PENUMBRA SYSTEM MAX

K113163 · Penumbra, Inc. · NRY · Nov 23, 2011 · Cardiovascular

Device Facts

• Record ID: K113163
• Device Name: PENUMBRA SYSTEM MAX
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Penumbra System MAX components are supplemental catheters and separators designed to provide a larger lumen for efficient thrombus removal from intracranial vessels. The system is used in a clinical setting by physicians to treat acute ischemic stroke. The device is inserted into the vasculature to access the occlusion; it utilizes aspiration to remove thrombus. The system includes reperfusion catheters and separators that track through the vasculature to the site of the clot. By removing the thrombus, the device restores blood flow (revascularization) to the brain, potentially improving patient outcomes. The system is provided sterile and is for single use only.

Clinical Evidence

No human clinical data provided. Evidence consists of biocompatibility testing (ISO 10993), bench-top design verification (tensile strength, burst, friction, flow rate, torsion, simulated use), and an in vivo animal study (swine model). The animal study showed no vessel injury, no abnormal histology, and no significant vascular response.

Technological Characteristics

Catheter-based thrombus removal system. Materials evaluated per ISO 10993. Testing includes ASTM methods for hemolysis. Features include reperfusion catheters (3MAX/4MAX) and separators. Connectivity: None. Energy source: None (mechanical aspiration). Sterilization: 2x sterilized. Software: None.

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, 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)

Submission Summary (Full Text)

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NOV 2 3 2011

KIL3163 ps/5

# 10 510(k) Summary of Safety & Effectiveness

(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® MAX components.

# 10.1 Sponsor/Applicant Name and Address

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

### 10.2 Sponsor Contact Information

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

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

October 24, 2011

#### 10.4 Device Trade or Proprietary Name

Penumbra System® MAX

#### 10.5 Device Classification

Regulatory Class: II Cardiovascular Classification Panel: Classification Name: Catheter, Thrombus Removal 21 CFR §870.1250 Regulation Number: Product Code: NRY

#### 10.6 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. |

#### 10.7 Device Description

The Penumbra System MAX components are additional components of the currently available Penumbra System. The Penumbra System MAX components provide a larger lumen to assist in the efficient removal of thrombus from the

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brain. The devices are provided sterile, non-pyrogenic, and intended for single use only.

#### 10.8 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.

#### 10.9 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's, which substantiates the safe and effective performance of the Neuron MAX System as well as its substantial equivalence to the predicate devices:

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

The subject Penumbra System MAX components met all established requirements.

#### 10.9.1 Biocompatibility Testing

The Penumbra System MAX components were classified in accordance with 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 System MAX components to be biocompatible according to the requirements of ISO 10993 requirements, including:

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| Test | Method | Results |
|-------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------|
| In Vitro<br>Cytotoxicity | ISO Elution Test (MEM<br>Extract) | No evidence of cell lysis or<br>toxicity |
| Acute<br>Intracutaneous<br>Reactivity<br>(Irritation) | ISO Intracutaneous<br>(Intradermal) Injection Test | No evidence of irritation |
| Acute Systemic<br>Toxicity | ISO Acute Systemic Injection<br>Test | No evidence of systemic<br>toxicity |
| Rabbit Pyrogen<br>Study | USP Material-Mediated<br>Rabbit Pyrogen Test | No evidence of material-<br>mediated pyrogenicity |
| Sensitization | ISO Maximization Test for<br>Delayed Hypersensitivity | Non-Sensitizing |
| Hemo-compatibility | | |
| -In Vitro<br>Hemolysis | ASTM Methode (Extraction &<br>Direct Contact) | Non-hemolytic |
| -In Vitro<br>Coagulation (PT,<br>PTT) | Prothrombin Time (PT) Assay | Coagulation times are within<br>the normal rang |
| | Partial Thromboplastin Time<br>(PTT) Assay | Non-Thrombogenic |
| -Complement<br>Activation | C3a and SC5b-9 through<br>Enzyme Assay | No greater biological response<br>than corresponding control |

# 10.9.2 Bench-top Testing

The physical, mechanical and performance testing of the Penumbra System MAX components demonstrates that the devices are substantially equivalent to the currently marketed predicate devices:

Design Verification testing was conducted to evaluate the physical and mechanical properties of the Penumbra System MAX components. All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements. The tests performed on the Penumbra System MAX components included:

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| Test / Test Subject | Attribute | Sample Size | Result |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------|
| Pouch Seal | Pouch Seal Strength | 30 | Pass |
| Dimensional / Visual<br>Inspection | These evaluations confirm that the units used in this Design Verification testing meet<br>all inspection criteria for release of finished goods (clinically acceptable) product. | | Pass |
| Simulated Use<br>[Intracranial Access &<br>Thrombus Removal] | These evaluations confirm that the units used in this Design Verification testing meet<br>all inspection criteria for release of finished goods (clinically acceptable) product. | | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Hub /Shaft & Hub / HypotubeTensile Strength | 30 | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Joint Tensile Strength | 30 | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Hub Air Aspiration | 30 | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Burst Test | 30 | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Particulate Testing (Hydrophilic Coating) | 10 | Pass |
| Reperfusion Catheter4MAX/<br>Sheath or 8F Guide<br>compatibility<br>(Friction Force) | | | Pass |
| Reperfusion Catheter 4MAX/<br>0.014" Guidewire compatibility<br>(Friction Force) | | | Pass |
| Reperfusion Catheter 3MAX/<br>Reperfusion Catheter 054<br>(Friction Force) | Friction Force | 30 | Pass |
| Reperfusion Catheter 3MAX/<br>0.014" Guide wire<br>compatibility<br>(Friction Force) | | | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Flow Rate | 3 | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Elongation to Failure | 30 | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Corrosion | 30 | Pass |
| Reperfusion Catheter 3MAX /<br>Reperfusion Catheter 4MAX | Torsion | 30 | Pass |

# Design Verification (Bench-Top Testing) Summary – Reperfusion Catheters

# Design Verification (Bench-Top Testing) Summary - Separator 3MAX

| Test / Test Subject | Attribute | Sample<br>Size | Result |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------|
| Dimensional / Visual Inspection<br>(all sizes) | These evaluations confirm that the units used in this Design<br>Verification testing meet all inspection criteria for release of<br>finished goods (clinically acceptable) product. | | Pass |
| Simulated Use: | Hub Transition | N=30 | Pass |
| Reperfusion Catheter 3MAX /<br>Separator 3MAX / Aspiration<br>Tubing Assembly Performance | Tracking | N=30 | Pass |
| | Separator 3MAX & Reperfusion Catheter<br>Compatible | N=30 | Pass |
| | Separator 3MAX / Reperfusion Catheter / Pump<br>and accessories / Aspiration Tubing (Aspiration<br>Remove Clot) | N=30 | Pass |
| | Separator 3MAX and Reperfusion Catheter | N=30 | Pass |

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| Test / Test Subject . | Attribute | Sample<br>Size | Result |
|---------------------------|---------------------------------------------|----------------|--------|
| | Compatibility (Separator Advance / Retract) | | |
| Separator Bond Joint Test | Separator 054 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 041 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 032 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 026 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 3MAX and Wire Joint Break Force | N=30 | Pass |

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 System MAX components are acceptable for the intended use and substantially equivalent to the predicate devices.

# 10.9.3 Animal Study

An animal study was conducted to evaluate the safe use of the Penumbra System MAX in a swine model. The study 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 Penumbra System MAX components resulted in no significant vascular response in these experimental conditions.

# 10.9.4 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.

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Image /page/5/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 lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, vectorized design.

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

Penumbra, Inc. c/o Mr. Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502

NOV 2 3 2011

Re: K113163

Trade/Device Name: Penumbra System® MAX Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NR Y Dated: October 25, 2011 Received: October 26, 2011

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 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.

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Page 2 - Mr. Seth A. Schulman

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 device-related 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/ResourcesforYou/Industry/default.htm.

Sincerety Vours.

.

Melvin R. Felder, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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#### Statement of Indication for Use 11

| Indications for Use |
|---------------------|
|---------------------|

| 510(k) Number (if known): | K113163 |
|---------------------------|----------------------|
| Device Name: | Penumbra System® MAX |

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR Over The Counter Use (21 CFR 801 Subpart C)

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) JEFFREY TOY

> > (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K113163

510(k) Number