PENUMBRA CATHERER 025

K100826 · Penumbra, Inc. · DQY · Jul 13, 2010 · Cardiovascular

Device Facts

• Record ID: K100826
• Device Name: PENUMBRA CATHERER 025
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Penumbra Catheter 025 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.

Device Story

Penumbra Catheter 025 is a variable stiffness, coil-reinforced, hydrophilically coated catheter; features PTFE-lined lumen; distal outer diameter 0.040", proximal 0.045", inner diameter 0.025". Available in various tip configurations (straight, 45°, 90°, J) for navigation. Used by physicians to access target sites in peripheral and neuro vasculature; serves as a reinforcing conduit for other intravascular devices. Inserted via guide catheter or vascular sheath. Provided sterile for single use; includes rotating hemostasis valve, tip shaping mandrel, and introducer sheath. Benefits patient by facilitating precise delivery of diagnostic/therapeutic agents to target vasculature.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO-10993-1: cytotoxicity, sensitization, irritation, systemic toxicity, haemocompatibility, pyrogenicity) and design verification (dimensional/visual inspection, trackability, friction, torsion, joint tensile strength, burst, flow rate, elongation, kink resistance, corrosion, and GLP simulated use). All tests passed.

Technological Characteristics

Variable stiffness, coil-reinforced catheter; PTFE-lined lumen; Nitinol shaft support; Platinum/Iridium markerbands; hydrophilic coating. Dimensions: 0.040" distal OD, 0.045" proximal OD, 0.025" ID. Sterilized via EtO. Single-use, sterile, non-pyrogenic.

Indications for Use

Indicated for patients requiring delivery of diagnostic agents (contrast media) or therapeutic agents (occlusion coils) into the peripheral 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

• Penumbra Neuron Intracranial Access System (K070970, K082290 & K083125)
• Excelsior SL-10 / 1018 (K042568)

Submission Summary (Full Text)

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## Penumbra Catheter 025

## 510(K) SUMMARY

Penumbra

## JUL 1 3 2010

(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 Cather 025.

#### 1.1 Sponsor/Applicant Name and Address

Penumbra Inc.

1

1351 Harbor Bay Parkway Alameda, CA 94502

#### 1.2 Sponsor Contact Information

Seth A. Schulman Director, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

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

March 22, 2010

#### Device Trade or Proprietary Name 1.4

TBD

#### Device Common/Usual or Classification Name ાં ડ

Catheter, Percutaneous (Product Code: DQY)

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### Identification of the Legally Marketed Devices to which Equivalence 1.6 is Being Claimed:

| Name of Predicate Device | Name of Manufacturer<br>(Town, State) | 510(k) Number |
|-----------------------------------------------|---------------------------------------------------|----------------------------------|
| Penumbra Neuron Intracranial<br>Access System | Penumbra, Inc<br>Alameda, CA | K070970,<br>K082290 &<br>K083125 |
| Excelsior SL-10 / 1018 | Boston Scientific<br>Neurovascular<br>Fremont, CA | K042568 |

#### 1.7 Device Description:

Penu

The Penumbra Catheter 025 is a variable stiffness, coil reinforced catheter with a maximum distal outer diameter of 0.040" and a maximum proximal outer diameter of 0.045". It is available with an inner diameter of 0.025". The Penumbra Catheter 025 has a PTFE-lined lumen, is coil re-enforced, flexible, and hydrophilically coated. The Penumbra Catheter 025 is inserted through a guide catheter or vascular sheath, provides access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The device is provided sterile and includes a rotating hemostasis valve, tip shaping mandrel and introducer sheath.

The Penumbra Catheter 025 will be available in various tip configurations including straight, 45°, 90° and J, to allow physician ease of device tracking to the target site. The Penumbra Catheter 025 is sterile, non-pyrogenic and intended for single use only.

#### 1.8 Intended Use:

The Penumbra Catheter 025 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.

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| | Excelsior SL-10 / 1018 | Penumbra Neuron<br>Intracranial Access<br>System | Penumbra Catheter<br>025 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) No. | K042568 | K070970, K082290 &<br>K083125 | To be determined |
| Classification | Class II, DQY | Class II, DQY | Class II, DQY |
| Indication | Boston Scientific's<br>Excelsior™ SL-10 Pre-<br>Shaped microcatheter<br>and Excelsior™ 1018™<br>Pre-Shaped<br>microcatheter are<br>intended to assist in the<br>delivery of diagnostic<br>agents, such as contrast<br>media, and therapeutic<br>agents, such as occlusion<br>coils to the peripheral,<br>coronary, and neuro<br>vasculature. | The Neuron™<br>Intracranial Access<br>System is indicated for<br>the introduction of<br>interventional devices ·<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | Same as Excelsior SL-<br>10 / 1018 |
| Materials | | | |
| - Catheter Shaft/Hub | Thermoplastic,<br>hydrophilic coating | Nylon, PTFE,<br>Polyurethane,<br>hydrophilic coating | SAME |
| - Catheter shaft support | Metal | Stainless Steel | Nitinol |
| - Catheter Markerband | Platinum / Iridium | Platinum / Iridium | SAME |
| - Packaging | PET/PE/Tyvek pouch,<br>polyethylene hoop,<br>SBS carton | PET/PE/Tyvek pouch,<br>polyethylene hoop,<br>SBS carton | SAME<br>(A PET Tray is used<br>instead of the PE Hoop) |
| Sterilization | EtO | EtO | SAME |
| Shelf Life | 36 Months | 36 Months | SAME |

#### 1.9 Comparison to Predicate Devices

#### 1.10 Summary of Non-clinical Data

#### 1.10.1 Biocompatibility

Biocompatibility tests conducted with the Penumbra Catheter 025 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 Practices.

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Image /page/3/Picture/1 description: The image contains the word "Penumbra" in a simple, sans-serif font. To the right of the word is a circular logo with a stylized "P" inside. The logo is black with a white outline of the "P" and a white line extending from the "P" to the edge of the circle.

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

## ISO-10993 GLP Testing Summary for Penumbra Catheter 025

In summary, non-clinical testing found the Penumbra Catheter 025 to be non-cytotoxic, non-mutagenic, non-reactive (short and long-term implantation), nonsensitizing, a negligible irritant, non-pyrogenic, and non-toxic (acute systemic).

#### 1.10.2 Design Verification (Bench-Top Testing)

The physical, mechanical and performance testing of the Penumbra Catheter 025 demonstrates that the product is substantially equivalent to the currently marketed predicate devices:

Design Verification testing was conducted to evaluate the physical and mechanical properties of the Penumbra Catheter 025. 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 Catheter 025 included:

- . Dimensional / Visual Inspection

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## Penumbra Catheter 025

- Trackability .
Penumbra

- Friction .
- Torsion .
- Joint Tensile Strength .
- Catheter Burst .
- Catheter Flow Rate .
- Catheter Elongation .
- Kink Resistance .
- Corrosion .
- GLP Simulated Use .

All tests performed passed successfully.

The physical, mechanical and performance testing of the subject Penumbra Catheter 025 demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

## JUL 1 3 2010

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

Re: K100826

Trade/Device Name: Penumbra Catheter 025 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 22, 2010 Received: March 24, 2010

### 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

via R. Vorher

Image /page/6/Picture/8 description: The image contains a close-up of a handwritten letter 'B' next to a symbol that looks like a cursive letter 'C'. The letter 'B' is in uppercase and appears to be written in a simple, clear font. The cursive 'C' is slightly more stylized and is positioned to the left of the 'B'.

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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# STATEMENT OF INDICATION FOR USE

Indications for Use

510(k) Number (if known): Not Yet Assigned K100826

Device Name: Penumbra Catheter 025 (Trade Name TBD)

Indications for Use:

2

The Penumbra Catheter 025 is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.

> 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)

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sion Sign-Off Division Sign-On)
Sign-Only

510(k) Number K700826

Page | of |

Proprietary and Confidential DOCUMENT INFO: Penumbra Catheter 025 510K FINAL.DOC