Penumbra System Reperfusion Catheter JET 7

K173761 · Penumbra, Inc. · NRY · Aug 17, 2018 · Cardiovascular

Device Facts

• Record ID: K173761
• Device Name: Penumbra System Reperfusion Catheter JET 7
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Aug 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are 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 Reperfusion Catheter JET 7 is a neurovascular catheter designed for thrombus removal; provides larger lumen than predicate ACE 68. Used in clinical settings by physicians; delivered through neurovasculature to occlusion site; connected to Penumbra Aspiration Pump via sterile tubing. Device applies vacuum to aspirate thrombus; restores blood flow in acute ischemic stroke patients. Benefits include efficient clot removal; reduced procedure time. Performance verified via bench-top testing in anatomical models and porcine vascular models comparing vascular response to predicate.

Clinical Evidence

No clinical study conducted. Substantial equivalence supported by bench testing (dimensional, simulated use, kink resistance, particulate, bond strength) and GLP animal testing (porcine model comparing vascular response to predicate). Literature review of clinical outcomes for technologically equivalent devices provided additional support.

Technological Characteristics

Externally communicating, blood-contacting catheter (<24h). Materials: Grilamid (hub), 304 SS (strain relief), PTFE (liner), Polyurethane/PEBA/Nylon12 (shaft), NiTi/SS wire (reinforcement), Pt/Ir (markerband). Hydrophilic coating. Dimensions: 0.085 in max OD, 0.072 in min ID. EO sterilized. Single-use. Standalone device used with vacuum pump.

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, basilar, and vertebral arteries) 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 System – ACE 68 Reperfusion Catheter (K161640)
• Penumbra System – 3D Revascularization Device (K162901)

Reference Devices

• Boston Scientific Excelsior SL-10 microcatheter

Submission Summary (Full Text)

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August 17, 2018

Penumbra, Inc. Michaela Mahl, MSBE Senior Manager Regulatory Affairs One Penumbra Place Alameda, California 94502

Re: K173761

Trade/Device Name: Penumbra System (Reperfusion Catheter JET 7) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 17, 2018 Received: July 18, 2018

Dear Michaela Mahl:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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 [phone] 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) K173761

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 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*)

| <div> <b> <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </b> </div> |
|-----------------------------------------------------------------------------------------------------------|
| <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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Image /page/3/Picture/1 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The logo features the word "Penumbra" in a red sans-serif font. To the right of the name is a red circular graphic with a white "P" inside, which is the company's symbol.

#### 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

Michaela Mahl Senior Manager, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

#### 1.3 Date of Preparation of 510(k) Summary

July 17, 2018

#### 1.4 Device Trade or Proprietary Name

Penumbra System® (Reperfusion Catheter JET 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 | | |
| K161640 cleared on July 12, 2016 | Penumbra System – ACE 68<br>Reperfusion Catheter | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
| Additional Predicate Device | | |
| K162901 (applicable for indication<br>only) cleared on April 20, 2017 | Penumbra System – 3D<br>Revascularization Device | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |

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Image /page/4/Picture/0 description: The image shows the word "Penumbra" in a red font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line through the middle. The logo is simple and clean, with the company name clearly displayed next to its icon.

#### Predicate Comparison 1.7

| System Name | Penumbra System® | | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------------|
| Device Name | ACETM 68 | JET 7 | |
| 510(k) No. | K161640 (applicable for ACE 68)<br>K162901 (applicable for indication only) | K173761 | |
| Classification | Class II, NRY | SAME | |
| Indication | Penumbra Reperfusion Catheters and Separators<br>As part of the Penumbra System, the<br>Reperfusion Catheters and Separators are<br>indicated for use in the revascularization of<br>patients with acute ischemic stroke secondary to<br>intracranial large vessel occlusive disease<br>(within the internal carotid, middle cerebral –<br>M1 and M2 segments, basilar, and vertebral<br>arteries) within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or who fail IV<br>t-PA therapy are candidates for treatment.<br><br>Penumbra 3D Revascularization Device<br>As part of the Penumbra System, the Penumbra<br>3D Revascularization Device is indicated for use<br>in the revascularization of patients with acute<br>ischemic stroke secondary to intracranial large<br>vessel occlusive disease (within the internal<br>carotid, middle cerebral – M1 and M2 segments)<br>within 8 hours of symptom onset. Patients who<br>are ineligible for intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-PA therapy<br>are candidates for treatment.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the Penumbra<br>Sterile Aspiration Tubing is indicated to connect<br>the Penumbra Reperfusion Catheters to the<br>Penumbra Aspiration Pump.<br><br>Penumbra Aspiration Pump<br>The Penumbra Aspiration Pump is indicated as a<br>vacuum source for Penumbra Aspiration<br>Systems. | SAME | |
| System Name | Penumbra System® | | JET 7 |
| Device Name | ACETM 68 | | |
| 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 yellow [black foil] | | Polyolefin, PET black [white foil] |
| Liner | PTFE | | SAME |
| Catheter Shaft | | | |
| Extrusions | Polyurethane, Polyether Block Amide, Nylon12 | | SAME |
| Distal Coil Reinforcement | NiTi wire | | SAME |
| Proximal Coil<br>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) | | SAME |
| Dimensions | | | |
| Proximal OD | 0.084 in Max | | 0.085 in Max |
| Proximal ID | 0.068 in Min | | 0.072 in Min |
| Distal OD | 0.084 in Max | | 0.085 in Max |
| Distal ID | 0.068 in Min | | 0.072 in Min |
| 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 | | | |
| Pouch | Polyester/Polyethylene/Tyvek | | SAME |
| Packaging Hoop | Polyethylene | | SAME |
| Packaging Tray<br>(Kit Configuration) | Polyethylene terephthalate, Polystyrene | | SAME |
| Packaging Card | Polyethylene | | SAME |
| Display Carton | SBS Paperboard | | SAME |
| | Hoop: Hoop/Packaging Card/Pouch/Box | | SAME |
| Packaging Configuration | Kit: Tray/Retainer/Lid/Aspiration<br>Tubing/Accessory Pouch/Pouch/Box | | SAME |
| Sterilization | EO | | SAME |
| Shelf-Life | 36 Months | | 6 Months |
| System Name | Penumbra System® | | |
| Device Name | ACE™ 68…