PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM

K121917 · Penumbra, Inc. · QEW · Sep 19, 2012 · Cardiovascular

Device Facts

• Record ID: K121917
• Device Name: PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
• Applicant: Penumbra, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Sep 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.

Device Story

System utilizes aspiration to remove fresh, soft emboli/thrombi from peripheral arterial vessels. Components include aspiration catheter, separator, and aspiration tubing. Separator functions to break up clot within catheter to facilitate aspiration. Used in clinical settings by physicians. Device is sterile, single-use. Performance verified via bench-top mechanical testing and animal studies confirming safety and efficacy. Output is physical removal of thrombus, benefiting patient by restoring blood flow.

Clinical Evidence

No human clinical data. Evidence consists of biocompatibility testing (EN ISO 10993-1), bench-top mechanical testing (visual/dimensional, tensile, bond, burst, friction, flow, torsion, simulated use, particulate, flexibility), and animal studies. Animal studies showed no vessel injury, no abnormal histology, and no significant vascular response.

Technological Characteristics

Components: aspiration catheter, separator, aspiration tubing. Materials: biocompatible per EN ISO 10993-1. Sterilization: ethylene oxide (double cycle). Principle: mechanical aspiration. Form factor: intravascular catheter system. Connectivity: none (standalone).

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial system vessels. Contraindicated for use in coronary, venous, or neurovascular systems.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Merit Embolectomy Catheter (K100569)
• Penumbra System (K072718)
• Penumbra System 054 (K090752)
• Penumbra System Separator Flex [026, 032, 041, 054] (K100769)
• Penumbra System MAX (K113163)

Submission Summary (Full Text)

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

#### 9 510(K) SUMMARY

(as required by 21 CFR 807.92)

SEP
19 2012

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 Embolectomy Aspiration System.

#### Sponsor/Applicant Name and Address 9.1

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

#### 9.2 Sponsor Contact Information

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

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

September 14, 2012

#### 9.4 Device Trade or Proprietary Name

Penumbra Embolectomy Aspiration System

#### તે તે રે Common/Usual Name

Penumbra Embolectomy Aspiration System

#### 9.6 Device Classification

Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Embolectomy catheter Regulation Number: 21 CFR § 870.5150 Product Code: DXE

#### 9.7 Predicate Devices

| 510(k) Number /<br>Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|-----------------------------------|--------------------------------------------------------|--------------------------------|
| K100569 / 11Mar2011 | Merit Embolectomy Catheter | Merit Medical<br>Systems, Inc. |
| K072718 / 28Dec2007 | Penumbra System | Penumbra, Inc. |
| K090752 / 21Sep2009 | Penumbra System 054 | Penumbra, Inc. |
| K100769 / 21May2010 | Penumbra System Separator Flex [026, 032,<br>041, 054] | Penumbra, Inc. |
| K113163 / 23Nov2011 | Penumbra System MAX | Penumbra, Inc. |

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

#### Device Description 9.8

The Penumbra Embolectomy Aspiration System's fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.

#### و. و Intended Use

The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.

# 9.10 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 safety and effectiveness of the device follows.

Included in this section are descriptions of the testing, which substantiates the safe and effective performance of the Penumbra Embolectomy Aspiration System as well as its substantial equivalence to the predicate devices:

- . Biocompatibility / Pyrogenicity
- . Design Verification (Bench-Top Testing)
- . Animal Study

For the subject Penumbra Embolectomy Aspiration System all established requirements and acceptance criteria were met.

## 9.10.1 Biocompatibility Testing

Biocompatibility is established for the Penumbra Embolectomy Aspiration System devices based on tests selected in accordance with EN ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices) for limited duration (<24 hours), external communicating devices, contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. In summary, non-clinical testing found the Penumbra Embolectomy Aspiration

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

System devices to be biocompatible according to the requirements of EN ISO 10993 requirements. In summary the following tests were performed:

| Test | Method | Result |
|-------------------------------------------|----------------------------------------------|-----------------------------------------------------------------|
| Cytotoxicity | L929 MEM Elution<br>Test | Non-Toxic |
| Sensitization | Kligman Maximization | Non-Sensitizing |
| Intracutaneous<br>Reactivity (Irritation) | Intracutaneous Injection<br>Test | Non-Irritant |
| Systemic Toxicity<br>(Acute) | ISO Acute Systemic<br>Injection Test | Non-Toxic |
| Haemocompatibility | Complement Activation | No greater biological<br>response than<br>corresponding control |
| | Hemolysis | Non-Hemolytic |
| | Coagulation - PT | No Statistical Difference<br>from control |
| | Coagulation - PTT | No Statistical Difference<br>from control |
| | In vivo thrombogenicity | Non-Thrombogenic |
| Pyrogenicity | USP Material Mediated<br>Rabbit Pyrogen Test | Non-Pyrogenic |

### 9.10.2 Bench-top Testing

Testing was based on the design specifications, risk analysis and available guidance documents. These guidance documents include:

- . Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (FDA - 1995)
- EN ISO 10555-1:2009 Sterile, single-use intravascular catheters Part 1: . ● General Requirements

Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle.

The physical and mechanical properties of the Penumbra Embolectomy Aspiration System devices were assessed using standard test methods and predetermined acceptance criteria. All established acceptance criteria were met. The following tests were performed:

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

| • | Visual & Dimensional |
|---|----------------------|
|---|----------------------|

Pouch Seal Strength .

- Tensile Strength .
- Bond Strenght .
- . Hub Air Aspiration
- . Burst Test
- .
- Friction Test .
- Flow Rate Test .
- Elongation Test .
- Corrosion Test .
- . Torsion Test
- Simulated Use .
- Particulate Test
- Flexibility ●

The results of the tests appropriately address the physical and mechanical performance expectations of the device. This is further supported by the surgical handling and performance results reported in the in vivo study. Based on these overall results, the physical and mechanical properties of the Penumbra Embolectomy Aspiration System devices are acceptable for the intended use and substantially equivalent to the predicate devices.

## 9.10.3 Animal Study

Animal studies were conducted to evaluate the safe use of the Penumbra Embolectomy Aspiration System devices. The studies concluded that:

- No vessel injury was noted on the final angiograms following the vessel ● response procedure.
- No abnormal gross or histology findings were noted in test vessel segments. .
- The use of the devices resulted in no significant vascular response in these . experimental conditions.

### 9.10.4 Summary of Substantial Equivalence

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

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

SEP 19 2012

Penumbra, Inc. c/o Michaela Mahl Regulatory Affairs Program Manager 1351 Harbor Bay Parkway Alameda, CA 94502

Re: K121917

Trade/Device Name: Penumbra Embolectomy Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 29, 2012 Received: July 2, 2012

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. However, we remind you 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

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

Page 2 - Ms. Michaela Mahl

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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

#### 10 Statement of Indication for Use

### Indications for Use

510(k) Number (if known): K121917

Device Name: _ Penumbra Embolectomy Aspiration System

Indications for Use:

The Penumbra Embolectorny Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.

AND/OR Over The Counter Use Prescription Use_ X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

WZ

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KIZL 9/7