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510(k) Data Aggregation
(210 days)
Fast Warm - NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.
Fast Warm – NX is a dual-buffered solution (HEPES & MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) dextran serum supplement (DSS), and 1.0M trehalose. DSS is a protein supplement consisting of 50 mg/mL human serum albumin (HSA) and 20 mg/mL dextran. DSS is used at 20% (v/v) in Fast Warm – NX for a final concentration of 10 mg/mL HSA and 4 mg/mL dextran. The product is supplied as a ready to use liquid in two (2) different configurations, a kit containing multiple vials of either two (2) x 20mL or six (6) x 2mL. The medium can be used for up to 14 days after bottle opening.
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(199 days)
CryoX™ Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
CryoX™ Vitrification Thaw Kit is intended for use in the thawing of virified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
CryoX™ Vitrification Freeze Kit is designed to facilitate dehydration of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos before vitrification via rapid cooling in liquid nitrogen. CryoX™ Vitrification Freeze Kit contains two solutions to be used sequentially during vitrification. Both solutions consist of Medium 199 (M199), human serum albumin (HSA) and gentamicin sulfate. They also contain varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), ethylene glycol (EG), and sucrose.
CryoX™ Vitrification Thaw Kt contains three solutions to be used sequentially during oocyte and embryo thawing procedures. All three solutions contain M199, HSA, and gentamicin sulfate. They also contain decreasing concentrations of cryoprotectant.
The five solutions in the CryoX™ Vitrification Freeze Kit and Thaw Kt are aseptically filtered and provided in 4.5 mLPETG vials. The solutions in these kits are single-use only. They have a shelf-life of 6 months when stored at 2-8℃
The document you provided is a 510(k) Premarket Notification from the FDA for a device called "CryoX™ Vitrification Freeze Kit / Thaw Kit." It details the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance testing.
Based on the provided text, here's the information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are the product specifications that were tested during shelf-life testing. The reported device performance is indicated by the statement that these specifications "were met at time 0 and after accelerated aging."
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Clean, transparent, pink; no impurities | Met (implicitly, as specifications were met) |
| pH (per USP <791>) | 7.2-7.6 | Met (implicitly, as specifications were met) |
| Osmolality (mOsmol/kg) | ES: 855 | Met (implicitly, as specifications were met) |
| Sterility (per USP <71>) | No microbial growth | Met (implicitly, as specifications were met) |
| Bacterial Enodtoxin (per USP <85>) | < 0.5 EU/mL | Met (implicitly, as specifications were met) |
| Mouse Embryo Assay (1-Cell MEA) | ≥ 80% embryos developed to expanded blastocyst at 96 hours | Met (implicitly, as specifications were met) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance tests (e.g., pH, osmolality, sterility, bacterial endotoxin, MEA).
The data provenance is from non-clinical performance testing conducted by the manufacturer, Zhejiang Horizon Medical Technology Co., Ltd. The document does not specify the country of origin of the data beyond the manufacturer's location in China, nor does it explicitly state whether the studies were retrospective or prospective, though performance testing for product validation is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the performance tests. These tests are primarily laboratory-based measurements of chemical and biological properties according to established standards (e.g., USP, ASTM, FDA guidance). The Mouse Embryo Assay (MEA) results are quantitative and follow a specified threshold rather than expert consensus.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Since the tests are largely objective measurements against defined numerical or qualitative criteria (e.g., pH range, endotoxin limit, percentage of blastocyst development), human adjudication in the typical sense (e.g., 2+1 reading) is not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or other AI-driven tools where human interpretation plays a significant role. The CryoX™ Vitrification Freeze Kit / Thaw Kit is a reproductive media product, and its evaluation focuses on its chemical and biological properties and performance in preserving and thawing oocytes/embryos, not on human interpretive tasks.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable to the device described. The CryoX™ Vitrification Freeze Kit / Thaw Kit is a biological reagent kit, not an algorithm or AI-driven device. Its performance is intrinsic to the chemical formulation and its biological effect on cells, not an algorithmic output.
7. The Type of Ground Truth Used
The ground truth for the performance tests is based on defined quantitative and qualitative specifications derived from established standards and biological efficacy requirements. For example:
- pH, Osmolality, Bacterial Endotoxin: Numerical ranges or limits according to USP monographs.
- Sterility: Absence of microbial growth as per USP <71>.
- Mouse Embryo Assay (MEA): A specific developmental endpoint (≥ 80% expanded blastocyst development) at 96 hours, as per FDA guidance.
These are objective, rather than subjective, ground truths typically established by consensus or pathology.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are relevant for machine learning or AI models. This product is a medical device in the category of reproductive media, and its development and validation involve formulation, manufacturing, and performance testing, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" does not apply to this device, the question of how its ground truth was established is not applicable.
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