(164 days)
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.
The Penumbra System Reperfusion Catheter JET 7 (modified) is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 (modified) delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.
The provided document is a 510(k) Premarket Notification for the Penumbra System® (Reperfusion Catheter JETTM 7). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria for an AI/device performance.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in a clinical or comparative effectiveness setting (especially for AI where human-in-the-loop performance is assessed) cannot be fully provided based on the given text.
The document does include acceptance criteria for biocompatibility testing and bench-top testing and reports whether the device passed these criteria. However, these are engineering and materials performance criteria, not clinical performance criteria with a test set of patient data, ground truth established by experts, or MRMC studies typically seen for AI-based diagnostic devices.
Here's what can be extracted and what cannot:
Information that CAN be extracted and presented:
- Table of acceptance criteria and reported device performance (for non-clinical tests): This is available for biocompatibility and bench-top testing.
- Sample size for non-clinical testing: This is generally implied by "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)" for biocompatibility and for bench tests by "These evaluations confirm that the units used in this Design Verification testing meet all product specifications." but specific numbers are not given for each test.
- Data provenance for non-clinical testing: Performed internally by Penumbra, Inc. labs or contracted labs following GLP.
- Ground truth type for non-clinical testing: Based on established industry standards and regulatory guidelines (e.g., EN ISO 10993-1, specific assay results, physical measurements).
Information that CANNOT be extracted from the provided text:
- Sample sized used for the test set (clinical data): No specific clinical test set data is provided. The document states "No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes."
- Data provenance (e.g., country of origin of the data, retrospective or prospective) for clinical data: Not applicable, as no new clinical study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new clinical study was conducted involving expert ground truth for patient data. Physician evaluation was done for bench testing, but details on the number and qualifications of physicians are not given, nor is it a blind adjudication process.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, but a physical medical device (catheter).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical data: Not applicable.
- The sample size for the training set (for AI): Not applicable.
- How the ground truth for the training set was established (for AI): Not applicable.
Acceptance Criteria and Device Performance (Non-Clinical Data from provided text):
The device is a medical catheter, and the performance criteria discussed are related to its physical properties, material safety, and mechanical function, not an AI's diagnostic performance.
1. Table of acceptance criteria and the reported device performance (for Biocompatibility and Bench-Top Testing):
Biocompatibility Test Results
| Tests | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| Cytotoxicity: MEM Elution (10993-5) | Sample extracts must have a cytotoxic reactivity score of grade 2 or lower. | Grade = 0 (Reactivity None) | Pass, Non-cytotoxic |
| Delayed-type hypersensitivity (Sensitization) (10993-10) | Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided Control Group yields Grade < 1). | NaCl Extract: Grade = 0; CSO Extract: Grade = 0 | Pass, Non-sensitizing |
| Intracutaneous Reactivity (Irritation) (10993-10) | The difference between the average scores for the extract of the test article and the control is ≤ 1.0. | NaCl Extract: Difference = 0.0; CSO Extract: Difference = 0.0 | Pass, Non-irritating |
| Systemic Toxicity: Acute Systemic Injection (10993-11) | Sample extracts must not cause significant biological reaction greater than control. That is: • Death in 2 or more animals • Signs of toxicity in 2 or more animals (i.e. convulsions, prostration) • Weight loss > 10% in 3 or more animals. | No evidence of systemic toxicity from sample extracts (both NaCl and CSO extracts). That is: No deaths; No signs consistent with toxicity; No weight loss > 10%. | Pass, Non-toxic |
| Systemic Toxicity: Material Mediated Pyrogen (10993-11, USP) | Sample extracts must not cause a total rise in body temperature of ≥ 0.5°C. | Non-pyrogenic: no single animal had an individual rise in body temperature ≥ 0.5°C. | Pass, Non-pyrogenic |
| Hemocompatibility: In vitro Thrombogenicity (10993-4) | The test article must have similar or less thrombus formation than predicate after 4 hours in vitro. | Test Article: 1, Thromboresistant; Control Article: 1, Thromboresistant | Pass, Thromboresistant |
| Hemocompatibility: Prothrombin Time (PT) (10993-4) | Clotting times of test article must be similar to predicate values using analysis of variance. | Test article coagulation times are statistically similar to predicate. | Pass, Hemocompatible |
| Hemocompatibility: Partial Thromboplastin Time (PTT) (10993-4) | Clotting times of test article must be similar to predicate values using analysis of variance. | Test article coagulation times are statistically similar to predicate. | Pass, Hemocompatible |
| Hemocompatibility: Complement Activation (10993-4) | The concentrations of C3a and SC5b-9 of test article must be similar to predicate values using analysis of variance. | C3a: Test article concentrations are statistically similar to predicate at all exposure time points (30 min, 60 min, 90 min); SC5b-9: Test article concentrations are statistically similar to predicate at all exposure time points (30 min, 60 min, 90 min). | Pass, Hemocompatible |
| Hemocompatibility: Hemolysis, indirect contact (10993-4) | Sample extracts must be non-hemolytic (≤ 2% hemolytic index). | Hemolytic Index = 0.00% | Pass, Non-hemolytic |
| Hemocompatibility: Hemolysis, direct contact (10993-4) | Sample must be non-hemolytic (≤ 2% hemolytic index). | Hemolytic Index = 0.00% | Pass, Non-hemolytic |
Design Verification - Bench Top Testing
| 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 | Simulated use testing of the Penumbra System Reperfusion Catheter 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 | 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 JET 7 and ACE 68 used as a baseline. | Pass |
| Reperfusion Catheter / Sheath or 8F Guide compatibility (Friction Force) | Maximum value per specification. | Pass |
| Reperfusion Catheter / 0.014" Guidewire compatibility (Friction Force) | Maximum value per specification. | Pass |
| Markerband Visibility | The markerband is fluoroscopically visible. | Pass |
| Torsion | Number of turns will be recorded for informational purposes only (FIPO). | FIPO |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately after corrosion testing procedure. | Pass |
| Particulate Testing | ≥ 10 µm will be ≤ 6000 particles; ≥ 25 µm will be ≤ 600 particles; ≥ 75 µm particles will be recorded for informational purposes only; ≥ 125 µm particles will be recorded for informational purposes only. | Pass |
| Coating Integrity | Coating has not delaminated, peeled, or flaked after simulated use particulate testing. | Pass |
| Hub/Air Aspiration | When negative pressure is pulled, no air may leak into hub. | Pass |
| Pressure Test | Minimum value per specification. | Pass |
| Markerband Section Bond Strength | Minimum value per specification. | Pass |
| Bond Strength Distal Joint 1 | Minimum value per specification. | Pass |
| Bond Strength Distal Joint 2 | Minimum value per specification. | Pass |
| Bond Strength Midjoint | Minimum value per specification. | Pass |
| Proximal Joints: Hub to Shaft Bond Strength / Hub to Hypotube Bond Strength | Minimum value per specification. | Pass |
| Elongation to Failure - Reperfusion Catheter | Elongation ≥ 5%. | Pass |
2. Sample sized used for the test set and the data provenance:
- Biocompatibility: "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)." Specific sample sizes for each test are not detailed but are implied by GLP standards. Data provenance is implied to be laboratory testing within the US (due to FDA submission) or by a GLP-compliant lab.
- Bench-Top Testing: No specific sample sizes mentioned for each attribute, but the results indicate performance of "the units used in this Design Verification testing." Data provenance is laboratory testing.
- Clinical/AI study: No clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Biocompatibility/Bench-Top Testing: For "Physician Evaluation" in bench testing, "Multiple Physician performance evaluation" was conducted. The specific number or qualifications are not provided beyond "Physician." This is not establishing "ground truth" in the sense of clinical disease states.
- Clinical/AI study: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set for diagnosis/AI performance was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Biocompatibility: Ground truth is based on established, quantitative laboratory standards and biological responses as defined by ISO and USP guidelines.
- Bench-Top Testing: Ground truth is based on engineering specifications, physical measurements, and functional performance in simulated environments.
- Clinical/AI study: Not applicable.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
In summary, the provided document details the non-clinical (biocompatibility and bench) testing and acceptance criteria for a physical medical device (catheter) to demonstrate substantial equivalence, rather than a clinical study for an AI-based diagnostic device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
June 16, 2019
Penumbra, Inc. Micaela Victoria Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K190010
Trade/Device Name: Penumbra System® (Reperfusion Catheter JETTM 7) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: May 16, 2019 Received: May 17, 2019
Dear Micaela Victoria:
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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190010
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 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.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Penumbra, a healthcare company. The logo consists of the word "Penumbra" in a red sans-serif font, followed by a circular symbol. The symbol is red with a white "P" inside, and a white line extending from the "P" to the edge of the circle. The logo is simple and modern, and the red color gives it a sense of energy and urgency.
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
Micaela Victoria Regulatory Affairs Specialist III Phone: (510) 748-2082 FAX: (510) 217-6414 Email: mvictoria@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
May 16, 2018
1.4 Device Trade or Proprietary Name
Penumbra System® (Reperfusion Catheter JETTM 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 | ||
| K173761 cleared on August 8, 2018 | Penumbra System – JET 7Reperfusion Catheter | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
| Reference Device | ||
| K161640 cleared on July 12, 2016(applicable to packaging validationonly) | Penumbra System – ACE 68Reperfusion Catheter | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
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Image /page/4/Picture/0 description: The image contains the word "Penumbra" in a bold, red font. To the right of the word is a circular logo, also in red, with a white "P" inside. The logo has a white line extending from the "P" to the edge of the circle, giving the impression of motion. The overall design is clean and modern.
Predicate Comparison 1.7
| System Name | Penumbra System® | ||
|---|---|---|---|
| Device Name | JET 7(Predicate) | Modified JET 7(Subject) | |
| 510(k) No. | K173761 (applicable for JET 7)K161640 (applicable for packaging validationonly - Reference Device) | K190010 | |
| 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® | ||
| Device Name | JET 7(Predicate) | Modified JET 7(Subject) | |
| 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 black [white foil] | SAME | |
| Liner | PTFE | SAME | |
| Catheter Shaft | |||
| Extrusions | Polyurethane | Equivalent | |
| Polyether Block Amide | SAME | ||
| Nylon 12 | 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) | Equivalent | |
| Dimensions | |||
| Proximal OD | 0.085 in Max | SAME | |
| Proximal ID | 0.072 in Min | SAME | |
| Distal OD | 0.085 in Max | SAME | |
| Distal ID | 0.072 in Min | SAME | |
| 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 | |||
| System Name | Penumbra System® | ||
| Device Name | JET 7(Predicate) | Modified JET 7(Subject) | |
| 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 | |
| Packaging Configuration | Hoop: Hoop/Packaging Card/Pouch/Box | SAME | |
| Kit: Tray/Retainer/Lid/AspirationTubing/Accessory Pouch/Pouch/Box | SAME | ||
| Sterilization | EO | SAME | |
| Shelf-Life | 36 Months | 12 Months | |
| Use | Single use, disposable | SAME |
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Image /page/5/Picture/0 description: The image shows the logo for Penumbra, a healthcare company. The word "Penumbra" is written in a bold, red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.
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1.8 Device Description
The Penumbra System Reperfusion Catheter JET 7 (modified) is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 (modified) delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, 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.
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Image /page/7/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red serif font. To the right of the word is a red circle with a white "P" inside of it.
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.
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 safe and effective performance of the subject Penumbra System JET 7 (modified) device as well as its substantial equivalence to the predicate device:
- Biocompatibility .
- Design Verification (Bench-Top Testing) ●
- Design Validation (GLP Animal Testing) .
The subject Penumbra System Reperfusion Catheter JET 7 (modified) met all established requirements.
1.10.1 Biocompatibility Testing
Biocompatibility was conducted on the subject Reperfusion Catheter JET 7 (modified). The studies were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), externally communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).
| Tests | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| Cytotoxicity: MEM Elution(10993-5) | Sample extracts must have acytotoxic reactivity score of grade2 or lower | Grade = 0 (ReactivityNone) | PassNon-cytotoxic |
| Delayed-type hypersensitivity(Sensitization)(10993-10) | Test Group shall yield Grade < 1score on Magnusson and Kligmanscale (provided Control Groupyields Grade < 1) | NaCl ExtractGrade = 0CSO ExtractGrade = 0 | PassNon-sensitizing |
| Intracutaneous Reactivity(Irritation)(10993-10) | The difference between theaverage scores for the extract ofthe test article and the control is ≤1.0 | NaCl ExtractDifference = 0.0CSO ExtractDifference = 0.0 | PassNon-irritating |
| Systemic Toxicity: Acute SystemicInjection(10993-11) | Sample extracts must not causesignificant biological reactiongreater than control. That is:• Death in 2 or more animals• Signs of toxicity in 2 or moreanimals (i.e. convulsions,prostration)• Weight loss > 10% in 3 ormore animals | No evidence ofsystemic toxicity fromsample extracts (bothNaCl and CSOextracts). That is:No deaths• No signsconsistent withtoxicityNo weight loss > 10% | PassNon-toxic |
| Systemic Toxicity: MaterialMediated Pyrogen(10993-11, USP) | Sample extracts must not cause atotal rise in body temperature of≥ 0.5°C | Non-pyrogenic: nosingle animal had anindividual rise in bodytemperature ≥ 0.5°C | PassNon-pyrogenic |
| Hemocompatibility: In vitroThrombogenicity(10993-4) | The test article must have similaror less thrombus formation thanpredicate after 4 hours in vitro | Test Article: 1,ThromboresistantControl Article: 1,Thromboresistant | PassThromboresistant |
| Hemocompatibility: ProthrombinTime (PT)(10993-4) | Clotting times of test article mustbe similar to predicate valuesusing analysis of variance. | Test articlecoagulation times arestatistically similar topredicate | PassHemocompatible |
| Hemocompatibility: PartialThromboplastin Time (PTT)(10993-4) | Clotting times of test article mustbe similar to predicate valuesusing analysis of variance | Test articlecoagulation times arestatistically similar topredicate | PassHemocompatible |
| Hemocompatibility: ComplementActivation(10993-4) | The concentrations of C3a andSC5b-9 of test article must besimilar to predicate values usinganalysis of variance | C3aTest articleconcentrations arestatistically similar topredicate at allexposure time points:• 30 min• 60 min• 90 minSC5b-9Test article | PassHemocompatible |
| predicate at allexposure time points:• 30 min• 60 min• 90 min | |||
| Hemocompatibility: Hemolysis,indirect contact(10993-4) | Sample extracts must be non-hemolytic (≤ 2% hemolytic index) | Hemolytic Index =0.00% | PassNon-hemolytic |
| Hemocompatibility: Hemolysis,direct contact(10993-4) | Sample must be non-hemolytic(≤ 2% hemolytic index) | Hemolytic Index =0.00% | PassNon-hemolytic |
Biocompatibility Test Results
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In summary, non-clinical testing substantiates that the Penumbra System Reperfusion Catheter JET 7 (modified) device is non-cytotoxic, non-sensitizing, non-irritating, non-
toxic, non-pyrogenic, non-hemolytic, and non-thrombogenic.
1.10.2 Design Verification - Bench Top Testing
The physical and mechanical properties of the Reperfusion Catheter JET 7 (modified) 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[IntracranialAccess &VesselAccess EntryPerformance,Delivery/RetrievalForces & ClotRemoval] | Simulated use testing of the PenumbraSystem Reperfusion Catheter was performed with accessorydevices in an anatomical model which simulated the tortuosity ofthe neurovasculature. Devices were delivered through thetortuous anatomical model to evaluate the effectiveness of thedevices to remove clots and that the Reperfusion Catheter doesnot collapse under vacuum. | Pass |
| PhysicianEvaluation[Deliverability& ClotRemoval] | Multiple Physician performance evaluation of the PenumbraSystem Reperfusion Catheter JET 7 in a simulated neurovasculartortuosity model with the predicate Penumbra SystemReperfusion Catheter JET 7 and ACE 68 used as a baseline. | Pass |
| Attribute | Specification | Results |
| ReperfusionCatheter /Sheath or 8FGuidecompatibility(Friction Force) | Maximum value per specification | Pass |
| ReperfusionCatheter /0.014"Guidewirecompatibility(Friction Force) | Maximum value per specification | Pass |
| MarkerbandVisibility | The markerband is fluoroscopically visible | Pass |
| Torsion | Number of turns will be recorded for informational purposes only[FIPO]. | FIPO |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately aftercorrosion testing procedure | Pass |
| ParticulateTesting | ≥ 10 µm will be ≤ 6000 particles | Pass |
| ≥ 25 µm will be ≤ 600 particles | Pass | |
| ≥ 75 µm particles will be recorded for informational purposesonly | FIPO | |
| ≥ 125 µm particles will be recorded for informational purposesonly | FIPO | |
| CoatingIntegrity | Coating has not delaminated, peeled, or flaked after simulateduse particulate testing | Pass |
| Hub/AirAspiration | When negative pressure is pulled, no air may leak into hub | Pass |
| Pressure Test | Minimum value per specification | Pass |
| MarkerbandSection BondStrength | Minimum value per specification | Pass |
| Bond StrengthDistal Joint 1 | Minimum value per specification | Pass |
| Bond StrengthDistal Joint 2 | Minimum value per specification | Pass |
| Attribute | Specification | Results |
| Bond StrengthMidjoint | Minimum value per specification | Pass |
| Proximal Joints: | Minimum value per specification | Pass |
| Hub to ShaftBond Strength | Minimum value per specification | Pass |
| Hub toHypotube BondStrength | Minimum value per specification | Pass |
| Elongation toFailure -ReperfusionCatheter | Elongation ≥ 5% | Pass |
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1.10.3 Design Validation - Animal Study
The safety and efficacy of the predicate Reperfusion Catheter JET 7 when "wedged" in a vessel and using maximum aspiration, was evaluated in the accepted porcine model [K173761]. The purpose of this study was to evaluate the aspiration vascular response of the predicate Reperfusion Catheter JET 7. The subject Reperfusion Catheter JET 7 (modified) dimensions are identical to that of the predicate device JET 7. Furthermore, the changes in material in the subject JET 7 compared to the predicate JET 7 have been evaluated in distal tip stiffness testing [bench model]. and the subject JET 7 distal tip was measured to be less stiff than the predicate JET 7, as well as the reference device ACE 68. As a result, no additional animal testing was required.
1.11 Performance Data - Clinical:
No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the predicate 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.
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1.12 Summary of Substantial Equivalence
The Reperfusion Catheter JET 7 (modified) is substantially equivalent to the predicate and reference devices, provided in Section 1.6, with regard to indications, intended use, design, performance, materials, sterilization and packaging.
§ 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).