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The Insemination Catheters are used for transferring sperms into the uterine cavity.
The catheter is used for intrauterine insemination.

The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.

Here's an analysis of the provided text regarding the Labotect Insemination Catheter 320301.

It's important to note that this document describes a traditional medical device (catheter) and not an AI/ML-driven device. Therefore, many of the questions related to AI performance, ground truth, training sets, and expert consensus for AI will not be directly applicable. The details provided are for a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, which focuses on design, material, and manufacturing standards, not algorithmic performance.

Acceptance Criteria and Device Performance

Since this is not an AI/ML device, the "acceptance criteria" are related to manufacturing standards, biocompatibility, and functional aspects for an insemination catheter. The device performance is tied to meeting these specific criteria for safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.

TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility. The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings. Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter. The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.

The provided text describes a 510(k) submission for a medical device called "TheCurve™," an intrauterine insemination catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "Select IUI®."

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly state "acceptance criteria" in a quantitative sense as might be found in a performance study with defined thresholds (e.g., minimum sensitivity, specificity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. The "performance" is implicitly deemed acceptable if the device is found substantially equivalent to the already approved predicate.

2. Sample Size Used for the Test Set and Data Provenance

The documents do not describe a formal "test set" or a study with human subjects (clinical trial) to evaluate the device's performance against specific acceptance criteria. This submission is a 510(k) for substantial equivalence based on device comparison and technical specifications, not a clinical performance study. Therefore, there's no sample size or data provenance in the context of a clinical test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. As no clinical study or performance evaluation with a "ground truth" was conducted or reported, no experts were involved in establishing such ground truth for a test set. The "truth" in this submission relies on the comparison of engineering specifications and intended use to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

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 a manual medical instrument (an intrauterine insemination catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a manual medical instrument and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and effectiveness of the predicate device (Select IUI®). The new device, TheCurve™, is compared against the predicate's specifications and intended use.

8. The Sample Size for the Training Set

Not applicable. Since there's no algorithm involved, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. Since there's no algorithm involved, there is no "training set" or ground truth for it.

In summary:

This 510(k) submission relies on a "benchmarking" or "comparison" approach rather than a clinical performance study with a defined test set and acceptance criteria. The "acceptance criteria" are implicitly met if the FDA determines the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, despite some minor physical differences that are argued to either have no impact or slightly improve usability (e.g., curved tip for easier insertion). The evidence provided is primarily a detailed technical comparison of the new device with the legally marketed predicate device.

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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.

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.

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For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity.

The provided 510(k) Premarket Notification for the MedWorks Visualization Insemination Catheter does not include any acceptance criteria or a study proving the device meets said criteria.

Instead, the document explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Visualization Catheter are equivalent to those of the predicate devices."

Therefore, based on the provided text, none of the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader studies can be provided. This device's submission relied on demonstrating substantial equivalence to predicate devices without presenting new performance data.

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For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Malleable catheter with distal side ports and balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.

The provided text is for a 510(k) Premarket Notification for an Insemination Catheter. It explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics, no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Insemination Catheter are equivalent to those of the predicate devices."

Therefore, the following information cannot be extracted from the given document as no performance or safety study was conducted or provided:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance data is present.
2. Sample size used for the test set and the data provenance: No test set information is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No 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: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool. No standalone performance study was conducted.
7. The type of ground truth used: Not applicable, as no ground truth was established for performance testing.
8. The sample size for the training set: Not applicable, as no training set was used for a performance study.
9. How the ground truth for the training set was established: Not applicable, as no training set was used for a performance study.

In summary, the MedWorks Insemination Catheter's approval was based on demonstrating substantial equivalence to predicate devices through design and performance characteristics, without the need for new performance or safety studies involving acceptance criteria and clinical data.

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EMBRYON® Intra-uterine Insemination Cathetors are purpose designed for the introduction of washed spermatazon into the uterus.

EMBRYON® Intra-uterine Insemination Catheters

The provided text is a 510(k) summary for the EMBRYON® Intra-uterine Insemination Catheters. It asserts substantial equivalence to predicate devices already on the market. However, it does not contain any information regarding specific acceptance criteria, device performance metrics from a study, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details of comparative effectiveness studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study summary.

The "Summary of Safety and Effectiveness" section only states: "The devices we believe are safe and effective for the application for which they are intended, intrauterine insemination, having been subjected to full design evaluation. They have been on sale and in commercial distribution within the UK and many other countries for more than 6 years." This is a general statement, not a reporting of specific study results with acceptance criteria.

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The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes. This catheter is not intended for assisted reproduction procedures.

The Mini Embryon IUI is a 5Fr Intrauterine Inseminator made of clear polyethylene, 18 cm in length, with an OD of 1.6 mm and an ID of 1.0 mm. A 5 cm distal segment with double side eyes and a rounded tip insures a very smooth entry with minimal disturbance to the endometrial bed. This is complemented with 11 cm of marked catheter shaft with 7 Fr in diameter for better and more secure handling. A proximal Luer Lock allows for connection with a syringe. It is to be supplied in two versions, Soft & Hard.

The provided text is a 510(k) summary for the "Mini-Embryon Intra Uterine Insemination Catheter." In this type of submission, the manufacturer is demonstrating that their new device is "substantially equivalent" to legally marketed predicate devices, rather than proving its safety and effectiveness through new clinical studies measuring specific performance metrics against pre-defined acceptance criteria.

Therefore, the sections of your request regarding acceptance criteria, specific study designs (like MRMC or standalone), sample sizes, and ground truth establishment are not directly applicable or explicitly detailed in this 510(k) summary. The document focuses on comparing the technological characteristics of the new device to existing predicate devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific device performance metrics in the way a clinical study report would. Instead, it offers a "Summary comparing technological characteristics with other predicate devices." The acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device.

The table indicates that for various technological characteristics, the Mini-Embryon Catheter is deemed "Equivalent" (E) or "Similar" (S) to the six predicate devices.

Reported Device Performance:
The "Performance" characteristic is deemed "Similar" (S) to the predicate devices. The document does not elaborate on what specific performance aspects were compared or what the quantitative "similarity" entails beyond the general statement that it is "safe and effective as other predicate devices cited above."

2. Sample Sizes used for the test set and the data provenance:

• Sample Size: Not applicable. This is not a study that involved a "test set" of patients or data in the traditional sense. The submission relies on a comparison of technical specifications and intended use against existing devices.
• Data Provenance: Not applicable. There is no patient data or clinical data provenance discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in the context of clinical studies, is not established for this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance.

4. Adjudication method for the test set:

Not applicable. There was no test set or adjudication process as typically performed in clinical trials or diagnostic accuracy studies.

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 is a medical device (catheter) submission, not an AI or diagnostic imaging device. No MRMC study was conducted or referenced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device. The concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The manufacturer is asserting that their new device shares sufficient technological characteristics and intended use with these predicates to be considered substantially equivalent. There is no new clinical "ground truth" generated from patient outcomes or pathology for the Mini-Embryon catheter in this submission.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for a physical medical catheter in this context.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

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The TomCat allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes, which may increase the pregnancy rate in couples with unexplained infertility

The TomCat IUI catheter is a 3 ½ french catheter with a length of 5 ½ ". This catheter expands in size in the proximal area to accommodate a syringe tip. It is made out of propylene of class VI Grade.

The provided document is a 510(k) Pre-Market Notification for a medical device (TomCat IUI catheter). It is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices, not a study proving the device meets specific acceptance criteria through clinical trials or performance metrics.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, and ground truth information) are not applicable or cannot be extracted from this type of document. The document focuses on comparing the technological characteristics of the TomCat IUI catheter to predicate devices.

Here's what can be extracted and a clear explanation of why certain information is not present:

Description of Device Acceptance Criteria and Supporting Study

The provided document describes a 510(k) Pre-Market Notification (K972245) for the TomCat IUI catheter. The purpose of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, not to establish novel acceptance criteria proven through a specific clinical study with performance metrics in the way a new diagnostic algorithm might.

The "acceptance criteria" in this context are the characteristics and intended use that allow the device to be considered substantially equivalent to already approved devices. The "study" is the comparison presented in the 510(k) submission against those predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific numerical performance metrics (like sensitivity, specificity, accuracy), the "acceptance criteria" here are the characteristics of the device that are deemed similar or equivalent to predicate devices. The "reported device performance" is essentially the similarity demonstrated in the comparative table.

(Note: The table above synthesizes the claims made in the "Summary comparing technological characteristics with other predicate devices" found in the document. The specific entry for "TomCat Performance" is derived from the "E" or "S" markings in the predicate comparison table, indicating the applicant's claim of equivalence or similarity to established devices.)

2. Sample size used for the test set and the data provenance:

• Not applicable. This document is a 510(k) pre-market notification, which relies on demonstrating substantial equivalence to existing legally marketed devices, rather than an independent clinical trial with a "test set" in the context of AI/diagnostic device performance studies. The comparison is based on the technical specifications and intended use of the new device against predicate devices.
• The data provenance is the applicant's comparison to established predicate devices, which are already marketed. This is not a "study" with a data set from a specific country or collected prospectively/retrospectively in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no "test set" and thus no "ground truth" established by experts in the context of a new diagnostic algorithm's performance. The basis for approval is the comparison of the device's characteristics to already-approved predicate devices by the submitter, which is then reviewed by the FDA.

4. Adjudication method for the test set:

• Not applicable. As there is no test set or expert ground truth establishment described, no adjudication method would be detailed.

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 medical device for intrauterine insemination, not an AI-powered diagnostic tool, and 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 device is an IUI catheter, a physical medical instrument. The concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. Ground truth generation for a diagnostic algorithm is not relevant to a 510(k) submission for a physical medical device demonstrating substantial equivalence. The "truth" in this context is that the predicate devices are legally marketed and considered safe and effective for their intended use.

8. The sample size for the training set:

• Not applicable. This submission does not involve a training set for an algorithm.

9. How the ground truth for the training set was established:

• Not applicable. This submission does not involve a training set or ground truth establishment in the context of algorithm development.

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Used for intrauterine insemination. The MicroSpan Delivery Catheter is designed to fit through the larger diameter MicroSpan Access Catheter for delivery of washed spermatozoa to the uterine cavity or for laparoscopic instillation and/or aspiration of media. Laparoscopically, the device is specifically intended for use to aspirate ascitic fluids, aspirate fluid from the cul-de-sac for cytologic screening and bacteriologic cultures, irrigation and aspiration of larger volumes of fluid from ovarian tumors, irrigation and rinsing of the operative field, aspiration of bloody fluid resulting from a tubal pregnancy or post operative bleeding, and instillation of sterile saline or Ringer's solution.

The MicroSpan Insemination System is a sterile device consisting of two components: the MicroSpan Access Catheter (introducer) and the MicroSpan Delivery Catheter. The MicroSpan Insemination System is designed to be introduced through the MicroSpan Hysteroscope Sheath for intrauterine insemination procedures or introduced through the operative channel of a laparoscope for laparoscopic instillation and/or aspiration of media.

The provided text is a 510(k) summary for the MicroSpan Insemination System. It describes the device, its intended use, and states that non-clinical tests were performed to demonstrate adequate performance. However, it does not contain any information about acceptance criteria, a study proving device performance against those criteria, or any of the detailed aspects requested in the prompt.

Therefore, I cannot provide the requested information based on the input text.

The input document is a regulatory submission summary document, which typically focuses on describing the device and its intended use, and asserting that testing was performed, rather than providing the detailed results and methodologies of those tests. To answer your questions, one would need to refer to the actual test reports, study protocols, and results that would have been part of the full 510(k) submission.

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The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.

The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document, K964848 (Wallace Artificial Insemination Catheters), there is no detailed study information or specific acceptance criteria for performance metrics as would be expected for a diagnostic or AI-driven device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with quantitative results.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text as the information is not present.

However, I can extract the closest information to "acceptance criteria" based on the substantial equivalence argument, which implies that the device is deemed acceptable if it is comparable to the predicate device in terms of materials, sterilization, and intended use.

Here's the breakdown of what can be derived from the provided input:

1. A table of acceptance criteria and the reported device performance

Since specific quantitative performance acceptance criteria are not explicitly stated, the "acceptance criteria" are implied by the substantial equivalence argument – that the new device should be similar to the predicate device. The "reported device performance" is essentially the comparison to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document describes a comparison of device characteristics, not a clinical performance study with a test set.

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. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication process 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 not an AI device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No ground truth established for performance. The "ground truth" for the substantial equivalence claim is the characteristics of the predicate device (Edwards-Wallace Catheters).

8. The sample size for the training set

• Not applicable. This is not a device that relies on a training set in the AI sense.

9. How the ground truth for the training set was established

• Not applicable.

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