(76 days)
The Cook Otrieva™ Tapered Ovum Aspiration Needles are used for laproscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.
This device is intended for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.
The needle is passed through a transvaginal ultrasound transducer or placed through a cannula for a laparoscopic procedure to advance into the ovarian follicle.
The main body of the cannula is 17 gage, which tapers to 20 gage at the distal tip. Although the outer diameter of the needle tapers, a constant 0.60 mm internal diameter is maintained.
The Otrieva™ needles are available in two lengths: 30cm and 35cm. The needles are provided with an aspiration tube of 90 cm length and a vacuum tube with a length of 50 cm. The tubing is connected to a silicone bung.
The materials used in the device include: stainless steel, polycarbonate, PTFE, silicone, FEP and copolyester.
The provided text describes a 510(k) premarket notification for the Otrieva™ Tapered Ovum Aspiration Needle, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with clinical performance metrics as typically expected for algorithmic-based devices.
Therefore, many of the requested sections (2-6, 8-9) are not applicable as this document does not describe an AI/algorithmic device or a study designed to establish clinical performance against predefined acceptance criteria for such a device. Instead, it describes engineering and pre-clinical tests to support substantial equivalence.
Here's the information that can be extracted and inferred from the document:
1. A table of (implied) acceptance criteria and the reported device performance
Since this is a submission to demonstrate substantial equivalence, the "acceptance criteria" are implicitly the performance specifications of the predicate device. The new device must perform at least as well as the predicate device or demonstrate that modifications do not introduce new safety/effectiveness questions.
| Characteristic / Implied Acceptance Criteria (based on Predicate Device) | Reported Device Performance (Otrieva™ Tapered Ovum Aspiration Needle) |
|---|---|
| Material Biocompatibility: | The materials (stainless steel #304, polycarbonate, PTFE, FEP, silicone, copolyester) are standard for medical devices and consistent with or acceptable variations from the predicate device materials. |
| Sterility: | Sterile (SAL 10⁻⁶) using Ethylene Oxide sterilization. |
| Endotoxin Level: | USP endotoxin (LAL) tested and passed with 20EU or less per device. |
| Embryo Biocompatibility (MEA): | Two-cell MEA tested and passed with 80% or greater Blastocyst rate at 72h. (Predicate: 1-cell MEA, 75% or greater blastocyst rate at 96h. The change in test method is noted as acceptable and does not alter safety/effectiveness). |
| Mechanical Integrity: | Testing confirmed that design modifications had no adverse effect on needle performance for: Resistance to breakage, Air tightness, Tensile strength testing between the tubing and handle junction, and Leakage testing. (Specific metrics for these tests are not provided in the summary). |
| Shelf Life: | 3 years. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes pre-clinical (bench) testing and biocompatibility verification, not a clinical test set from human data for an AI/algorithmic device. The "test set" here refers to device samples used in the non-clinical testing. The document does not specify the number of units tested for each non-clinical test (e.g., how many needles were subjected to "Resistance to breakage testing"). The manufacturer is William A. Cook Australia.
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)
Not applicable. Ground truth as typically understood for AI/algorithmic devices does not apply to this type of medical device submission. Biocompatibility and engineering tests do not rely on expert consensus for "ground truth" in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No human adjudication is described for the non-clinical tests performed.
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 is not an AI/algorithmic medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithmic medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" implicitly refers to objective measurements and pass/fail criteria defined by engineering standards, biocompatibility regulations (e.g., ISO standards), and internal quality controls. For the Mouse Embryo Assay (MEA), the "ground truth" is the observed blastocyst rate in the tested embryos, which is a biological outcome.
8. The sample size for the training set
Not applicable. This is not an AI/algorithmic medical device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithmic medical device.
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).