Penumbra 3D Revascularization Device

K162901 · Penumbra, Inc. · NRY · Apr 20, 2017 · Cardiovascular

Device Facts

• Record ID: K162901
• Device Name: Penumbra 3D Revascularization Device
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Apr 20, 2017
• 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-Ml 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 3D Revascularization Device is an accessory to the Penumbra System; assists reperfusion catheters in thrombus removal via aspiration. Device delivered to intracranial target site via catheter; used by physicians in clinical settings. Principle of operation involves mechanical assistance to aspiration to draw clot into catheter. Output is successful revascularization (mTICI 2-3). Benefits include improved recanalization in acute ischemic stroke patients.

Clinical Evidence

Prospective, randomized, multi-center, non-inferiority trial (Penumbra 3D Trial) comparing 3D/Penumbra System (n=74) to Penumbra System alone (n=76). Primary effectiveness endpoint (mTICI 2-3) was 86.5% vs 85.5% (difference 1.0%, 90% CI: -8.4%, 10.3%). Primary safety endpoint (procedure-related SAEs at 24h) was 10.2% vs 15.1%. Secondary endpoint (mRS 0-2 at 90 days) was 38.0% vs 37.0% (p=1.0).

Technological Characteristics

Catheter-based thrombus removal device. Materials: 304 Stainless Steel, Nitinol, Platinum/Tungsten alloy, Gold/Silver solder, PTFE coating, FEP introducer sheath. Sterilization: Ethylene Oxide (EO). Single-use, sterile, non-pyrogenic. Dimensions: 4.5 mm OD, 20 mm length. No active electronic components; mechanical aspiration system.

Indications for Use

Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, 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 and Penumbra Pump MAX (K160449)

Reference Devices

• Solitaire™ Platinum Revascularization Device (K153071)
• Penumbra System ACE 68 Reperfusion Catheter (K161640)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2017

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

Re: K162901

Trade/Device Name: Penumbra 3D Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 20, 2017 Received: March 21, 2017

Dear Ms. 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Carlos L. Pena-S

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) K162901

Device Name Penumbra 3D Revascularization Device

### 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-Ml 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) | <div> <span style="font-size: 20px;">☑</span> </div> |
|----------------------------------------------|------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span>☐</span> </div> |

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### 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.

#### Sponsor/Applicant Name and Address 1

Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA

#### ನ Sponsor Contact Information

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

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

April 19, 2017

#### 4 Device Trade or Proprietary Name

Penumbra 3D Revascularization Device

#### Device Classification 5

| Regulatory Class: | II Classification Panel: |
|----------------------|----------------------------------|
| | Neurology |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR §870.1250 |
| Product Code: | NRY (Catheter, Thrombus Removal) |

#### Predicate and Reference Devices 6

| 510(k) Number/<br>Clearance Date | Name of Predicate Device | Name of Manufacturer |
|----------------------------------|-------------------------------------------------|-----------------------------------------------------|
| Predicate Device | | |
| K160449 [25May2016] | Penumbra System and Penumbra Pump MAX | Penumbra, Inc. |
| Reference Devices | | |
| K153071 [23Dec2015] | Solitaire™ Platinum Revascularization<br>Device | Micro Therapeutics, Inc. d/b/a<br>ev3 Neurovascular |
| K161640 [12Jul2016] | Penumbra System ACE 68 Reperfusion<br>Catheter | Penumbra, Inc. |

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#### 7 Predicate Comparison

| | Predicate Device | Primary Reference Device | Subject Device |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate 510(k) | Penumbra System : K160449 | Solitaire™ Platinum<br>Revascularization Device:<br>K153071 | Penumbra 3D Revascularization Device:<br>K162901 |
| Classification | Class II, NRY | Same | Same |
| Indication for Use | Penumbra Reperfusion Catheters and<br>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<br>secondary to intracranial large vessel<br>occlusive disease (within the internal carotid,<br>middle cerebral – M1 and M2 segments,<br>basilar, and vertebral arteries) within 8 hours<br>of symptom onset.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the<br>Penumbra Sterile Aspiration Tubing is<br>indicated to connect the Penumbra<br>Reperfusion Catheters to the Penumbra<br>Pump MAX.<br><br>Penumbra Pump MAX<br>The Penumbra Pump MAX is indicated as a<br>vacuum source for Penumbra Aspiration<br>Systems. | The Solitaire™ Platinum<br>Revascularization Device is<br>intended to restore blood flow by<br>removing thrombus from a large<br>intracranial vessel in patients<br>experiencing ischemic<br>stroke within 8 hours of symptom<br>onset. Patients who are ineligible<br>for intravenous tissue<br>plasminogen activator (IV t-PA)<br>or who fail IV t-PA therapy are<br>candidates for treatment. | Penumbra Reperfusion Catheters and<br>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<br>secondary to intracranial large vessel<br>occlusive disease (within the internal<br>carotid, middle cerebral - M1 and M2<br>segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset. Patients<br>who are ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or who fail<br>IV t-PA therapy are candidates for<br>treatment.<br><br>Penumbra 3D Revascularization Device As<br>part of the Penumbra System, the<br>Penumbra 3D Revascularization Device is<br>indicated for use in the revascularization of<br>patients with acute ischemic stroke<br>secondary to intracranial large vessel<br>occlusive disease (within the internal<br>carotid, middle cerebral – M1 and M2<br>segments) within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or<br>who fail IV t-PA therapy are candidates for treatment. |
| | Predicate Device | Primary Reference Device | Subject Device |
| Predicate 510(k) | Penumbra System : K160449 | Solitaire™ Platinum<br>Revascularization Device:<br>K153071 | Penumbra 3D Revascularization Device:<br>K162901 |
| | | | treatment.<br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the<br>Penumbra Sterile Aspiration Tubing is<br>indicated to connect the Penumbra<br>Reperfusion Catheters to the Penumbra<br>Aspiration Pump.<br>Penumbra Aspiration Pump<br>The Penumbra Aspiration Pump is indicated<br>as a vacuum source for Penumbra<br>Aspiration Systems. |
| System | Aspiration Pump | N/A | SAME as Predicate |
| Components | Aspiration Tubing | N/A | SAME as Predicate |
| | Reperfusion Catheter | Micro Catheter | SAME as Predicate |
| Materials | Separators | Solitaire™ Platinum | 3D Revascularization Device |
| Push-wire | N/A | N/A | N/A |
| Core wire | 304 Stainless Steel<br>or | N/A | SAME as Predicate |
| | Nitinol | SAME | N/A |
| Outer coil | 304 Stainless Steel | N/A | SAME as Predicate |
| Solder joint | Silver Solder (95% Sn / 5% Ag)<br>Gold Solder (80% Au / 20% Sn) | N/A | SAME as Predicate |
| Coating | PTFE Green (PC 8-403G) | N/A | SAME as Predicate |
| Shrink tubing | N/A | PTFE | N/A |
| | Predicate Device | Primary Reference Device | Subject Device |
| Predicate 510(k) | Penumbra System : K160449 | Solitaire™ Platinum<br>Revascularization Device:<br>K153071 | Penumbra 3D Revascularization Device:<br>K162901 |
| Distal Tip | | | |
| Outer coil | 304 Stainless Steel | N/A | SAME as Predicate |
| Inner coil /<br>Marker coils | Platinum Alloy (92% Pt / 8% W) | 90% Platinum / 10% Iridium | SAME as Predicate |
| Attachment tip | N/A | Unknown | 304 Stainless Steel |
| Solder joint | Gold Solder (80% Au / 20% Sn)<br>Silver Solder (95% Sn / 5% Ag) | N/A | Gold Solder (80% Au / 20% Sn)<br>Silver Solder (96.5% Sn / 3.5% Ag) |
| Stent | N/A | Nitinol | Same as Primary Reference |
| Radiopaque<br>Markers | N/A | 4 - 5 | Same as Primary Reference |
| Separator tip | Pebax 40D: green (026) ,yellow (032), blue<br>(041), purple (054) | N/A | N/A |
| ID band | Polyolefin (PET) | N/A | N/A |
| Introducer sheath | Pebax / Nylon | PTFE/Grilamid | FEP…