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510(k) Data Aggregation
(216 days)
Zhejiang Horizon Medical Technology Co., Ltd.
Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
The subject devices are single use sterile devices used for ultrasound-guided transvaginal aspiration of oocytes from ovarian follicles.
The Lotus Single Lumen Ovum Aspiration Needle consists of a stainless steel needle with a handle, which is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper is connected to a vacuum tube with a vacuum tubing connector at the other end. The vacuum tubing connector is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The Lotus Single Lumen Ovum Aspiration Needle is 35 cm in length and has device variations from 21 to 16 gauge with aspiration tubing of 600 or 900 mm in length.
The Lotus Double Lumen Ovum Aspiration Needle consists of a stainless steel needle with a Y shaped handle. The Y-shaped handle has two ports: the central port through which oocytes are aspirated via the aspiration lumen, and a secondary side port to allow flushing of follicles via the flushing lumen. The central port is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper has a vacuum connector that is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The side port is connected to a flushing tube with a flushing connector at the other end, which is a standard luer lock connector that can be connected to a compatible syringe for flushing of follicles. The Lotus Double Lumen Ovum Aspiration Needle is 17 gauge with an aspiration tubing length of 900 mm and with device variations of 30 or 35 mm needle length and flushing tubing of 700 or 1000 mm in length.
This document is an FDA 510(k) Premarket Notification for medical devices, specifically ovum aspiration needles. It does not describe a study involving an AI/Machine Learning device. Therefore, it is not possible to extract information about acceptance criteria or study details relevant to AI/ML device performance from this text.
The document discusses traditional medical device testing, such as:
- Biocompatibility testing: Cytotoxicity, Sensitization, Intracutaneous Irritation.
- Sterilization testing: Ethylene Oxide (EO) sterilization, residual testing.
- Simulated transportation: Adherence to ASTM D4169-22.
- Stability and Shelf Life testing: accelerated aging, package integrity, mechanical performance (appearance, dimensions, needle stiffness, breakage resistance, corrosion resistance, tip penetration force, needle bond strength, flow rate, ultrasound detectability, tubing bond strength, leak, aspiration test, component compatibility).
- Mouse Embryo Assay (MEA): This is a biological test to assess the non-toxicity of materials to embryos, not an AI performance metric. The acceptance criterion for 1-Cell MEA was ≥80% embryos developed to expanded blastocyst at 96 hours after 30 minute exposure.
- Endotoxin evaluation: Acceptance criterion was ≤ 20 EU/device.
Since the request specifically asks for details related to AI/Machine Learning device performance, and this document pertains to a traditional, non-AI medical device, I cannot fulfill the request as stated.
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(199 days)
Zhejiang Horizon Medical Technology Co., Ltd
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 ) | 7.2-7.6 | Met (implicitly, as specifications were met) |
| Osmolality (mOsmol/kg) | ES: 855~1042 (1:2 dilution) | |
| VS: 1916~2477 (1:2 dilution) | ||
| TS: 1653~2430 | ||
| DS: 871~1025 | ||
| WS: 307~318 | Met (implicitly, as specifications were met) | |
| Sterility (per USP ) | No microbial growth | Met (implicitly, as specifications were met) |
| Bacterial Enodtoxin (per USP ) | . |
- 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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