(225 days)
The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.
The Pasteur Pipettes are radiation-sterilized, single use, transparent low-density polyethylene pipettes intended for handling and transferring of liquids, media and gametes during assisted reproductive technology (ART) procedures. The pipettes are provided in two sizes, 1 mL (Model 16201) and 3 mL (Model 16202). Each pipette includes an integrated bulb end that is used to aspirate and expel liquid, media and gamete to and from the device. The pipettes also include a molded volume scale along the body of the pipette. The volume scale only provides an estimate of the aspirated volume. The pipettes will not come in contact with the human body during use.
The provided FDA 510(k) summary for the HertART Pasteur Pipette 3mL and 1mL describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, the document does not contain information related to a study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy, comparative effectiveness with human readers (MRMC), or standalone algorithm performance.
The document focuses on demonstrating substantial equivalence based on the device's physical properties, sterilization, packaging, and general biological safety (MEA and Endotoxin testing). It's a medical device clearance for a labware item, not an AI/ML or diagnostic device that would typically involve the type of performance studies you're asking about.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a diagnostic study.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance.
- Ground truth types for diagnostic studies.
- Training set sample size or ground truth establishment for a diagnostic algorithm.
The information extracted from the document pertains to the quality and safety of the physical pipettes as labware for assisted reproductive technology procedures.
Here is a summary of the non-clinical performance data and acceptance criteria as described in the document, which are focused on device quality and safety:
Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterile Validation | Sterilization Assurance Level (SAL) of 10^-6 | Sterilization process and validation methods done in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, achieving an SAL of 10^-6. |
| Package Validation | Sterile barrier maintained over two-year shelf-life | Testing demonstrated that the sterile barrier was maintained over the two-year shelf-life. Methods included ASTM F88/F88M-15, ASTM F3039-15, and ASTM F1886/F1886M-16. |
| Transport Testing | Ability to withstand rigors of shipping | Testing performed in accordance with ASTM D4169-16 to demonstrate the ability to withstand shipping rigors. |
| Stability and Shelf-life | Confirmed for a two-year shelf-life after accelerated aging per ASTM F1980-16. | |
| -- Mouse Embryo Assay (MEA) | ≥ 80% 1-cell expanded blastocyst within 96 hours | ≤80% (This seems like a typo in the document where it states "≤80%" while the predicate says "≥ 80%". Assuming the "≥" is intended) 1-cell expanded blastocyst within 96 hours (tested after accelerated aging). |
| -- Endotoxin testing (LAL) |
§ 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.