(164 days)
No
The 510(k) summary describes a mechanical aspiration system for stroke treatment and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes
The device is used for the revascularization of patients with acute ischemic stroke, aiming to treat a disease state.
No
The device is indicated for revascularization and thrombus removal in acute ischemic stroke, which are treatment procedures, not diagnostic functions.
No
The device description clearly outlines hardware components (catheters, separators, tubing, pump) used for mechanical thrombectomy. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for revascularization in patients with acute ischemic stroke. This is a therapeutic intervention performed directly on the patient's body to remove a blockage.
- Device Description: The device description details a catheter and system designed to deliver aspiration to remove thrombus from the neurovasculature. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to treat a condition, not to diagnose it.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
- Biocompatibility (Biocompatibility Testing): Studies selected in accordance with EN ISO 10993-1 guidelines for a limited exposure (
§ 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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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
1
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
2
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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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 7 | |
| Reperfusion Catheter | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| Reference Device | ||
| K161640 cleared on July 12, 2016 | ||
| (applicable to packaging validation | ||
| only) | Penumbra System – ACE 68 | |
| Reperfusion Catheter | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, 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 validation | |||
| only - Reference Device) | K190010 | ||
| Classification | Class II, NRY | SAME | |
| Indication | Penumbra Reperfusion Catheters and Separators | ||
| As part of the Penumbra System, the | |||
| Reperfusion Catheters and Separators are | |||
| indicated for use in the revascularization of | |||
| patients with acute ischemic stroke secondary to | |||
| intracranial large vessel occlusive disease | |||
| (within the internal carotid, middle cerebral - | |||
| M1 and M2 segments, basilar, and vertebral | |||
| arteries) within 8 hours of symptom onset. | |||
| Patients who are ineligible for intravenous tissue | |||
| plasminogen activator (IV t-PA) or who fail IV | |||
| t-PA therapy are candidates for treatment. | |||
| Penumbra 3D Revascularization Device | |||
| As part of the Penumbra System, the Penumbra | |||
| 3D Revascularization Device is indicated for use | |||
| in the revascularization of patients with acute | |||
| ischemic stroke secondary to intracranial large | |||
| vessel occlusive disease (within the internal | |||
| carotid, middle cerebral - M1 and M2 segments) | |||
| within 8 hours of symptom onset. Patients who | |||
| are ineligible for intravenous tissue plasminogen | |||
| activator (IV t-PA) or who fail IV t-PA therapy | |||
| are candidates for treatment. | |||
| Penumbra Aspiration Tubing | |||
| As part of the Penumbra System, the Penumbra | |||
| Sterile Aspiration Tubing is indicated to connect | |||
| the Penumbra Reperfusion Catheters to the | |||
| Penumbra Aspiration Pump. | |||
| Penumbra Aspiration Pump | |||
| The Penumbra Aspiration Pump is indicated as a | |||
| vacuum source for Penumbra Aspiration | |||
| Systems. | SAME | ||
| System Name | Penumbra System® | ||
| 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 Coil | |||
| Reinforcement | SS wire and NiTi wire | SAME | |
| Extrusion Colorants | Clear/ Natural or Purple | SAME | |
| Tip Shape | Straight | SAME | |
| Markerband | Platinum/Iridium (90% Pt, 10% Ir) | SAME | |
| Coating | Hydrophilic (proprietary) | 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/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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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 ( 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 | Pass
Hemocompatible |
| | | predicate at all
exposure 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% | Pass
Non-hemolytic |
| Hemocompatibility: Hemolysis,
direct contact
(10993-4) | Sample must be non-hemolytic
(≤ 2% hemolytic index) | Hemolytic Index =
0.00% | Pass
Non-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/ | ||
| 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/Retrie | ||
| val | ||
| Forces & Clot | ||
| Removal] | 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 | ||
| [Deliverability | ||
| & Clot | ||
| Removal] | Multiple Physician performance evaluation of the Penumbra | |
| System Reperfusion Catheter JET 7 in a simulated neurovascular | ||
| tortuosity model with the predicate Penumbra System | ||
| Reperfusion Catheter JET 7 and ACE 68 used as a baseline. | Pass | |
| Attribute | Specification | Results |
| 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 | Pass |
| ≥ 25 µm will be ≤ 600 particles | Pass | |
| ≥ 75 µm particles will be recorded for informational purposes | ||
| only | FIPO | |
| ≥ 125 µm particles will be recorded for informational purposes | ||
| only | FIPO | |
| 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 |
| Attribute | Specification | Results |
| Bond Strength | ||
| Midjoint | Minimum value per specification | Pass |
| Proximal Joints: | Minimum value per specification | Pass |
| Hub to Shaft | ||
| Bond Strength | Minimum value per specification | Pass |
| Hub to | ||
| Hypotube Bond | ||
| Strength | Minimum value per specification | Pass |
| Elongation to | ||
| Failure - | ||
| Reperfusion | ||
| Catheter | 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.