(220 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 JET 7 with MAX Delivery Device, known as Penumbra JET 7MAX, is an additional configuration being added to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the Penumbra JET 7 Reperfusion Catheter and is removed prior to aspiration. The Reperfusion Catheter Penumbra JET 7 delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.
The provided text describes the 510(k) submission for the Penumbra System® JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX). The submission primarily relies on non-clinical data (biocompatibility and bench-top testing) and reference to previous animal testing of a predicate device to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document clearly outlines acceptance criteria and results for Biocompatibility Testing and Design Verification (Bench-Top Testing).
Biocompatibility Testing (for MAX Delivery Device only, as Reperfusion Catheter was previously tested):
| Test | Acceptance Criteria | Reported Device Performance (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) |
| Sensitization: Magnusson-Kligman Method (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) |
| Irritation: Intracutaneous Reactivity (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). 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: 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 concentration of SC5b-9 of test article must be similar to predicate values using analysis of variance | SC5b-9 Test article concentrations are statistically similar to predicate at all exposure time points: 30min, 60min, 90min | Pass (Hemocompatible) |
| Hemocompatibility: Hemolysis (indirect contact) (10993-4) | Sample extracts must be non-hemolytic (≤ 2% hemolytic index) | Hemolytic Index = 0.22% | Pass (Non-hemolytic) |
| Hemocompatibility: Hemolysis (direct contact) (10993-4) | Sample must be non-hemolytic (≤ 2% hemolytic index) | Hemolytic Index = 0.00% | Pass (Non-hemolytic) |
| Hemocompatibility: In vitro Thrombogenicity (10993-4) | Device must be non-thrombogenic in vtro when compared to predicate device | Test article performed equal or better than predicate in three separate in vitro assays | Pass (Non-thrombogenic) |
Design Verification - Bench-Top Testing:
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/Visual Inspection | Evaluations confirm units meet all product specifications. | Pass |
| Simulated Use [Intracranial Access & Vessel Access Entry Performance, Delivery/Retrieval Forces] | Evaluate effectiveness of device to assist in delivery of Reperfusion Catheter to target site in anatomical neurovasculature model. | Pass |
| Reperfusion Catheter / Access Assist Tool compatibility (Friction Force) | Maximum value per specification | Pass |
| Access Assist Tool / 0.016" Guidewire compatibility (Friction Force) | Maximum value per specification | Pass |
| Markercoil Visibility | The markercoil is fluoroscopically visible | Pass |
| Torsion | Number of turns will be recorded for informational purposes only [FIPO]. | FIPO |
| Corrosion | No visible corrosion immediately after Corrosion Testing procedure | Pass |
| Particulate Testing (≥ 10 um) | ≤ 6000 particles | Pass |
| Particulate Testing (≥ 25 um) | ≤ 600 particles | Pass |
| Particulate Testing (≥ 75 um) | Recorded for informational purposes only [FIPO] | FIPO |
| Particulate Testing (≥ 125 um) | Recorded for informational purposes only [FIPO] | FIPO |
| Coating Integrity (Pre-Inspection) | Coating has not delaminated, peeled, or flaked prior to simulated use particulate testing | Pass |
| Coating Integrity (Post-Inspection) | 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 |
| Bond Strength Distal Joint 1 | Minimum value per specification | Pass |
| Bond Strength Distal Joint 2 | Minimum value per specification | Pass |
| Bond Strength Midjoint 1 | Minimum value per specification | Pass |
| Bond Strength Midjoint 2 | Minimum value per specification | Pass |
| Proximal Joint | Minimum value per specification | Pass |
| Hub to Shaft Bond Strength | Minimum value per specification | Pass |
| Elongation to Failure - Access Assist Tool | Meets value per specification | Pass |
| Pressure Test | Minimum value per specification | Pass |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated for each test, but implied to be sufficient for the "Pass" results, particularly for biocompatibility (e.g., "no single animal," "2 or more animals" in acceptance criteria implies a small animal sample). For bench testing, it refers to "the units used in this Design Verification testing." No human subjects were involved in the testing for this specific submission.
- Data Provenance: The data is non-clinical (biocompatibility and bench testing), conducted by the manufacturer, Penumbra, Inc. The biocompatibility studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The animal testing for the predicate device (Penumbra JET 7) was performed using a "porcine model" (K173761). The document does not specify the country of origin for the data other than the manufacturer being based in Alameda, California, USA. The studies are prospective in the sense of being planned tests to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission relies on objective physical and chemical testing (biocompatibility, bench testing) and animal study results rather than expert interpretation of patient data to establish ground truth for the device's performance. The ground truth for these tests is based on pre-defined scientific and engineering specifications and established biological responses.
4. Adjudication method for the test set
Not applicable. As the testing involves objective measurement of physical and biological properties against set specifications, expert adjudication (like in clinical trial image reading) is not required.
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
Not applicable. This device is a mechanical medical device (catheter system), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance for human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device. Its performance is evaluated through physical, mechanical, and biological testing.
7. The type of ground truth used
The ground truth for this submission is based on:
- Pre-defined quantitative specifications: For bench-top testing (e.g., minimum bond strength, maximum friction force, particulate counts, dimensional measurements).
- Biological response criteria: For biocompatibility testing, based on ISO standards (e.g., cytotoxicity grade, irritation difference, systemic toxicity signs, pyrogenicity temperature rise, hemolytic index, statistical similarity to predicate for clotting times and complement activation).
- Physiological/anatomical models: For simulated use in bench testing and animal models for previous evaluations of the predicate device.
8. The sample size for the training set
Not applicable. This is a medical device approval based on non-clinical performance data and substantial equivalence to a predicate, not an AI/ML model trained on a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model in this submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 27, 2020
Penumbra, Inc. Micaela Victoria Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K191946
Trade/Device Name: Penumbra System® JET™ 7 Reperfusion Catheter with MAX Delivery Device (JETTM 7MAX)] Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: January 27, 2020 Received: January 28, 2020
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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., M.S. 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) K191946
Device Name
Penumbra System® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)]
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/1 description: The image shows the word "Penumbra" in a red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern. The registered trademark symbol is visible in the bottom right corner of the circle.
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® Penumbra JET™ 7MAX (Penumbra JETTM 7 Reperfusion Catheter with MAX Delivery Device)
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
January 24, 2020
1.4 Device Trade or Proprietary Name
Penumbra System® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)]
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 | ||
| K190010 cleared on June 16, 2019 | Penumbra System® -Penumbra JETTM 7 ReperfusionCatheter | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
| Reference Device |
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| K173761 cleared on August 8, 2018(Animal Testing only) | Penumbra System® –Penumbra JETT™ 7 ReperfusionCatheter | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
|---|---|---|
| K083125 cleared on November 21,2008 (Biocompatibility Testingonly) | Neuron Intracranial AccessSystem – Neuron Select Catheter070 | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
1.7 Predicate Comparison
| System Name | Penumbra System® | |
|---|---|---|
| Device Name | Penumbra JET 7(Predicate) | Penumbra JET 7MAX(Subject) |
| 510(k) No. | K190010 (applicable for Penumbra JET 7 withAccess Assist Tool)K173761 (applicable for Animal Testing -Reference Device) | K191946 |
| Classification | Class II, NRY | SAME |
| System Name | Penumbra System® | |
| Device Name | Penumbra JET 7(Predicate) | Penumbra JET 7MAX(Subject) |
| 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 tissue | SAME |
| Reperfusion Catheter | Penumbra JET™ 7 | SAME |
| Accessories | ||
| Peelable Sheath | PTFE | SAME |
| Rotating Hemostasis Valve | Polycarbonate, silicone o-ring | SAME |
| System Name | Penumbra System® | |
| Device Name | Penumbra JET 7(Predicate) | Penumbra JET 7MAX(Subject) |
| Shaping Mandrel | Stainless Steel | SAME |
| Access Assist Tool | N/A – not included | Materials:Nylon 12, Copolyester, Polyolefin,Polyurethane, Polyether BlockAmide, PTFE, Platinum/Tungsten,Hydrophilic CoatingDimensions:ID: 0.018inOD: 0.071inExtension Length: 1.5cm |
| Packaging Materials | ||
| Pouch | Polyester/Polyethylene/Tyvek | SAME |
| Packaging Tray(Kit Configuration) | Polyethylene terephthalate, Polystyrene | SAME |
| Display Carton | SBS Paperboard | SAME |
| Kit PackagingConfiguration | Tray/Retainer/Lid/Aspiration Tubing/AccessoryPouch/Pouch/Box | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |
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Device Description 1.8
The Penumbra JET 7 with MAX Delivery Device, known as Penumbra JET 7MAX, is an additional configuration being added to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the Penumbra JET 7 Reperfusion Catheter and is removed prior to aspiration. The Reperfusion Catheter Penumbra JET 7 delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.
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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.
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 JET 7 with MAX Delivery Device as well as its substantial equivalence to the predicate and reference devices:
- Biocompatibility ●
- Design Verification (Bench-Top Testing) ●
- Design Validation (GLP Animal Testing) ●
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The subject Penumbra JET 7 with MAX Delivery Device met all established requirements.
1.10.1 Biocompatibility Testing
Biocompatibility was conducted on the subject Penumbra JET 7 with MAX Delivery Device. The studies were selected in accordance with 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). Reperfusion Catheter testing was previously performed on the predicate Penumbra JET 7 [K190010]; therefore, the scope of the testing (in the table below) was only performed on the MAX Delivery Device.
| Tests | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| Cytotoxicity:MEM Elution(10993-5) | Sample extracts must have acytotoxic reactivity score of grade2 or lower | Grade = 0 (Reactivity None) | PassNon-cytotoxic |
| Sensitization:Magnusson-Kligman Method(10993-10) | Test Group shall yield Grade < 1score on Magnusson and Kligmanscale (provided Control Groupyields Grade < 1) | NaCl ExtractGrade = 0CSO ExtractGrade = 0 | PassNon-sensitizing |
| Irritation:IntracutaneousReactivity(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 of systemictoxicity from sample extracts(both NaCl and CSO extracts).That is:No deaths• No signs consistent withtoxicityNo weight loss > 10% | PassNon-toxic |
| Systemic Toxicity:Material MediatedPyrogen(10993-11, USP) | Sample extracts must not cause atotal rise in body temperature of≥ 0.5 °C | Non-pyrogenic: no singleanimal had an individual risein body temperature ≥ 0.5 °C | PassNon-pyrogenic |
| Hemocompatibility:Prothrombin Time(PT) | Clotting times of test article mustbe similar to predicate values usinganalysis of variance. | Test article coagulation timesare statistically similar topredicate | PassHemocompatible |
| Biocompatibility Test Results | |||
|---|---|---|---|
| ------------------------------- | -- | -- | -- |
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| Tests | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| (10993-4) | |||
| Hemocompatibility:PartialThromboplastinTime (PTT)(10993-4) | Clotting times of test article mustbe similar to predicate values usinganalysis of variance | Test article coagulation timesare statistically similar topredicate | PassHemocompatible |
| Hemocompatibility:ComplementActivation(10993-4) | The concentration of SC5b-9 oftest article must be similar topredicate values using analysis ofvariance | SC5b-9Test article concentrations arestatistically similar to predicateat all exposure time points:• 30min• 60min• 90min | PassHemocompatible |
| Hemocompatibility:Hemolysis (indirectcontact)(10993-4) | Sample extracts must be non-hemolytic (≤ 2% hemolyticindex) | Hemolytic Index = 0.22% | PassNon-hemolytic |
| Hemocompatibility:Hemolysis (directcontact)(10993-4) | Sample must be non-hemolytic (≤ 2% hemolyticindex) | Hemolytic Index = 0.00% | PassNon-hemolytic |
| Hemocompatibility:In vitroThrombogenicity(10993-4) | Device must be non-thrombogenicin vitro when compared topredicate device | Test article performed equal orbetter than predicate in threeseparate in vitro assays | PassNon-thrombogenic |
In summary, non-clinical testing substantiates that the Penumbra System Penumbra JET 7 with MAX Delivery 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 subject Penumbra JET 7 with MAX Delivery Device was assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
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| Attribute | Specification | Results |
|---|---|---|
| Dimensional/Visual Inspection | These evaluations confirm that the units used in this DesignVerification testing meet all product specifications. | Pass |
| Simulated Use[IntracranialAccess & VesselAccess EntryPerformance.Delivery/RetrievalForces] | Simulated use testing of the Access Assist Tool with Penumbra JET7 Reperfusion Catheter and relevant accessory devices in ananatomical model which simulated the tortuosity of theneurovasculature. Devices were delivered through the tortuousanatomical model to evaluate the effectiveness of the device toassist in the delivery of the Reperfusion Catheter to the target site. | Pass |
| ReperfusionCatheter / AccessAssist Toolcompatibility(Friction Force) | Maximum value per specification | Pass |
| Access AssistTool / 0.016"Guidewirecompatibility(Friction Force) | Maximum value per specification | Pass |
| MarkercoilVisibility | The markercoil is fluoroscopically visible | Pass |
| Torsion | Number of turns will be recorded for informational purposes only[FIPO]. | FIPO |
| Corrosion | No visible corrosion immediately after Corrosion Testing procedure | Pass |
| ParticulateTesting | ≥ 10 um will be ≤ 6000 particles | Pass |
| ≥ 25 um will be ≤ 600 particles | Pass | |
| ≥ 75 um particles will be recorded for informational purposes only[FIPO] | FIPO | |
| ≥ 125 um particles will be recorded for informational purposes only[FIPO] | FIPO | |
| Coating Integrity(Pre-Inspection) | Coating has not delaminated, peeled, or flaked prior to simulateduse particulate testing | Pass |
| Coating Integrity(Post-Inspection) | Coating has not delaminated, peeled, or flaked after simulated useparticulate testing | Pass |
| Attribute | Specification | Results |
| Hub/AirAspiration | When negative pressure is pulled, no air may leak into hub | Pass |
| Bond StrengthDistal Joint 1 | Minimum value per specification | Pass |
| Bond StrengthDistal Joint 2 | Minimum value per specification | Pass |
| Bond StrengthMidjoint 1 | Minimum value per specification | Pass |
| Bond StrengthMidjoint 2 | Minimum value per specification | Pass |
| Proximal Joint | Minimum value per specification | Pass |
| Hub to ShaftBond Strength | Minimum value per specification | Pass |
| Elongation toFailure - AccessAssist Tool | Meets value per specification | Pass |
| Pressure Test | Minimum value per specification | Pass |
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1.10.3 Design Validation - Animal Study
The safety and efficacy of the reference device, Penumbra JET 7 Reperfusion Catheter (Penumbra JET 7) was evaluated in the accepted porcine model [K173761]. The purpose of this study was to evaluate the aspiration vascular response of the reference device Penumbra JET 7. The subject Penumbra JET 7 with MAX Delivery Device consists of a Penumbra JET 7 Reperfusion Catheter and optional catheter accessory, which is removed from the Reperfusion Catheter prior to aspiration. The subject, Penumbra JET 7 with MAX Delivery Device, Reperfusion Catheter dimensions are identical to that of the reference device Penumbra JET 7. As a result, no additional animal testing was required.
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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 for devices with similar dimensions used for direct aspiration. The literature review was used to support the determination of substantial equivalence by using clinical outcomes from devices that are considered technologically equivalent.
1.12 Summary of Substantial Equivalence
The Penumbra JET 7 with MAX Delivery Device 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).