Benchmark Intracranial Access System

K142321 · Penumbra, Inc. · DQY · Jan 26, 2015 · Cardiovascular

Device Facts

• Record ID: K142321
• Device Name: Benchmark Intracranial Access System
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Story

Benchmark Intracranial Access System consists of a delivery catheter (guide catheter) and a select catheter (microcatheter). Used by physicians in clinical settings to access target vasculature during interventional procedures. The system supports diagnostic or therapeutic devices, facilitating navigation to target vascular locations and delivery of agents. Compatible with off-the-shelf accessories. Provides physician convenience through various lengths and distal shapes. Benefits include improved access to complex neurovascular anatomy, aiding in the delivery of necessary interventional tools.

Clinical Evidence

Bench testing only. No clinical or animal data required. Biocompatibility testing per EN ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, thrombogenicity) passed. Mechanical bench testing (simulated use in anatomical models, coating integrity, particulate testing, air aspiration, pressure testing, friction force, tensile strength, bond strength, elongation) confirmed performance specifications met.

Technological Characteristics

Catheters constructed from medical-grade plastics and stainless steel. Features include various lengths and distal shapes. Sterilization via Ethylene Oxide (EtO). Compatible with off-the-shelf accessories. Biocompatibility verified per EN ISO 10993-1.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature in patients requiring interventional procedures.

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 Delivery Catheter 070 (K082290)
• Neuron Select Catheter 070 (K083125)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

January 26, 2015

Penumbra, Inc. Ms. Michaela Mahl Senior Manager, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, California 94502

Re: K142321

> Trade/Device Name: Benchmark Intracranial Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 15, 2014 Received: December 16, 2014

Dear Ms. Michaela 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

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the quality systems (OS) 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 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 yours,

# Carlos L. Pena - SD/△

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) K142321

Device Name Benchmark Intracranial Access System

Indications for Use (Describe)

The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| <table><tr><td><div> <input checked="true" type="checkbox"/> Research Use (Per 21 CFR 201.66 and .68) </div></td><td><div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.66 and .68) </div></td></tr></table> | <div> <input checked="true" type="checkbox"/> Research Use (Per 21 CFR 201.66 and .68) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.66 and .68) </div> |
| <div> <input checked="true" type="checkbox"/> Research Use (Per 21 CFR 201.66 and .68) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.66 and .68) </div> | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 Benchmark™ Intracranial Access System.

#### 7.1 Sponsor/Applicant Name and Address

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

#### 7.2 Sponsor Contact Information

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

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

January 20, 2015

#### 7.4 Device Trade or Proprietary Name

Benchmark™ Intracranial Access System

#### 7.5 Device Classification

| Regulatory Class: | ll |
|------------------------------------------|-----------------------------------------------|
| Classification Panel: Cardiovascular | |
| | Classification Name: Percutaneous Catheter |
| Regulation Number: | 21 CFR § 870.1250 |
| Product Code: | DOY |

#### 7.6 Predicate Devices

| 510(k) Number /<br>Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|-----------------------------------|------------------------------|-------------------------|
| K082290 / 31Oct2008 | Neuron Delivery Catheter 070 | Penumbra, Inc. |
| K083125 / 21Nov2008 | Neuron Select Catheter 070 | Penumbra, Inc. |

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#### 7.7 Predicate Comparison

| System Name | Neuron Intracranial Access System | Benchmark Intracranial Access System |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Neuron 070 Delivery Catheter | Benchmark Delivery Catheter |
| 510(k) No. | K082290 | K142321 |
| Classification | Class II, DQY | SAME |
| Indication | The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Catheter Materials | Commonly used medical grade plastics & stainless steel | SAME |
| Outer Dimension | 6F (0.081 in -0.083 in) | SAME |
| Inner Dimension | 0.070 in Min | SAME |
| Effective Length | 95 cm, 105 cm | 95 cm, 105 cm, 115 cm |
| Tip Shapes | Straight & Multi-Purpose | SAME |
| Packaging Materials | Commonly used medical device packaging materials | SAME |
| Sterilization | EtO | SAME |
| Shelf-Life | 36 Months | 12 Months [36 Months in-process] |

| System Name | Neuron Intracranial Access System | Benchmark Intracranial Access System |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Neuron Select Catheter 070 | 5F Select Catheter |
| 510(k) No. | K083125 | K142321 |
| Classification | Class II, DQY | Class II, DQY |
| Indication | The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Catheter Materials | Commonly used medical grade plastics & stainless steel | SAME |
| Outer Dimension | 5F (0.069in Max) | SAME |
| Inner Dimension | 0.043 in Max | SAME |
| Effective Length | 123 cm & 131.5cm | SAME |
| Tip Shapes | Berenstein, H1 & Simmons | SAME |
| Packaging Materials | Commonly use medical device packaging materials | SAME |
| Sterilization | EtO | SAME |
| Shelf-Life | 36 Months | SAME |

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#### 7.8 Device Description

The Benchmark™ Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. Benchmark Intracranial Access System is composed of a Delivery Catheter (guide catheter) used to support other diagnostic or therapeutic devices and a corresponding Select Catheter (microcatheter). Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of the necessary diagnostic and/or therapeutic agents. The Benchmark Intracranial Access System devices are compatible with off-the-shelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.

#### 7.9 Indications for Use

The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

### 7.10 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's. which substantiates the safe and effective performance of the Benchmark™ Intracranial Access System as well as its substantial equivalence to the predicate devices:

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

The subject Benchmark™ Intracranial Access System met all established requirements.

### 7.10.1 Biocompatibility Testing

Biocompatibility tests conducted on the materials of the BenchmarkTM Intracranial Access System were 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 Benchmark™ Intracranial Access System to be biocompatible according to the requirements of EN ISO 10993 requirements. The following tests were performed and all tests passed successfully:

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| Test | Acceptance Criteria | Results | Pass / Fail |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| <i>In Vitro</i> Cytotoxicity | Sample extracts must yield cell<br>lysis grade 2 or lower | Grade 0-1: None to Slight | Pass |
| Sensitization | Test Group shall yield Grade <<br>1 score on Magnusson and<br>Kligman scale (provided<br>control Grade < 1) | Grade 0: No visible change | Pass |
| Acute Intracutaneous<br>Reactivity (Irritation) | The difference in the mean test<br>article and mean control score<br>must be grade 1.0 or lower | Grade $\le$ 1.0 difference<br>between mean test article<br>and mean control score | Pass |
| Systemic Toxicity | | | |
| | Acute Systemic Toxicity | Sample extracts must not cause<br>the following:<br>• > 10% weight loss in 3 or<br>more test animals<br>• Mortality of 2 or more test<br>animals<br>• Abnormal behavior in 2 or<br>more test animals | No evidence of systemic<br>toxicity from sample<br>extracts<br>• No weight loss<br>• No death<br>• All test animals appeared<br>normal |
| Rabbit Pyrogen Study | Sample Extracts must not<br>cause a total rise in body<br>temperature of $\ge$ 0.5°C | Non-pyrogenic: No<br>evidence of material-<br>mediated pyrogenicity; no<br>single animal had a total<br>body temperature rise of<br>$\ge$ 0.5°C | Pass |
| Hemocompatibility | | | |
| | <i>In Vitro</i> Hemolysis<br>[Extract Methode] | Sample extracts must be non-<br>hemolytic ( $\le$ 2% hemolytic<br>index) | Non-hemolytic:<br>Hemolytic Index = 0.70% -<br>1.04%<br>Corrected Hemolytic index<br>= 0.00% - 0.23% |
| Complement Activation | The concentrations of C3a and<br>SC5b-9 in the test samples are<br>statistically similar to the<br>predicate (Exposure Control &<br>Ref Material) control and<br>statistically lower than the<br>positive control for all<br>exposure times | The test sample<br>concentrations of C3a and<br>SC5b-9 were statistically<br>similar or lower than the<br>predicate control sample<br>concentrations, and<br>statistically lower than the<br>positive control sample<br>concentration | Pass |
| Dog Thrombogenicity | The device must be non-<br>thrombogenic after 4 hours in<br><i>vivo</i> when compared to a<br>control device | Test Device was non-<br>thrombogenic after 4 hours<br>in <i>vivo</i> when compared to a<br>control device | Pass |

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## 7.10.2 Bench-top Testing

The physical and mechanical properties of the Benchmark™ Intracranial Access System were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:

| Attribute | Sample<br>Size | Specification | Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------|
| Dimensional/<br>Visual Inspection | | 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<br>[Intracranial<br>Access & Vessel<br>Access Entry<br>Performance] | | Simulated use testing of the Benchmark Delivery Catheter and<br>Benchmark Select Catheter was performed with accessory<br>devices in an anatomical model which simulated the tortuosity<br>of the neurovasculature. | | Pass |
| Catheter Coating<br>Integrity | N=30 | Coating has not delaminated,<br>peeled, or flaked after simulated<br>use | 100% Must<br>meet<br>Specification | 100% Pass |
| | N=10 | Coating has not further<br>delaminated, peeled, or flaked<br>from coating integrity baseline | 100% Must<br>meet<br>Specification | 100% Pass |
| Particulate<br>Testing (Catheter<br>Hydrophilic<br>Coating) | N=10 | The maximum number of<br>particles:<br><= 6000 particles ≥ 10 $μ$ m<br><= 600 particles ≥ 25 $μ$ m<br><= 600 particles ≥ 75 $μ$ m<br>0 particles ≥ 125 $μ$ m | 100% Must<br>meet<br>Specification | 10 $μ$ m - 100% Pass<br>25 $μ$ m - 100% Pass<br>75 $μ$ m - 100% Pass<br>125 $μ$ m - 100% Pass |
| Hub/Catheter Air<br>Aspiration | N=30 | When negative pressure is<br>pulled, no air may leak into hub | 100% Must<br>meet<br>Specification | 100% Pass |
| Pressure Test | N=30 | 45 psi for 30 sec MIN | 100% Must<br>meet<br>Specification | 100% Pass |
| Benchmark<br>Delivery<br>Catheter / Sheath<br>compatibility<br>(Friction Force) | N=30 | Maximum value per<br>specification | 100% Must<br>meet<br>Specification | 100% Pass |
| Benchmark<br>Delivery<br>Catheter /<br>Benchmark<br>Select Catheter<br>compatibility<br>(Friction Force) | N=30 | Maximum value per<br>specification | 100% Must<br>meet<br>Specification | 100% Pass |
| Catheter Shaft<br>Tensile Strength<br>(includes all<br>joints) | N=30 | Minimum value per specification | 100% Must<br>meet<br>Specification | 100% Pass |
| Attribute | Sample<br>Size | Specification | Acceptance<br>Criteria | Results |
| Hub to Shaft &<br>Hub to Hypotube<br>Bond Strength | N=30 | Minimum value per specification | 100% Must<br>meet<br>Specification | 100% Pass |
| Elongation to<br>Failure –<br>Catheter | N=30 | % Elongation ≥ 5% | 100% Must<br>meet<br>Specification | 100% Pass |

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The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the Benchmark™ Intracranial Access System are acceptable for the intended use and substantially equivalent to the predicate device.

## 7.10.3 Animal Study

No animal study was required.

## 7.10.4 Summary of Substantial Equivalence

The Benchmark™ Intracranial Access System is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelflife, packaging and sterilization processes.