NEURON MAX SYSTEM

K111380 · Penumbra, Inc. · DQY · Jul 19, 2011 · Cardiovascular

Device Facts

• Record ID: K111380
• Device Name: NEURON MAX SYSTEM
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Neuron™ MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Story

Neuron MAX System is a percutaneous catheter configuration providing a larger lumen than previous iterations to facilitate contrast injection and accommodate larger therapeutic devices (e.g., Penumbra System, Penumbra Coil 400). Used in peripheral, coronary, and neuro vasculature; operated by physicians in clinical settings. Device provides a flexible distal tip for navigation. Output is anatomical visualization via contrast and delivery of interventional devices. Benefits include improved access and visualization for complex interventional procedures.

Clinical Evidence

Bench testing and animal study (swine model) performed. Bench testing included biocompatibility (ISO 10993), tensile strength, burst testing, friction force, flow rate, and torsion. Animal study showed no vessel injury, no abnormal histology, and no significant vascular response.

Technological Characteristics

Percutaneous catheter system; sterile, single-use. Materials evaluated per ISO 10993. Features include larger lumen for contrast and device delivery, flexible distal tip. Mechanical testing per ASTM standards for hemolysis and physical performance. No software or electronic components.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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

• Neuron Intracranial Access System 053, Model 5F/6F (K070970)
• Neuron Delivery Catheter 070 (K082290)
• Neuron Select Catheter 070 (K083125)

Submission Summary (Full Text)

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KI11380 page 1.0+5

JUL 19 2011

# 510(k) Summary of Safety & Effectiveness 9

(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 Neuron™ MAX System.

## 9.1 Sponsor/Applicant Name and Address

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

#### 9.2 Sponsor Contact Information

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

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

June 24, 2011

## Device Trade or Proprietary Name 9.4

Neuron™ MAX System

#### 9.5 Device Classification

Regulatory Class: II Cardiovascular Classification Panel: Percutaneous Catheter Classification Name: 21 CFR § 870.1250 Regulation Number: Product Code: DQY

#### 9.6 Predicate Devices

| 510(k) Number /<br>Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|-----------------------------------|-------------------------------------------------------|-------------------------|
| K070970 / 17Aug2007 | Neuron Intracranial Access System<br>053, Model 5F/6F | Penumbra, Inc. |
| K082290 / 31Oct2008 | Neuron Delivery Catheter 070 | Penumbra, Inc. |
| K083125 / 21Nov2008 | Neuron Select Catheter 070 | Penumbra, Inc. |

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## 9.7 Device Description

The Neuron MAX System is an additional configuration to the currently available Neuron Intracranial Access System. The Neuron Max System provides a larger lumen to assist in utilizing contrast injections to further optimize anatomical visualization while maintaining a flexible distal tip. This larger lumen also accommodates larger therapeutic devices like the Penumbra System® and Penumbra Coil 400™ devices. The devices are provided sterile, non-pyrogenic, and intended for single use only.

## 9.8 Intended Use

The Neuron™ MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

## Summary of Non-Clinical Data و .و

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 Neuron MAX System met all established requirements.

# Biocompatibility Testing 9.9.1

Biocompatibility tests conducted with the Neuron MAX System were selected 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 In summary, non-clinical testing found the Neuron MAX System to be Practices. biocompatible according to the requirements of ISO 10993 requirements. The following tests were performed:

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:

| Test | Method | Results |
|-------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------|
| In Vitro Cytotoxicity | ISO Elution Test (MEM<br>Extract) | No evidence of cell<br>lysis or toxicity |
| Sensitization | ISO Maximization Test for<br>Delayed Hypersenitivity | Non-Sensitizing |
| Acute Intracutaneous<br>Reactivity (Irritation) | ISO Intracutaneous<br>(Intradermal) Injection<br>Test | No evidence of<br>irritation |
| Acute Systemic<br>Toxicity | ISO Acute Systemic<br>Injection Test | No evidence of<br>systemic toxicity |
| Rabbit Pyrogen Study | USP Material-Mediated<br>Rabbit Pyrogen Test | No evidence of<br>material-mediated<br>pyrogenicity |
| Hemo-compatibility | | |
| - In Vitro Hemolysis | ASTM Methode<br>(Extraction & Direct<br>Contact) | Non-Hemolytic |
| - In Vitro Coagulation<br>(PT, PTT) | Prothrombin Time (PT)<br>Assay | Coagulation times<br>are not significant<br>different than<br>corresponding<br>control |
| | Partial Thromboplastin<br>Time (PTT) Assay | Non-Thrombogenic |
| Complement<br>Activation | C3a and SC5b-9 through<br>Enzyme Assay | No greater<br>biological response<br>than corresponding<br>control |
| Dog Thrombogenicity | Thrombogenicity Study in<br>Dogs - ISO | Non-Thrombogenic |
| Genotoxicity | | |
| - Mouse Lymphoma | Mouse Lymphoma<br>Mutagenesis Assay - ISO | Non-Mutagenic |
| - Ames Mutagenicity | Ames Test | Non-Mutagenic |
| - In Vivo Mouse<br>Micronucleus | Micronucleus Assay - ISO | Non-Clastogenic |

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# Bench-top Testing 9.9.2

The physical and mechanical properties of the Neuron MAX System were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed:

| Test / Test Subject | Attribute | Result |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Pouch Seal | Pouch Seal Strength | Met established criteria |
| Dimensional / Visual<br>Inspection | These evaluations confirm that the units<br>used in this Design Verification testing meet<br>all inspection criteria for release of finished<br>goods (clinically acceptable) product. | Met established criteria |
| Simulated Use<br>[Intracranial Access<br>& Vessel Access<br>Entry Performance] | These evaluations confirm that the units<br>used in this Design Verification testing meet<br>all inspection criteria for release of finished<br>goods (clinically acceptable) product. | Met established criteria |
| MAX 088 Delivery<br>Catheter / Dilator | Hub /Shaft & Mid-shaft or Shaft Tensile<br>Strength | Met established criteria |
| 6F Select Catheter | Hub /Shaft & Mid-shaft Tensile<br>Strength | Met established criteria |
| MAX 088 Delivery | Hub Air Aspiration | Met established criteria |
| Catheter / 6F Select<br>Catheter / Dilator | Burst Test | Met established criteria |
| MAX 088 Delivery<br>Catheter | Particulate Testing (Hydrophilic Coating) | Met established criteria |
| MAX 088 Delivery<br>Catheter / 8F Sheath<br>compatibility | Friction Force | Met established criteria |
| MAX 088 Delivery<br>Catheter / 6F Select<br>Catheter compatibility | Friction Force | Met established criteria |
| 6F Select Catheter /<br>0.038" Guidewire<br>compatibility | Friction Force | Met established criteria |
| MAX 088 Delivery<br>Catheter / Neuron<br>MAX Dilator<br>compatibility | Friction Force | Met established criteria |
| Neuron MAX Dilator<br>/ 0.038" Guidewire<br>compatibility | Friction Force | Met established criteria |
| MAX 088 Delivery<br>Catheter / 6F Select<br>Catheter | Flow Rate | Met established criteria |
| MAX 088 Delivery<br>Catheter / 6F Select | Elongation to Failure | Met established criteria |
| Test / Test Subject | Attribute | Result |
| Catheter / Dilator | | |
| MAX 088 Delivery<br>Catheter / 6F Select<br>Catheter / Dilator /<br>RHV / HVA | Corrosion | Met established criteria |
| MAX 088 Delivery<br>Catheter / 6F Select<br>Catheter | Torsion | Met established criteria |

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

## 9.9.3 Animal Study

An animal study was conducted to evaluate the safe use of the Neuron MAX System 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 Neuron MAX System resulted in no significant vascular response . in these experimental conditions.

#### 9.9.4 Summary of Substantial Equivalence

The Neuron MAX System is 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

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

Re: K11380 Trade/Device Name: Neuron™ MAX System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DOY Dated: June 24, 2011 Received: June 27, 2011

JUL 1 9 2011

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Michaela Mahl

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/CDRH0ffices/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 D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 10 Statement of Indication for Use

Indications for Use 510(k) Number (if known): KIII380

Device Name:____ Neuron™ MAX System

Indications for Use:

The Neuron MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Prescription Use >> (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)

Signature

(Division Sigh-Off) Division of Cardiovaso r Devices 510(k) Number .. (