(66 days)
The sterile single-use device is intended to assess advancement through the cervical canal and positioning of the uterus.
The CooperSurgical Trial Transfer catheters are single-use sterile, disposable, flexible catheters with a round smooth distal end. The tip has a blind/closed end. The device has an overall length of either 18cm or 23cm including a polypropylene Luer Lock Adaptor that is affixed at its proximal end. The inner catheter is a clear tube with a 1.8mm outer diameter and a 0.8mm inner catheter is surrounded by an outer sheath with a 2.3mm outer diameter. This inner catheter has a series of graduated markings that are placed 1cm apart at the proximal end to provide reference to the degree of inner catherer insertion to the uters during embryo placement. The distal 0.1cm length of the outer sheath possesses a gradual taper and is shorter than the inner catheter leaving the distal 5cm of the inner catheter exposed. The proximal circumferences of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock Adaptor. Five black (ink) graduation markings are located on the distal portion of the outer sheath at 1cm increments to indicate the degree of advanced into the cervix. This facilitates catheter positioning and placement during embryo replacement with an assisted reproduction catheter.
This document describes the 510(k) premarket notification for the CooperSurgical Trial Transfer Catheter. However, it does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding diagnostic accuracy, sensitivity, or specificity.
The document indicates that the device has undergone biocompatibility testing and complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements. It also states that the device is substantially equivalent to a predicate device (Wallace Trial Transfer Catheter K990348) based on having the same indications for use, material composition, sterilization method, and working dimensions, with minor differences in luer size and packaging.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the format you've outlined, as that information is not present in the provided text. The submission focuses on substantial equivalence to an existing predicate device rather than presenting a performance study with defined acceptance criteria for diagnostic accuracy or similar metrics.
Here's what I can extract based on the provided text, along with explanations for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Performance / Diagnostic Accuracy) | Reported Device Performance (Summary from text) |
|---|---|
| Biocompatibility: Meet ISO 10993-1 requirements | The subject device has been subject to biocompatibility testing for its materials, which is equivalent to ISO 10993-1 Biocompatibility requirements. |
| Luer Taper: Comply with ISO 594-1 1986 | The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements. |
| Functional Equivalence: Same indications for use as predicate | The subject devices have the same indications for use as the predicate (Wallace Trial Transfer Catheter K990348). Intended use: "The sterile single-use device is intended to assess advancement through the cervical canal and positioning of the uterus." |
| Material Equivalence: Same material composition as predicate | The subject device is composed of the same materials as the predicate. (Detailed material list provided for inner catheter, outer sheath, and luers). |
| Sterilization Method Equivalence: Same sterilization method as predicate | The subject device is sterilized using the same method as the predicate. |
| Dimensional & Working Equivalence: Similar working dimensions as predicate | The subject device has similar working dimensions as the predicate. (Minor difference noted: "The luers of the subject device are slightly larger (both in diameter and length) than the predicate device.") |
| Packaging: Different but acceptable packaging | The subject device is packaged in a pouch composed of Tyvek and film, whereas the predicate device is packaged in a pouch composed of paper and film. (Considered a minor difference). |
| Safety and Effectiveness: As safe and effective as predicate | The submission concludes that "the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices," based on the substantial equivalence argument and compliance with biocompatibility and luer standards. No specific performance metrics for assessing "advancement through the cervical canal and positioning of the uterus" are provided. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission focuses on substantial equivalence based on design, materials, and existing standards, rather than a clinical performance study with a distinct "test set" in the context of diagnostic accuracy.
- The biocompatibility testing and luer taper compliance would have involved laboratory testing of samples, but the specific sample sizes for these tests are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This type of information is relevant for studies assessing diagnostic or clinical performance against a "ground truth" established by experts (e.g., radiologists, pathologists). This submission is for a medical device (catheter) based on substantial equivalence, and not a diagnostic tool requiring expert ground truth for a test set.
4. Adjudication method for the test set:
- Not applicable / Not provided. See point 3.
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:
- No. This is a submission for a physical medical device (catheter), not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used:
- For biocompatibility: In vitro and in vivo biological response criteria as defined by ISO 10993-1.
- For luer taper conformity: Engineering specifications and measurements against ISO 594-1 standards.
- For substantial equivalence: Comparison to the specifications, materials, and intended use of the legally marketed predicate device (Wallace Trial Transfer Catheter K990348).
- There is no clinical "ground truth" (e.g., pathology, outcomes data, expert consensus) mentioned for evaluating the catheter's intended use ("assessing advancement through the cervical canal and positioning of the uterus"), as the submission relies on substantial equivalence to a device already on the market.
8. The sample size for the training set:
- Not applicable / Not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. See point 8.
§ 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).