(81 days)
Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.
Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter
Embryo Replacement Catheters: The Embryo Replacement Catheters (for use in ultrasound-guided transfers) are single use devices for the introduction of embryos into the uterine cavity following in-vitro fertilisation. The devices have overall lengths; 18cm (CE 118A) and 23cm (CE 123A) and consist of a soft, flexible inner cannula, with end opening, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a lumen that is uniform throughout its length, with a series of 1cm graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.
Trial Transfer Catheters: The Trial Transfer Catheters (for use in ultrasound-guided transfers) are single use devices used to assess the passage through the cervix prior to embryo transfer. The devices have overall lengths; 18cm (CE 418A) and 23cm(CE 423A) and consist of a flexible inner cannula, with blind end, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a series of graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.
The provided text is a 510(k) premarket notification for a medical device, the Wallace (Sure View TM) Embryo Replacement Catheters & Trial Transfer Catheters. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies proving efficacy and safety with specific acceptance criteria as you might find for a novel device.
Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance derived from a study proving the device meets those criteria. Specifically, it lacks:
- Explicit Acceptance Criteria: The document does not define specific performance metrics (ee.g., sensitivity, specificity, accuracy, precision, etc.) that the device must meet, nor does it quantify acceptable thresholds for these metrics.
- A "Study" in the traditional sense: There isn't a prospective or retrospective clinical trial described with a defined protocol, recruitment, data collection, and statistical analysis to assess the device's performance against pre-defined criteria.
- Reported Device Performance: Since there's no study, there are no reported numerical performance results for the device.
Instead, the submission relies on the concept of substantial equivalence. The performance section states: "Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects." This implies that the device's performance characteristics are considered to be similar enough to the predicate devices that no new robust performance studies are deemed necessary by the submitter or the FDA (as indicated by the clearance letter).
Here's a breakdown of why the requested information isn't available in the provided text, and what information is present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for this 510(k)) | Reported Device Performance (Not Quantified for this 510(k)) |
|---|---|
| No explicit numerical performance criteria are defined in this 510(k) submission. The basis for clearance is "substantial equivalence" to predicate devices. | No quantitative performance metrics are reported from a dedicated study in this 510(k) submission. The submission claims "comparison of the performance... with the predicate confirms substantial equivalence in all aspects." |
Explanation: In a 510(k) for a substantially equivalent device, the "acceptance criteria" are implicitly that the device performs as well as or similarly to the predicate device, especially for its intended use and any new technological characteristics. Here, the key technological difference is enhanced ultrasound visibility, which is stated to be substantially equivalent to another predicate (Cook Echotip®). The "study" proving this is a comparison to the predicate devices rather than a de novo clinical trial with specific performance endpoints.
2. Sample size 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 document does not describe a clinical "test set" or a study involving patient data to assess performance. The comparison for substantial equivalence appears to be based on design, material, and manufacturing similarities, and the inherent properties of the enhanced ultrasound visibility material compared to a similar predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: There is no clinical "test set" and therefore no ground truth established by experts described in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or adjudication method is described.
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 catheter, not an AI or imaging diagnostic device. Therefore, an MRMC study with AI assistance is not relevant and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No: This is a physical medical catheter, not an algorithm, so a standalone performance study in this context is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided: No ground truth in the context of clinical performance assessment is described, as the submission focuses on substantial equivalence based on material, design, and intended use comparison to predicate devices. The "ground truth" for clearance in this context is the FDA's determination that the new device is as safe and effective as the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided: As there is no AI component or machine learning model, there is no "training set" in the context of this device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No training set is described.
Summary of what the document does provide regarding the "study":
The "study" in this 510(k) context is a demonstration of substantial equivalence to predicate devices. The key comparison for performance relates to the enhanced ultrasound visibility. The submission states:
- "The proposed devices are made from the same materials as Predicate 1 & 2. with the exception that the material is modified to enhance the visibility of the catheter under ultrasound. In this respect, the inner catheter is substantially equivalent to Predicate 3 [Cook Echotip® Soft-Pass Embryo Transfer Catheter already marketed in the USA under K983594]."
- "Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects."
This indicates that the "proof" the device meets implied performance criteria (i.e., being safe and effective for its intended use, particularly with enhanced ultrasound visibility) is based on:
- Material and design similarity: The proposed device's physical characteristics (tip protector, outer sheath, print markings, hubs) are identical or substantially equivalent in material composition and profile to existing predicate devices (Wallace Embryo Transfer Catheter, K990350; Wallace Trial Transfer Catheter, K990348).
- Comparison of enhanced feature to an already cleared predicate: The ultrasound visibility feature is deemed substantially equivalent to another predicate that already possesses such a feature (Cook Echotip® Soft-Pass Embryo Transfer Catheter, K983594).
No new clinical trials with specific performance endpoints were required or conducted as part of this 510(k) submission.
§ 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).