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The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.

The Kendall Ultraner Coude Foley Catheter is a sterile, single use unological catheter composed of natural rubber latex with a 5 cc or 30cc balloon and designed with a beat tip to provide transurethral access to an obstructed bladder, for purposes of irrigation and urine drainage. The Coude catheter is exclusively used in the male patient, typically in a hospital secting. The Kendall Ultramer Coude Foley Catheters will be marketed in 12-24 French sizes.

The provided text describes a medical device, the Kendall Ultramer Coude Foley Catheter, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria in the manner requested for AI/software devices.

As such, many of the requested categories are not applicable to this type of traditional medical device submission. The primary "study" conducted here is nonclinical testing to ensure fundamental safety and equivalence.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Flow rates
• Balloon integrity
• Inflated balloon response to traction
• Balloon volume maintenance
• Balloon size
• Shaft size
• Deflation reliability | The Kendall Coude catheter was found to meet ASTM F623-89 Standard Performance Specifications for Foley Catheters for the listed parameters. Testing also verified equivalence to the predicate device. |
  | Substantial Equivalence: Fabricated from similar materials, same function, equivalent indications for use, and similar overall design as the predicate device (Bardex Lubricath Coude Foley Catheter, 510(k) #K910195). | The Kendall Ultramer Coude Foley Catheter is equivalent to the referenced predicate device in materials, function, indications for use, and overall design. |

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

• Sample Size (Test Set): Not explicitly stated in terms of a "test set" for a diagnostic product. The nonclinical testing involves physical samples of the catheter, but the number of units tested for each functional/mechanical test is not provided.
• Data Provenance: The testing was conducted internally by The Kendall Company ("Nonclinical testing was performed on the Kendall cather..."). The country of origin for the data is implicitly the USA (Mansfield, MA). It is a prospective evaluation of newly manufactured devices.

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

• Not Applicable. This device is a physical medical catheter, not an AI/diagnostic software. Ground truth for its performance is established through standardized engineering and biocompatibility testing, not expert interpretation of diagnostic data.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing involves objective measurements against predefined standards.

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 physical device, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not Applicable. This is a physical device, not an algorithm or software. Its performance is inherent in its design and materials, and demonstrated through physical testing.

7. The type of ground truth used

• Engineering Standards and Biocompatibility Standards:
  • ASTM F623-89 Standard Performance Specifications for Foley Catheters: Provides quantifiable benchmarks for functional and mechanical aspects (e.g., flow rates, balloon integrity).
  • ISO-10993 Biological Evaluation of Medical Devices: Provides standardized methods and criteria for evaluating the biocompatibility of medical devices.
  • Predicate Device Equivalence: The ultimate "ground truth" for regulatory approval in this context is demonstrating substantial equivalence to a legally marketed predicate device, as required for a 510(k) submission.

8. The sample size for the training set

• Not Applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. See point 8.

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MONOJECT Insulin Syringes are used for subcutaneous injection of U-100 Insulin.

Monoject Insulin Syringes are sterile, single use, disposable hypodermic syringes with permanently affixed hypodermic needles. Monoject Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle permanently affixed to the tip of the syringe with epoxy. Monoject Insulin Syringes are available in 1.0 cc (100 units), 0.5 cc (50 Units) and 0.3 cc (30 units) syringe capacities with the following sizes of hypodermic needle: 28 GA x ½ inch, 29 GA x ½ inch and 30 GA x 5/16 inch.

The provided text is a 510(k) Premarket Notification for Monoject Insulin Syringes. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not include a study proving the device meets specific acceptance criteria. This type of regulatory submission typically focuses on demonstrating equivalence to existing legally marketed devices rather than presenting a performance study with detailed acceptance criteria.

Therefore, I cannot provide the requested information as the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Details of a study for the device.
3. Sample size used for a test set or data provenance.
4. Number of experts and their qualifications for ground truth establishment.
5. Adjudication method for a test set.
6. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
7. Information on a standalone algorithm performance study.
8. Type of ground truth used (expert consensus, pathology, outcome data).
9. Sample size for a training set.
10. How ground truth for a training set was established.

The document primarily focuses on regulatory compliance, specifically the device's design, materials, and intended use being substantially equivalent to predicate devices, and its conformity to ISO 8537:1991(E) where applicable (with an exception for the new 30-gauge needle not covered by the standard).

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The Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.

The Kendall Suprapubic Catheter Trays and Kits are sterile, single use devices which are designed to provide suprapubic access to the bladder for bladder irrigation and urine drainage. The proposed device consists of 100% silicone suprapubic catheters in 10, 12 and 14 French sizes packaged with various accessories.

The catheters are two-way balloon catheters having a drainage and inflation lumen.

This is a 510(k) summary for a suprapubic catheter. 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not on clinical studies proving device performance against acceptance criteria in the way a PMA (Pre-Market Approval) submission would. Therefore, the information requested in your prompt regarding acceptance criteria, study design, ground truth, sample sizes, and expert adjudication for proving device performance is generally not applicable or not present in a 510(k) summary.

Here's a breakdown based on the provided document:

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

   • Not applicable in the context of a 510(k) summary. This document does not describe specific numerical acceptance criteria for clinical performance that would be met by a clinical study. Substantial equivalence is demonstrated through material, function, indications for use, and design comparison to a predicate device.

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 clinical test set or data provenance is mentioned in this 510(k) summary. The testing performed was non-clinical.

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 by experts is described as there were no clinical studies or test sets that would require such an assessment.

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

   • Not applicable. No clinical test set requiring adjudication 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 device is a suprapubic catheter, not an AI-assisted diagnostic tool.

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

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

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

   • Not applicable. No ground truth is established for clinical performance as no clinical studies are described. The equivalence is based on engineering and material properties.

8. The sample size for the training set

   • Not applicable. There is no "training set" in the context of a 510(k) submission for this type of physical device.

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

   • Not applicable. See point 8.

Information that is provided in the 510(k) summary related to testing:

The 510(k) summary does mention Nonclinical Testing:

• Biocompatibility testing: Performed following ISO-10993 Biological Evaluation of Medical Devices. The finding was that "the material contained no toxic diffusible substances." This is a pass/fail criterion based on established standards. No specific numerical metrics are given beyond this qualitative statement.
• Functional/Mechanical testing: Performed to determine:
  • Flow rates
  • Balloon burst volume
  • Valve retention
  • Funnel/shaft bond strength
  • Static load
  • Dynamic load
  • Water loss
  • Non-deflator test
  • Reported Finding: "Testing showed equivalence between the proposed catheter and commercially available suprapubic catheters." Again, this is a statement of equivalence rather than a specific performance metric against a pre-defined acceptance criterion. The acceptance criteria for these tests would be internal specifications (e.g., "flow rate must be within X% of predicate," "balloon burst volume must be Y mL ± Z%"), but these are not disclosed in the 510(k) summary.

In summary, for a 510(k) submission like this, the focus is on demonstrating that the new device is "substantially equivalent" to an already legally marketed predicate device, primarily through non-clinical testing and comparison of design, materials, and intended use. It does not typically involve the type of clinical performance studies with acceptance criteria, ground truth, and expert adjudication that would be found in a PMA or a submission for a novel, high-risk device.

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