(262 days)
EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an occyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.
The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.
The EZ-Tip pipette is an extruded medical grade polycarbonate capillary that is pulled at one end to form a tapered tip. It has an outer diameter (OD) of 0.9 mm at the proximal end and fits to an actuating device such as the EZ-Grip. All tips are approximately 90 mm in length and depending on the size of the tip they have a volumetric capacity of 15.9 - 25.4 µl.
Pipette Tips are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:
- Size 75 µm, 200 µm, 250 µm, 290 µm, 600 µm are suitable for specimen handling
- Sizes 125 µm, 135 µm, 145 µm, 155 µm, 170 µm are suitable for denudation
The EZ-Tip is supplied sterile in one of two packaging options; individually blister packed or pouch packed in a vial containing 20 tips. All pipettes are intended single use and disposable.
The EZ-Grip is a hand held, reusable actuator or pipeter for plastic pipettes. It consists of a machined aluminium barrel containing stainless steel and PTFE internal working mechanisms, a titanium plunger wire and medical grade silicone and nylon seals. The plunger mechanism is designed to be compatible with 0.9 mm OD plastic pipettes and it has an aspiration volume range of 0.2 µl to 3 µl with a blow-out volume of 1.4 µl above the adjusted aspiration volume setting.
The EZ-Grip is supplied non-sterile with validated protocols for cleaning and sterilization included in the Instructions for Use.
The provided document describes the non-clinical testing and assessment of the EZ-Tip and EZ-Grip devices to demonstrate their substantial equivalence to predicate devices (The Stripper micropipet and micropipeter tips and The Stripper device, respectively). The study does not involve human subjects or AI, but rather focuses on physical, chemical, and biological performance characteristics relevant to assisted reproductive techniques (ART).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| EZ-Tip | ||
| Mouse Embryo Assay (MEA) | ≥80% hatched blastocysts at 120 h | Passed (three lots demonstrated ≥80% hatched blastocysts at 120 h) |
| Endotoxin (LAL) | ≤20 EU/device | Passed (three lots demonstrated ≤20 EU/device) |
| Sterilization | Compliance with ISO11137-1:2006 and ISO11137-2:2012 | Sterilization validated in compliance with these standards |
| Packaging Integrity | Compliance with ISO11607-2:2006, ASTM F1886/F1886M - 09, ASTM F1929-12, ASTM F1140-07, and ASTMF1980:07(2011) | Validation studies conducted per these standards; accelerated aged samples conditioned per ASTMF1980:07(2011) |
| Shelf-Life (EZ-Tip Vial of 20) | Supported by packaging and performance tests | Three years (supported by real-time and accelerated aging) |
| Shelf-Life (EZ-Tip Singles) | Supported by packaging and performance tests | Five years (supported by real-time and accelerated aging) |
| EZ-Grip | ||
| Mouse Embryo Assay (MEA) (Plunger Wires) | ≥80% hatched blastocysts at 120 h | Passed (three lots of plunger wires demonstrated ≥80% hatched blastocysts at 120 h) |
| Reprocessing Validation | Compliance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" | Reprocessing validated in accordance with this guidance |
| Device Life (Simulated Use) | Performs according to product specifications after routine maintenance and reprocessing | Confirmed to perform after 16,000 actuations (measuring aspirated volume, delivered volume, force) |
2. Sample Size Used for the Test Set and Data Provenance
- EZ-Tip MEA & Endotoxin Testing: Three lots of EZ-Tip were tested.
- EZ-Grip MEA Testing (Plunger Wires): Three lots of EZ-Grip plunger wires were tested.
- EZ-Grip Device Life Bench Testing: Not explicitly stated as a number of devices, but it involved simulating one year of use (16,000 actuations) on at least one device.
- Provenance: All tests described are non-clinical, laboratory-based assessments of the physical device components and their interaction with biological samples (mouse embryos). The data provenance is from laboratory testing and not from human clinical data, nor is country of origin of the data specified beyond the company being in the UK.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the described studies are non-clinical and do not involve human diagnostic assessment or expert-determined ground truth in the typical clinical sense. The "ground truth" here is objective laboratory measurements (e.g., percentage of hatched blastocysts, endotoxin levels, physical performance metrics).
4. Adjudication Method for the Test Set
This information is not applicable as the described studies are non-clinical and do not involve human diagnostic assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A MRMC comparative effectiveness study was not done. This study is focused on the non-clinical performance of medical devices for ART, not comparative effectiveness of human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is not an AI/algorithm-based device. It is a physical medical device (pipettes and a pipettor).
7. The Type of Ground Truth Used
- For Mouse Embryo Assays (MEA): The "ground truth" is the observed biological outcome of mouse embryo development (percentage of hatched blastocysts), which is a direct biological measure.
- For Endotoxin Testing: The "ground truth" is the measured endotoxin level, a chemical quantification.
- For Sterilization, Packaging, and Bench Testing: The "ground truth" is compliance with established international standards and internal product specifications for physical and functional performance.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" as this is not an AI/machine learning study.
9. How the Ground Truth for the Training Set was Established
Not Applicable. There is no "training set" as this is not an AI/machine learning study.
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.