Penumbra Coil 400, Ruby Coil System, POD System

K173614 · Penumbra, Inc. · HCG · Apr 17, 2018 · Neurology

Device Facts

• Record ID: K173614
• Device Name: Penumbra Coil 400, Ruby Coil System, POD System
• Applicant: Penumbra, Inc.
• Product Code: HCG · Neurology
• Decision Date: Apr 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Penumbra Coil 400 The Penumbra Coil 400 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. Ruby Coil System Ruby Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. POD System (For POD Coils with nominal sizes ≤ 6 mm) 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. POD System (For POD Coils with nominal sizes > 6 mm) The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.

Device Story

Neurovascular/peripheral embolization system; consists of bare platinum coil, delivery pusher with radiopaque marker, and introducer sheath. Used by trained physicians in interventional procedures. Coil deployed via microcatheter to target site; creates stasis to induce thrombosis, excluding treatment area from blood flow. Detachment handle used for multiple coil deployments per procedure. System provides mechanical occlusion of aneurysms and vascular abnormalities; benefits patient by preventing blood flow into targeted malformations or aneurysms.

Clinical Evidence

Bench testing only. No clinical data presented. Verification included dimensional inspection, fatigue resistance, torsional resistance, friction testing, simulated use flow model testing, tensile testing, and stiffness testing. Biocompatibility and MR compatibility testing performed per ISO 10993 and ASTM standards.

Technological Characteristics

Materials: Platinum/Tungsten, Nitinol, Adhesive, Gold/Tin, PET, Titanium. Principle: Mechanical embolization via coil deployment. Energy: None (mechanical). Connectivity: None. Sterilization: Ethylene Oxide (EO). Form factor: Coil/pusher assembly.

Indications for Use

Indicated for patients requiring embolization of intracranial aneurysms, neurovascular abnormalities (AVMs, AV 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

• Penumbra Coil System (K120330)

Reference Devices

• POD Packing Coil (K170852)

Submission Summary (Full Text)

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April 17, 2018

Penumbra, Inc. Aditi Kolla Regulatory Specialist III One Penumbra Place Alameda, California 94502

Re: K173614

Trade/Device Name: Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System); POD System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: March 10, 2018 Received: March 13, 2018

Dear Aditi Kolla:

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 mav, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Image /page/1/Picture/6 description: The image shows the text "Carlos L. Pena -S-D". The text is written in a simple, sans-serif font. The letters are black, and the background is white. The letters "FDA" are in the background in a light blue color.

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) K173614

#### Device Name

Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System) POD System

#### Indications for Use (Describe)

#### Penumbra Coil 400

The Penumbra Coil 400 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.

#### Ruby Coil System

Ruby Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.

#### POD System (For POD Coils with nominal sizes ≤ 6 mm)

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.

#### POD System (For POD Coils with nominal sizes > 6 mm)

The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | ☒ |
|----------------------------------------------|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |

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## 510(k) Summary

# K173614

(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 subject Penumbra Coil System and POD System.

## 1. Sponsor/Applicant Name and Address

Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA

# 2. Sponsor Contact Information

Aditi Kolla Regulatory Affairs Specialist III Phone: [phone] Fax: [phone] Email: [e-mail]

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

March 10, 2018

# 4. Device Trade or Proprietary Name

Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System) POD System

## 5. Primary Device Classification

II Regulatory Class: Classification Panel: Neurology Classification Name: Neurovascular Embolization Device Regulation Number: 21 CFR 882.5950 Product Code: HCG

## 6. Secondary Device Classification

Regulatory Class: Classification Panel: Classification Name: Regulation Number: Product Code:

II Cardiovascular Vascular Embolization Device 21 CFR 870.3300 KRD

## 7. Predicate and Reference Devices

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| 510(k)<br>Number | Clearance Date | of Predicate Device | Name of<br>Manufacturer |
|------------------|----------------|----------------------|-------------------------|
| Predicate Device | | | |
| K120330 | April 02, 2012 | Penumbra Coil System | Penumbra, Inc. |
| Reference Device | | | |
| K170852 | July 19, 2017 | POD Packing Coil | Penumbra, Inc. |

# 8. Predicate Device Comparison

| Attribute | Penumbra Coil<br>System<br>(Predicate Device) | POD Packing Coil<br>(Reference Device) | Penumbra Coil<br>System and POD<br>System (Subject<br>Device) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| General | | | |
| 510(k) No. | K120330 | K170852 | K173614 |
| Classification | Class II (HCG, KRD) | SAME | SAME |
| Intended Use | Indicated for the<br>embolization of:<br>-Intracranial aneurysms<br>-Other neurovascular<br>abnormalities such as<br>arteriovenous<br>malformations and<br>arteriovenous fistulae.<br>-Arterial and venous<br>embolizations in the<br>peripheral vasculature. | SAME | SAME |
| Materials/<br>Construction | | | |
| Coil | Platinum/Tungsten<br>(92% Pt, 8% W),<br>Nitinol (55% Ni, 45%<br>Ti), Adhesive,<br>Gold/Tin (80% Au,<br>20% Sn), Polyethylene<br>Terephthalate (PET),<br>Titanium | Platinum/Tungsten<br>(92% Pt, 8% W),<br>Polymer, Adhesive,<br>Polyethylene<br>Terephthalate (PET),<br>Titanium | SAME as<br>Reference |
| Dimensions/Shape | | | |
| Coil Shape | Complex, Helical, J | Wave | SAME as Predicate |
| Coil Length | 1 - 60 cm | 2 - 60 cm | SAME as Predicate |
| Coil<br>Secondary | 2-32 mm | Not Present | 2-40 mm |
| Attribute | Penumbra Coil<br>System<br>(Predicate<br>Device) | POD Packing Coil<br>(Reference Device) | Penumbra Coil<br>System and POD<br>System (Subject<br>Device) |
| Diameter<br>Coil Primary Diameter | 0.022 in. max | SAME | SAME |
| Device Packaging | specified in K120330 | SAME | SAME |
| Sterilization | Ethylene Oxide (EO) | SAME | SAME |
| Shelf-Life<br>(Coil/Pusher<br>assembly) | 8 years | 8 years | Penumbra Coil System: 8 years<br>POD System: 5 years |

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# 9. Device Description

The subject devices (Penumbra Coil System and POD System) are designed for embolization in the neuro and/or peripheral vasculature. This is achieved by using coils to exclude the intended treatment area from blood flow, thus creating stasis and allowing thrombosis to occur. The subject devices consist of a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. The devices should only be used by physicians who have received appropriate training in interventional techniques.

The subject devices consist of the following components:

- . Coil: The Coil is attached to a Delivery Pusher both contained within an Introducer Sheath. The Coil is an implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur.
- . Delivery Pusher: The Delivery Pusher is composed of a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT) and a pull wire. The Delivery Pusher may also be referred to as the Detachment Pusher.
- . Introducer Sheath: The Introducer Sheath is intended to cover the entire length of the Coil and the distal flexible segment of the Delivery Pusher. The Introducer Sheath is secured onto the Delivery Pusher with a friction lock to prevent unsheathing until use.
- Detachment Handle: The Detachment Handle is packaged separately. It is intended for ● use in multiple coil detachments performed during a single procedure.

# 10. Indications for Use

# Penumbra Coil 400

The Penumbra Coil 400 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. ●

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# Ruby Coil System

Ruby Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.

# POD System (For POD Coils with nominal sizes ≤ 6 mm)

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. ●

## POD System (For POD Coils with nominal sizes > 6 mm)

The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.

## 11. Summary of Non-Clinical Data

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of information regarding Substantial Equivalence of the device is as follows.

Included in this section are descriptions of the design control testing performed on the subject Penumbra Coil System and POD System. Design Verification (Bench-Top Testing and MR Characterization Testing) was performed on the subject devices as a part of the design control activities. The subject devices met all established requirements.

# 12. Bench-Top Testing

Design verification testing was conducted to evaluate the physical and mechanical properties of the subject devices and demonstrate substantial equivalence to predicate. The following tests were performed and all tests passed:

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| Attribute | Specification | Results |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensional/Visual<br>Inspection | Confirm the dimensions of the units meet all<br>product specifications. | Pass |
| Fatigue Resistance | The Coil retains its secondary shape after being<br>cycled into/out of the 0.025 inch inner diameter<br>(ID) microcatheter. | Pass |
| Torsional Resistance | Minimum value per specification | Pass |
| Friction through a 0.025 in.<br>ID microcatheter – Pull &<br>Push | Maximum value per specification | Pass |
| Simulated Use Flow Model<br>Testing | Simulated use testing with accessory devices in<br>an anatomical model which simulated the<br>tortuosity of the neurovasculature. Devices were<br>delivered through the model to evaluate the<br>effectiveness of the devices to embolize targeted<br>vasculature. | Pass |
| Distal System Tensile Test | Minimum per specification | Pass |
| Stiffness Testing | Maximum value per specification | Pass |

# 12.1. Biocompatibility Testing

Biocompatibility testing previously applicable to the predicate device and reference device substantiates the biocompatibility of the subject devices. 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 on the predicate and reference devices:

| Test | Method | Results |
|-------------------------------------------|--------------------------------------------------------|------------------|
| In Vitro Cytotoxicity | ISO Elution Test (MEM Extract) | Non-Toxic |
| Sensitization | Magnusson-Kligman Method | Non-Sensitizing |
| Irritation (Intracutaneous<br>Reactivity) | ISO Intracutaneous (Intradermal)<br>Injection Test | Non-Irritant |
| Implant study | Intramuscular Implant Test | Non-Irritant |
| Systemic Toxicity (Acute) | | |
| Acute Systemic Toxicity | ISO Acute Systemic Injection Test | Non-Toxic |
| Material Mediated Pyrogen | USP Material-Mediated Rabbit<br>Pyrogen Test | Non-pyrogenic |
| Sub-Chronic Toxicity (Sub-Acute Toxicity) | | |
| Sub-Chronic/Sub-Acute<br>Toxicity | 14 day / 14 dose Repeat Dose study | Non-Toxic |
| Hemo-compatibility | | |
| In Vitro Hemolysis | ASTM Method (Extraction &<br>Direct Contact) | Non-Hemolytic |
| Dog Thrombogenicity<br>Coagulation | Thrombogenicity Study in Dogs - ISO<br>PT and PTT Test | Non-Thrombogenic |

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| Complement Activation | C3a and SC5b-9 through<br>Enzyme Assay | No greater<br>biological response<br>than corresponding<br>control |
|-------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|
| Genotoxicity | | |
| Mouse Lymphoma | ISO In Vitro Mouse Lymphoma | Non-Mutagenic |
| Ames Mutagenicity | Salmonella typhimurium<br>Reverse Mutation Assay (Ames<br>Test) | Non-Mutagenic |
| In Vivo Mouse<br>Micronucleus | ISO In Vivo Mouse<br>Micronucleus Assay | Non-Mutagenic |

The leveraged non-clinical testing substantiates that the subject Penumbra Coil System and POD System is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, nonmutagenic, non-genotoxic, non-hemolytic, and non-thrombogenic.

## 12.2. MR Compatibility Testing

Testing in 1.5T & 3T MR environment was performed to advise the MR conditional statement in the Instructions for Use (IFU). Testing was done in accordance to standards ASTM F2182-11, ASTM F2052-15, ASTM F2213-06 (R-11), and ASTM F2119-07 (R-13).

## 12.3. MRA Testing

MRA artifact associated with a Penumbra coil array in the form of an 8 mm diameter sphere was assessed per ASTM F2119-07 (R-13) using a clinical MRA sequence. The maximum artifact distance beyond the implant was 2 mm using this sequence.

#### 13. Summary of Substantial Equivalence

The subject Penumbra Coil System (i.e., Penumbra Coil 400 and Ruby Coil System) and POD System are substantially equivalent to the predicate device Penumbra Coil System. The subject devices have identical intended use as the predicate device. The subject and the predicate devices differ slightly in regards to minor technological variations, while maintaining the same fundamental scientific technology. However, these differences do not raise different questions of safety and effectiveness.

The device testing described in the 510(k) Summary demonstrate the subject devices are substantially equivalent to the predicate device in regards to operating principle, fundamental technology and device performance.