PENUMBRA EMBOLIZATION COIL SYSTEM

K103305 · Penumbra, Inc. · HCG · Jan 26, 2011 · Neurology

Device Facts

• Record ID: K103305
• Device Name: PENUMBRA EMBOLIZATION COIL SYSTEM
• Applicant: Penumbra, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jan 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Penumbra Coil 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

Penumbra Coil System comprises implantable embolization coils (Complex Standard, Complex Soft, J Soft, Curve Extra Soft) and a detachment handle. Coils are platinum/tungsten and Nitinol; detachment pusher is stainless steel/polymer. Device used by physicians in clinical settings for neurovascular and peripheral vascular embolization. Coils are delivered to target site; detachment handle triggers release from pusher. Mechanical embolization occludes blood flow to aneurysms or vascular abnormalities. System is sterile, single-use, and non-pyrogenic.

Clinical Evidence

No clinical data. Evidence consists of bench-top design verification and biocompatibility testing. Biocompatibility testing (ISO 10993) included cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, haemocompatibility, and pyrogenicity. Design verification included dimensional inspection, joint tensile strength, fatigue, friction, torsion, stiffness, corrosion, handle function, MRI compatibility, and GLP simulated use. All tests passed.

Technological Characteristics

Coils: Platinum/tungsten and Nitinol wire. Pusher: Stainless steel and polymer. Detachment mechanism: Mechanical. Sterilization: Ethylene Oxide (EtO). Shelf-life: 36 months. Single-use, sterile, non-pyrogenic. MRI compatible.

Indications for Use

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

• Guglielmi Detachable Coil (GDC™) (K031049, K093142)

Submission Summary (Full Text)

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K1033Q5

Penumbra Coil System

#### 7 510(K) SUMMARY

JAN 2 6 2011

(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 Embolization Coils (Trade Name TBD).

### 7.1 Sponsor/Applicant Name and Address

Penumbra, Inc.

1351 Harbor Bay Parkway Alameda, CA 94502

### 7.2 Sponsor Contact Information

Seth A. Schulman

Director, Regulatory Affairs

Phone: [phone]

FAX: [phone]

email: [e-mail]

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

November 8, 2010

### 7.4 Device Trade or Proprietary Name

Penumbra Coil System / Penumbra Coil 400™

### Device Common/Usual or Classification Name 7.5

Device, Vascular and Neurovascular Embolization (Product Code: HCG& KRD)

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

| Name of Predicate<br>Device | Name of Manufacturer (Town,<br>State) | 510(k) Number |
|--------------------------------------|------------------------------------------------|---------------------|
| Guglielmi Detachable Coil<br>(GDCTM) | Boston Scientific Neurovascular<br>Fremont, CA | K031049&<br>K093142 |

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### 7.7 Device Description:

The Penumbra Coil System consists of the following components, which are sold separately:

- . Complex Standard Implantable Embolization Coils attached to detachment pusher
- . Complex Soft Implantable Embolization Coils attached to detachment pusher
- . J Soft Implantable Embolization Coils attached to detachment pusher
- . Curve Extra Soft Implantable Embolization Coils attached to detachment pusher
- . Detachment Handle

The coils are primarily manufactured from platinum wire and Nitinol wire. The coils are attached to a stainless steel / polymer detachment pusher. The coils are available in varying secondary diameters and shapes based on coil type.

The Penumbra Embolization Coils are sterile, non-pyrogenic and intended for single use only. The Penumbra Detachment Handle is sterile, non-pyrogenic and may be used to detach multiple coils within a single patient procedure.

### 7.8 Intended Use:

The Penumbra Embolization Coils are intended for the embolization of:

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

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# Penu

### 7.9 Comparison to predicate Device

| | Guglielmi Detachable Coil (GDC™) | Penumbra<br>Embolization Coil |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k) No. | K031049, K093142 | To be determined |
| Classification | Class II, HCG, KRD | Class II, HCG, KRD |
| Indication | Intended for the embolization of: | Same |
| | • 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 | |
| Materials | Coil:<br>Platinum/tungsten, Polypropylene<br>Pusher: stainless steel | Coil:<br>Platinum/tungsten,<br>Nitinol<br>Pusher: stainless steel,<br>polymer |
| Sterilization | EtO | Same |
| Shelf-Life | 36-Months | 36-Months) |

### 7.10 Summary of Non-clinical Data:

### Biocompatibility 7.10.1

Biocompatibility tests conducted with Penumbra Coil System were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for a blood contacting permanent implant device. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

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| Test | Method | Result |
|----------------------------------------|-------------------------------------------|-----------------------------------------------------------|
| Cytotoxicity | L929 MEM Elution Test | Non-Toxic |
| Sensitization | Kligman Maximization | Non-Sensitizing |
| Intracutaneous Reactivity (Irritation) | Intracutaneous Injection Test | Non-Irritant |
| Systemic Toxicity* (Acute) | ISO Acute Systemic Injection Test | Non-Toxic |
| Subacute / Subchronic Toxicity | <i>In vivo</i> Subacute Toxicity | Non-Toxic |
| Genotoxicity | Ames test | Non-Mutagenic |
| | Mouse Lymphoma | Non-Mutagenic |
| Implantation | <i>In vivo</i> Implantation | Non-Irritant |
| Haemocompatibility | Complement Activation | No greater biological response than corresponding control |
| | Hemolysis | Non-Hemolytic |
| | <i>In vivo</i> thrombogenicity | Non-Thrombogenic |
| Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test | Non-Pyrogenic |

## ISO-10993 GLP Testing Summary for the Penumbra Coil System

In summary, non-clinical testing found the Penumbra Coil System to be biocompatible according to the requirements of ISO 10993-1. Additionally, the product was found to be non-pyrogenic.

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

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

- . Dimensional / Visual Inspection (all sizes)
- . Joint Tensile Strength
- . Fatigue

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### Penumbra Coil System

Image /page/4/Picture/1 description: The image shows the word "Penumbra" in a sans-serif font, followed by a hyphen and a stylized letter "P" inside a black circle. The letter "P" is white and has a small dot to the lower right of the circle. The word "Penumbra" is in black and appears to be the name of a company or product.

- . Friction
- . Torsion
- Stiffness .
- Corrosion .
- Handle Function .
- . MRI Compatibility
- . GLP Simulated Use

All tests performed passed successfully.

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

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

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

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

JAN 2 6 2011

Re: K103305

Trade/Device Name: Penumbra Coil System / Penumbra Coil 400™ Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 8, 2010 Received: November 9, 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.

2017 07:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 10:00 PM 1

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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 (2) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melvin R. Laird

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K103305

Device Name: Penumbra Coil System / Penumbra Coil 400™

Indications For Use:

The Penumbra Coil 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 .

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kitt

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KIO3305

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number.