Penumbra System 3D Revascularization Device
Device Facts
| Record ID | K190464 |
|---|---|
| Device Name | Penumbra System 3D Revascularization Device |
| Applicant | Penumbra, Inc. |
| Product Code | NRY · Cardiovascular |
| Decision Date | Apr 26, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Penumbra System 3D Revascularization Device assists reperfusion catheters in removing thrombus during acute ischemic stroke treatment. Device consists of delivery wire with nitinol 3D lattice; used in conjunction with reperfusion catheter, aspiration tubing, and vacuum pump. Operated by trained interventional neuro-endovascular physicians in clinical settings. Mechanism involves aspiration to draw clot into catheter; 3D device aids in clot engagement/removal. Output is physical removal of intracranial occlusion. Benefits include restored blood flow in stroke patients. Device provided sterile, single-use.
Clinical Evidence
No clinical study conducted. Substantial equivalence supported by bench-top design verification (simulated use, radial pressure, torsion, kink resistance, tensile strength) and literature review of clinical outcomes for technologically equivalent devices.
Technological Characteristics
Materials: Nitinol (3D lattice), stainless steel (core wire, outer coil), platinum alloy (radiopaque markers, distal inner coil), PTFE coating, silver solder. Sterilization: Ethylene Oxide (EO). Shelf-life: 36 months. Form factor: 26 mm total length, 4.5 mm nominal OD. Connectivity: N/A (mechanical system).
Indications for Use
Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral segments) within 8 hours of symptom onset. Candidates include patients ineligible for or failing IV t-PA therapy.
Regulatory Classification
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.
Predicate Devices
- Penumbra 3D Revascularization Device (K162901)
Submission Summary (Full Text)
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April 30, 2019
Penumbra, Inc. Michaela Mahl Senior Manager of Regulatory Affairs One Penumbra Place Alameda, California 94502
Re: K190464
Trade/Device Name: Penumbra System (3D Revascularization Device) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: February 25, 2019 Received: February 26, 2019
Dear Michaela Mahl:
This letter corrects our substantially equivalent letter of April 26, 2019.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Xiaolin Zheng -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K190464
Device Name
Penumbra System (3D Revascularization Device)
### 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) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr><tr><td><span style="font-size:120%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:120%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| <span style="font-size:120%">☐</span> 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® 3D Revascularization Device.
#### 1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
#### 1.2 Sponsor Contact Information
Michaela Mahl Senior Manager, Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: mmahl@penumbrainc.com
#### 1.3 Date of Preparation of 510(k) Summary
February 22, 2019
#### 1.4 Device Trade or Proprietary Name
Penumbra System® (3D Revascularization Device)
#### 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 Retriever)
#### 1.6 Predicate and Reference Devices
| 510(k) Number/Clearance Date | Name of Device | Name of Manufacturer |
|-----------------------------------|-----------------------------------------|---------------------------------------------------------------|
| Predicate Device | | |
| K162901 cleared on April 20, 2017 | Penumbra 3D<br>Revascularization Device | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
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#### Predicate Comparison 1.7
| System Name | Penumbra System® | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | Predicate Device | Subject Device |
| Device Name | Penumbra 3D Revascularization Device | Penumbra 3D<br>Revascularization<br>Device (Modified) |
| 510(k) No. | K162901 | K190464 |
| Classification | Class II, NRY | SAME |
| Indication for Use | Penumbra Reperfusion Catheters and Separators<br>As part of the Penumbra System, the Reperfusion Catheters and Separators are<br>indicated for use in the revascularization of patients with acute ischemic stroke<br>secondary to intracranial large vessel occlusive disease (within the internal<br>carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset. Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are<br>candidates for treatment.<br>Penumbra 3D Revascularization Device<br>As part of the Penumbra System, the Penumbra 3D Revascularization Device<br>is indicated for use in the revascularization of patients with acute ischemic<br>stroke secondary to intracranial large vessel occlusive disease (within the<br>internal carotid, middle cerebral – M1 and M2 segments) within 8 hours of<br>symptom onset. Patients who are ineligible for intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.<br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is<br>indicated to connect the Penumbra Reperfusion Catheters to the Penumbra<br>Aspiration Pump.<br>Penumbra Aspiration Pump<br>The Penumbra Aspiration Pump is indicated as a vacuum source for<br>Penumbra Aspiration Systems. | SAME |
| | Reperfusion Catheter and Separators | SAME |
| System Components | 3D Revascularization Device | SAME |
| | Aspiration Tubing | SAME |
| | Aspiration Pump & Pump Canister | SAME |
| Materials | Penumbra 3D Revascularization Device | Penumbra 3D<br>Revascularization<br>Device (Modified) |
| Delivery-Wire | | |
| Core wire | Stainless Steel | SAME |
| Coating | PTFE Green PC 8-403G | SAME |
| Outer coil | Stainless Steel | SAME |
| Proximal Solder | Silver Solder | SAME |
| System Name | Penumbra System® | |
| Distal Inner Coil | N/A | Platinum Alloy |
| Distal Solder | Silver Solder | SAME |
| Distal Tip | | |
| Outer coil | Stainless Steel | SAME |
| Radiopaque Markers | Platinum Alloy | SAME |
| Attachment Tip | Stainless Steel | SAME |
| Solder joint | Gold Solder / Silver Solder | Silver Solder |
| 3D Nitinol Device | | |
| 3D lattice | Nitinol | SAME |
| Introducer sheath | FEP | SAME |
| Dimensions | | |
| - Device Nominal<br>Total Length | 26 mm | SAME |
| - Device Nominal OD | 4.5 mm | SAME |
| - Device Nominal<br>Usable Length | 20 mm | SAME |
| - Delivery Wire Distal<br>OD | 0.014" | SAME |
| - Delivery Wire<br>Length | 200 cm | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | SAME |
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#### Device Description 1.8
The Penumbra System 3D Revascularization Device is designed to revascularize patients experiencing acute ischemic stroke as a component of the Penumbra System. The Penumbra System's fundamental mechanism of action is aspiration removes clot by drawing it into the Penumbra Reperfusion Catheter. The 3D Revascularization Device is designed to assist the Reperfusion Catheter with thrombus removal if needed. Intended users for this device are physicians who have received appropriate training in interventional neuro-endovascular techniques and treatment of acute ischemic stroke. The device is provided sterile, non-pyrogenic, and intended for single use only.
#### 1.9 Indications for Use
# Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and
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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 descriptions of the testing, which substantiates the safe and effective performance of the subject Penumbra System 3D Revascularization Device as well as its substantial equivalence to the predicate device:
- Biocompatibility
- Design Verification (Bench-Top Testing) ●
- Design Validation (Animal Study) ●
- . Performance Data
The subject, Penumbra System 3D Revascularization Device met all established requirements.
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## 1.10.1 Previously Completed Biocompatibility Testing
The materials used in the subject Penumbra System 3D Revascularization Device [modified] are identical to those in the predicate device, Penumbra System 3D Revascularization Device [K162901]. The subject Penumbra System 3D Revascularization Device [modified] uses identical materials, equivalent processing, and identical sterilization methods as products that Penumbra has already successfully conducted biocompatibility testing per BS EN ISO 10993. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), external communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).
The classification for the predicate, Penumbra System 3D Revascularization Device [K162901] and subject device, Penumbra System 3D Revascularization Device [modified] are identical. All biocompatibility risks have been mitigated through successful completion of prior biocompatibility testing per ISO 10993-1:2009/AC: 2010 which will be used to support the biocompatibility for the subject Penumbra System 3D Revascularization Device [modified]. Therefore, no further biocompatibility testing was conducted on the subject device.
### 1.10.2 Design Verification - Bench-top Testing
The physical and mechanical properties of the 3D Revascularization Device was assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Result |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Pouch Seal Strength | Minimum value per specification | Pass |
| Dimensional / Visual<br>Inspection | These evaluations confirm that the units used in this Design Verification<br>testing meet all product specifications. | Pass |
| Simulated Use<br>[Intracranial Access,<br>Vessel Access Entry<br>Performance & Clot<br>Removal] | Simulated use testing of the Reperfusion Catheter and 3D Revascularization<br>Device was performed with accessory devices in an anatomical model<br>which simulated the tortuosity of the neurovasculature. Devices were<br>delivered through the tortuous anatomical model to evaluate the<br>effectiveness of the devices to remove clots. | Pass |
| Physician Evaluation<br>[Deliverability & Clot<br>Removal] | Multiple Physician performance evaluation of the subject Penumbra System<br>3D Revascularization Device in a simulated neurovascular tortuosity model<br>with the Penumbra System 3D Revascularization Device used as a baseline. | Pass |
| Particulate Testing | The maximum number of particles: | Pass |
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| Attribute | Specification | Result |
|--------------------------------------|-------------------------------------------------------------------------|--------|
| | $\ge$ 10 μm will be $\le$ 6000 particles | |
| | $\ge$ 25 μm will be $\le$ 600 particles | Pass |
| | $\ge$ 75 μm will be measured for informational purposes only<br>(FIFO) | FIFO |
| | $\ge$ 125 μm will be measured for informational purposes only<br>(FIFO) | FIFO |
| Radial Pressure | Value within the specification range | Pass |
| Torsion | Minimum value per specification | Pass |
| Kink Resistance | No kinking when formed in a defined radius | |
| Device Af | Maximum value per specification | Pass |
| Corrosion | Specimens will be free from signs of corrosion | |
| Tensile Strength -<br>Markerband | Minimum value per specification | Pass |
| Tensile Strength -Wire<br>Attachment | Minimum value per specification | Pass |
### 1.10.3 Design Validation - Previously Completed Animal Study
The subject, 3D Revascularization Device [modified] uses the same materials, has the same indication for use, and has the same intended use as the predicate, 3D Revascularization Device. In addition, the subject, 3D Revascularization Device [modified] will be held to the same maximum radial pressure specification as the predicate, 3D Revascularization Device [K162901]. Therefore, the subject, 3D Revascularization Device [modified] presents an equivalent challenge for vessel response compared to the predicate device. Rabbit vessel response studies have been performed for the predicate, 3D Revascularization Device [K162901] with successful results. Based on the existing GLP test results, the interaction of the predicate, 3D Revascularization Device [K162901] with the rabbit vasculature is well understood. Therefore, the existing rabbit vessel response animal study results mitigate all vessel response risks for the subject, 3D Revascularization Device [modified].
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### 1.10.4 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 device and other devices with similar dimensions used for clot removal. The literature review was used to support the determination of substantial equivalence by using clinical outcomes from devices that are considered technologically equivalent.
### 1.11 Summary of Substantial Equivalence
The subject, Penumbra System 3D Revascularization Device is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
