(142 days)
Not Found
No
The device description and performance studies focus on the physical properties and cryopreservation function of the device, with no mention of AI or ML.
No.
The device is for storage of embryos and does not directly treat or diagnose a disease or condition.
No
This device is a vitrification storage device used to contain and maintain human embryos for preservation and storage, not for diagnosing any medical condition.
No
The device description clearly outlines physical components (PET film sheet, PET handle, PVC cap) and performance testing related to these physical properties (cooling/warming rates, durability, tensile strength, etc.), indicating it is a hardware device.
Based on the provided information, this 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 or blastocyst stage embryos" during vitrification procedures. This is a storage and preservation function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they function to protect and store the embryos in liquid nitrogen. It doesn't mention any analysis of biological samples or providing information for diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information for the diagnosis of a disease or condition.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely for the physical preservation of embryos.
N/A
Intended Use / Indications for Use
This device is a vitrification storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos.
Product codes (comma separated list FDA assigned to the subject device)
MOK
Device Description
Cryotec is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos. It is designed to enable physicians and embryologists to preserve and to store vitrified embryos for assisted reproduction technology procedures.
The Cryotec device is composed of a two piece assembly with a polyethylene terephthalate (PET) film sheet attached to a PET handle, and a weighted polyvinylchloride cap to cover the film sheet during handling and storage. During vitrification procedures, the film sheet is loaded with embryos, capped, and immersed in liquid nitrogen. The capped design creates a hermetic seal, resulting in a closed system keeping the film sheet and embryos isolated from liquid nitrogen. The cap is weighted to allow proper alignment in the storage container. The Cryotec device is provided sterile and is for single use only. The Cryotec device has been designed to maintain the integrity of the human embryos the freezing and thawing process.
The specifications for the Cryotec are as follows:
Appearance: Particle free, no cracks
Durability: No breakage, no liquid nitrogen inside the cap
Tensile Strength: ≥ 5N
Endotoxin:
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
Reprolife Inc. % Diane Sudduth Sr. Consultant, RA/QA Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701
Re: K162051
Trade/Device Name: Cryotec Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: Class II Product Code: MOK Dated: November 11, 2016 Received: November 14, 2016
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. 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. 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
1
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,
Joyce M. Whang -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)
Device Name Cryotec
Indications for Use (Describe)
This device is a vitrification storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or 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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510(k) Summary
for
CRYOTEC
K162051
1. Submission Sponsor
REPROLIFE Inc. 2-5-5-8F, Shinjuku Shinjuku-ku, Tokyo 160-0022 JAPAN Phone: +(81) 3-5925-8931 Contact: Koichi Takeda, Director, Global Certification Division
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, Sr. Consultant RA/QA Email: project.management@emergogroup.com
3. Date Prepared
12/12/2016
4. Device Identification
| Trade/Proprietary Name: | Cryotec |
|---|---|
| Common/Usual Name: | Cryopreservation storage device |
| Classification Regulation: | 884.6160 |
| Classification Name: | Assisted Reproduction Labware |
| Product Code: | MQK (Labware, Assisted Reproduction) |
| Device Class: | Class II |
| Classification Panel: | Obstetrics and Gynecology |
5. Legally Marketed Predicate Device(s)
Kitazato, CryotopUS, K153027. The predicate device has not been subject to a design-related recall.
6. Device Description
Cryotec is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos. It is designed to enable physicians and embryologists to preserve and to store vitrified embryos for assisted reproduction technology procedures.
4
The Cryotec device is composed of a two piece assembly with a polyethylene terephthalate (PET) film sheet attached to a PET handle, and a weighted polyvinylchloride cap to cover the film sheet during handling and storage. During vitrification procedures, the film sheet is loaded with embryos, capped, and immersed in liquid nitrogen. The capped design creates a hermetic seal, resulting in a closed system keeping the film sheet and embryos isolated from liquid nitrogen. The cap is weighted to allow proper alignment in the storage container. The Cryotec device is provided sterile and is for single use only. The Cryotec device has been designed to maintain the integrity of the human embryos the freezing and thawing process.
The specifications for the Cryotec are as follows:
| Appearance: | Particle free, no cracks |
|---|---|
| Durability: | No breakage, no liquid nitrogen inside the cap |
| Tensile Strength: | $\geq 5N$ |
| Endotoxin: | $ |