(62 days)
The Swemed Pipettes are intended to be used to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ISCI, or other assisted reproduction methods.
The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Swemed Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Swemed Denuding Pipettes are used to remove the cumulus cell layers; and the Swemed Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.
The Swemed Pipettes are manufactured by Swemed of borosilicate glass. The pipettes have inner diameters ranging from .0048 - . 190 mm and outer diameters ranging from . 0068 - . 280 mm. The pipette length ranges from 50 to 90 mm. The Denuding Pipette does not have a beveled tip. The ICSI, the holding, and the Assisted Hatching/Zona Drilling Pipettes have a 30-35° beveled tip. The pipettes are packaged in a rubber holder together with a glass tube. The tube is then provided in a seal made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.
The provided document is a 510(k) Summary for Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes.
Crucially, this document focuses on establishing substantial equivalence to a predicate device (Cook OB/GYN Pipettes) rather than presenting a performance study with defined acceptance criteria and detailed study results as would be found in a clinical trial report or a comprehensive validation study.
Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided text. The document is primarily a regulatory submission demonstrating a lack of significant differences from a legally marketed device.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of quantitative performance metrics. The basis for substantial equivalence is "the same intended use" and "same indications for use" as the predicate device. Minor differences in dimensions and aspiration method are stated to "not affect the safety or effectiveness of the device." | The document states that the Swemed Pipettes "are very similar devices" to the Cook Pipettes, with minor differences in: |
- Dimensions: "inside and outside diameters, pipette lengths, and bevel angles are slightly different"
- Aspiration Method for Denuding Pipettes: "Cook Denuding Pipettes can be ordered with a mouth aspiration tubing line, whereas the Swemed Denuding Pipettes are intended for use with a vacuum device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No dedicated performance test set (as in a clinical study) is described. The comparison is based on device specifications and intended use against a predicate device.
- Data Provenance: Not applicable. No clinical data or performance study data is presented to analyze.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. No "ground truth" establishment from experts is described for a performance study.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No performance study requiring adjudication is presented.
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
- MRMC Study: No. This device is a micro-tool pipette, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. The "ground truth" for this 510(k) submission is the existence and performance of the legally marketed predicate device (Cook Pipettes) and the manufacturer's assertion that the Swemed Pipettes perform equivalently for their intended use.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.