(279 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a cryopreservation storage device, with no mention of AI or ML.
No.
The device is for cryopreservation of embryos, which is a storage function, not a therapeutic treatment.
No
The device is described as a cryopreservation storage device for containing and maintaining embryos, not for diagnosing a condition or disease. It is used in the process of vitrification for preservation.
No
The device description clearly outlines physical components made of polycarbonate and describes mechanical testing, indicating it is a hardware device.
Based on the provided information, the Cryopette is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "contain and maintain human blastocyst stage embryos" during vitrification procedures. This describes a device used for the storage and handling of biological material, not for performing a diagnostic test on that material.
- Device Description: The description focuses on the physical components and their function in aspirating, dispensing, and storing the embryo within the device. There is no mention of reagents, analytical processes, or the generation of diagnostic information.
- Performance Studies and Key Metrics: The performance studies and metrics evaluate the device's ability to safely and effectively store and preserve the embryos (e.g., embryo survivability, cooling/warming rates, mechanical integrity). These are performance characteristics relevant to a cryopreservation device, not to a diagnostic test.
An IVD device is typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cryopette's function is to facilitate the cryopreservation process itself, not to analyze the embryo for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
Product codes
MQK
Device Description
The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette.
The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling.
The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.
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)
The following testing was performed:
- Mouse Embryo Assay (MEA): >70% hatching at 96 hours MEA testing was performed to ensure that the Cryopette is nontoxic to embryos. Testing demonstrated that the hatching percentage well exceeded the specification of >70% at 96 hours, and this information will be provided on a Certificate of Analysis accompanying packages of the product.
- Endotoxin (LAL) Levels: 70% hatching at 96 hours
- Endotoxin (LAL) Levels:
§ 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
Submitted by: Mid-Atlantic Diagnostics, Inc.
77 Elbo Lane Mount Laurel, NJ 08054
DEC - 6 2010
Telephone: (856) 762-2000 Facsimile: (856) 762-2009
Contact: Susan Bush, Quality & Regulatory Affairs Manager
Date Submitted: November 8, 2010
Device Identification:
| Trade Name: | Cryopette™ |
|---|---|
| Common Name: | Cryopreservation container |
| Classification Name: | Assisted Reproduction Labware (21 CFR 884.6160) |
| Product Code: | MQK |
Irvine Scientific CryoTip (K041562) Predicate Device:
Description:
The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette.
The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling.
The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.
Intended Use:
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
Performance Data:
l
1
The following testing was performed:
-
- Mouse Embryo Assay (MEA): >70% hatching at 96 hours MEA testing was performed to ensure that the Cryopette is nontoxic to embryos. Testing demonstrated that the hatching percentage well exceeded the specification of >70% at 96 hours, and this information will be provided on a Certificate of Analysis accompanying packages of the product.
-
- Endotoxin (LAL) Levels: