(249 days)
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.
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.
The Penumbra System Reperfusion Catheter JET 7 is a medical device for revascularization in acute ischemic stroke. It was compared to a predicate device, the Penumbra System ACE 68 Reperfusion Catheter, to demonstrate substantial equivalence through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent various non-clinical tests (biocompatibility, bench-top, and animal studies) to confirm its safety and performance. The tables below summarize the acceptance criteria and results for key tests mentioned in the provided text.
Biocompatibility Testing
| 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 < 1 score on Magnusson and Kligman scale (provided control Grade < 1) | Grade 0: No visible change | Pass |
| Acute Intracutaneous Reactivity (Irritation) | The difference in the mean test article and mean control score must be grade 1.0 or lower | Grade ≤ 1.0 difference between mean test article and mean control score | Pass |
| Acute Systemic Toxicity | No evidence of systemic toxicity (e.g., > 10% weight loss in ≥3 animals, ≥2 mortalities, ≥2 abnormal behaviors) | No evidence of systemic toxicity (no weight loss, no death, all 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 single animal had a total body temperature rise of ≥0.5°C | Pass |
| 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 |
| Complement Activation | Concentrations of C3a and SC5b-9 in test samples statistically similar to predicate and lower than positive control | Test sample concentrations of C3a and SC5b-9 were statistically similar or lower than predicate, and statistically lower than positive control | Pass |
| Dog Thrombogenicity | Device must be non-thrombogenic after 4 hours in vivo compared to a control device | No significant thrombosis with a Grade of 0 observed in 2 out of 2 test and 2 out of 2 control sites | Pass |
Bench-top Testing
| Attribute | Specification | Results |
|---|---|---|
| Dimensional / Visual Inspection | Units meet all product specifications. | Pass |
| Simulated Use (Intracranial Access, Vessel Access Entry Performance, Delivery/Retrieval Forces & Clot Removal) | Effectiveness of clot removal and catheter does not collapse under vacuum in an anatomical model. | Pass |
| Physician Evaluation (Deliverability & Clot Removal) | Performance evaluated in a simulated neurovascular tortuosity model with predicate as baseline. | Pass |
| Kink Resistance (Distal, Midshaft, Proximal) | No kinking when formed in 2.5 mm, 10 mm, and 25 mm radius. | Pass |
| Particulate testing | ≥ 10 μm ≤ 6000 particles; ≥ 25 μm ≤ 600 particles | Pass (for mandated sizes) |
| 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 |
| Corrosion | No visible corrosion immediately after corrosion testing procedure. | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
- Biocompatibility: The specific number of samples for each biocompatibility test (e.g., number of extracts, animals) is not explicitly stated in the summary, but it implies standard practices for these types of tests conducted under GLP. The data provenance is from previously performed studies (leveraged from the predicate device ACE 68, K161640 cleared on July 12, 2016). These studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The location of these previous studies is not specified but is assumed to be within a regulated, GLP-compliant environment.
- Bench-Top Testing: The text does not specify exact sample sizes for each bench-top test, but it states that "the units used in this Design Verification testing meet all product specifications," suggesting multiple samples were tested for each attribute.
- Animal Study: The study used porcine subjects. "One side of each swine was treated with the Reperfusion Catheter JET 7 and the contralateral side was treated with predicate device." The exact number of swine is not stated, but the Dog Thrombogenicity test (part of biocompatibility) mentions "2 out of 2 test site and 2 out of 2 control sites," suggesting a small number of animals for that specific test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Biocompatibility: Not directly applicable in the sense of expert consensus for ground truth on performance. Biocompatibility results are based on objective laboratory measurements against established standards (EN ISO 10993-1:2009/AC:2010). The animal study involved a "Sponsor Pathologist" to assess vascular response by gross necropsy and histopathology. No specific number or additional qualifications beyond "Sponsor Pathologist" are provided.
- Bench-Top Testing: A "Physician Evaluation" was performed for deliverability and clot removal. The number of physicians and their specific qualifications are not detailed beyond "Multiple Physician."
4. Adjudication Method for the Test Set
- Biocompatibility: For tests like Systemic Toxicity, the results were assessed based on objective criteria (e.g., weight loss, mortality, abnormal behavior). For the Dog Thrombogenicity study, assessment of thrombosis was made by the Sponsor Pathologist. No formal adjudication (e.g., 2+1, 3+1) is mentioned as it's typically not explicitly used for these types of non-clinical tests unless there are subjective interpretations needing consensus, which isn't detailed here.
- Bench-Top Testing (Physician Evaluation): The method of physician evaluation for deliverability and clot removal is not described as having an adjudication process beyond "multiple physician performance evaluation."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission states, "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes." The comparison was primarily against the predicate device based on non-clinical data and leveraging clinical outcomes from existing literature on similar devices.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This device (Penumbra System Reperfusion Catheter JET 7) is a physical medical device, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance is inherently "standalone" in vitro and in vivo animal testing, with human involvement primarily in operating the device and evaluating the results.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth was established by adherence to recognized international standards (EN ISO 10993-1:2009/AC:2010) and objective measurements defined within these standards. For the animal study, pathology (gross necropsy and histopathology by a Sponsor Pathologist) served as the ground truth for vascular response.
- Bench-Top Testing: Ground truth was established by engineering specifications, physical measurements, and qualitative assessments (e.g., "no kinking," "no leaks," "fluoroscopically visible") based on predefined acceptance criteria. For the "Physician Evaluation," the ground truth was expert opinion/observation on deliverability and clot removal compared to a baseline (predicate device).
8. The Sample Size for the Training Set
This product is a physical medical device and not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's design and manufacturing processes are developed based on engineering principles and prior knowledge from predicate devices.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" does not apply to this physical medical device.
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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
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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
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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 68Reperfusion Catheter | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
| Additional Predicate Device | ||
| K162901 (applicable for indicationonly) cleared on April 20, 2017 | Penumbra System – 3DRevascularization Device | Penumbra, Inc.One Penumbra PlaceAlameda, 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 SeparatorsAs part of the Penumbra System, theReperfusion Catheters and Separators areindicated for use in the revascularization ofpatients with acute ischemic stroke secondary tointracranial large vessel occlusive disease(within the internal carotid, middle cerebral –M1 and M2 segments, basilar, and vertebralarteries) within 8 hours of symptom onset.Patients who are ineligible for intravenous tissueplasminogen activator (IV t-PA) or who fail IVt-PA therapy are candidates for treatment.Penumbra 3D Revascularization DeviceAs part of the Penumbra System, the Penumbra3D Revascularization Device is indicated for usein the revascularization of patients with acuteischemic stroke secondary to intracranial largevessel occlusive disease (within the internalcarotid, middle cerebral – M1 and M2 segments)within 8 hours of symptom onset. Patients whoare ineligible for intravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PA therapyare candidates for treatment.Penumbra Aspiration TubingAs part of the Penumbra System, the PenumbraSterile Aspiration Tubing is indicated to connectthe Penumbra Reperfusion Catheters to thePenumbra Aspiration Pump.Penumbra Aspiration PumpThe Penumbra Aspiration Pump is indicated as avacuum source for Penumbra AspirationSystems. | 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 CoilReinforcement | 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/AspirationTubing/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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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 (< 24 hours), externally
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 < 1 score on Magnusson and Kligman scale (provided control Grade < 1) | Grade 0: No visible change | Pass |
| Acute Intracutaneous Reactivity (Irritation) | The difference in the mean test article and mean control score must be grade 1.0 or lower | Grade ≤ 1.0 difference between mean test article and mean control score | Pass |
| Systemic Toxicity | |||
| Acute Systemic Toxicity | Sample extracts must not cause the following:• > 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 andSC5b-9 in the test samples arestatistically similar to thepredicate (Exposure Control &Ref Material) control andstatistically lower than thepositive control for allexposure times | The test sampleconcentrations of C3a andSC5b-9 were statisticallysimilar or lower than thepredicate control sampleconcentrations, andstatistically lower than thepositive control sampleconcentrations at all threeexposure times | Pass |
| Dog Thrombogenicity | The device must be non-thrombogenic after 4 hours invivo when compared to acontrol device (BostonScientific Excelsior SL-10microcatheter) | No significant thrombosiswith a Grade of 0 wasobserved in 2 out 2 test siteand 2 out of 2 control sites.Based on the evaluationcriteria, the amount ofthrombosis was notconsidered 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 / VisualInspection | These evaluations confirm that the units used in this DesignVerification testing meet all product specifications. | Pass |
| Simulated Use[Intracranial Access, VesselAccess Entry Performance,Delivery/Retrieval Forces &Clot Removal] | Simulated use testing of the Penumbra System Reperfusion CatheterJET 7 was performed with accessory devices in an anatomical modelwhich simulated the tortuosity of the neurovasculature. Devices weredelivered through the tortuous anatomical model to evaluate theeffectiveness of the devices to remove clots and that the ReperfusionCatheter does not collapse under vacuum. | Pass |
| Physician Evaluation[Deliverability & ClotRemoval] | Multiple Physician performance evaluation of the Penumbra SystemReperfusion Catheter JET 7 in a simulated neurovascular tortuositymodel with the predicate Penumbra System Reperfusion CatheterACE 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 aftersimulated 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 GuideCatheter Friction Force | Maximum value per specification | Pass |
| JET 7 / 0.014 in. GuidewireFriction Force | Maximum value per specification | Pass |
| Joint sections bond strength | Minimum value per specification | Pass |
| Markerband Section BondStrength | Minimum value per specification | Pass |
| Hub to Shaft Bond Strength | Minimum value per specification | Pass |
| Hub to Hypotube BondStrength | 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 aftercorrosion 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.
§ 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).