Search Results

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.

Ask a specific question about this device