POD SYSTEM

K141134 · Penumbra, Inc. · HCG · Jul 3, 2014 · Neurology

Device Facts

• Record ID: K141134
• Device Name: POD SYSTEM
• Applicant: Penumbra, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jul 3, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The POD System is indicated for the embolization of: Intracranial aneurysms . Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae . Arterial and venous embolizations in the peripheral vasculature

Device Story

The POD System is a neurovascular/vascular embolization device used by physicians in clinical settings to occlude targeted vasculature. The system consists of a soft platinum coil implant, a detachment pusher, and a detachment handle. The device is delivered endovascularly to the target site; the coil is deployed to pack the vessel and achieve occlusion. The system functions similarly to existing bare-platinum embolization coils. The device benefits patients by providing a mechanism for embolizing aneurysms and other vascular abnormalities. The healthcare provider uses the device under fluoroscopic guidance to place the coil; the resulting occlusion prevents blood flow into the targeted abnormality.

Clinical Evidence

No clinical data. Evidence consists of bench-top testing (dimensional/visual inspection, fatigue, friction, stiffness, simulated use flow model, tensile testing) and GLP animal testing (swine venous pouch aneurysm model) which characterized the device's interaction with the vasculature. Biocompatibility was established via testing per EN ISO 10993, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and hemocompatibility.

Technological Characteristics

Components: Platinum/tungsten/nitinol coil, stainless steel/polymer/platinum-iridium/nitinol detachment pusher, plastic handle. Dimensions: Secondary diameter 4-8 mm, secondary length 1-60 cm. Sterilization: EtO. Shelf life: 8 years. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring endovascular embolization of intracranial aneurysms, neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), and arterial/venous embolizations in the peripheral vasculature.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Predicate Devices

• Penumbra Coil System (K103305)
• Penumbra Coil System (K120330)

Submission Summary (Full Text)

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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 POD™ System.

## Sponsor/Applicant Name and Address

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

## Sponsor Contact Information

Charles DeNault Regulatory Affairs Specialist . Phone: [phone] Fax: [phone] Email: [e-mail]

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

April 30, 2014

#### Device Trade or Proprietary Name

POD™ System

#### Device Classification

II Regulatory Class: Classification Panel: Neurology Neurovascular/vascular embolization device Classification Name: 21 CFR 882.5950, 21 CFR 870.3300 Regulation Number: Product Code: HCG, KRD

#### Predicate Devices

| 510(k) Number /<br>Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|-----------------------------------|--------------------------|-------------------------|
| K103305 / 26-Jan-2011 | Penumbra Coil System | Penumbra, Inc. |
| K120330 / 02-Apr-2012 | Penumbra Coil System | Penumbra, Inc. |

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## Predicate Comparison

| | Penumbra Coil System | POD System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 510(k) No. | K103305 & K120330 | To be determined |
| Classification | Class II, HCG, KRD | Same |
| Indication | Indicated for the endovascular<br>embolization of:<br>• Intracranial aneurysms<br>• Other neurovascular abnormalities such<br>as arteriovenous malformations and<br>arteriovenous fistulae<br>•Arterial and venous embolizations in the<br>peripheral vasculature | Same |
| Materials | | |
| Coil | Platinum/Tungsten, Nitinol | Same |
| Detachment Pusher | Stainless steel, Polymer,<br>Platinum/Iridium, Nitinol | Same |
| Detachment Handle Shell/Funnel | Plastic | |
| Dimensions/Shape | | |
| Coil Secondary Length | 1-60 cm | Same |
| Coil Secondary Diameter | 2-32 mm | 4-8 mm* |
| Coil Secondary Shape | Complex (Standard, Soft, Extra Soft),<br>Helical (Curve), J | Complex |
| Accessories | | |
| Introducer Sheath | Polypropylene (color: orange) | Same |
| Packaging Materials | | |
| Coil Hoop | Polyethylene | Same |
| Pouch | Polyester/Polyethylene/Tyvek | Same |
| Display Carton | SBS Paperboard | Same |
| Sterilization/Shelf Life | | |
| Sterilization Method | EtO | Same |
| Shelf Life | 8 years | Same |

*The proximal segment of the coil will have a reduced secondary diameter

## Device Description

ﮨ

The POD System functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion in an equivalent fashion to existing bare-platinum embolization coils. The POD System

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consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.

## Intended Use

The POD System is indicated for the embolization of:

- Intracranial aneurysms .
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- . Arterial and venous embolizations in the peripheral vasculature

## 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 POD System as well as its substantial equivalence to the predicate devices:

- . Biocompatibility
- Design Verification (Bench-Top Testing) .
- MRI Compatibility .
- . Design Validation (GLP Animal Testing)

The subject POD System met all established requirements.

## Biocompatibility Testing

Non-clinical testing found POD to be biocompatible according to the requirements of EN ISO 10993 requirements. Biocompatibility for POD was derived from studies on the predicate device. Studies, were selected in accordance with EN ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The following tests were performed:

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| Test | Pass/Fail |
|------------------------------------------------------------------------------------------|-----------|
| In Vitro Cytotoxicity (MEM Elution) | Pass |
| Sensitization (Kligman Maximization) | Pass |
| Irritation (Intracutaneous Reactivity) | Pass |
| Systemic Toxicity | |
| Acute Toxicity (ISO Systemic Injection) | Pass |
| In Vivo Sub-acute / Sub-chronic Toxicity | Pass |
| Sub-chronic Toxicity Subchronic (30-Day) | Pass |
| Intravenous Toxicity Study - Mice | Pass |
| Materials Mediated Pyrogen - Rabbit | Pass |
| Genotoxicity | |
| Mouse Lymphoma | Pass |
| Ames Mutagenicity | Pass |
| In Vivo Mouse Micronucleus | Pass |
| Implantation GLP Study - Penumbra Coil<br>System in Swine Venous Pouch Aneurysm<br>Model | Pass |
| Intramuscular Implant Test 13 Week Duration | Pass |
| Hemocompatibility | |
| Hemolysis | Pass |
| Complement Activation | Pass |
| Dog Thrombogenicity | Pass |

## Bench-top Testing

The physical, mechanical and performance testing of the POD System components demonstrate 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 POD System 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 POD System components included:

| Attribute | Specification | Results |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Dimensional / Visual<br>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. | 100% Pass |
| Fatigue Testing | The Coil Implant shall retain its secondary shape after being<br>cycled into/out of introducer sheath 5 times | 100% Pass |
| Friction Testing | Push/pull friction acceptable through an 0.025in ID<br>microcatheter | 100% Pass |
| Stiffness Testing | Appropriate stiffness per coil specifications | 100% Pass |
| Simulated Use Flow Model<br>Testing | These evaluations confirm that the units used in this Design<br>Verification testing meet all inspection criteria for release of | 100% Pass |

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| Attribute | Specification | Results |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------|
| | finished goods (clinically acceptable) product. | |
| Coil Dimensional Inspection<br>(after simulated use testing) | These evaluations confirm that the units used in this Design<br>Verification testing withstood the simulated use testing | 100% Pass |
| Distal System Tensile Test | Coil Implant and Detachment Pusher joints has sufficient<br>tensile strength' | 100% Pass |

All testing met specification. 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 POD System are acceptable for the intended use and substantially equivalent to the predicate devices.

## MRI Compatibility

Penumbra consulted with an MR scanning expert and concluded minor design changes will have no impact on RF heating, and the same MRI conditions that are safe for the Penumbra Coil System Coil Implants arrays will also be safe for the POD Coil Implants.

## Design Validation (GLP Animal Testing)

The existing Penumbra Coil System GLP animal study fully characterizes the POD System's interaction with the vasculature. No additional animal testing is required for the POD System.

#### Summary of Substantial Equivalence

The POD 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

July 3, 2014

Penumbra, Inc. Mr. Charles Denault Regulatory Affairs Specialist 1351 Harbor Bay Parkway Alameda, California 94502

Re: K141134

> Trade/Device Name: POD system Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: June 4, 2014 Received: June 6, 2014

Dear Mr. Denault:

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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Page 2 - Mr. Charles Denault

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,

## Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological

and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K141134

Device Name POD (Penumbra Occlusion Device) System

Indications for Use (Describe) The POD System is indicated for the embolization of:

Intracranial aneurysms

Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae

Arterial and venous embolizations in the peripheral vasculature

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# pe Aguel -S Date: 2014.07.03 12:31:39
04'00'

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