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To replace: Cracked or broken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumen Catheter.

The Dialysis Catheter Repair kit is used to perform a repair of an Equistream Long-Term Dual Lumen Catheter, replacing cracked or broken luer-lock connectors, clamps and/or damaged extension legs when a minimum of 4.5 cm of viable extension tubing exists. The repair kit components are made from Delrin.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This device is a Catheter Repair Kit with Replacement Connector (K101261). It is essentially a repair kit for specific hemodialysis catheters, designed to replace damaged Luer-lock connectors or extensions.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with quantitative acceptance criteria (e.g., specific tensile strength values, leak rates, etc.) and corresponding reported device performance. Instead, it states that the device "met all predetermined acceptance criteria derived from the above mentioned references." The references listed are:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term & Long-Term Intravascular Catheters; March 16, 1995
• ISO 10555-1:1995/Amd 1:1999, Amd 2:2004; Sterile, single-use intravascular catheters, Part 1. General requirements
• AAMI/ANSI/ISO 10993-1:2003; Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
• ISO 594-2: 1998: Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment—Part 2: Lock Fittings
• AAMI/ANSI/ISO 11135-1:2007, Sterilization of Health Care Products - Ethylene Oxide –Part 1: Requirement for the development, Validation and Routine Control of a Sterilization Process for Medical Devices.

The general performance statement is: "Design validation was conducted on the subject Catheter Repair Kit with Replacement Connector configuration and yielded acceptable results."

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

The document does not specify exact sample sizes for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generically states: "Tests were performed on sterilized, finished devices."

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

This type of information is not applicable to this device. This is a physical medical device (a catheter repair kit), and its performance is evaluated through non-clinical bench testing against established engineering and medical device standards, not through expert review of diagnostic images or clinical data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As the device performance is evaluated using non-clinical, objective testing (e.g., mechanical strength, leak tests, biocompatibility), there is no "adjudication method" in the sense of human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. This device is a repair kit for a catheter, and its effectiveness is determined through physical and material property testing, not human reader performance.

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 or AI system. Therefore, the concept of "standalone performance" in the context of AI is irrelevant here. Its performance is inherent in its design and manufacturing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and medical device standards (e.g., ISO and AAMI standards) and in-house protocols that specify acceptable measurable parameters for catheter components regarding mechanical integrity, fluidic performance (e.g., Luer-lock fit), biocompatibility, and sterilization efficacy.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the physical testing of a medical device like a catheter repair kit.

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

Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth established in the context of data for an algorithm. The "ground truth" for its design and manufacturing is adherence to established regulatory and engineering standards.

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To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell* Long-Term Dual Lumen Catheter, Opti-Flow* Long-Term Dual Lumen Catheter, Slim-Cath* Short-Term Dual Lumen Catheter, Vaccess* Short-Term Single Lumen Catheter, HemoStar* Long-Term Dual Lumen Catheter, Flexxicon* Short-Term Dual Lumen Catheter, Niagara* Short-Term Dual Lumen Catheter, Flexxicon* II Short-Term Dual Lumen Catheter, HemoGlide* Long-Term Dual Lumen Catheter, and HemoSplit* Long-Term Hemodialysis Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

Here's an analysis of the provided text regarding the Catheter Repair Kit with Replacement Connector:

The provided document is a 510(k) summary for a medical device called the "Catheter Repair Kit with Replacement Connector." This type of submission aims to demonstrate that a new device is substantially equivalent to a previously cleared device (predicate device), rather than proving stand-alone safety and effectiveness through extensive clinical trials. Therefore, the information typically found in studies designed to "prove the device meets acceptance criteria" in the way one might expect for novel, high-risk devices or AI algorithms is not present here.

Instead, the "study" demonstrating that the device meets acceptance criteria primarily consists of non-clinical performance testing to show equivalence to the predicate device, especially in light of a minor material formulation change.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical format of sensitivities, specificities, or other statistical measures for a decision-making algorithm. Instead, the acceptance criteria implicitly relate to the device functioning in a manner equivalent to the predicate device after a material change. The "performance" is demonstrated through non-clinical testing.

   Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
   Safety and Effectiveness not adversely affected by minor material change.	FMEA conducted, no new safety/effectiveness questions raised. Performance data demonstrate equivalence.
   Maintain intended use and functional characteristics of predicate device.	Testing based on FDA guidance and standards to evaluate performance. Performance data demonstrate equivalence.
   Compatibility with listed catheters for repair (cracked/broken luer lock, damaged extension).	Assumed to be met through equivalence to predicate device and non-clinical testing.

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

   • Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of units or test iterations.
   • Data Provenance: Not applicable in the context of human data. The testing would be laboratory-based (in-vitro) on device components.

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

   • This is not applicable as the study described is for a physical medical device (catheter repair kit) and not an AI/diagnostic algorithm where expert ground truth is typically established. The "ground truth" would be the engineering specifications and intended function of the device.

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

   • Not applicable as this is not a study involving human readers or diagnostic interpretation. The "adjudication" of test results would be based on engineering and quality control 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:

   • No. This is not an AI device.

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):

   • For this type of device, the "ground truth" for performance testing (e.g., tensile strength, leak resistance, biocompatibility) would be defined by engineering specifications, recognized industry standards (e.g., ISO), and FDA guidance documents. The device must meet these predetermined physical and functional criteria.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. As above, there is no training set for this type of device.

Summary of the "Study" from the document:

The "study" referenced in the 510(k) process for the Catheter Repair Kit with Replacement Connector is a non-clinical performance testing program. This program was undertaken because of a minor material formulation change in the new device compared to its predicate.

• Objective: To determine if the material change affects the safety or effectiveness of the device and to demonstrate substantial equivalence to the predicate device (K030442).
• Methodology:
  • A Failure Modes and Effects Analysis (FMEA) was conducted in accordance with ISO 14971:2000 to identify potential risks.
  • Performance testing was conducted based on FDA guidance documents and standards.
• Results/Conclusion:
  • The FMEA did not raise any new types of safety or effectiveness questions.
  • The performance data generated from the testing demonstrated equivalence to the predicate device.

This approach is standard for 510(k) submissions where changes to an existing device are minor and do not introduce new scientific or technological challenges. The "acceptance criteria" are intrinsically linked to demonstrating that the new device performs identically (or equivalently) to the already cleared predicate device, ensuring no new risks or diminished effectiveness due to the material change.

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To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter, and HemoSplit™ Long-Term Hemodialysis Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

Here's an analysis of the provided text regarding the HemoSplit Repair Kit, focusing on the acceptance criteria and study information:

HemoSplit Repair Kit: Acceptance Criteria and Study Information

Note: The provided documentation (K030442) is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) or a more extensive clinical trial report would. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement, and advanced study methodologies like MRMC or standalone performance, is not present in this document. The "study" here is largely based on demonstrating equivalence rather than new performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are interpreted as the requirements for demonstrating substantial equivalence, and the "reported device performance" is framed in terms of meeting those equivalence criteria.

Conclusion from the 510(k): Based on these criteria, the Catheter Repair Kit with Replacement Connector (HemoSplit Repair Kit) was deemed substantially equivalent to the predicate device (Catheter Repair Kit with Replacement Connector, K022561).

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

• Sample Size for Test Set: Not applicable / Not mentioned. This 510(k) submission does not describe a separate "test set" in the context of performance evaluation with specific data points. The focus is on comparing the design and stated intended use to a predicate device.
• Data Provenance: Not applicable / Not mentioned. No specific data is presented that would have a country of origin or be classified as retrospective/prospective.

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

• Number of Experts: Not applicable / Not mentioned. As there is no specific "test set" described for performance evaluation, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable / Not mentioned. Without a test set and expert review, an adjudication method is not relevant to this submission.

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

• MRMC Study: No. This type of study is not described or referenced in the 510(k) summary. The device is a physical repair kit, not an AI or imaging diagnostic tool where MRMC studies are common.
• Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable. (See above.)

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not applicable. This device is a physical product (a repair kit), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI/software does not apply.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this 510(k) submission is the established performance and safety profile of the predicate device (Catheter Repair Kit with Replacement Connector, K022561). The new device demonstrates "substantial equivalence" to this known entity.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not mentioned. This submission does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

• How Ground Truth for Training Set Was Established: Not applicable / Not mentioned. (See above.)

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To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following Vas-Cath catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

The provided document is a 510(k) summary for a Catheter Repair Kit with Replacement Connector. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical performance studies with acceptance criteria.

Therefore, this document does not contain information regarding:

• Acceptance criteria and reported device performance in the context of a clinical study.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, expert consensus).
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and intended use.

Here's a breakdown of what the document does state in relation to the prompt:

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

• Not Applicable. This document does not describe performance in terms of clinical acceptance criteria for a device. It asserts that the new device has "exactly the same" technological characteristics as the predicate device (K011015) and that the intended use is "identical" or "the same." The only difference noted is the addition of one catheter trade name (HemoGlide™) to the list of repairable catheters and a minor labeling consistency change (temporary to short-term).
• The "performance" implied is that it will perform identically to the predicate device because it is technologically the same.

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 clinical data is presented or referenced for device performance. The 510(k) relies on comparison to a predicate.

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 for a test set is described.

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

• Not Applicable. No test set or 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 is not an AI (Artificial Intelligence) device, and no MRMC study or AI assistance is discussed.

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

• Not Applicable. This is a physical medical device (catheter repair kit), not an algorithm or software. "Standalone performance" in this context would typically refer to bench testing, which is assumed to be part of the product development but not detailed as a comparative study in this 510(k) summary.

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

• Not Applicable. The concept of "ground truth" in the context of clinical data for performance assessment is not relevant to this 510(k) submission. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set:

• Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not Applicable. No training set or ground truth establishment for a training set is discussed.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence of a physical medical device (Catheter Repair Kit) to a predicate device, rather than presenting a clinical study with acceptance criteria, ground truth, or statistical performance metrics.

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