PENUMBRA DDC CATHETERS

K122772 · Penumbra, Inc. · DQY · Nov 20, 2012 · Cardiovascular

Device Facts

• Record ID: K122772
• Device Name: PENUMBRA DDC CATHETERS
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The DDC™ Catheters are indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

DDC™ Catheters are variable stiffness, percutaneous catheters designed for use in peripheral and neurovascular procedures. The device features a stainless steel or Nitinol coil-reinforced shaft, a PTFE-lined lumen, and a radiopaque distal markerband. It is hydrophilically coated to facilitate navigation. The catheter is inserted via a guide catheter or vascular sheath by a physician to provide a reinforcing conduit for the delivery of other interventional devices to a target site. The system includes a rotating hemostasis valve and a tip-shaping mandrel. By providing a stable, trackable pathway, the device assists clinicians in accessing complex vascular anatomy, potentially improving the efficiency and success of interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility per ISO-10993-1 and mechanical testing (tracking over guidewire, microcatheter compatibility, friction force, and torsion) with 100% pass rates against established acceptance criteria.

Technological Characteristics

Variable stiffness catheter; stainless steel or Nitinol coil-reinforced shaft; PTFE-lined lumen; hydrophilic coating; radiopaque markerband (Platinum/Iridium). Dimensions vary by configuration. Sterilization via Ethylene Oxide (EtO). Standalone device.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neurovasculature.

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 PICA™ Catheter (K093970)
• Penumbra System Reperfusion Catheters (K072718, K090752 & K113163)

Submission Summary (Full Text)

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510(k) Summary

K122772

#### Sponsor/Applicant Name and Address 1.1

Penumbra Inc.

1351 Harbor Bay Parkway Alameda, CA 94502

#### Sponsor Contact Information 1.2

Seth A. Schulman

Director, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

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

September 7, 2012

#### Device Trade or Proprietary Name 1.4

DDC™ Catheters

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

Catheter, Percutaneous (Product Code: DQY)

NOV 2 0 7012

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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 PICA™ Catheter | Penumbra, Inc<br>Alameda, CA | K093970 |
| Penumbra System Reperfusion<br>Catheters | Penumbra, Inc<br>Alameda, CA | K072718,<br>K090752 &<br>K113163 |

#### 1.7 Device Description:

The DDC™ Catheters are variable stiffness catheter with various diameters, a catheter shaft reinforced with a stainless steel or Nitinol coil, and have a radiopaque markerband on the distal end. They are available in various lengths. The DDC™ Catheters have a PTFE-lined lumen, which is coil re-enforced, flexible, and hydrophilically coated. The DDC™ Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The devices are provided sterile and include a rotating hemostasis valve and tip shaping mandrel. The DDC™ Catheters will be available in various configurations to allow physician ease of device tracking to the target site

#### 1.8 Intended Use:

The DDC™ Catheters are indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

#### Comparison to Predicate Devices 1.9

The DDC™ Catheters include design modifications that enable improved trackability and therapeutic device deliverability to the vasculature. This submission also includes larger lumen catheters in various lengths compared to the predicate PICA™ Catheter.

| | | Penumbra System<br>Reperfusion Catheters | PICA™ Catheter | Subject DDC™<br>Catheters |
|--|--|------------------------------------------|----------------|---------------------------|
|--|--|------------------------------------------|----------------|---------------------------|

1.6

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| | Penumbra System<br>Reperfusion Catheters | PICATM Catheter | Subject DDCTM<br>Catheters |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Indication | The Penumbra System™<br>is intended for use in the<br>revascularization of<br>patients with acute<br>ischemic stroke<br>secondary to intracranial<br>large vessel occlusive<br>disease (within the<br>internal carotid, middle<br>cerebral - M1 and M2<br>segments, basilar, and<br>vertebral arteries) within<br>8 hours of symptom<br>onset. | The PICA™ Catheter<br>is indicated for the<br>introduction of<br>interventional devices<br>into the peripheral and<br>neuro vasculature. | SAME<br>(PICA) |
| Materials | | | |
| - Catheter<br>Shaft/Hub | Nylon, PTFE,<br>Polyurethane,<br>Polycarbonate,<br>hydrophilic coating | Nylon, PTFE,<br>Polyurethane,<br>Polycarbonate,<br>hydrophilic coating | SAME |
| - Catheter shaft<br>support | Stainless Steel/Nitinol | Stainless Steel | SAME<br>(Penumbra System<br>Reperfusion Catheters) |
| - Catheter<br>Markerband | Platinum / Iridium | Platinum / Iridium | SAME |
| - Packaging | Tyvek/Mylar pouch,<br>polyethylene hoop<br>paper packaging card,<br>SBS carton | Tyvek/Mylar pouch,<br>polyethylene hoop<br>paper packaging card,<br>SBS carton | SAME |
| Sterilization | EtO | EtO | SAME |
| Shelf-Life | 36 Months | 36 Months | SAME |

#### 1.10 Summary of Non-clinical Data:

Biocompatibility tests conducted for the DDC™ Catheters were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for external communicating devices contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

Non-clinical testing found the DDC™ Catheters to be biocompatible and non-pyrogenic. The physical, mechanical and performance testing of the subject DDC™ Catheters demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.

## Table 1: DDC Performance Testing

Attribute Acceptance Criteria Results

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| Attribute | Acceptance Criteria | Results |
|---------------------------------------------|---------------------|-----------|
| DDC must be<br>compatible with 6F<br>sheath | 100% Pass | 100% Pass |
| DDC tracking over<br>0.038" guidewire | 100% Pass | 100% Pass |
| 0.038" Guidewire<br>Compatible | 100% Pass | 100% Pass |
| Hub Transition | 100% Pass | 100% Pass |
| Microcatheter<br>compatibility | 100% Pass | 100% Pass |
| Microcatheter<br>friction | 100% Pass | 100% Pass |
| Microcatheter<br>support | 100% Pass | 100% Pass |
| 0.038in guidewire<br>compatibility | 100% Pass | 100% Pass |
| (Friction Force)<br>(DDC 5MAX only) | 100% Pass | 100% Pass |
| Torsion<br>(DDC 4MAX only) | 100% Pass | 100% Pass |

:

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its body and wings.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 20, 2012

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

Re: K122772

Trade/Device Name: DDCTM Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 7, 2012 Received: September 10, 2012

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting 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: K122772

Device Name: DDC™ Catheters

Indications For Use:

The DDC™ Catheters are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Prescription Use _ XX (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K122772

# Joyce M. Whang

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number

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