(87 days)
The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.
The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.
The IM-11 Pneumatic Microinjector is a manually operated pneumatically actuated screw driven microinjector incorporating coarse and fine control knobs. The coarse control knob is used to perform coarse movement operation while the fine control knob is used to perform fine movement operation. It is easy to use simply by turning the control knob clockwise for injection and counterclockwise for aspiration.
The IM-11 Pneumatic Microinjector is a component part of a micromanipulator system.
The provided text is a 510(k) summary for the Narishige IM-11 Pneumatic Microinjector. It focuses on establishing substantial equivalence to a predicate device, the IM-9C Pneumatic Injector, rather than presenting a study demonstrating the device meets specific acceptance criteria for performance.
Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in the provided document. The document primarily relies on a comparison of technological characteristics and intended use to claim substantial equivalence.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided. The document does not define specific quantitative acceptance criteria for the IM-11. Instead, it compares the IM-11's technological characteristics to those of its predicate device, the IM-9C, implying that performance is acceptable if these characteristics are similar or improved.
| Feature / Characteristic | Acceptance Criteria (Implicit) | IM-11 Pneumatic Microinjector (Subject Device) Performance | IM-9C Pneumatic Injector (Predicate Device) Performance |
|---|---|---|---|
| Maximum Operating Range | Similar to or better than predicate device | 40mm (coarse and fine combined) | |
| 30mm by Coarse Control Knob | |||
| 17mm by Fine Control Knob | 53mm | ||
| Distance Plunger Travels & Volume Controlled by One Rotation | Similar to predicate device performance | Coarse Control Knob: Approx. 6.0mm and 1ml (theoretical) | |
| Fine Control Knob: Approx. 1.4mm and 250ul (theoretical) | Approx. 6.0mm and 480ul | ||
| Pressure Relief Valve | Functional pressure release mechanism | Lever-activated pressure relief valve | Valve plug on tube connector |
| Syringe Volume | Functional for intended use | 7,900ul | 4,240ul |
| Dimensions | Suitable for intended use | 167-214(W)x55(D)x78(H)mm | 136-189(W)x55(D)x74(H)mm |
| Weight | Suitable for intended use | 680g | 640g |
| Intended Use | Same as predicate for core functions | Aspirate/inject sperm into oocytes, hold oocytes during ICSI | Inject solutions, aspirate fluids, hold cells/eggs |
Note: The IM-11's maximum operating range (40mm) is less than the IM-9C (53mm), but this is not presented as a deficiency, likely because the combined coarse and fine controls offer sufficient precision and range for ICSI procedures. The larger syringe volume and the more convenient pressure relief valve (lever vs. plug) are presented as improvements or at least not negatively impacting safety/effectiveness.
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable/Not provided. This document does not describe a clinical study with a test set of data. The assessment is based on a technical comparison of the device itself and its predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable/Not provided. No "test set" or "ground truth" using human experts is described in this document.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No test set or expert adjudication is described.
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
Not applicable. This device is a pneumatic microinjector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device, not an algorithm. Therefore, a standalone algorithm performance study is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The submission does not define a "ground truth" as it would for a diagnostic or AI device. Instead, the "truth" is established by comparing the technological characteristics and documented performance/safety of the predicate device.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a medical device for physical manipulation, not an AI/algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
§ 884.6150 Assisted reproduction micromanipulators and microinjectors.
(a)
Identification. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.