Search Results

Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject® PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The proposed Spectrum Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr and 5.0 Fr single and double lumen catheters. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

The provided text describes a 510(k) summary for the Cook Medical Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set. It outlines the device's intended use, comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For "Static Failure Pressure Testing" and "Antimicrobial Testing", the specific numerical acceptance criteria (other than >15mm for antimicrobial, which is also stated as "predetermined") are not explicitly defined in the document, but the document states the device met them.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., number of catheters tested for tensile strength or leakage).
The data provenance is retrospective, as the submission is for modifications to previously cleared devices (K081690, K072625, K132334, K132885). The testing was conducted to demonstrate substantial equivalence to these predicate devices. The country of origin of the data is not specified, but the applicant address is in Bloomington, IN, USA.

3. Number of Experts and Qualifications

The document does not mention the involvement of experts to establish ground truth for a test set. The tests describe physical and performance characteristics of the device, which are typically evaluated through laboratory testing against predefined engineering specifications.

4. Adjudication Method

Not applicable. This type of submission (510k for a medical device) typically relies on laboratory testing and engineering specifications rather than expert adjudication of a test set, which is more common in diagnostic device or AI algorithm evaluations.

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

No MRMC comparative effectiveness study was mentioned. The device is a "Peripherally Inserted Central Venous Catheter Set," a physical medical device, not a diagnostic imaging or AI-assisted system that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established criteria for medical device safety and effectiveness. For example:

• Tensile strength: Measured against a force (10 N).
• Leakage: Absence of liquid/air leakage.
• Pressure: Ability to withstand specified pressure (325 psi).
• Antimicrobial activity: Measured zone of inhibition (15 mm).
  These are objective, quantitative measurements against predefined standards.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal validation and verification activities, but these are not referred to as training sets.

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

Not applicable, as there is no training set for this type of device. The specifications and acceptable performance limits are derived from industry standards (e.g., ISO 10555-1:1995), regulatory requirements, and the performance characteristics of predicate devices.

Ask a specific question about this device

The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheterrelated bloodstream infections (CRBSIs). The Spectrum Turbo-JeCT PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The Spectrum Turbo-JeCT catheter is a radiopaque polyurethane peripherally inserted central venous catheter impregnated with antimicrobials and intended for short- or longterm use. The Spectrum Turbo-JeCT PICCs are 60 cm in length and available in 4 and 5 Fr single lumen and 5 Fr double lumen configurations.

The set components include an introducer needle, wire guide, locking Peel-Away introducer, 12cc syringe, drape, injection cap, catheter fixation device, tape measure, safety scalpel, and a hydrophilic-coated wire guide obturator for non-over-the-wire versions.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Spectrum® Turbo-JeCT™ PICC device:

The provided text is a 510(k) summary for a medical device (PICC catheter), which primarily focuses on demonstrating substantial equivalence to predicate devices and lists the types of tests performed. It does not contain the detailed information required to populate all the requested fields, especially concerning the acceptance criteria for each test, specific numerical results against those criteria, or complex study designs like MRMC studies or ground truth establishment for AI systems. This is typical for a 510(k) summary, which is a high-level overview.

However, I can extract what is present and indicate where information is missing.

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

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

• Sample Size: Not specified in the provided summary for any of the tests.
• Data Provenance: Not specified, but likely from in-house laboratory testing (prospective, non-clinical). The equipment used for flow rates (Medrad Stellant® CT injector system) is a commercial product. The "Omnipaque 300®" contrast is a commercial product (Amersham Health, New Jersey).

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

• This question is not applicable. The device is a physical medical device (PICC catheter), not an AI/software device requiring expert interpretation of diagnostic images or data for ground truth establishment. The "ground truth" here is the physical performance of the catheter itself against engineering and physiological requirements.

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

• This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, not for physical performance testing of a catheter.

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

• This question is not applicable. This device is a physical catheter, not an AI or software device intended for diagnostic interpretation or to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• This question is not applicable. This device is a physical catheter, not an algorithm or software. "Standalone performance" in this context would refer to the catheter's physical performance, as evaluated by the listed tests, independent of human operators (though human operators would be involved in setting up the tests). The tests performed are effectively "standalone" in this physical sense.

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

• The "ground truth" for the physical performance tests would be defined by engineering specifications, regulatory standards, and established physiological requirements for central venous catheters. For example:
  • Flow rate ground truth: The measured flow rate through the catheter compared against the specified maximum flow rate for safe and effective contrast delivery.
  • Pressure ground truth: The pressure the catheter can withstand compared against the maximum allowed pressure for power injectors.
  • Material integrity ground truth: Absence of leakage, breakage, or degradation under specified conditions.
  • Biocompatibility ground truth: Absence of cytotoxic effects, sensitization, irritation, etc., as per ISO 10993 standards.

8. The sample size for the training set

• This question is not applicable. This device is a physical catheter, not an AI/machine learning model that requires a "training set" of data.

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

• This question is not applicable for the same reason as #8.

Ask a specific question about this device