Search Results

The Medtronic model 6248VAL adjustable valve is intended to minimize blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories such as guide wires and subselecting catheters.

The 6248VAL Adjustable Valve is a single use valve designed to reduce blood loss during percutaneous catheter procedures. The valve sealing diameter is adjustable so it may be tightened or loosened to provide an appropriate seal around devices such as leads, guidewires, and catheters, which are passed through the main valve port. Blood flow through the valve is reduced as the valve is closed.

Here's an analysis of the provided text regarding the 6248VAL Adjustable Valve:

It's important to note that this document is a 510(k) summary for a medical device (an adjustable valve), not an AI/ML-driven device. Therefore, many of the typical acceptance criteria and study components for AI/ML devices, such as performance metrics like sensitivity/specificity, sample sizes for test sets, ground truth establishment by experts, MRMC studies, or training sets, are not applicable here.

The summary focuses on demonstrating "substantial equivalence" to predicate devices through traditional engineering and biocompatibility testing.

Acceptance Criteria and Reported Device Performance

Study Details (as inferable from the document)

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

• Sample Size: Not specified. The document states "Device verification testing was performed to demonstrate the valve meets established performance criteria." This typically involves a defined number of units or test samples, but the specific quantity is not reported.
• Data Provenance: Not specified, but implied to be internal laboratory testing conducted by Medtronic (the manufacturer). This would be prospective testing 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. For a physical device like a valve, "ground truth" is typically defined by engineering specifications, material standards, and functional requirements. Expert medical consensus or pathology is not relevant for this type of testing.

4. Adjudication method for the test set:

• Not applicable. This concept pertains to resolving discrepancies in interpretations, usually for image-based or diagnostic AI/ML systems. For mechanical testing, results are typically objective measurements against a defined specification.

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/ML diagnostic or assistive tool.

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.

7. The type of ground truth used:

• Engineering Specifications and Performance Standards: The "ground truth" for this device's performance would be the pre-defined engineering design specifications, functional requirements (e.g., ability to reduce blood loss, seal effectively), and compliance with relevant standards (like ISO 10993-1 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device; there is no "training set."

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

• Not applicable. This is not an AI/ML device; there is no "training set."

Overall Conclusion from the Document:

The 510(k) summary for the 6248VAL Adjustable Valve demonstrates substantial equivalence to predicate devices based on:

• Similar intended use.
• Equivalent design, function, materials, and method of operation.
• Successful completion of visual, mechanical, and performance testing, indicating all design and performance requirements were met.
• Biocompatibility testing consistent with ISO 10993-1.
• Validated sterilization process.

The document does not provide the detailed raw data or specific quantitative results from these tests, but rather states that the criteria were "met" and "conducted," which is typical for a 510(k) summary demonstrating substantial equivalence for a non-AI/ML device.

Ask a specific question about this device

The deflectable catheter delivery system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The 6226DEF system features a percutaneous needle and syringe to access the venous insertion site, a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a deflectable catheter dilator to facilitate deflectable catheter passage, and a slitter to remove the deflectable catheter.

The Attain 6226DEF Deflectable Catheter Delivery System combines devices that are either pre-amendment devices, devices that are cleared for market distribution via 510(k), or are exempt from premarket notification because of Class I designation.

The key changes being made to the system versus the predicate 10600 device are a decrease in the length of the deflectable catheter, a reduction in the stiffness of the deflectable catheter tip, and a change in the articulated shape of the catheter. The dilator length is also decreased in line with the catheter. In addition the slitters are replaced by a Universal Slitter and the adjustable hemostasis valve is replaced by an introducer valve. The entire system is packaged in a revised packaging configuration.

The provided document is a 510(k) premarket notification for a medical device, the ATTAIN™ 6226DEF Deflectable Catheter Delivery System. It establishes substantial equivalence to existing predicate devices based on design, technology, features, functions, intended use, and in vitro testing, as well as biocompatibility and sterilization validation.

However, the document does not contain specific acceptance criteria tables nor detailed study results that would typically be used to "prove" the device meets such criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device, or specific success rates for a therapeutic device). This type of information is not typically presented in a 510(k) summary focused on substantial equivalence to a predicate device.

Instead, the document states that:"In vitro testing and biocompatibility/sterilization testing was performed to support substantial equivalence to the predicate device. The results of this testing indicates that the Attain 6226DEF meets all of its design and performance requirements."

Without access to the full submission, which would include the detailed testing reports, it's impossible to extract the specific acceptance criteria and detailed performance data.

Therefore, for the information requested, I can only provide what is explicitly stated or inferable from the document:

1. A table of acceptance criteria and the reported device performance:
   The document states: "The results of this testing indicates that the Attain 6226DEF meets all of its design and performance requirements." However, specific numerical acceptance criteria (e.g., tensile strength > X, deflection angle > Y) and the corresponding measured performance values are not provided in this summary. The summary refers to in vitro testing and biocompatibility/sterilization testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions in vitro testing and biocompatibility/sterilization testing. It does not specify sample sizes, data provenance, or whether the tests were retrospective or prospective. In vitro tests generally refer to laboratory-based experiments rather than human 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):
   This information is not applicable or provided. The testing described is in vitro (laboratory) and biocompatibility/sterilization, which does not involve human subjects or expert assessment of "ground truth" in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable or provided. Adjudication methods are typically used in clinical studies with human assessors, which is not described here.

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 information is not applicable or provided. The device is a "Deflectable Catheter Delivery System," a medical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable or provided. The device is a physical catheter delivery system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For in vitro and biocompatibility/sterilization testing, "ground truth" would typically refer to established engineering specifications, material standards, and validated sterilization protocols. The document does not specify the exact "ground truth" used for each specific test, but implies adherence to "design and performance requirements" and ISO10993 for biocompatibility.

8. The sample size for the training set:
   This information is not applicable or provided. The device is a physical medical instrument, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established:
   This information is not applicable or provided for the same reason as point 8.

Ask a specific question about this device

The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use

The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria for the Cook Vascular SERPENTA™ Coronary Sinus Introducer System. The document is a 510(k) premarket notification summary from the FDA, which primarily focuses on establishing substantial equivalence to predicate devices, device description, and indications for use.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text.

Ask a specific question about this device

The Attain™ Access 6218A Left-heart delivery system is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The left-heart delivery system features two guide wires to facilitate venous access, adjustable hemostasis valves to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters or appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

The Attain Access 6218A Left-heart delivery system combines devices that are either cleared for market distribution via 510(k) or are exempt from premarket notification because of Class I designation.

The key changes being made to the system are the addition of Tungsten Carbidefilled polyether block amide material to the guide catheter distal tip segment and the addition of extra slitters and adjustable hemostasis valves in a revised system configuration.

The provided text describes a 510(k) submission for the Medtronic Attain™ Access 6218A Left-heart delivery system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a standalone study with defined endpoints.

Here's a breakdown based on the request, highlighting what is and isn't available in the provided text:

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

Explanation: The document does not explicitly state numerical acceptance criteria or specific performance metrics as would be found in a clinical trial or a detailed engineering specification report. Instead, it relies on demonstrating that the device performs as well as or similarly to a legally marketed predicate device, and that it meets general design and performance requirements supported by in vitro and biocompatibility testing.

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

• Sample Size: Not specified for any particular test. The document mentions "representative samples" for biocompatibility testing.
• Data Provenance: Not explicitly stated. The testing was performed internally by Medtronic.

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

• Not applicable. This submission does not involve clinical data requiring expert review for ground truth establishment. The evaluation is based on device characteristics, in vitro testing, and comparison to a predicate device.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is mentioned as there's no expert review of cases or outcomes to adjudicate.

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/software device and no MRMC study was performed or mentioned.

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

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

7. The type of ground truth used:

• Not explicitly stated as "ground truth" in the context of clinical outcomes or pathology. For biocompatibility, the "ground truth" is adherence to ISO 10993-1 standards. For sterilization, it's successful validation of the ETO process. For substantial equivalence, the "ground truth" is the established characteristics and performance of the predicate device.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described is a set of in vitro testing, biocompatibility testing, and sterilization validation.

• Biocompatibility Testing: Performed on "representative samples" of the Attain product. The criteria for acceptance were based on adherence to ISO 10993-1, and the results indicated that "all materials were found to be biocompatible."
• Sterilization Validation: The device is sterilized using a 100% Ethylene Oxide (ETO) process. "Appropriate processes for sterilizing the devices were validated," implying that the validation study confirmed the sterilization method effectively renders the device sterile.
• In vitro Testing: Mentioned as being performed "to support substantial equivalence to the predicate device." The results indicated that the "Attain Access 6218A meets all of its design and performance requirements." Specific parameters or acceptance criteria for this in vitro testing are not detailed in the provided text, but it would likely include mechanical strength, flow characteristics, and component inter-compatibility, all compared against the predicate device or internal specifications.

The overall conclusion is based on demonstrating substantial equivalence to a previously cleared predicate device (Medtronic Attain Access 6218 Left-heart Delivery System, K012083) and adherence to recognized standards (ISO 10993-1 for biocompatibility). The 510(k) process accepts this approach for devices that are similar to existing ones.

Ask a specific question about this device

The Medtronic Model 10600 Deflectable Catheter System is indicated to provide a pathway through which diagnostic and therapeutic devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The Medtronic Model 10600 Deflectable Catheter System features a percutaneous needle and syringe to access the venous insertion site, a guide wire to access the vein, an adjustable hemostasis valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a deflectable catheter dilator to facilitate deflectable catheter passage, and slitters to remove the deflectable catheter.

The Model 10600 Deflectable Catheter System is provided STERILE and is intended for single use only.

The Model 10600 Deflectable Catheter System combines devices that are either cleared for market distribution via 510(k) or are exempt from Premarket notification because of Class I designation.

The provided text describes a 510(k) Premarket Notification for the Medtronic Model 10600 Deflectable Catheter System. This notification focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria in the way a new, novel AI or diagnostic device would.

Therefore, many of the typical acceptance criteria and study details requested (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission. The submission relies on engineering and integrity testing to show that the new device performs comparably to established devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests. The "Summary of Studies" indicates that "Device integrity testing was conducted," but does not provide details on the number of units tested.
• Data Provenance: Not applicable in the context of clinical data for a diagnostic/AI device. The testing described is laboratory-based engineering and material testing performed by the manufacturer, Medtronic, Inc.

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

• Not Applicable. This submission is for a medical catheter system, not a diagnostic or AI device that requires expert-established ground truth from clinical data. The "ground truth" for this device relates to meeting engineering specifications and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no clinical data or expert interpretation involved, no adjudication method would be used.

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 hardware medical device (catheter system), not an AI or diagnostic imaging device. Therefore, no MRMC study would be performed, nor would there be human readers, AI assistance, or an effect size for improvement.

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

• Not Applicable. This is a hardware medical device; there is no algorithm or AI component to test in a standalone manner.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering specifications, recognized standards (like ISO 10993-1 for biocompatibility), and validated processes (for sterilization). The device is deemed acceptable if it meets these predetermined technical and safety requirements.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device