(149 days)
Embryo Transfer Catheter used to introduce embryos into the body.
The Embryo Transfer Catheter There will be two (2) catheters made The Linbryo Transhals in order to accommodate the market from the same basic and for more difficult transfers. The catalog numbers of the two models are GECT-100 and GETC-200.
The basic design of the two models will consist of an inner catheter of 5 French The basic dosign of theter of 9 French tapering to 7 French O.D. with a one O.D.and an outlor batheter of the inner catheter has a support/holding continution mailking on from the handle end along the catheter for 5 cm.
The inner catheter will extend approximately 5 cm out of the outer catheter when f no inner catiforer will the standard model and 3 cm for the difficult transfer model.
The materials are of implant grade medical polymers, to be wrapped for single use.
There will be three variations of the catheter made to suit the market needs. All will be of a polymer that may be gamma radiated or E-Beamed. We consider these to be equivalent in the method and results, and may use both in the process.
This is a 510(k) premarket notification for a medical device, the Embryo Transfer Catheter, seeking clearance based on substantial equivalence to predicate devices. This type of submission does not typically include a detailed clinical study with acceptance criteria and device performance as one might find for a PMA (Premarket Approval) device, especially for a Class II device like this one.
The provided documents focus on:
- Device identification and classification: Name, manufacturer, classification, and procode.
- Predicate devices: Stating that the device is substantially equivalent to legally marketed predicate catheters.
- Device description: Design, materials, and sterilization.
- Intended Use: "Embryo Transfer Catheter used to introduce embryos into the body."
- Regulatory clearance: The FDA's letter granting clearance based on substantial equivalence.
Therefore, many of the requested items (acceptance criteria, specific study results, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not typically part of a 510(k) submission for this type of device and are not present in the provided text.
Based on the provided text, here is the information that can be extracted, along with explanations for what is not applicable:
1. Table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. For a 510(k) submission, especially for a Class II device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific quantifiable clinical performance metrics with statistical targets. The acceptance is based on the FDA's regulatory review of the declaration of substantial equivalence, material properties, sterilization validation, and intended use as compared to predicates. No specific performance metrics or acceptance criteria are reported in this document.
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 / Not Provided. The provided document does not describe a clinical "test set" or clinical study in the sense of a prospective performance evaluation on human subjects. This is a 510(k) premaket notification, which relies on demonstrating substantial equivalence to existing predicate devices, often through bench testing, material characterization, and comparison to published literature or predicate device specifications, rather than a new clinical study.
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 / Not Provided. As no clinical test set requiring ground truth establishment is described, this information is not relevant or present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. As no clinical test set requiring ground truth establishment is described, this information is not relevant or present in the document.
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 / Not Provided. This device is an "Embryo Transfer Catheter," a physical medical device. It is not an AI/Software as a Medical Device (SaMD) that involves "human readers" or AI assistance. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a physical embryo transfer catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No clinical ground truth is established or used for this 510(k) submission.
8. The sample size for the training set
- Not Applicable / Not Provided. No "training set" in the context of machine learning or clinical study data is described for this 510(k) submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set mentioned, the method for establishing its ground truth is also not applicable.
Summary of focus for this 510(k) submission:
The Embryo Transfer Catheter (CC Glider™) secured 510(k) clearance (K991266) based on substantial equivalence to predicate devices already legally marketed in the United States. The submission detailed the device's design (inner catheter of 5 French O.D., outer catheter of 9 French tapering to 7 French O.D.), materials (implant grade medical polymers), and sterilization methods (gamma radiated or E-Beamed). Its intended use is simply stated as "Embryo Transfer Catheter used to introduce embryos into the body." The clearance process for such a Class II device primarily involves demonstrating that it is as safe and effective as existing devices through comparisons of technological characteristics, materials, and intended use, rather than extensive new clinical performance studies with acceptance criteria as would be required for a novel or higher-risk device.
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).