PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX

K133317 · Penumbra, Inc. · NRY · May 13, 2014 · Cardiovascular

Device Facts

• Record ID: K133317
• Device Name: PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: May 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Device Story

Penumbra System/MAX components are thrombus removal catheters used for revascularization in acute ischemic stroke. Device utilizes aspiration (suction) to remove clots from intracranial vessels. Operated by physicians in clinical settings. System includes reperfusion catheters; for catheters with I.D. ≥ 0.054in, use of a separator is optional. Aspiration pressure is applied via an external pump. Bench testing confirms aspiration flow rates and clot removal efficacy with and without separators. Modifications in this submission clarify instructions for use, including PIVITOL trial data and separator usage guidelines. Benefits include effective clot removal to restore blood flow in stroke patients.

Clinical Evidence

Bench testing only. Testing included catheter tip pressure measurements, aspiration flow rate comparisons with/without separators, and simulated clot removal in glass models. Results demonstrated that aspiration pressure at the distal tip equals pump settings and that reperfusion catheters (054, 5MAX, 5MAX ACE) effectively remove clots without a separator.

Technological Characteristics

Thrombus removal catheter system. Components include reperfusion catheters and optional separators. Operates via vacuum-assisted aspiration. Materials and design are consistent with previously cleared Penumbra System components. No electronic or software components described.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset.

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 [026, 032, 041] (K072718)
• Penumbra System [054] (K090752)
• Penumbra System Separator Flex [026, 032, 041, 054] (K100769)
• Penumbra System® MAX (K113163)

Submission Summary (Full Text)

{0}------------------------------------------------

K133317

### 510(k) Summary of Safety & Effectiveness 1

(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 System® MAX components.

#### 1.1 Sponsor/Applicant Name and Address

Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA

### 1.2 Sponsor Contact Information

Seth Schulman Director, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

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

May 13, 2014

#### Device Trade or Proprietary Name 1.4

Penumbra System® / Penumbra System® MAX

#### 1.5 Device Classification

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

#### 1.6 Predicate Devices

| 510(k) Number /<br>Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|-----------------------------------|--------------------------------------------------------|-------------------------|
| K072718 [28Dec2007] | Penumbra System [026, 032, 041] | Penumbra, Inc. |
| K090752 [21Sep2009] | Penumbra System [054] | Penumbra, Inc. |
| K100769 [21May2010] | Penumbra System Separator Flex<br>[026, 032, 041, 054] | Penumbra, Inc. |
| K113163 [28NOV2011] | Penumbra System® MAX | Penumbra, Inc. |

#### 1.7 Device Description

The purpose of this 510(k) pre-market notification is to implement the following modifications to the Instructions for Use for clarity.

{1}------------------------------------------------

- . Added Summary of PIVITOL Trial Clinical Data
- . Moved a precaution statement to the Warnings section
- Added statement that the use of a Separator may not be needed for . Reperfusion Catheters with an I.D. of 0.054in or larger.

### 1.8 Intended Use

The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

### 1.9 Summary of Non-Clinical Data

The following non-clinical testing was performed to support the proposed wording clarifications in the Instructions for Use.

| Test | Test Method Summary | Result |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Catheter Tip Pressure | Aspiration (Suction)<br>pressure was measured at<br>the distal tip of the<br>Reperfusion catheters (All<br>Sizes). | The aspiration pressure at<br>the distal tip of the<br>Reperfusion Catheters<br>was equal to the pressure<br>set at the Pump. |
| Aspiration Flow Rate | The flow rate through the<br>Reperfusion Catheter was<br>measured with and<br>without Separators<br>present in the catheter<br>lumen. (054, 5MAX &<br>5MAX ACE) | The flow rate was<br>consistently higher<br>without the presence of<br>the Separator in Lumen. |
| Clot Removal Simulated<br>Use | Clot was removed from a<br>glass model under - 20<br>inHg vacuum (without<br>Separator). (054, 5MAX<br>& 5MAX ACE) | All Reperfusion Catheters<br>were able to completely<br>remove the clot without<br>the use of a Separator. |

{2}------------------------------------------------

# 1.10 Summary of Substantial Equivalence

.

The Penumbra System MAX components are substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Public Health Service

May 13, 2014

Penumbra, Inc. Mr. Seth Schulman Director, Regulatory Affairs 1352 Harbor Bay Parkway Alameda, CA 94502

Re: K133317

> Trade/Device Name: Ponumbra System and Penumbra System MAX Regulation Number: 21 CFR 870.1250 Regulation Name: Thrombus Removal Catheter Regulatory Class: Class II Product Code: NRY Dated: April 7, 2014 Received: April 8, 2014

Dear Mr. Schulman:

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

{4}------------------------------------------------

Page 2 - Mr. Seth Schulman

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Carlos L. Piena -S

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K133317

### Device Name

Penumbra System / Penumbra System MAX

### Indications for Use (Describe)

The Penumbra System / Penumbra System MAX are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal caroiid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Carlos L. Pena -S

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{6}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of Information unless it displays a currently valid OMB number."