Search Results

The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.

The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.

Here's an analysis of the provided text regarding the CrossBay Medical SonoSure Sonohysterography and Endometrial Sampling Device:

Acceptance Criteria and Device Performance Study

Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily evaluated through non-clinical performance data (bench testing and biocompatibility). The document emphasizes substantial equivalence to predicate devices rather than establishing novel clinical performance metrics with specific acceptance criteria in a dedicated clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the "test set" in terms of clinical subjects. The performance data discussed is non-clinical (bench testing, biocompatibility, sterilization, packaging). For these types of tests, samples would be units of the device itself (e.g., a certain number of devices for mechanical testing, material samples for biocompatibility). Specific numbers are not provided.
• Data Provenance: The data is generated through "physical bench testing," "biocompatibility testing," and "sterilization" and "packaging and shipping validation studies." This indicates the data is from laboratory or controlled testing environments, not from clinical subjects or patient data. Therefore, "country of origin" or "retrospective/prospective" is not applicable in the typical sense for clinical studies. It's internal product development and testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This question is not applicable as the provided documentation describes non-clinical performance and does not involve establishing ground truth from experts on a test set (e.g., imaging diagnosis, pathology review). The "ground truth" for these tests are typically established by objective, measurable engineering and scientific standards (e.g., pass/fail criteria for mechanical strength, established limits for cytotoxicity).

4. Adjudication Method for the Test Set

• This question is not applicable as the assessment is based on non-clinical performance data against established standards and specifications, not on subjective expert interpretation requiring adjudication.

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, an MRMC comparative effectiveness study was not done.
• The device is a physical medical instrument (catheter, brush), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone performance study was not done.
• The device is a physical medical instrument, not an algorithm, and does not operate "standalone" without human interaction/use.

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

• For the non-clinical tests described, the "ground truth" is derived from established scientific and engineering standards and specifications. For instance:
  • Mechanical strength: Pass/fail criteria dictated by product specifications and engineering principles.
  • Biocompatibility: Conformance to ISO 10993 standards and FDA guidance.
  • Sterilization: Compliance with ISO 11135-1 and ISO 10993-7.
  • Packaging: Adherence to ASTM guidelines.
• There is no mention of expert consensus, pathology, or outcomes data being used to establish a "ground truth" for the performance evaluation presented.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical medical instrument and does not involve machine learning or AI, thus there is no "training set."

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

• This question is not applicable as there is no training set for this device.

Ask a specific question about this device

The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavily for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.

The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use. The materials used in the construction of the Cook® Sonohysterography Biopsy Device are well known in the medical field. Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective. Literary articles prove the usefulness of this type of device to the clinician and patient population.

The provided text is a 510(k) summary for the Cook® Sonohysterography Biopsy Catheter, submitted in 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the document does not contain this information.

The document details:

• Device Description: The Cook® Sonohysterography Biopsy Catheter is designed for saline infusion sonohysterography and, if indicated, endometrial biopsy using the same device. It is supplied sterile for one-time use.
• Substantial Equivalence: The submission asserts that the device is substantially equivalent to existing predicate devices based on its indications for use, materials, physical construction, manufacturing process controls, quality assurance, packaging, and sterilization procedures.
• Predicate Devices: Several predicate devices are listed for both the sonohysterography function (e.g., Tampa Catheter, EZ-HSG Catheter, Cook Hysterocath™, Goldstein Sonohysterography Catheter) and the biopsy function (e.g., Probet, Uterine Explora Model I, Wallace Suresample, Pipelle de Cornier®, Aspiracath™).
• Testing Mentioned: The document briefly states, "Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective." However, it does not elaborate on these "test requirements," specific acceptance criteria, or the results of these tests in detail. It also mentions "Literary articles prove the usefulness of this type of device," implying reliance on existing scientific literature rather than a new, specific performance study for this device.

None of the requested specific information about acceptance criteria, a formal study demonstrating performance against these criteria, sample sizes, ground truth establishment, or expert involvement is present in the provided text. The 510(k) process for this type of device often relies on demonstrating similarity to already marketed devices, and detailed performance studies with explicit acceptance criteria might not be fully presented in the public summary.

Ask a specific question about this device