(69 days)
The GIFT Catheter Set/s are used to transfer gametes directly into the fallopian tube. These sets are sterile and intended for one-time use.
The GIFT Catheter Set/s are used to transfer gametes directly into the fallopian tube. The materials used in this device are stainless steel, silicone, polyethylene and TFE. These materials are widely used in the medical field and biocompatibility testing is assured.
The provided document is a 510(k) Premarket Notification for the GIFT Catheter Set/s by Cook OB/GYN, submitted in 1996 and approved in 1998. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document. The 510(k) process for this type of device at that time typically relied on demonstrating similarity to already legally marketed devices, rather than conducting new clinical trials to establish performance against pre-defined metrics.
Here's a breakdown of what can be extracted from the document in relation to your request, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable. The document explicitly 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." It then claims substantial equivalence based on "indications for use, design, construction and materials equivalence" to these predicate devices. There are no specific acceptance criteria or quantitative performance metrics reported for the GIFT Catheter Set/s itself within this document. The focus is on demonstrating that it is "substantially equivalent" to existing devices.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. No test set or associated data provenance is mentioned. The submission is based on comparison to predicate devices, not a new performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. No test set requiring expert ground truth is mentioned.
4. Adjudication Method for the Test Set
- Not Applicable. No test set requiring adjudication is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. without AI assistance
- Not Applicable. This is a medical device (catheter) submission from 1996/1998, long before AI in medical imaging or diagnostics was a primary consideration for device approval in this context. No MRMC study or AI component is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable. There is no performance study or ground truth established for this device within this document. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. There is no training set mentioned, as this is not a machine learning or algorithm-based device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As no training set is mentioned, there is no ground truth established for one.
Summary of Device and Approval Process from the Document:
- Device: GIFT Catheter Set/s
- Indication for Use: To transfer gametes directly into the fallopian tube. Sterile and intended for one-time use.
- Predicate Devices: Lingard Laparoscopic GIFT Catheter Introducer Set and Cook Molloy Catheter (both manufactured by Cook Australia).
- Basis for Approval: Substantial Equivalence to predicate devices in terms of indications for use, design, construction, and materials.
- Materials: Stainless steel, silicone, polyethylene, and TFE (materials widely used in the medical field, with biocompatibility assured).
- Regulatory Focus: Compliance with general controls provisions of the Medical Device Amendments and current Good Manufacturing Practice (GMP) requirements.
This document serves as an example of a 510(k) submission where regulatory clearance is achieved primarily through demonstrating equivalence to existing safe and effective devices, rather than through de novo studies with specific performance criteria and ground truth validation.
§ 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).