(153 days)
Not Found
No
The description focuses on the mechanical and physical properties of the aspiration system components and their function in removing thrombus. There is no mention of any computational analysis, learning algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature, which is a direct treatment of a medical condition.
No
The device is indicated for the removal of fresh, soft emboli and thrombi, not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including catheters, tubing, a pump, and other physical accessories used in a medical procedure.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature." This is a therapeutic procedure performed directly on the patient's body (in vivo).
- Device Description: The description details a system designed to physically remove thrombus from blood vessels using aspiration. This involves catheters, tubing, and a pump, all used within the patient's circulatory system.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used for a therapeutic intervention within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data Summary:
- Biocompatibility Test Summary:
- In Vitro Cytotoxicity, Method: ISO Elution Test (MEM Extract), Results: Non-Toxic
- Sensitization, Method: ISO Maximization Test for Delayed Hypersensitivity, Results: Non-Sensitizing
- Acute Intracutaneous Reactivity (Irritation), Method: ISO Intracutaneous (Intradermal) Injection Test, Results: Non-Irritant
- Acute Systemic Toxicity, Method: ISO Acute Systemic Injection Test, Results: Non-Toxic
- Rabbit Pyrogen Study, Method: USP Material-Mediated Rabbit Pyrogen Test, Results: No evidence of material-mediated pyrogenicity
- Hemo-compatibility:
- In Vitro Hemolysis, Method: ASTM Method (Extraction & Direct Contact), Results: Non-Hemolytic
- In Vitro Coagulation (PT, PTT), Method: Prothrombin Time (PT) Assay, Results: No Statistical Difference from control
- Partial Thromboplast Time (PTT) Assay, Results: Non-Thrombogenic
- Complement Activation, Method: C3a and SC5b-9 through Enzyme Assay, Results: No greater biological response than corresponding control
- Dog Thrombogenicity, Method: Thrombogenicity Study in Dogs - ISO, Results: Non-Thrombogenic
- Bench-top Testing:
- Dimensional/Visual Inspection, Result: Pass
- Simulated Use (Peripheral Access, Vessel Access Entry Performance & Clot Removal), Result: Pass
- CAT RX Aspiration Catheter:
- Shaft Kink Resistance (distal, midshaft, proximal), Sample Size: 30, Acceptance Criteria: No kinking when formed in 5 mm (distal) or 25 mm (midshaft and proximal) radius loop, Result: Pass
- Markerband Visibility, Sample Size: 30, Acceptance Criteria: Markerband is fluoroscopically visible, Result: Pass
- Particulate Testing (particulates generated in simulated tortuosity, coating integrity and printed band integrity), Sample Size: 10, Acceptance Criteria: 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, Result: Pass
- Hub/Air Aspiration, Sample Size: 30, Tolerance/Acceptance Criteria: No leakage of air when negative pressure is pulled, Result: Pass
- Static Burst Pressure, Sample Size: 30, Tolerance/Acceptance Criteria: 45 psi for 30 sec min, Result: Pass
- Friction, Sample Size: 30, Tolerance/Acceptance Criteria: 1.25 lbf maximum with 6F guide catheter; 0.50 lbf maximum with 0.014" guidewire., Result: Pass
- Markerband/Distal Guidewire lumen section bond strength, Acceptance Criteria: 0.50 lbf minimum, Result: Pass
- Distal Shaft/Guidewire lumen section 1 bond strength, Acceptance Criteria: 0.75 lbf minimum, Result: Pass
- Distal Shaft/Guidewire lumen section 2 bond strength, Sample Size: 30, Acceptance Criteria: 0.75 lbf minimum, Result: Pass
- Midjoint/Proximal Guidewire lumen section bond strength, Acceptance Criteria: 0.75 lbf minimum, Result: Pass
- Hub/Shaft bond strength, Acceptance Criteria: 2.0 lbf minimum, Result: Pass
- Elongation to failure, Sample Size: 30, Acceptance Criteria: ≥ 5%, Result: Pass
- Torsion, Sample Size: 30, Acceptance Criteria: Must rotate at least 2 times prior to failure, Result: Pass
- Corrosion, Sample Size: 30, Acceptance Criteria: No visible catheter corrosion after ISO corrosion testing, Result: Pass
- Aspiration Tubing:
- Compatibility with RHV (performed as part of Simulated Use), Sample Size: 30, Acceptance Criteria: Aspiration Tubing attaches to side port of RHV, Result: Pass
- Sterilization: The subject CAT RX Aspiration Catheter and Aspiration Tubing are sterile in accordance with EN ISO 11135:2014.
- Shelf-life: The subject CAT RX Aspiration Catheter and Aspiration Tubing have a 12-month shelf life.
Key results: All non-clinical testing met predetermined requirements, demonstrating safe and effective performance and substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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.
1
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.
2
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
3
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 of
Manufacturer |
|------------------|--------------------|----------------------------|-------------------------|
| 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 and | |
| Separators | ||
| As part of the Penumbra Aspiration | ||
| System, the Penumbra Aspiration | ||
| Catheters and Separators are | ||
| indicated for the removal of fresh, | ||
| soft emboli and thrombi from | ||
| vessels in the coronary and | ||
| peripheral vasculature. |
Penumbra Aspiration Tubing
As part of the Penumbra Aspiration
System, the Penumbra Sterile
Aspiration Tubing is indicated to
connect the Penumbra Aspiration
Catheters to the Penumbra
Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is
indicated as a vacuum source for
Penumbra Aspiration Systems. | INDIGO CAT RX Aspiration Catheters
and INDIGO Separator 4
As part of the INDIGO Aspiration
System, the INDIGO CAT RX
Aspiration Catheters and INDIGO
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. |
| Catheter | Aspiration Catheter | CAT RX Aspiration Catheter |
| Materials | Biocompatible, commonly utilized
for 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 utilized
for interventional devices | Same |
| Dimensions | | |
| - ID | 0.118" | Same |
| - OD | 0.188" | Same |
| - Length | 112.0" | 105.0" |
| Packaging Materials
& Configuration | Commonly utilized for
interventional 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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Image /page/7/Picture/0 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The word "Penumbra" is written in a bold, sans-serif font in red. To the right of the word is a circular logo, also in red, with a white "P" inside.
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 Vitro | ||
| Cytotoxicity | ISO Elution Test (MEM Extract) | Non-Toxic |
| Sensitization | ISO Maximization Test for Delayed | |
| Hypersenitivity | Non-Sensitizing | |
| Acute | ||
| Intracutaneous | ||
| Reactivity | ||
| (Irritation) | ISO Intracutaneous (Intradermal) | |
| Injection Test | Non-Irritant | |
| Acute Systemic | ||
| Toxicity | ISO Acute Systemic Injection Test | Non-Toxic |
| Rabbit Pyrogen | ||
| Study | USP Material-Mediated Rabbit | |
| Pyrogen Test | No evidence of material- | |
| mediated pyrogenicity | ||
| Hemo-compatibility | ||
| In Vitro Hemolysis | ASTM Method (Extraction & Direct | |
| Contact) | Non-Hemolytic | |
| In Vitro Coagulation | ||
| (PT, PTT) | Prothrombin Time (PT) Assay | No Statistical Difference |
| from control | ||
| Partial Thromboplastin Time (PTT) | ||
| Assay | Non-Thrombogenic | |
| Complement | ||
| Activation | C3a and SC5b-9 through Enzyme | |
| Assay | No greater biological | |
| response than | ||
| corresponding control | ||
| Dog | ||
| Thrombogenicity | Thrombogenicity Study in Dogs - | |
| ISO | Non-Thrombogenic |
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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 (