(153 days)
INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4
As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX 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 Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vessels by aspirating the proximal side of the thrombus using the Aspiration Catheter, Separator, and Aspiration Tubing. The Penumbra Aspiration System components were originally cleared under K161506.
The Penumbra Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and the Pump Canister/Tubing. The Aspiration Catheter is provided with a rotating hemostasis valve and an introducer sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheters and Separators are visible under fluoroscopy.
The CAT RX Aspiration Catheter is a dual lumen, rapid exchange, intravascular catheter. It is designed and composed of materials common to interventional devices. The distal lumen is PTFE lined and the shaft is reinforced with both nitinol round wire and a flexible laser cut stainless steel hypotube. The shaft has variable stiffness with progressively softer polymer extrusion materials moving distally along its length. The distal portion of the shaft is hydrophilically coated for lubricity. The distal tip has a radiopaque platinum/iridium markerband.
The CAT RX Aspiration Catheter is available in effective lengths ranging from 120cm to 160cm and is provided sterile for single use. The CAT RX Aspiration Catheter is packaged in a kit with the Aspiration Tubing. The kit also contains a rotating hemostasis valve (RHV) and introducer sheath.
The Aspiration Tubing connects the Penumbra Aspiration Pump to the CAT RX Aspiration Catheter within the sterile field. The Aspiration Tubing has a flow valve which connects directly to the CAT RX Aspiration Catheter hub or RHV and allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is provided sterile, and is available either individually packaged or in a kit with the CAT RX Aspiration Catheter.
The provided text describes the safety and performance testing for the Penumbra INDIGO Aspiration System, specifically focusing on the CAT RX Aspiration Catheter and Aspiration Tubing, in comparison to a predicate device. It details non-clinical data, including biocompatibility and bench-top testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test / Test Subject | Attribute | Acceptance Criteria | Result |
|---|---|---|---|
| All (CAT RX Aspiration Catheter & Aspiration Tubing) | Dimensional/Visual Inspection | Meet all product specifications. | Pass |
| All (CAT RX Aspiration Catheter & Aspiration Tubing) | Simulated Use (Peripheral Access, Vessel Access Entry Performance & Clot Removal) | Effectiveness of devices to track to the target site, to remove clots and that the Aspiration Catheter does not collapse under vacuum in an anatomical Vascular Flow model simulating tortuosity. | Pass |
| CAT RX Aspiration Catheter | Shaft Kink Resistance (distal, midshaft, proximal) | No kinking when formed in 5 mm (distal) or 25 mm (midshaft and proximal) radius loop. | Pass |
| CAT RX Aspiration Catheter | Markerband Visibility | Markerband is fluoroscopically visible. | Pass |
| CAT RX Aspiration Catheter | Particulate Testing (particulates generated in simulated tortuosity, coating integrity and printed band integrity) | The maximum number of particles: ≥ 10 µm will be ≤ 6000 particles; ≥ 25 µm will be ≤ 600 particles. Coating and printed bands have not delaminated, peeled, or flaked prior to and after particulate testing. | Pass |
| CAT RX Aspiration Catheter | Hub/Air Aspiration | No leakage of air when negative pressure is pulled. | Pass |
| CAT RX Aspiration Catheter | Static Burst Pressure | 45 psi for 30 sec minimum. | Pass |
| CAT RX Aspiration Catheter | Friction | 1.25 lbf maximum with 6F guide catheter; 0.50 lbf maximum with 0.014" guidewire. | Pass |
| CAT RX Aspiration Catheter | Markerband/Distal Guidewire lumen section bond strength | 0.50 lbf minimum. | Pass |
| CAT RX Aspiration Catheter | Distal Shaft/Guidewire lumen section 1 bond strength | 0.75 lbf minimum. | Pass |
| CAT RX Aspiration Catheter | Distal Shaft/Guidewire lumen section 2 bond strength | 0.75 lbf minimum. | Pass |
| CAT RX Aspiration Catheter | Midjoint/Proximal Guidewire lumen section bond strength | 0.75 lbf minimum. | Pass |
| CAT RX Aspiration Catheter | Hub/Shaft bond strength | 2.0 lbf minimum. | Pass |
| CAT RX Aspiration Catheter | Elongation to failure | ≥ 5%. | Pass |
| CAT RX Aspiration Catheter | Torsion | Must rotate at least 2 times prior to failure. | Pass |
| CAT RX Aspiration Catheter | Corrosion | No visible catheter corrosion after ISO corrosion testing. | Pass |
| Aspiration Tubing | Compatibility with RHV (performed as part of Simulated Use) | Aspiration Tubing attaches to side port of RHV. | Pass |
Biocompatibility test results:
- In Vitro Cytotoxicity: Non-Toxic
- Sensitization: Non-Sensitizing
- Acute Intracutaneous Reactivity (Irritation): Non-Irritant
- Acute Systemic Toxicity: Non-Toxic
- Rabbit Pyrogen Study: No evidence of material-mediated pyrogenicity
- In Vitro Hemolysis: Non-Hemolytic
- In Vitro Coagulation (PT, PTT): No Statistical Difference from control / Non-Thrombogenic
- Complement Activation: No greater biological response than corresponding control
- Dog Thrombogenicity: Non-Thrombogenic
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Bench-top Testing:
- Shaft Kink Resistance: 30
- Markerband Visibility: 30
- Particulate Testing: 10
- Hub/Air Aspiration: 30
- Static Burst Pressure: 30
- Friction: 30
- Bond Strengths (Markerband/Distal Guidewire, Distal Shaft/Guidewire section 1, Distal Shaft/Guidewire section 2, Midjoint/Proximal Guidewire, Hub/Shaft): 30 for Distal Shaft/Guidewire section 2, sample size not explicitly stated for others but assumed to be similar given similar rows.
- Elongation to failure: 30
- Torsion: 30
- Corrosion: 30
- Compatibility with RHV for Aspiration Tubing: 30 (as part of Simulated Use)
- Data Provenance: The studies are non-clinical, bench-top, and biocompatibility studies. The document does not specify the country of origin for the data, but it is submitted to the U.S. FDA. The nature of the studies implies they are prospective tests conducted to evaluate the device's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This document describes non-clinical, bench-top, and biocompatibility testing. It does not involve human expert interpretation of images or clinical outcomes that would require "ground truth" established by experts in the context of, for example, an AI/radiology study. The "ground truth" for these tests is based on objective, measurable physical properties and standardized testing methods (e.g., ISO standards, ASTM methods, USP tests).
4. Adjudication Method for the Test Set:
- This is not applicable as the studies described are non-clinical bench-top tests and biocompatibility evaluations, not reader studies or clinical trials requiring adjudication of human observations. The results are quantitative measurements or qualitative observations against predefined criteria.
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, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of a medical device (catheter and tubing) based on its physical, mechanical, and biological properties, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a physical medical device (catheter system), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The performance is the direct mechanical and biological behavior of the device itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is established by:
- Defined physical and mechanical specifications: For example, a target burst pressure, a maximum friction force, or a minimum bond strength.
- Standardized assay results: For biocompatibility, results like "Non-Toxic," "Non-Sensitizing," "Non-Hemolytic" are determined by specific laboratory assays and their established cut-offs/controls.
- Visual observation against criteria: For example, "No kinking," "Markerband is fluoroscopically visible," "No visible catheter corrosion."
8. The Sample Size for the Training Set:
- This document describes testing performed to demonstrate substantial equivalence for a physical medical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm. The "training" in this context refers to the manufacturing and design iterations that lead to the final device components.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for an algorithm. The device's design and manufacturing are based on engineering principles, material science, and regulatory requirements, culminating in the performance demonstrated by the testing described.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2017
Penumbra, Inc. Richard Kimura Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502
Re: K163618
Trade/Device Name: INDIGO Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 21, 2017 Received: April 24, 2017
Dear Richard Kimura:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions section of the device's labeling:
-
- The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) have not been established. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention.
Furthermore, the indication for removal of fresh, soft emboli and thrombi from the coronary vasculature must be prominently displayed in all labeling, including pouch box, and carton
- The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) have not been established. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention.
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labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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Sincerely,
Barbara A. Zimmerman -S 2017.05.24 16:45:39 -04'00'
for William H. Maisel, MD, MPH Director, Office of Device Evaluation (Acting) Deputy Director for Science and Chief Scientist Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163618
Device Name INDIGO Aspiration System
Indications for Use (Describe)
INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4
As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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1 510(k) Summary
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra Inc. is providing the summary of Substantial Equivalence for the subject CAT RX Aspiration Catheter and Aspiration Tubing.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Sponsor Contact Information 1.2
Richard Kimura Regulatory Affairs Specialist Phone: (510) 995-2034 Fax: (510) 217-6414 Email: rkimura@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
April 21, 2017
1.4 Device Trade or Proprietary Name
INDIGO Aspiration System
1.5 Device Classification
Regulatory Class: II Classification Panel: Cardiovascular Catheter, Embolectomy Classification Name: Regulation Number: 21 CFR 870.5150 Product Code: DXE
1.6 Predicate Device
| 510(k)Number | Clearance Date | Name of Predicate Device | Name ofManufacturer |
|---|---|---|---|
| K161506 | September 26, 2016 | Penumbra Aspiration System | Penumbra, Inc. |
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| Common Device Name | Penumbra Aspiration System | |
|---|---|---|
| Trade Name | INDIGO Aspiration System | |
| 510(k) No. | K161506 | K163618 |
| Classification | Class II, DXE | Class II, DXE |
| Indication | Penumbra Aspiration Catheters andSeparatorsAs part of the Penumbra AspirationSystem, the Penumbra AspirationCatheters and Separators areindicated for the removal of fresh,soft emboli and thrombi fromvessels in the coronary andperipheral vasculature.Penumbra Aspiration TubingAs part of the Penumbra AspirationSystem, the Penumbra SterileAspiration Tubing is indicated toconnect the Penumbra AspirationCatheters to the PenumbraAspiration Pump.Penumbra Aspiration PumpThe Penumbra Aspiration Pump isindicated as a vacuum source forPenumbra Aspiration Systems. | INDIGO CAT RX Aspiration Cathetersand INDIGO Separator 4As part of the INDIGO AspirationSystem, the INDIGO CAT RXAspiration Catheters and INDIGOSeparator 4 are indicated for theremoval of fresh, soft emboli andthrombi from vessels in the coronaryand peripheral vasculature.INDIGO Aspiration TubingAs part of the INDIGO AspirationSystem, the INDIGO Sterile AspirationTubing is indicated to connect theINDIGO CAT RX Aspiration Cathetersto the Penumbra Aspiration Pump.Penumbra Aspiration PumpThe Penumbra Aspiration Pump isindicated as a vacuum source forPenumbra Aspiration Systems. |
| Catheter | Aspiration Catheter | CAT RX Aspiration Catheter |
| Materials | Biocompatible, commonly utilizedfor interventional devices | Same |
| Dimensions | ||
| - Distal OD | 0.072" max | 0.069" max |
| - Effective Lengths | 125, 127, 132 cm | 120 - 160cm |
| Accessories | Torque Device, Introducer Sheath,and Shaping Mandrel | Torque Device and Introducer Sheath |
| Aspiration Tubing | ||
| Materials | Biocompatible, commonly utilizedfor interventional devices | Same |
| Dimensions | ||
| - ID | 0.118" | Same |
| - OD | 0.188" | Same |
| - Length | 112.0" | 105.0" |
| Packaging Materials& Configuration | Commonly utilized forinterventional devices | Same |
| Aspiration Source | Penumbra Aspiration Pump | Same |
| Sterilization | EO | Same |
1.7 Predicate Comparison
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| Common Device Name | Penumbra Aspiration System | |
|---|---|---|
| Trade Name | INDIGO Aspiration System | |
| 510(k) No. | K161506 | K163618 |
| Shelf-Life | 36 Months | 12 Months |
1.8 Device Description
The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vessels by aspirating the proximal side of the thrombus using the Aspiration Catheter, Separator, and Aspiration Tubing. The Penumbra Aspiration System components were originally cleared under K161506.
The Penumbra Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and the Pump Canister/Tubing. The Aspiration Catheter is provided with a rotating hemostasis valve and an introducer sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheters and Separators are visible under fluoroscopy.
The CAT RX Aspiration Catheter
The CAT RX Aspiration Catheter is a dual lumen, rapid exchange, intravascular catheter. It is designed and composed of materials common to interventional devices. The distal lumen is PTFE lined and the shaft is reinforced with both nitinol round wire and a flexible laser cut stainless steel hypotube. The shaft has variable stiffness with progressively softer polymer extrusion materials moving distally along its length. The
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distal portion of the shaft is hydrophilically coated for lubricity. The distal tip has a radiopaque platinum/iridium markerband.
The CAT RX Aspiration Catheter is available in effective lengths ranging from 120cm to 160cm and is provided sterile for single use. The CAT RX Aspiration Catheter is packaged in a kit with the Aspiration Tubing. The kit also contains a rotating hemostasis valve (RHV) and introducer sheath.
The Aspiration Tubing
The Aspiration Tubing connects the Penumbra Aspiration Pump to the CAT RX Aspiration Catheter within the sterile field. The Aspiration Tubing has a flow valve which connects directly to the CAT RX Aspiration Catheter hub or RHV and allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is provided sterile, and is available either individually packaged or in a kit with the CAT RX Aspiration Catheter.
1.9 Indications For Use
INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4
As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
1.10 Summary of Non-Clinical Data
Included in this section is a description of the testing, which substantiates the safe and effective performance of the subject CAT RX Aspiration Catheter and Aspiration Tubing as well as its substantial equivalence to the predicate device:
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- Biocompatibility .
- Design Verification (Bench-Top Testing) .
- Sterilization ●
- Shelf-life .
The subject CAT RX Aspiration Catheter and Aspiration Tubing met all predetermined test requirements.
1.10.1 Biocompatibility Testing
Biocompatibility testing performed on the proposed CAT RX Aspiration Catheter substantiates the biocompatibility of the CAT RX Aspiration Catheter. Studies were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The following tests were performed:
| Biocompatibility Test Summary | ||
|---|---|---|
| Test | Method | Results |
| In VitroCytotoxicity | ISO Elution Test (MEM Extract) | Non-Toxic |
| Sensitization | ISO Maximization Test for DelayedHypersenitivity | Non-Sensitizing |
| AcuteIntracutaneousReactivity(Irritation) | ISO Intracutaneous (Intradermal)Injection Test | Non-Irritant |
| Acute SystemicToxicity | ISO Acute Systemic Injection Test | Non-Toxic |
| Rabbit PyrogenStudy | USP Material-Mediated RabbitPyrogen Test | No evidence of material-mediated pyrogenicity |
| Hemo-compatibility | ||
| In Vitro Hemolysis | ASTM Method (Extraction & DirectContact) | Non-Hemolytic |
| In Vitro Coagulation(PT, PTT) | Prothrombin Time (PT) Assay | No Statistical Differencefrom control |
| Partial Thromboplastin Time (PTT)Assay | Non-Thrombogenic | |
| ComplementActivation | C3a and SC5b-9 through EnzymeAssay | No greater biologicalresponse thancorresponding control |
| DogThrombogenicity | Thrombogenicity Study in Dogs -ISO | Non-Thrombogenic |
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Image /page/9/Picture/0 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The logo consists of the word "Penumbra" in a red sans-serif font, followed by a stylized "P" inside a red circle. The "P" is formed by a white line that wraps around the circle, creating a sense of movement and innovation. The logo is simple, modern, and easily recognizable.
The subject Aspiration Tubing uses identical raw materials and processes/environment as the predicate Aspiration Tubing, therefore biocompatibility of the predicate Aspiration Tubing can be applied to the subject Aspiration Tubing, which can be considered biocompatible for a limited exposure (<24 hours), surface device with skin contact.
1.10.2 Bench-top Testing
The physical and mechanical properties of subject CAT RX Aspiration Catheter were assessed using standard test methods and pre-determined acceptance criteria. Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle. The subject Aspiration Tubing and predicate Aspiration Tubing are identical with the exception of the presence of a distal tubing section on the predicate Aspiration Tubing. Therefore, previous Design Verification test results for the predicate Aspiration Tubing apply to the subject Aspiration Tubing. The subject Aspiration Tubing was tested for overall length and compatibility with a standard luer connection (RHV).
A summary of the testing performed on subject CAT RX Aspiration Catheter and Aspiration Tubing are provided in the table below:
| Test/Test Subject | Attribute | SampleSize | Acceptance Criteria | Result |
|---|---|---|---|---|
| Dimensional/Visual Inspection | These evaluations confirm that the CAT RX Aspiration Catheter andAspiration Tubing test units used in this Design Verification testingmeet all product specifications. | Pass | ||
| Simulated Use(PeripheralAccess, VesselAccess EntryPerformance &Clot Removal) | Simulated use testing of the CAT RX Aspiration Catheter andAspiration Tubing was performed with accessory devices in ananatomical Vascular Flow model which simulated the tortuosity of theperipheral and coronary vasculature. Devices were delivered through thetortuous anatomical model to evaluate the effectiveness of the devicesto track to the target site, to remove clots and that the Aspiration Catheterdoes not collapse under vacuum. | Pass | ||
| CAT RXAspirationCatheter | Shaft Kink Resistance (distal,midshaft, proximal) | 30 | No kinking when formedin 5 mm (distal) or 25mm (midshaft andproximal) radius loop | Pass |
| Markerband Visibility | 30 | Markerband isfluoroscopically visible | Pass | |
| Particulate Testing (particulatesgenerated in simulatedtortuosity, coating integrity andprinted band integrity) | 10 | The maximum numberof particles:$≥ 10 µm will be ≤ 6000$particles | Pass |
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| Test/Test Subject | Attribute | SampleSize | Acceptance Criteria | Result |
|---|---|---|---|---|
| ≥ 25 µm will be ≤ 600particlesCoating and printedbands have notdelaminated, peeled, orflaked prior to and afterparticulate testing | ||||
| Hub/Air Aspiration | 30 | No leakage of air whennegative pressure ispulled | Pass | |
| Static Burst Pressure | 30 | 45 psi for 30 sec min | Pass | |
| Friction | 30 | 1.25 lbf maximum with6F guide catheter;0.50 lbf maximum with0.014" guidewire. | Pass | |
| Markerband/Distal Guidewirelumen section bond strength | 0.50 lbf minimum | Pass | ||
| Distal Shaft/Guidewire lumensection 1 bond strength | 0.75 lbf minimum | Pass | ||
| Distal Shaft/Guidewire lumensection 2 bond strength | 30 | 0.75 lbf minimum | Pass | |
| Midjoint/Proximal Guidewirelumen section bond strength | 0.75 lbf minimum | Pass | ||
| Hub/Shaft bond strength | 2.0 lbf minimum | Pass | ||
| Elongation to failure | 30 | ≥ 5% | Pass | |
| Torsion | 30 | Must rotate at least 2times prior to failure | Pass | |
| Corrosion | 30 | No visible cathetercorrosion after ISOcorrosion testing | Pass | |
| AspirationTubing | Compatibility with RHV(performed as part of SimulatedUse) | 30 | Aspiration Tubingattaches to side port ofRHV | Pass |
All testing met the acceptance criteria. The results of the tests appropriately address the physical and mechanical performance expectations of the devices. Based on these overall results, the physical and mechanical properties of the subject CAT RX Aspiration Catheter and Aspiration Tubing are acceptable for the intended use and substantially equivalent to the predicate device.
1.10.3 Sterilization
The subject CAT RX Aspiration Catheter and Aspiration Tubing have been proven to be sterile in accordance with EN ISO 11135:2014.
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Image /page/11/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, with a focus on the company name and a recognizable symbol.
1.10.4 Shelf-life
The subject CAT RX Aspiration Catheter and Aspiration Tubing have a 12-month shelf life.
1.11 Summary of Substantial Equivalence
The subject CAT RX Aspiration Catheter and Aspiration Tubing are substantially equivalent to the predicate Penumbra Aspiration System devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).