(131 days)
The COOK® Ultra Quiet Vacuum Pump & Regulator is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.
The COOK® Ultra Quiet Vacuum Pump & Regulator provides high vacuum, ranging from -30 to -300 ± 5 mmHg, low flow aspiration.
The provided 510(k) Premarket Notification for the COOK® Ultra Quiet Vacuum Pump & Regulator does not contain a study that establishes performance against acceptance criteria in the manner typically found for novel diagnostic devices or algorithms.
Instead, this submission is for a medical device (a vacuum pump and regulator) that is demonstrating substantial equivalence to a predicate device. The "Discussion of Tests and Test Results" section primarily focuses on technical safety and performance, rather than clinical efficacy measured by metrics like sensitivity, specificity, or accuracy.
Here's an analysis based on the provided text, addressing the requested information where applicable, and noting where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility (EMC) requirements | The COOK® Ultra Quiet Vacuum Pump & Regulator passed the requirements of all tests. |
| High vacuum range | -30 to -300 ± 5 mmHg |
| Low flow aspiration | (Implicitly met as part of the device description, but no specific threshold or test result provided for 'low flow') |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical data or patient samples. The testing mentioned refers to electromagnetic compatibility (EMC) and device specifications. Therefore, sample size, data provenance (country of origin, retrospective/prospective), and related details are not applicable as these types of clinical studies were not performed or reported.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, this submission focuses on device design and technical safety/performance, not clinical diagnostic accuracy requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or ground truth adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. An MRMC study is not mentioned or implied in the submission. This type of study is more relevant for diagnostic imaging or interpretation algorithms where human readers' performance is being evaluated or augmented by AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a physical medical device (vacuum pump), not a software algorithm or AI, so the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device relates to its electrical and mechanical performance specifications and safety standards (e.g., electromagnetic compatibility). The ground truth for these tests would be the established engineering/safety standards themselves, not clinical outcomes or pathology.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this device is a physical product and not an AI/machine learning algorithm that requires a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
Summary of the 510(k) Submission's Approach:
The 510(k) for the COOK® Ultra Quiet Vacuum Pump & Regulator primarily demonstrates substantial equivalence to a predicate device. The "Discussion of Tests and Test Results" focuses on:
- Technical Specifications: The device provides high vacuum ranging from -30 to -300 ± 5 mmHg and low flow aspiration.
- Safety Testing: Specifically, electromagnetic compatibility (EMC) testing was performed, and the device passed all requirements.
The conclusion is that the device is "similar, with respect to intended use and technological characteristics, to the FDA published predicate device description." This type of submission relies on demonstrating that the new device shares fundamental technological characteristics and performs within established safety and functional parameters, similar to an already cleared device, rather than requiring extensive new clinical efficacy studies with ground truth establishment in the way AI or diagnostic algorithms would.
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.