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510(k) Data Aggregation
(158 days)
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.
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.
The provided text describes a 510(k) premarket notification for two new cryopreservation storage devices: Cryotop®US-flash and Cryotop®US-scoop. The submission aims to demonstrate substantial equivalence to a predicate device, Cryotop®US (K153027). The document focuses on non-clinical performance data to support this claim, rather than a clinical study comparing the devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test / Criterion | Acceptance Criteria | Reported Device Performance (Cryotop®US-flash & Cryotop®US-scoop) |
|---|---|---|---|
| Performance | Cooling Rate | 3,000°C/min | Passed: 3,000°C/min |
| Warming Rate | 44,000°C/min | Passed: 44,000°C/min | |
| Physical/Mechanical | Dimensional Testing | Outer diameter and length per specifications (specific values not provided in this extract) | Passed (implied) |
| Durability Testing | No burst or liquid nitrogen ingress into straw after 30-second immersion | Passed | |
| Mechanical Tensile Testing | Tensile strength to withstand 5N | Passed | |
| Biocompatibility | Bacterial Endotoxins | <0.5 EU/device per USP <85> and ANSI/AAMI ST72:2002/(R)2010 | Passed: <0.5 EU/device |
| Mouse Embryo Assay (MEA) | ≥80% of 1-cell embryos developed to blastocysts at 96 hours | Passed: ≥80% | |
| Environmental | Transportation Simulation Testing | Per ASTM D4169-09 | Passed (implied) |
| Shelf-Life | Package Integrity Testing: Dye penetration | Per ASTM F1929-15 | Passed (implied) |
| Package Integrity Testing: Seal strength | Per ASTM F88/F88M-15 | Passed (implied) | |
| Shelf-Life (Dimensional, Mechanical, Durability, Endotoxin, MEA) | In accordance with methods & acceptance criteria mentioned above for each test | Passed (implied) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each individual test. The document mentions "non-clinical performance testing" was conducted, implying multiple tests on multiple units, but no specific numbers of devices tested are provided.
- Data Provenance: The tests were conducted by the manufacturer, Kitazato Corporation, as "internal requirements." The text does not specify the country of origin of the data beyond "Kitazato Corporation 81 Nakajima, Fuji-city Shizuoka 416-0907 JAPAN." These are retrospective tests performed for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the tests are non-clinical, laboratory-based performance tests, not clinical studies requiring expert interpretation of outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication in the context of clinical outcomes. The results are objective measurements against defined criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This is a 510(k) submission for a medical device (cryopreservation storage device), not an AI-powered diagnostic tool, and therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the submission is for a medical device (cryopreservation storage device), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests, the "ground truth" is established by objective physical, chemical, and biological measurements against pre-defined, quantitative standards and specifications (e.g., specific temperatures, mechanical forces, endotoxin levels, embryo development rates).
8. The sample size for the training set:
- This concept is not applicable to this submission, as it's for physical medical devices and the non-clinical tests described do not involve machine learning or a training set.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no training set for the described non-clinical performance tests for this medical device.
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