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K Number
K983593
Device Name
OVUM PICK-UP ASPIRATION NEEDLES
Manufacturer
COOK OB/GYN
Date Cleared
1999-01-21

(100 days)

Product Code
MQE
Regulation Number
884.6100
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Ovum Pick-Up Aspiration Needles are used for aspiration and flushing of oocytes from ovarian follicles.

Device Description

The Ovum Pick-Up Aspiration Needle is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocytes from ovarian follicles.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that evaluates the device's performance. The document is a 510(k) summary and an FDA clearance letter for an "Ovum Pick-Up Aspiration Needle." It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's intended use.

The text does not contain the following information:

  1. A table of acceptance criteria and the reported device performance: This type of data is typically found in performance studies, which are not present in this document.
  2. Sample size used for the test set and the data provenance: No performance testing data is provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The document states: "Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness." and "The Ovum Pick-Up Aspiration Needle is substantially equivalent to predicate Ovum Pick-Up Aspiration Needles in terms of indications for use, design, construction and materials equivalence." This indicates that the clearance was based on substantial equivalence (comparing to existing similar devices) rather than new performance studies with specific acceptance criteria.

§ 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).