(89 days)
The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.
The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.
The provided text describes a 510(k) premarket notification for a medical device called 'The Inseminator' by Wallach Surgical Devices, Inc. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting new clinical study data.
Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from the provided text.
The document explicitly states:
"Substantial equivalence for this device is based solely on design and performance characteristics; no performance or safety data is included in this premarket notification. The materials, performance specifications and essential design characteristics of the Wallach's Insemination Catheter are equivalent to those of the predicate devices."
The submission relies on a comparison of design, materials, sterilization, and intended use with existing predicate devices to demonstrate safety and effectiveness.
Here's what can be provided based on the available information:
1. A table of acceptance criteria and the reported device performance:
Since no performance data or specific acceptance criteria for performance were included in the submission beyond showing equivalence to predicate devices, this table cannot be fully populated as requested. The criteria for acceptance in this context refer to the characteristics being compared for substantial equivalence.
| Acceptance Criteria (for Substantial Equivalence to Predicate Devices) | Reported Device (Wallach Surgical 'Inseminator') |
|---|---|
| Materials | polypropylene |
| Sterilization | EtO - SAL 10-6 |
| Design | Equivalent to predicate devices |
| Target Population | Infertile Couples |
| Where Used | By a Physician |
2. Sample size used for the test set and the data provenance: Not applicable. No test set data was provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment from experts was described for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was 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: Not applicable. This device is an intrauterine insemination catheter, not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for performance was established within this submission; substantial equivalence was based on design and characteristic comparison to predicate devices.
8. The sample size for the training set: Not applicable. This device is not an AI-based system and does not have a training set in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission leverages the "substantial equivalence" pathway, which allows a new device to be marketed without new clinical trials if it can be shown to be as safe and effective as a legally marketed predicate device. The information provided focuses on demonstrating this equivalence through comparative tables of device characteristics, not through new performance studies.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).