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510(k) Data Aggregation
(29 days)
INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.
INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
The INDIGO® Aspiration System is comprised of the several devices: INDIGO Aspiration Catheter, Penumbra Aspiration Pump, INDIGO Aspiration Pump Canister, INDIGO Aspiration Tubing, INDIGO Separator. The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. TraX may be used with its prepackaged Aspiration Catheter to facilitate access to the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, introducer, and TraX. TraX compatibility is limited to its prepackaged Aspiration Catheter. The INDIGO Separator may be provided with an introducer and torque device.
The provided document is a 510(k) Premarket Notification from the FDA for the Penumbra, Inc. Indigo® Aspiration System - Aspiration Catheter 6X. It details the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical (bench-top) performance testing.
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as it is related to a physical medical device (catheter) rather than a diagnostic algorithm or AI. Instead, it lists various bench-top performance tests conducted. For each test, the implicit acceptance criterion is that the device met all requirements.
| Test Category | Reported Device Performance (Acceptance Criteria) |
|---|---|
| Particulate Testing | Met all requirements |
| Dimensional/Visual Inspection | Met all requirements |
| Friction Testing | Met all requirements |
| Performance/Simulated Use Testing | Met all requirements |
| Markerband Visibility | Met all requirements |
| Tensile Testing | Met all requirements |
| Pressure Testing | Met all requirements |
| Elongation Testing | Met all requirements |
| Torsion Testing | Met all requirements |
| Hub Air Aspiration | Met all requirements |
| Corrosion Testing | Met all requirements |
| Biocompatibility (ISO 10993-1) | Met all requirements |
| Shelf-Life | Established for 12 months based on accelerated aging data |
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 primarily describes bench-top testing for a physical device. It does not mention a "test set" in the context of data used for an algorithm or AI. Therefore, concepts like sample size for a test set, country of origin, retrospective or prospective data are not applicable. The data provenance would be from internal laboratory testing conducted by Penumbra, Inc.
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 as the document describes bench-top performance testing of a physical medical device (catheter), not a diagnostic algorithm or AI that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason 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 done. The study described is for a physical medical device, not an AI or diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study in the context of an algorithm or AI was not done. The performance evaluation was of the physical device's mechanical, material, and functional properties on a test bench.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench-top tests, the "ground truth" would be defined by engineering specifications, material science standards, and functional performance benchmarks for the device. For example, a tensile test would measure the force required to break the catheter, with the "ground truth" being the specified minimum tensile strength that the device must meet according to its design requirements. Similarly, biocompatibility is assessed against ISO 10993-1 standards.
8. The sample size for the training set
This information is not applicable as the document describes bench-top performance testing of a physical medical device, not an AI or algorithm that uses a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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(344 days)
072 Aspiration Catheter: As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.
Aspiration Tubing: As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump.
The 072 Aspiration Catheter is a single lumen, variable stiffness catheter. The catheter has a hydrophilic coating to reduce friction during use. The catheter includes radiopaque markers on the distal end for angiographic visualization and a Luer hub on the proximal end allowing attachments for flushing and aspiration. The Delivery Tool is an optional accessory for use with the 072 Aspiration Catheter and should be removed prior to aspiration. The 072 Aspiration Catheter, Delivery Tool. Rotating Hemostasis Valve, and Flow Switch are included in the package. The Aspiration Tubing is provided in a separate package. For the aspiration source, the 072 Aspiration Catheter is used in conjunction with a compatible suction pump with prespecified performance parameters that is connected using the Aspiration Tubing.
Here's a breakdown of the acceptance criteria and study information for the Q'Apel Medical, Inc. 072 Aspiration System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally phrased as meeting "predetermined acceptance criteria" or specific ISO standards. The reported device performance for all bench tests and animal studies is "Pass," indicating that all samples met the defined criteria.
Note: For bench tests, specific numerical acceptance criteria are not detailed in the provided summary, only the general statement that "All samples met the predetermined acceptance criteria." For biocompatibility, the specific numerical acceptance criteria are listed.
| Test Category | Acceptance Criteria (as stated) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Visual Surface Requirement | Device meets visual surface requirements. | Pass |
| Packaging Visual Inspection | Packaging meets visual inspection. | Pass |
| Dimensional/Visual Inspection | Device dimensions conform to specifications. | Pass |
| Liquid Leakage Under Pressure | Catheter joint strength meets freedom from leakage requirements of ISO 10555-1:2013, Annex C. | Pass |
| Hub Aspiration Air Leakage | Device passes hub aspiration air leakage test of ISO 10555-1:2013, Annex D. | Pass |
| Simulated Use | Effectiveness of device at retrieval of soft and firm clots and mechanical integrity after multiple passes. | Pass |
| Flex Fatigue | Meets minimum value per specification for multiple passes in the simulated use model. | Pass |
| Track and Advance Force | Test specimens meet track and advance force criteria. | Pass |
| Tip Deflection | Test specimens meet tip deflection forces criteria and compare favorably to predicate catheters. | Pass |
| Torque | Number of revolutions to failure of the Catheter in simulated anatomy meets criteria. | Pass |
| Tip Elongation and Compression | Test specimens meet tip elongation and compression criteria. | Pass |
| Peak Tensile | Tensile strength of catheter sections and bonds meets criteria after simulated use. | Pass |
| Particulates, Coating Integrity | Integrity of hydrophilic coating evaluated after multiple insertion/withdrawal cycles, and particulates measured during simulated use compared to reference device, meet criteria. | Pass |
| Flow Rate | Flow rate through a catheter meets ISO 10555-1, Annex E. | Pass |
| Aspiration Flow Rate | Aspiration flow rate through the aspiration catheter meets criteria when connected to a constant vacuum source. | Pass |
| Kink Resistance | Test specimen segments formed into a defined bend diameter meet kink resistance criteria. | Pass |
| Corrosion Resistance | No visible corrosion immediately after Corrosion Testing procedure based on ISO 10555-1, Annex A. | Pass |
| Radiopacity | Marker band is fluoroscopically visible. | Pass |
| Burst Pressure-Static | Tested per ISO 10555-1:2013, Annex F, after simulated use, meets criteria. | Pass |
| Burst Pressure-Dynamic | Minimum value per specification. | Pass |
| Connectors for Intravascular | Hubs tested per ISO 80369-7. | Pass |
| Lumen Collapse | Aspiration Catheter samples meet lumen patency under maximum applied vacuum pressures. | Pass |
| Manual Syringe Injection Peak Pressure | Measure peak pressure during manual injection of contrast media with a syringe, meets criteria. | Pass |
| Aspiration Tubing Bench Testing | ||
| Dimensional/Visual Inspection | Aspiration Tubing meets all dimensional and visual specifications. | Pass |
| Tensile Strength | Aspiration Tubing meets existing tensile strength specifications. | Pass |
| Simulated Use Test | Aspiration Tubing passes testing specified in the simulated use test protocol. | Pass |
| Resistance to Collapse and Leakage at Maximum Aspiration Pressures | Aspiration Tubing resistance to collapse at maximum aspiration pressure meets testing specified in the test protocol and does not show signs of leakage at maximum aspiration pressure. | Pass |
| Flow Switch Functionality Testing | Flow Control Switch completely and immediately stops fluid flow after a specified number of ON/OFF cycles. | Pass |
| Biocompatibility Testing (072 Aspiration Catheter and Delivery Tool) | ||
| Cytotoxicity - MEM Elution | The achievement of a numerical grade greater than 2 is considered a cytotoxic effect. (Implicit acceptance: numerical grade ≤ 2) | Non-cytotoxic |
| Sensitization | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. (Implicit acceptance: no statistically significant sensitization compared to control) | Non-sensitizing |
| Irritation: Intracutaneous Reactivity | The requirements of the test were met if the final test article score was ≤ 1.0. | Non-irritating |
| Acute Systemic Toxicity | If using five animals per group, the test article meets the requirement of the test if: 1. Two or more animals from the test group die. 2. Animal behavior, such as convulsions or prostration, occurs in two or more animals from the test group. 3. A final (end of study) body weight loss > 10% occurs in three or more animals from the test group. (Implicit acceptance: none of these conditions occurred) | Non-toxic |
| Material Mediated Pyrogenicity | The requirements of the test were met if no rabbit showed an individual rise in temperature of 0.5 °C or more above its respective baseline temperature throughout the duration of the test. | Non-pyrogenic |
| ASTM Hemolysis- Direct | The positive control's mean hemolytic index above the negative control must be ≥ 5% for the direct method. The negative control must display a mean hemolytic index of < 2% for the direct method. (Implicit acceptance: test article meets non-hemolytic criteria based on these controls) | Non-hemolytic for the Direct Method |
| ASTM Hemolysis- Indirect | The positive control's mean hemolytic index above the negative control must be ≥ 5% for the indirect method. The negative control must display a mean hemolytic index of < 2% for the indirect method. (Implicit acceptance: test article meets non-hemolytic criteria based on these controls) | Non-hemolytic for the Indirect Method |
| Hemocompatibility- Complement Activation | The negative control (HDPE) concentration must not be significantly higher when compared to the NHS at 37 °C concentration or the final concentration must fall within ± 1 standard deviation of the mean in the test facility historical range for HDPE. The positive reference control (Latex) concentration must be statistically significant when compared to the NHS at 37 °C concentration or the final concentration must fall within ± 1 standard deviation of the mean in the test facility historical range for Latex. (Implicit acceptance: test article acts like negative control) | Non-activator of the Complement System |
| Thrombogenicity | The thrombogenic potential of a blood-contacting medical device must be comparable to a predicate device. (Implicit acceptance: comparable to predicate device) | Non-thrombogenic |
| Biocompatibility Testing (Aspiration Tubing) | ||
| Cytotoxicity - MEM Elution | The achievement of a numerical grade greater than 2 is considered a cytotoxic effect. (Implicit acceptance: numerical grade ≤ 2) | Non-cytotoxic |
| Sensitization | Test group shall yield Grade < 1 score on Magnusson and Kligman scale (provided control group yields Grade < 1). (Implicit acceptance: Grade < 1) | Non-sensitizer |
| Irritation: Intracutaneous Reactivity | The test requirements are met if the difference between the test mean score and the control mean score is 1.0 or less and the test does not fail at any observation period. Differences of less than 0 are reported as 0. (Implicit acceptance: difference < 1.0) | Non-irritant |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document consistently states "All samples met the predetermined acceptance criteria" for each bench test. However, the exact numerical sample size for each specific bench test is not provided.
- Animal Study: The study involved a "porcine model." The exact number of animals used is not specified. The study was conducted "according to Good Laboratory Practices (GLP) per 21 CFR Part 58," which indicates controlled experimental conditions.
- Data Provenance:
- Bench Testing: In-house testing by Q'Apel Medical, Inc.
- Animal Study: Experimental, prospective study in a porcine (animal) model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Bench Testing: Not applicable in the context of expert ground truth. These tests likely involved technicians or engineers following standardized protocols.
- Animal Study: The document doesn't specify the number or qualifications of experts (e.g., veterinarians, pathologists) involved in establishing ground truth (e.g., assessing vessel histology or clot aspiration results). It mentions that "Sub-chronic and chronic time points were assessed" and that "Clot aspiration and wedge assessment were comparable between the test and control catheters, and both were shown to be safe in porcine vessels via angiography and vessel histology." This implies expert assessment of the outcomes, but details are absent.
4. Adjudication Method for the Test Set
- Bench Testing: Not applicable. Bench tests typically rely on objective measurements against predefined specifications.
- Animal Study: Not specified. While the results were declared "comparable" and "safe," it's not explicitly stated if multiple experts reviewed the outcomes and how any discrepancies were resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes and to support the substantial equivalence of the 072 Aspiration System." Therefore, there is no effect size reported for human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. The device is a physical medical instrument (an aspiration catheter system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance reviewed is the device's physical function.
7. The Type of Ground Truth Used
- Bench Testing: Reference standards (e.g., ISO standards), design specifications, and comparison to a reference device (K211564 for simulated use particulates) were used to establish "ground truth" (i.e., expected performance).
- Animal Study: Angiography and vessel histology were used as ground truth for assessing safety and effectiveness (clot aspiration, wedge assessment, tissue response) in the porcine model. These are objective measures collected during and after the animal procedures.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical instrument, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used to train an AI model.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, this is not an AI device, so there is no training set or ground truth for a training set.
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