(150 days)
Not Found
No
The device description and performance studies focus on the physical properties and cryopreservation function of a storage device, with no mention of AI or ML.
No.
This device is designed for the cryopreservation and storage of human embryos, which is a supportive function in fertility procedures, not directly therapeutic for a medical condition in a living patient.
No
This device is a cryopreservation storage device designed to contain and maintain human embryos for vitrification procedures. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (ABS handle shaft, PET film tip, polypropylene straw enclosure, weight) and describes their physical interactions and properties, indicating it is a hardware device.
Based on the provided information, the Cryotop®US 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 or condition.
- Device Description: The description details the physical components and how the device is 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 focus on the physical properties of the device (cooling/warming rates, durability, mechanical strength, sterility, endotoxin levels) and its ability to support embryo development after the process (Mouse Embryo Assay). These are performance characteristics of a storage device, not diagnostic accuracy metrics.
- Lack of Diagnostic Elements: There is no mention of analyzing a biological sample, detecting a substance, or providing diagnostic information.
The Cryotop®US is a medical device used in assisted reproductive technology (ART) procedures for the cryopreservation of embryos. It facilitates a process, but it doesn't perform a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
MOK
Device Description
CryotopUS 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. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopUS device for subsequent storage.
The CryotopUS device is composed of an acrylonitrile butadiene styrene (ABS) handle shaft with a polyethylene terephthalate (PET) film tip and a polypropylene straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopUS device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The handle shaft is designed with a "stop" for inserting the film tip/shaft handle into the straw enclosure. A hermetic seal is created via a tapered shaft handle with a stop location integrated into the handle is placed into the straw enclosure this creates a closed system keeping the film tip isolated from the liquid nitrogen. The straw enclosure system has a weight at the distal end to place the straw and the shaft inside in a correct position in the liquid nitrogen. The CryotopUS device is provided sterile and is for single use only. The CryotopUS device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.
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
Non-clinical performance tests were conducted. The CryotopUS device passed all testing in accordance with internal requirements and applicable standards.
- 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
- Durability Testing: No burst or liguid nitrogen inside the straw after 30 second immersion
- 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
- Shelf life testing
- Package integrity testing
Key Metrics
Not Found
Predicate Device(s)
K122982, CRYOLOCK™
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2016
KITAZATO BioPharma Co., Ltd. % Richard A. Vincins, CBA, CQA, RAC (US,EU) Vice President, Quality Assurance Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701
Re: K153027
Trade/Device Name: Cryotop® US Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MOK Dated: February 9, 2016 Received: February 12, 2016
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 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
Page 2 - Richard A. Vincins, CBA, CQA, 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -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
2
Indications for Use
510(k) Number (if known) K153027
Device Name Cryotop®US
Indications for Use (Describe)
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.
| 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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3
510(k) Summary
Cryotop®US
K153027
1. Submission Sponsor
KITAZATO BioPharma Co., Ltd.
81 Nakajima, Fuji-city
Shizuoka 416-0907
JAPAN
Phone number: +(81) 545-66-2202
Contact: Futoshi Inoue
Title: President
2. Submission Correspondent
Emergo Global Consulting, LLC
816 Congress Avenue, Suite 1400
Austin, TX 78701
Office Phone: (512) 327 - 9997
Contact: Richard A. Vincins, Vice President, Quality Assurance/Regulatory Affairs
Email: project.management@emergogroup.com
3. Date Prepared
March 9, 2016
4. Device Identification
| Trade/Proprietary Name: | Cryotop®US |
|---|---|
| Common/Usual Name: | Cryopreservation Storage Device |
| Classification Name: | Assisted Reproduction Labware |
| Regulation Number: | 884.6160 |
4
Product Code:
Device Class: Class II
Classification Panel: Obstetrics/Gynecology
MOK
5. Legally Marketed Predicate Device
K122982, CRYOLOCK™, BioTech Inc.
6. Device Description
CryotopUS 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. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopUS device for subsequent storage.
The CryotopUS device is composed of an acrylonitrile butadiene styrene (ABS) handle shaft with a polyethylene terephthalate (PET) film tip and a polypropylene straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopUS device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The handle shaft is designed with a "stop" for inserting the film tip/shaft handle into the straw enclosure. A hermetic seal is created via a tapered shaft handle with a stop location integrated into the handle is placed into the straw enclosure this creates a closed system keeping the film tip isolated from the liquid nitrogen. The straw enclosure system has a weight at the distal end to place the straw and the shaft inside in a correct position in the liquid nitrogen. The CryotopUS device is provided sterile and is for single use only. The CryotopUS device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.
7. Indication for Use Statement
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.
8. Substantial Equivalence Discussion
The following Table 1 compares the CryotopUS to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.
5
| Manufacturer | Kitazato BioPharma Co.,
Ltd. | BioTech Inc. | Significant
Differences |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop®US | CRYOLOCK™ | |
| 510(k) Number | Not assigned | K122982 | |
| Product Code | MQK | MQK | Same |
| Regulation Number | 884.6160 | 884.6160 | Same |
| Regulation Name | Assisted Reproduction
Labware | Assisted Reproduction
Labware | Same |
| Indications for Use | 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 | The CRYOLOCK™ is a
cryopreservation storage
device that is intended
for use in Vitrification
procedures to contain
and maintain human 1-
cell stage embryos | Similar; the
indications for use are
both for the
vitrification and
storage of human
embryos. |
| Mechanism of Action | Vitrification Method | Vitrification Method | Same |
| Technology
Overview | The CryotopUS 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 handle
shaft and straw are
designed to be closed
system. The straw is
weighted to allow proper
alignment in the storage
container. The
CryotopUS device is
packaged in a single
barrier sterilization
pouch. | The Cryolock is designed
to contain, freeze and
maintain embryos. The
device is a square shape
stick with four flat
surfaces. The device is
composed of two piece
assembly with the main
part for the embryo
placement and the
handle shaft and cap
designed to be a closed
system. The CryoLock
device is packaged in a
single barrier sterilization
pouch. | Same |
| Manufacturer | Kitazato BioPharma Co.,
Ltd. | BioTech Inc. | Significant
Differences |
| Trade Name | Cryotop®US | CRYOLOCK™ | |
| Material
Composition | PET, ABS, Polypropylene | PET, Polypropylene | Similar; both devices are made of medical grade plastics that are commonly used. |
| Sterile | Radiation, SAL 10-6 | Radiation, SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Cooling Rate | 3,000°C/min | 1,494°C/min | Different; though the cooling rate is different, non-clinical performance testing from both devices support intended use. |
| Rewarming Rate | 44,000°C/min | 21,000°C/min | Different; though the warming rate is different, non-clinical performance testing from both devices support intended use. |
| Contact with
Warming Medium | The tip (film) and the shaft of CryotopUS are taken out from the straw. Directly immerse the tip (film) into thawing solution | The tip (film) and the shaft of Cryolock are taken out from the body. Directly immerse the tip (film) into thawing solution. | Same |
| Performance Testing | Passed | Passed | Same |
| Mouse Embryo
Testing | Passed | Passed | Same |
| Sterility Validation
Testing | Passed | Passed | Same |
Table 1– Comparison of Characteristics
6
The technological characteristics of the CryotopUS are comparable to the predicate device. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
7
9. Non-Clinical Performance Data
As part of demonstrating substantial equivalence to the predicate device, Kitazato BioPharma completed a number of non-clinical performance tests. The CryotopUS device meets all the requirements for overall design, sterilization, and performance testing results, confirming that the design output meets the design inputs and specifications for the device.
The CryotopUS device passed all the testing in accordance with internal requirements and applicable standards that is shown below to support substantial equivalence of the subject device:
- . 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
- . Durability Testing: No burst or liguid nitrogen inside the straw after 30 second immersion
- . 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
- . Shelf life testing
- . Package integrity testing
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 CryotopUS device.
10. Conclusion
The results of the testing described above provide reasonable assurance that the CryotopUS is as safe and effective as the predicate device and supports a determination of substantial equivalence.