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510(k) Data Aggregation
(103 days)
The MAHURKAR™ Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
The MAHURKAR™ Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large lumens (arterial and venous) and one smaller medial lumen running longitudinally along the length of the catheter shaft. The two large lumens either have curved or straight extensions and the smaller medial lumen have a straight extension. At the distal end of the catheter there is a tapered green, soft radiopaque catheter tip. Each lumen terminates at a separate location along the catheter shaft, designated as the arterial, venous, or medial outlets. The catheter is available in four implantable lengths (13 cm, 16 cm, and 24 cm) with two clear silicone catheters extensions and three internal lumina distinguished by color coded adapters
The provided text describes a 510(k) summary for the MAHURKAR™ Triple Lumen Dialysis Catheter, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not contain information typically associated with acceptance criteria and study details for an AI/ML powered device, specifically due to the device being a physical medical product (catheter) rather than a software-as-a-medical-device (SaMD).
Therefore, a significant portion of your requested information (sample size for test/training, number of experts, adjudication, MRMC, standalone performance, ground truth types) is not applicable to this physical device submission.
Here's a breakdown of what can be extracted and what cannot:
Acceptance Criteria and Device Performance
The submission focuses on demonstrating substantial equivalence to predicate devices through performance data related to physical and functional aspects of the catheter. The "acceptance criteria" are implied by the successful testing showing equivalence and mechanical integrity.
| Acceptance Criterion (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Catheter mechanical integrity maintained after power injections | "Tensile testing and leak and burst testing to ensure catheter mechanical integrity was not diminished after power injections." | Testing was performed to ensure the catheter's physical structure remains intact after high-pressure injections, a key safety and functionality aspect. The implication is that the device met these standards. |
| Accurate Central Venous Pressure (CVP) Monitoring | "Central Venous Pressure testing was conducted to verify that the catheter was capable of being used for accurate pressure monitoring as compared to the predicate device." | This confirms the device's ability to fulfill its CVP monitoring function. The implication is that the device performs accurately for CVP monitoring. |
| Substantial Equivalence to Predicate Devices | "Results of the verification / validation testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate devices." | The overall acceptance criterion is to prove substantial equivalence to existing, legally marketed devices (K020089 and K083675) for the expanded indications. The reported performance confirms this. |
| Adherence to maximum recommended infusion rate for power injection | Maximum recommended infusion rate is 5 mL/sec for power injection of contrast media. | This is an intended use specification, and the prior testing (mechanical integrity) supports the catheter's ability to safely handle this rate. |
Study Details for a Physical Medical Device (Catheter)
The following details are not relevant or available for this physical device as they typically apply to AI/ML software evaluations.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical catheters subjected to various engineering tests (tensile, leak, burst, CVP). Data provenance would be from materials testing and physical experiments, not country of origin of data in a clinical sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical integrity is established by engineering standards and measurement equipment, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This method is used for resolving discrepancies in expert labeling or diagnoses, not for physical product testing.
- 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 for AI-assisted diagnostic tools, not a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, physical measurements from testing (e.g., pressure readings, force measurements during tensile tests, observation of leaks/bursts), and comparison to the established performance of predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what is present:
The study described is a series of engineering verification and validation tests aimed at demonstrating the MAHURKAR™ Triple Lumen Dialysis Catheter's performance characteristics (mechanical integrity, pressure monitoring capability) and its substantial equivalence to predicate devices (Mahurkar™ Triple Lumen Dialysis Catheter K020089 and Bard Power-Trialysis Triple Lumen Dialysis Catheter K083675). The data provenance is from laboratory testing of the physical device. The "ground truth" for this context is the adherence to engineering standards and comparison against the known performance of the predicate devices.
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iDrive™ Powered Handle: The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
iDrive™ RALC: The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
Surgical stapler with Powered Handle, delivering implantable titanium staples. The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.
The provided document is a 510(k) summary for a surgical stapler system (iDrive™ System), which describes the device, its intended use, and performance data from in-vitro and in-vivo testing. However, it does not contain specific acceptance criteria values or detailed study results in numerical format that would directly enable me to fill out a table of acceptance criteria and reported performance with numerical values.
The document lists various performance tests conducted, but it doesn't provide the quantitative acceptance criteria for each test or the specific quantitative results achieved by the device against those criteria. For example, it lists "Staple line pull-apart strength test" but doesn't state what the minimum acceptable pull-apart strength was or what the device's measured pull-apart strength was.
Therefore, I cannot generate the table requested in point 1 or provide detailed answers to points 2, 3, 4, 5, 6, 7, 8, and 9 as they pertain to specific quantitative study outcomes and methodologies that are not present in this summary.
Based on the information provided in the 510(k) summary, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
Information Not Available in Document: The document lists various performance tests but does not provide specific numerical acceptance criteria or the quantitative results achieved by the device for these tests. Therefore, a table with these details cannot be generated from the provided text.
| Acceptance Criteria (e.g., Min. Pull-Apart Strength) | Reported Device Performance (e.g., Measured Pull-Apart Strength) |
|---|---|
| Not specified in document | Not specified in document |
| e.g., Staple formation: >95% acceptable formation | e.g., Staple formation: X% acceptable formation |
| e.g., Burst strength: Minimum X mmHg without leak | e.g., Burst strength: Y mmHg without leak |
| ...and so on for listed tests | ...and so on for listed tests |
2. Sample Size Used for the Test Set and Data Provenance
Information Not Available in Document: The document mentions "In-vitro and in-vivo testing" but does not specify the sample sizes used for any of the tests listed (e.g., number of staple lines tested, number of animals in in-vivo studies, etc.). The provenance of the data (e.g., country of origin) is also not stated beyond being internal Covidien testing. The document is a regulatory submission, implying the studies were conducted by the manufacturer. Whether the studies were retrospective or prospective is not explicitly mentioned, but performance testing is typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Information Not Available in Document: The document does not describe the use of human "experts" to establish ground truth in the context of these performance tests. These are engineering and biological performance tests, not diagnostic image interpretation.
4. Adjudication Method for the Test Set
Information Not Available in Document: Adjudication methods (like 2+1, 3+1) are relevant to situations where subjective interpretation or consensus among multiple human reviewers is required (e.g., clinical trials with expert readers assessing outcomes). This is not applicable to the engineering and biological performance tests described in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Information Not Available in Document: An MRMC comparative effectiveness study, typically comparing human readers with and without AI assistance, is not mentioned. The device is a surgical stapler, not an AI or imaging diagnostic device where such studies are common.
6. Standalone (Algorithm Only) Performance Study
Information Not Available in Document: This question is relevant to AI algorithms. The device is a physical surgical stapler system, not an algorithm, so a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
For the performance tests listed:
- Staple line pull-apart strength test: Actual measured mechanical strength.
- Staple formation test: Visual and/or microscopic assessment against defined criteria for properly formed staples.
- Staple line burst strength test: Pressure required to cause a leak in a stapled tissue sample.
- Hemostasis (free bleed time) evaluation: Time to cessation of bleeding after stapling in in-vivo models.
- Air leak test: Presence or absence of air leakage.
- Tissue trauma evaluation: Histopathological assessment of tissue damage in in-vivo models.
- Knife Cutting Performance test: Assessment of cut quality, completeness, and effort.
- Product security on Tissue test while clamping and firing: Observational and/or force-based assessment of device stability and tissue retention.
- Autoclave Reliability test: Functional performance after sterilization cycles.
- Egress of material test: Gravimetric or qualitative assessment of material release.
- Fire and clamp Shaft peak stall output torque measurement: Mechanical force measurements.
- Battery and Battery charger tests: Electrical and functional performance of power components.
The "ground truth" for these tests would be the objective physical or biological measurements and observations against pre-defined engineering and biological specifications.
8. Sample Size for the Training Set
Not Applicable / Information Not Available in Document: This question refers to machine learning algorithms. The iDrive™ System is a mechanical device, not an AI system that requires a "training set" in the machine learning context. All tests described are performance and safety evaluations, not data used for model training.
9. How the Ground Truth for the Training Set was Established
Not Applicable / Information Not Available in Document: As explained in point 8, there is no "training set" for this type of device.
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