(249 days)
Not Found
No
The 510(k) summary describes a mechanical thrombectomy system and its components. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on mechanical properties, biocompatibility, and animal testing.
Yes
The device is used for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease, which is a medical treatment aiming to restore blood flow to an area, thereby providing a therapeutic effect.
No
Explanation: The device, the Penumbra System, is explicitly described for "revascularization of patients with acute ischemic stroke" and "efficient removal of thrombus." These are therapeutic procedures, not diagnostic ones. The descriptions of the various components (catheters, separators, tubing, pump) all relate to the physical removal of a blockage, which is a treatment.
No
The device description and performance studies clearly indicate this is a physical medical device (catheter, tubing, pump) used for mechanical thrombectomy, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for the revascularization of patients with acute ischemic stroke. This involves physically removing blood clots from blood vessels.
- Device Description: The description details a catheter and related components designed for insertion into the neurovasculature.
- Performance Studies: The performance studies involve bench-top testing and animal testing focused on the physical and mechanical properties of the device and its interaction with blood vessels. There is no mention of testing involving in vitro analysis of biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or treatment. This device operates directly within the patient's body.
N/A
Intended Use / Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are 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) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion 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)
NRY
Device Description
The Penumbra System Reperfusion Catheter JET 7 is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 component provides a larger lumen to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
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)
-
Biocompatibility:
- In Vitro Cytotoxicity: Sample extracts yielded cell lysis Grade 1 (Slight). Pass.
- Sensitization: Test Group yielded Grade 0 (No visible change). Pass.
- Acute Intracutaneous Reactivity (Irritation): Difference in mean test article and mean control score was ≤ 1.0. Pass.
- Systemic Toxicity: No evidence of systemic toxicity from sample extracts (no weight loss, no death, all animals appeared normal). Pass.
- Rabbit Pyrogen Study: Non-pyrogenic; no single animal had a total body temperature rise of ≥ 0.5°C. Pass.
- In Vitro Hemolysis: Non-hemolytic; Hemolytic Index = 0.70%, Corrected Hemolytic index = 0.00%. Pass.
- Coagulation (Prothrombin Time): Test article coagulation times were statistically lower than negative control. Pass.
- Coagulation (Partial Thromboplastin Time): Test article coagulation times were statistically similar to the predicate. Pass.
- Complement Activation: Test sample concentrations of C3a and SC5b-9 were statistically similar or lower than the predicate control, and statistically lower than the positive control. Pass.
- Dog Thrombogenicity: No significant thrombosis (Grade 0) was observed in 2 out of 2 test sites and 2 out of 2 control sites. Pass.
-
Bench-Top Testing:
- Dimensional / Visual Inspection: Units met all product specifications. Pass.
- Simulated Use [Intracranial Access, Vessel Access Entry Performance, Delivery/Retrieval Forces & Clot Removal]: Devices were effective in removing clots and the Reperfusion Catheter did not collapse under vacuum in an anatomical model. Pass.
- Physician Evaluation [Deliverability & Clot Removal]: Multiple physician performance evaluations showed satisfactory results in a simulated neurovascular tortuosity model comparable to the predicate. Pass.
- Kink Resistance (Distal, Midshaft, Proximal): No kinking observed at 2.5 mm, 10 mm, and 25 mm radii. Pass.
- Particulate testing: Pass for particles ≥ 10 μm (≤ 6000 particles) and ≥ 25 μm (≤ 600 particles). FIPO for ≥ 75 μm and ≥ 125 μm.
- Coating Integrity: No delamination, peeling, or flaking. Pass.
- Markerband Visibility: Fluoroscopically visible. Pass.
- Hub Air Aspiration: No leaks detected. Pass.
- Pressure Test: Maintained 45 psi for 30 sec minimum. Pass.
- JET 7 / Sheath or 8F Guide Catheter Friction Force: Maximum value per specification. Pass.
- JET 7 / 0.014 in. Guidewire Friction Force: Maximum value per specification. Pass.
- Joint sections bond strength: Minimum value per specification. Pass.
- Markerband Section Bond Strength: Minimum value per specification. Pass.
- Hub to Shaft Bond Strength: Minimum value per specification. Pass.
- Hub to Hypotube Bond Strength: Minimum value per specification. Pass.
- Elongation to failure: Elongation ≥ 5%. Pass.
- Torsion: Number of turns recorded for informational purposes only. FIPO.
- Corrosion: No visible corrosion. Pass.
-
Animal Study:
- Study Type: GLP Animal Testing comparing Reperfusion Catheter JET 7 to predicate Reperfusion Catheter ACE 68 in a porcine vascular model.
- Sample Size: Not explicitly stated, but implies multiple swine were used as one side was treated with JET 7 and the contralateral side with ACE 68.
- Key Results: Evaluated the aspiration vascular response when "wedged" within a swine artery. Safety assessed by acute and chronic vascular response via contrast angiography, gross necropsy, and histopathology. Results demonstrated substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (For clinical performance)
Biocompatibility metrics: In Vitro Cytotoxicity (Grade 1), Sensitization (Grade 0), Acute Intracutaneous Reactivity (Irritation) (Grade ≤ 1.0 difference), Systemic Toxicity (No weight loss, no death, normal behavior), Rabbit Pyrogen Study (Non-pyrogenic), In Vitro Hemolysis (Hemolytic Index = 0.70%, Corrected Hemolytic index = 0.00%).
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 17, 2018
Penumbra, Inc. Michaela Mahl, MSBE Senior Manager Regulatory Affairs One Penumbra Place Alameda, California 94502
Re: K173761
Trade/Device Name: Penumbra System (Reperfusion Catheter JET 7) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 17, 2018 Received: July 18, 2018
Dear Michaela Mahl:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Xiaolin Zheng -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173761
Device Name
Penumbra System (Reperfusion Catheter JET 7)
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are 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) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion 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)
| ☑ 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 Penumbra System® Reperfusion Catheter JET 7.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Michaela Mahl Senior Manager, Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: mmahl@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
July 17, 2018
1.4 Device Trade or Proprietary Name
Penumbra System® (Reperfusion Catheter JET 7)
1.5 Device Classification
Regulatory Class: II Classification Panel: Neurology Classification Name: Percutaneous Catheter Regulation Number: 21 CFR §870.1250 Product Code: NRY (Catheter, Thrombus Removal)
1.6 Predicate Devices
| 510(k) Number / Clearance Date | Name of Device | Name of Manufacturer |
|---|---|---|
| Primary Predicate Device | ||
| K161640 cleared on July 12, 2016 | Penumbra System – ACE 68 | |
| Reperfusion Catheter | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| Additional Predicate Device | ||
| K162901 (applicable for indication | ||
| only) cleared on April 20, 2017 | Penumbra System – 3D | |
| Revascularization Device | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA |
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Predicate Comparison 1.7
| System Name | Penumbra System® | ||
|---|---|---|---|
| Device Name | ACETM 68 | JET 7 | |
| 510(k) No. | K161640 (applicable for ACE 68) | ||
| K162901 (applicable for indication only) | K173761 | ||
| Classification | Class II, NRY | SAME | |
| Indication | Penumbra Reperfusion Catheters and Separators | ||
| As part of the Penumbra System, the | |||
| Reperfusion Catheters and Separators are | |||
| 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) or who fail IV | |||
| t-PA therapy are candidates for treatment. |
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra
3D Revascularization Device 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)
within 8 hours of symptom onset. Patients who
are ineligible for intravenous tissue plasminogen
activator (IV t-PA) or who fail IV t-PA therapy
are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra
Sterile Aspiration Tubing is indicated to connect
the Penumbra Reperfusion Catheters to the
Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a
vacuum source for Penumbra Aspiration
Systems. | SAME | |
| System Name | Penumbra System® | | JET 7 |
| Device Name | ACETM 68 | | |
| Materials | | | |
| Proximal hub | Grilamid (TR55-LX) | | SAME |
| Strain Relief [Hub Sleeve] | Grilamid (TR55) | | SAME |
| Strain Relief | 304 Stainless Steel (SS) | | SAME |
| ID Band | Polyolefin, PET yellow [black foil] | | Polyolefin, PET black [white foil] |
| Liner | PTFE | | SAME |
| Catheter Shaft | | | |
| Extrusions | Polyurethane, Polyether Block Amide, Nylon12 | | SAME |
| Distal Coil Reinforcement | NiTi wire | | SAME |
| Proximal Coil
Reinforcement | SS wire and NiTi wire | | SAME |
| Extrusion Colorants | Clear/ Natural or Purple | | SAME |
| Tip Shape | Straight | | SAME |
| Markerband | Platinum/Iridium (90% Pt, 10% Ir) | | SAME |
| Coating | Hydrophilic (proprietary) | | SAME |
| Dimensions | | | |
| Proximal OD | 0.084 in Max | | 0.085 in Max |
| Proximal ID | 0.068 in Min | | 0.072 in Min |
| Distal OD | 0.084 in Max | | 0.085 in Max |
| Distal ID | 0.068 in Min | | 0.072 in Min |
| Effective Length | 115, 120, 125, 127, 132 cm | | SAME |
| Distal Flex Length | 30 cm | | SAME |
| Coating Length | 30 cm | | SAME |
| Accessories | | | |
| Peelable Sheath | PTFE | | SAME |
| Rotating Hemostasis Valve | Polycarbonate, silicone o-ring | | SAME |
| Shaping Mandrel | 0.038in OD stainless steel | | SAME |
| Packaging Materials | | | |
| Pouch | Polyester/Polyethylene/Tyvek | | SAME |
| Packaging Hoop | Polyethylene | | SAME |
| Packaging Tray
(Kit Configuration) | Polyethylene terephthalate, Polystyrene | | SAME |
| Packaging Card | Polyethylene | | SAME |
| Display Carton | SBS Paperboard | | SAME |
| | Hoop: Hoop/Packaging Card/Pouch/Box | | SAME |
| Packaging Configuration | Kit: Tray/Retainer/Lid/Aspiration
Tubing/Accessory Pouch/Pouch/Box | | SAME |
| Sterilization | EO | | SAME |
| Shelf-Life | 36 Months | | 6 Months |
| System Name | Penumbra System® | | |
| Device Name | ACE™ 68 | JET 7 | |
| Use | Single use, disposable | SAME | |
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Image /page/6/Picture/0 description: The image contains the word "Penumbra" in red font, followed by a red circular logo with a white "P" inside. The logo is positioned to the right of the word "Penumbra". The font is sans-serif and the logo is simple and modern.
Device Description 1.8
The Penumbra System Reperfusion Catheter JET 7 is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 component provides a larger lumen to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
1.9 Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are 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) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
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1.10 Summary of Non-Clinical Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows.
Included in this section are summary descriptions of the testing, which substantiates the substantially equivalent performance of the subject Penumbra System JET 7 device to the predicate device:
- Biocompatibility .
- Design Verification (Bench-Top Testing) .
- Design Validation (GLP Animal Testing) ●
The subject Penumbra System Reperfusion Catheter JET 7 met all established requirements.
1.10.1 Leveraged Biocompatibility Testing
The materials used in Reperfusion Catheter JET 7 are currently utilized in the currently available predicate device, Reperfusion Catheter ACE 68. The JET 7 device is manufactured using the same processes and in the same environment as ACE 68. The predicate. ACE 68 is classified as an externally communicating device with circulating blood contact and limited exposure less than 24 hours, which is the same proposed classification for JET 7. All biocompatibility risks have been mitigated through successful completion of prior biocompatibility testing per
EN ISO 10993-1:2009/AC: 2010 which will be leveraged for the JET 7 device. Therefore, no further biocompatibility testing is required.
Evidence of the biocompatibility of the Reperfusion Catheter JET 7 is derived from a series of previously performed studies listed and summarized in the table below. The studies were selected in accordance with EN ISO 10993-11 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (1 EN ISO 10993-1: 2009/AC:2010 Biological Evaluation of Medical Devices, Part 1: Evaluation and testing within a risk management process
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communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).
| Test | Acceptance Criteria | Results | Pass / Fail |
|---|---|---|---|
| In Vitro Cytotoxicity | Sample extracts must yield cell lysis grade 2 or lower | Grade 1: Slight | Pass |
| Sensitization | Test Group shall yield Grade 10% weight loss in 3 or more test animals | ||
| • Mortality of 2 or more test animals | |||
| • Abnormal behavior in 2 or more test animals | No evidence of systemic toxicity from sample extracts | ||
| • No weight loss (all gained weight) | |||
| • No death | |||
| • All test animals appeared normal | Pass | ||
| Rabbit Pyrogen Study | Sample Extracts must not cause a total rise in body temperature of ≥0.5°C | Non-pyrogenic: No evidence of material-mediated pyrogenicity; no single animal had a total body temperature rise of ≥0.5°C | Pass |
| Hemocompatibility | |||
| In Vitro Hemolysis | Sample extracts must be non-hemolytic (≤ 2% hemolytic index) | Non-hemolytic: | |
| Hemolytic Index = 0.70% | |||
| Corrected Hemolytic index = 0.00% | Pass | ||
| Coagulation | |||
| (Prothrombin Time) | Clotting times must be similar to negative control values | Test article coagulation times were statistically lower than negative control | Pass |
| Coagulation | |||
| (Partial Thromboplastin Time) | Clotting times must be similar to predicate (negative control) values using analysis of variance | Test article coagulation times were statistically similar to the predicate | Pass |
| Test | Acceptance Criteria | Results | Pass / Fail |
| Complement Activation | The concentrations of C3a and | ||
| SC5b-9 in the test samples are | |||
| statistically similar to the | |||
| predicate (Exposure Control & | |||
| Ref Material) control and | |||
| statistically lower than the | |||
| positive control for all | |||
| exposure times | The test sample | ||
| concentrations of C3a and | |||
| SC5b-9 were statistically | |||
| similar or lower than the | |||
| predicate control sample | |||
| concentrations, and | |||
| statistically lower than the | |||
| positive control sample | |||
| concentrations at all three | |||
| exposure times | Pass | ||
| Dog Thrombogenicity | The device must be non- | ||
| thrombogenic after 4 hours in | |||
| vivo when compared to a | |||
| control device (Boston | |||
| Scientific Excelsior SL-10 | |||
| microcatheter) | No significant thrombosis | ||
| with a Grade of 0 was | |||
| observed in 2 out 2 test site | |||
| and 2 out of 2 control sites. | |||
| Based on the evaluation | |||
| criteria, the amount of | |||
| thrombosis was not | |||
| considered significant | Pass |
EN ISO-10993 GLP Testing Summary
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In summary non-clinical testing substantiates that the Penumbra System Reperfusion Catheter JET 7 device is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, nonpyrogenic, non-hemolytic, and non-thrombogenic.
1.10.2 Bench-top Testing
The physical and mechanical properties of the Reperfusion Catheter JET 7 device was assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Results |
|---|---|---|
| Dimensional / Visual | ||
| Inspection | These evaluations confirm that the units used in this Design | |
| Verification testing meet all product specifications. | Pass | |
| Simulated Use | ||
| [Intracranial Access, Vessel | ||
| Access Entry Performance, | ||
| Delivery/Retrieval Forces & | ||
| Clot Removal] | Simulated use testing of the Penumbra System Reperfusion Catheter | |
| JET 7 was performed with accessory devices in an anatomical model | ||
| which simulated the tortuosity of the neurovasculature. Devices were | ||
| delivered through the tortuous anatomical model to evaluate the | ||
| effectiveness of the devices to remove clots and that the Reperfusion | ||
| Catheter does not collapse under vacuum. | Pass | |
| Physician Evaluation | ||
| [Deliverability & Clot | ||
| Removal] | Multiple Physician performance evaluation of the Penumbra System | |
| Reperfusion Catheter JET 7 in a simulated neurovascular tortuosity | ||
| model with the predicate Penumbra System Reperfusion Catheter | ||
| ACE 68 used as a baseline. | Pass | |
| Kink Resistance | ||
| (Distal, Midshaft, Proximal) | No kinking when formed in a 2.5 mm, 10 mm, and 25 mm radius | Pass |
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| Attribute | Specification | Results |
|---|---|---|
| Particulate testing | ≥ 10 μm will be ≤ 6000 particles | Pass |
| ≥ 25 μm will be ≤ 600 particles | Pass | |
| ≥ 75 μm will be measured for informational purposes only (FIPO) | FIPO | |
| ≥ 125 μm will be measured for informational purposes only (FIPO) | FIPO | |
| Coating Integrity | Coating has not delaminated, peeled, or flaked prior to or after | |
| simulated use particulate testing | Pass | |
| Markerband Visibility | The markerband is fluoroscopically visible | Pass |
| Hub Air Aspiration | No leaks detected when vacuum is pulled on the injection lumen | Pass |
| Pressure Test | 45 psi for 30 sec minimum | Pass |
| JET 7 / Sheath or 8F Guide | ||
| Catheter Friction Force | Maximum value per specification | Pass |
| JET 7 / 0.014 in. Guidewire | ||
| Friction Force | Maximum value per specification | Pass |
| Joint sections bond strength | Minimum value per specification | Pass |
| Markerband Section Bond | ||
| Strength | Minimum value per specification | Pass |
| Hub to Shaft Bond Strength | Minimum value per specification | Pass |
| Hub to Hypotube Bond | ||
| Strength | Minimum value per specification | Pass |
| Elongation to failure | Elongation ≥ 5% | Pass |
| Torsion | Number of turns will be recorded for informational purposes only. | FIPO |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately after | |
| corrosion testing procedure | Pass |
1.10.3 Animal Study
The safety and performance of the Reperfusion Catheter JET 7 compared to the predicate Reperfusion Catheter ACE 68, when "wedged" in a vessel and using maximum aspiration, was evaluated in the accepted porcine vascular model. One side of each swine was treated with the Reperfusion Catheter JET 7 and the contralateral side was treated with predicate device. The purpose of this study was to evaluate the Reperfusion Catheter JET 7 aspiration vascular response when "wedged" within a swine artery compared to the predicate device. Safety of the test articles was assessed by consideration of the acute and chronic vascular response. Vascular response was assessed by contrast angiography and by gross necropsy and histopathology of associated vasculature performed by the Sponsor Pathologist. As testing included the predicate device, results were compared to demonstrate substantial equivalence.
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1.11 Performance Data – Clinical:
No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the Predicate Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the determination of substantial equivalence by leveraging clinical outcomes from devices that are considered technologically equivalent.
1.12 Summary of Substantial Equivalence
The subject Penumbra System Reperfusion Catheter JET 7 device is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.