(220 days)
No
The document describes a mechanical aspiration system for stroke treatment and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is used for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic intervention.
No
The device is indicated for treatment (revascularization of patients with acute ischemic stroke) and is described as assisting in the removal of thrombus, not for diagnosing conditions.
No
The device description clearly outlines physical components like catheters, separators, tubing, and a pump, which are hardware. The performance studies also focus on biocompatibility and bench-top testing of physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device's function as part of a system for the revascularization of patients with acute ischemic stroke. This involves physically removing thrombus from blood vessels.
- Device Description: The description details a system of catheters, separators, tubing, and a pump designed to deliver aspiration directly to the site of occlusion. This is a mechanical intervention.
- Lack of Diagnostic Function: An IVD is a medical device intended to be used in vitro for the examination of specimens, including blood and tissue, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures. This device does not perform any such diagnostic testing on specimens.
- Anatomical Site: The device is used directly within the intracranial vasculature, not for analyzing samples outside the body.
The device is a therapeutic medical device used for a physical intervention (thrombus removal) within the body, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries (intracranial large vessel occlusive disease)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
- Study Type: Biocompatibility studies in accordance with ISO 10993-1 guidelines for a limited exposure ( 10%) - Pass (Non-toxic)
- Material Mediated Pyrogen: Non-pyrogenic (no single animal had an individual rise in body temperature ≥ 0.5 °C) - Pass (Non-pyrogenic)
- Hemocompatibility (Prothrombin Time (PT)): Test article coagulation times are statistically similar to predicate - Pass (Hemocompatible)
- Hemocompatibility (Partial Thromboplastin Time (PTT)): Test article coagulation times are statistically similar to predicate - Pass (Hemocompatible)
- Hemocompatibility (Complement Activation): SC5b-9 Test article concentrations are statistically similar to predicate at all exposure time points (30min, 60min, 90min) - Pass (Hemocompatible)
- Hemocompatibility (Hemolysis (indirect contact)): Hemolytic Index = 0.22% - Pass (Non-hemolytic)
- Hemocompatibility (Hemolysis (direct contact)): Hemolytic Index = 0.00% - Pass (Non-hemolytic)
- Hemocompatibility (In vitro Thrombogenicity): Test article performed equal or better than predicate in three separate in vitro assays - Pass (Non-thrombogenic)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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
2
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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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 Reperfusion | ||
| Catheter | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| Reference Device |
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Image /page/4/Picture/1 description: The image shows the word "Penumbra" in a red font, followed by a red circle with a white "P" inside. The "P" is formed by a white line that extends from the left side of the circle to the right side, creating the shape of the letter. The logo is simple and modern, with a focus on the company name and a stylized initial.
| K173761 cleared on August 8, 2018
(Animal Testing only) | Penumbra System® –
Penumbra JETT™ 7 Reperfusion
Catheter | Penumbra, Inc.
One Penumbra Place
Alameda, CA 94502 USA |
|----------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|
| K083125 cleared on November 21,
2008 (Biocompatibility Testing
only) | Neuron Intracranial Access
System – Neuron Select Catheter
070 | Penumbra, Inc.
One Penumbra Place
Alameda, 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 with | |
| Access 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 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 | ||
| 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 Block | ||
| Amide, PTFE, Platinum/Tungsten, | ||
| Hydrophilic Coating | ||
| Dimensions: | ||
| ID: 0.018in | ||
| OD: 0.071in | ||
| Extension Length: 1.5cm | ||
| Packaging Materials | ||
| Pouch | Polyester/Polyethylene/Tyvek | SAME |
| Packaging Tray | ||
| (Kit Configuration) | Polyethylene terephthalate, Polystyrene | SAME |
| Display Carton | SBS Paperboard | SAME |
| Kit Packaging | ||
| Configuration | Tray/Retainer/Lid/Aspiration Tubing/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/6/Picture/1 description: The image shows the Penumbra logo. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern.
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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Image /page/7/Picture/1 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern.
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 ( 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:
Prothrombin Time
(PT) | 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 |
| Biocompatibility Test Results | |||
|---|---|---|---|
| ------------------------------- | -- | -- | -- |
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| Tests | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| (10993-4) | |||
| 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 vitro when compared to | |||
| predicate device | Test article performed equal or | ||
| better than predicate in three | |||
| separate in vitro assays | Pass | ||
| Non-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 Design | |
| Verification testing meet all product specifications. | Pass | |
| Simulated Use | ||
| [Intracranial | ||
| Access & Vessel | ||
| Access Entry | ||
| Performance. | ||
| Delivery/Retrieval | ||
| Forces] | Simulated use testing of the Access Assist Tool with Penumbra JET | |
| 7 Reperfusion Catheter and relevant 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 device to | ||
| assist in the delivery of the Reperfusion Catheter to the target site. | 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 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 simulated | |
| use particulate testing | Pass | |
| Coating Integrity | ||
| (Post-Inspection) | Coating has not delaminated, peeled, or flaked after simulated use | |
| particulate testing | Pass | |
| Attribute | Specification | Results |
| 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 |
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Image /page/11/Picture/1 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, with the wordmark and symbol working together to create a recognizable brand identity. The red color is bold and eye-catching, while the white "P" provides contrast and visual interest.
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.