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The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.

The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

Here's a breakdown of the acceptance criteria and study information for the Symetrex™ Long Term Hemodialysis Catheter with Sideholes, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily demonstrated through equivalence to the predicate device and compliance with various ISO and ASTM standards. The document doesn't explicitly state quantitative acceptance criteria in all cases, but rather reports the device performance against established standards through "performance testing."

Key performance aspects are outlined in the comparison to the predicate device and in the performance standards section.

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

The document does not specify the sample sizes used for the performance testing (test set) for the device. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily in vitro (Recirculation) or bench/laboratory testing (physical, mechanical, packaging, luer fittings, biocompatibility).

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

This information is not provided in the document. The studies described are non-clinical, benchtop, and in vitro tests governed by engineering and scientific standards, rather than clinical trials requiring expert-established ground truth in the medical diagnostic sense.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and therefore not provided in the document. The studies are non-clinical hardware tests.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a physical medical device (catheter), not an AI-powered diagnostic system. Therefore, the concept of "human readers improve with AI" is not relevant here.

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

This information is not applicable as the device is a physical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance testing and biocompatibility studies, the "ground truth" is established by:

• Engineering and Scientific Standards: Compliance with relevant ISO and ASTM standards (e.g., ISO 10555-1 for intravascular catheters, ISO 11607-1 for packaging, ISO 594-1/2 for luer fittings, and various ISO 10993 parts for biocompatibility).
• Measurement and Comparison: Direct measurement of physical properties (e.g., priming volumes) and comparison to the predicate device.
• Established Test Methods: In vitro testing for recirculation rates.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this physical medical device. The device is not learning-based.

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

This information is not applicable as there is no "training set" for this physical medical device.

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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central catheters (PICC). The C3 Wave provides real-time catheter tip location by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contrindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave: Atrial fibrillation Atrial flutter Severe tachycardia Pacemaker-Driven Rhythm Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a guide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.

This document details the substantial equivalence review for the Medcomp C3 Wave System (K180567), which is an update to a previously cleared device (K170934). The current submission focuses on expanding accessory pack offerings, specifically adding a larger drape and revising the packaging system. Therefore, the "study" described relates to the testing performed to ensure the safety and effectiveness of these modifications, rather than a clinical efficacy study of the core device functionality.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All testing was completed and is the subject of this submission" and concludes that the device raises "no new questions of safety or effectiveness compared to the predicate device." This implies that all acceptance criteria for the non-clinical testing performed on the modified accessory pack were met. Specific numerical performance metrics for each test (beyond the EO residuals) are not detailed in this summary.

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

The provided text describes non-clinical laboratory testing performed on the modified accessory pack. It does not mention a "test set" in the context of patient data or clinical performance. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or not provided for this specific submission, as it focuses on accessory modifications rather than the primary device's clinical performance.

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

This information is not applicable or not provided as the submission focuses on non-clinical testing of device accessories (drape and packaging), not on clinical performance requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or not provided for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not performed or described in this document. The C3 Wave System is an ECG-based positioning aid for PICC lines, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. This submission specifically addresses modifications to accessory packs.

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

A standalone performance study of an algorithm is not discussed or applicable to this submission. The C3 Wave System is a device that provides real-time data to a human operator (skilled nurse, physician, or trained medical professional) to aid in PICC placement. The submission pertains to modifications to non-electronic accessories.

7. The Type of Ground Truth Used

For the non-clinical testing of accessories, the "ground truth" would be established by standardized laboratory testing procedures and the specifications of relevant international and national consensus standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization, ASTM F1929 and F1140 for packaging). This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since the submission refers to modifications of accessories and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable or not provided as there is no "training set" in the context of this submission.

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The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The CT Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid contamination. Female luer connectors provide the connection for intravenous administration.

The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.

The provided document is a 510(k) premarket notification for a medical device (CT Midline) and primarily discusses its substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific acceptance criteria.

The submission states that the purpose of this particular 510(k) is to "remove a contraindication that was once cited in the Journal of Infusion Nursing but has since been revised." This is a change to the labeling, not a new performance claim or a new device design that would necessitate a comprehensive performance study with acceptance criteria and reported results.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of why each point cannot be thoroughly answered from the provided text:

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

   • The document implies that the device's performance (e.g., flow rates for power injection) is identical to the predicate device K141151.
   • Table 5.1 "Design Comparison Matrix" lists "Performance Testing" with "Power Injection: 5cc/sec (4F), 7cc/sec (5F)" for both the proposed and predicate devices, stating "Identical, no change." This indicates the expected performance, but not explicit acceptance criteria, nor the results of a new study designed to meet those criteria for this specific submission. It's a statement of equivalence.

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

   • No test set is described for evaluating new performance. The comparison is based on the predicate device's existing performance data.

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 as no new performance test set requiring expert ground truth is described.

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

   • Not applicable.

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 an intravascular catheter, not an AI-powered diagnostic tool.

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

   • Not applicable.

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

   • Not applicable. The "ground truth" here is the established performance of the predicate device, against which the proposed device is declared equivalent.

8. The sample size for the training set:

   • Not applicable as this is a physical medical device, not an algorithm requiring a training set.

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

   • Not applicable.

Summary from the document:

The submission explicitly states under "Bench / Performance Data / Non-Clinical Testing":
"No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151)."

The basis for equivalence is that the "Proposed CT Midline is substantially equivalent to the predicate device. CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization." The only difference is a "revision to the instructions for use (labeling)" to remove a contraindication.

Therefore, for this specific 510(k) submission (K170770), no new study was conducted to prove the device meets performance acceptance criteria, because the device itself and its performance characteristics are deemed identical to a previously cleared predicate device. The change is solely in the labeling information, specifically removing a contraindication.

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