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The intended use of "The Advance Catheter for HSG and SIS" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (SIS) into the female reproductive tract for examination of the uterus and/or fallopian tubes.

The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency.

The Advance Catheter for HSG and SIS will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.

The "The Advance Catheter for HSG and SIS (Advance Catheter) consist of a plastic tube, the distal end of which has an inflatable balloon. When the balloon is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids.

An introducing sheath is placed over the tube to provide a stiffener and quide. The sheath can be placed into the endocervix to the level of the internal os with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity. The Advance catheter like its predicate will be available in 5F and 7F sizes.

This summary describes the acceptance criteria and study information for "The Advance Catheter for HSG and SIS" based on the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The submission does not explicitly state sample sizes for tests such as biocompatibility, flow rate, or tensile strength. It refers to "test reports in sections 15 and 18," which are not provided in this excerpt. The tests appear to be non-clinical, laboratory-based performance tests, not human trials. Therefore, data provenance related to human subjects (e.g., country of origin, retrospective/prospective) is not applicable.

3. Number of Experts and Qualifications for Ground Truth

The provided document does not indicate the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The study focused on engineering performance characteristics and substantial equivalence to legally marketed devices.

4. Adjudication Method

Not applicable. The study primarily describes non-clinical performance testing and a comparison to predicate devices, not an assessment requiring expert adjudication of a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported in this submission. This device is an instrument for delivering contrast media, not a diagnostic imaging AI with human-in-the-loop performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

For the non-clinical tests (biocompatibility, flow rate, tensile strength), the "ground truth" was defined by pre-specified engineering requirements and ISO standards (e.g., ISO10993). For the overall device, the "ground truth" for regulatory clearance was substantial equivalence to existing legally marketed devices, demonstrating comparable safety and effectiveness based on similar design, materials, and intended use.

8. Sample Size for Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established

Not applicable. As described above, there was no training set in the context of an algorithm.

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Delivery of washed sperm into the uterus.

The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.

The provided text describes a 510(k) summary for the "IUI Catheter" (K120154). This submission is for a medical device that claims substantial equivalence to a predicate device, not for an AI/ML powered device. As such, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sensitivity, specificity, F1-score, reader studies, training sets, and ground truth establishment by experts) are not applicable or detailed in this document.

The acceptance criteria and study information provided focus on the physical and functional characteristics of the traditional medical device, particularly in comparison to its predicate.

Here's an analysis of the provided information based on your request, highlighting where information is absent or not applicable due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The "Equivalence Summary" table on page 2 of the 510(k) document serves as the primary source for acceptance criteria and how the proposed device (IUI Catheter) meets them by demonstrating equivalence to the predicate device.

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The intended use of the HS Catheter is for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes. The intended use of the SHG Catheter is for the delivery of saline into the female reproductive tract for examination of the uterus and fallopian tubes.

The HS Catheter devices consist of a plastic tube, the distal end of which has an inflatable cuff. A sheath is over the tube to provide a stiffener and guide. When the cuff is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the cuff with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. The HS catheters will be available in 5F and 7F sizes.

The SHG Catheter devices consist of a plastic tube with a blunt tip and one or more side holes at the distal tip. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. A sponge stop is provided to press on the external os of the cervix to reduce the back leakage of injected fluids. This devices is intended for use with saline solution, only. I n addition to the individual catheters, convenience kits will be offered that provide the physician with items helpful to the completion of the procedure.

The provided text is a 510(k) summary for a medical device (HS and SHG Catheters) and does not describe a study involving acceptance criteria in the typical sense of a performance study for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not applicable in this context, as they pertain to clinical or performance studies that were not provided or performed for this specific 510(k) submission.

Here's the breakdown based on the information available:

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

• Not Applicable. The 510(k) summary does not report on specific performance metrics or acceptance criteria for a new clinical study. The basis for clearance is substantial equivalence to legally marketed predicate devices, not meeting specific performance thresholds in a new study.

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

• Not Applicable. No test set or associated data provenance is mentioned as no new clinical study was provided.

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 ground truth establishment for a test set is mentioned.

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

• Not Applicable. No test set or adjudication method is mentioned.

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 catheter, not an AI/ML device. No MRMC study was performed.

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

• Not Applicable. This is a medical catheter, not an AI/ML device. No standalone algorithm performance was assessed.

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

• Not Applicable. No new clinical data requiring ground truth was presented. The substantial equivalence argument relies on comparing the device's technological characteristics, intended use, and operating principles to those of predicate devices.

8. The sample size for the training set

• Not Applicable. This is a medical catheter, not an AI/ML device. No training set was used.

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

• Not Applicable. This is a medical catheter, not an AI/ML device. No training set or ground truth for it was established.

Summary of Device and Regulatory Pathway based on the Input:

• Device Name: H/S Catheter Set (Proprietary Name: HS and SHG Catheters)
• Applicant: Catheter Research, Inc. (CRI)
• Intended Use: For the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes.
• Regulatory Pathway: 510(k) Pre-market Notification, claiming substantial equivalence to predicate devices (K020292, K020951 & K020951, K022503).
• Key Basis for Clearance: The device has "the same technological characteristics as the predicate devices. The intended use and operating principles are identical. The H/S Catheter Set incorporates similar product design, materials packaging and sterilization as the predicate products."
• Clinical/Non-Clinical Testing: "None provided." This indicates that the substantial equivalence argument was made without new performance data, relying instead on comparison to existing legally marketed devices.

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To be used during hysterosalpingograms, salpingoplasties, and hydrotubation.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a Uterine Injector device. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document is solely an FDA clearance letter acknowledging the device's substantial equivalence to a predicate device for its stated intended uses.

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Esophageal Stethoscope: Monitoring heart and breath sounds.
Esophageal Stethoscope with Electrical Conductors: Monitoring heart and breath sounds, and core temperature.

Disposable Esophageal Stethoscope

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Disposable Esophageal Stethoscope, dated March 19, 1998. This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device's performance evaluation as would be required to answer your request.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (monitoring heart and breath sounds, and core temperature for models with electrical conductors). It does not include a performance study summary or the details of how the substantial equivalence was demonstrated in terms of specific performance metrics.

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To be used during diagnostic laparoscopy, minilaparotomy, fertility examinations, and salpingoplasty.

Uterine Manipulator / Injector

The provided text is a 510(k) clearance letter from the FDA for a Uterine Manipulator/Injector, dated February 2, 1998. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as typically found in submissions for AI/ML-based medical devices.

The document pertains to a physical medical device (Uterine Manipulator/Injector) cleared through the 510(k) pathway, indicating substantial equivalence to a predicate device. This pathway generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with acceptance criteria thresholds for performance metrics like sensitivity, specificity, or AUC as seen in AI/ML device submissions.

Therefore, I cannot provide the requested information because it is not present in the provided text. The questions posed in your prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are relevant to the evaluation of AI/ML-based devices and are not applicable to the traditional medical device clearance described in this document.

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