Benjamin Fisher -S" in a bold, sans-serif font. The letters "FDA" are stylized and overlaid on top of the name. The letters "FDA" are outlined with a thick border and have a decorative pattern inside.
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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K140072
Device Name Cryotop@SC
Indications for Use (Describe)
The Cryotop®SC 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.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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