POD Packing Coil

K170852 · Penumbra, Inc. · HCG · Jul 19, 2017 · Neurology

Device Facts

• Record ID: K170852
• Device Name: POD Packing Coil
• Applicant: Penumbra, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jul 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

POD Packing Coil is a bare platinum embolization coil; used for endovascular treatment of intracranial aneurysms, neurovascular abnormalities, and peripheral vascular embolization. Device consists of coil, delivery pusher, introducer sheath, and detachment handle. Physician delivers coil through microcatheter to target site; coil excludes treatment area from blood flow to induce stasis and thrombosis. Detachment performed via handle. Used in clinical settings by trained interventional physicians. Benefits include effective occlusion of vascular abnormalities. Device is a modification of existing POD system with wave-shaped coil geometry.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included dimensional/visual inspection, fatigue resistance, torsional resistance, friction testing, simulated use in anatomical models, and distal system tensile testing. All tests passed. Biocompatibility leveraged from predicate/reference devices per ISO 10993-1.

Technological Characteristics

Implantable bare platinum coil; materials include platinum/tungsten, nitinol, gold/tin, PET, and titanium. Wave-shaped geometry. Delivered via pusher/introducer sheath system. Sterilized via Ethylene Oxide (EO). Mechanical device; no software or energy source.

Indications for Use

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

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

• POD System (K141134)

Reference Devices

• Penumbra Smart Coil (K160832)

Submission Summary (Full Text)

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

July 19, 2017

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

Re: K170852

Trade/Device Name: POD Packing Coil Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: May 25, 2017 Received: May 25, 2017

Dear Ms. 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 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 device

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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 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,

# Carlos L. Pena -S

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) K170852

Device Name POD Packing Coil

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

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

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image features the word "Penumbra" in a bold, red font, followed by a circular logo. The logo is red with a white "P" inside. The overall design is clean and professional.

### 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 subject POD Packing Coil.

#### 1.1 Sponsor/Applicant Name and Address

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

#### 1.2 Sponsor Contact Information

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

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

July 18, 2017

#### Device Trade or Proprietary Name 1.4

POD Packing Coil

#### 1.5 Primary Device Classification

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

#### 1.6 Secondary Device Classification

Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Vascular embolization device Regulation Number: 21 CFR 870.3300 Product Code: KRD

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#### Predicate and Reference Devices 1.7

| 510(k) Number | Clearance Date | Name of Device | Name of Manufacturer |
|------------------|----------------|---------------------|----------------------|
| Predicate Device | | | |
| K141134 | July 03, 2014 | POD System | Penumbra, Inc. |
| Reference Device | | | |
| K160832 | April 20, 2016 | Penumbra Smart Coil | Penumbra, Inc. |

#### Device Description 1.8

The Penumbra Occlusion Device (POD), including the subject device, is a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. It is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. It is also intended for arterial and venous embolization in the peripheral vasculature. The POD System should only be used by physicians who have received appropriate training in interventional techniques.

The POD System consists 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

#### 1.9 Indications For Use

POD is indicated for the endovascular 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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Image /page/5/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, and the colors are bold and eye-catching.

# 1.10 Predicate Device Comparison

| Attribute | POD System<br>(Predicate Device) | Penumbra Smart Coil<br>(Reference Device) | POD Packing Coil<br>(Subject Device) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------|
| General | | | |
| 510(k) No. | K141134 | K160832 | K170852 |
| Classification | Class II (HCG, KRD) | SAME | SAME |
| Intended Use | Indicated for the<br>endovascular<br>embolization of:<br>• Intracranial<br>aneurysms<br>• Other neurovascular<br>abnormalities such<br>as arteriovenous<br>malformations and<br>arteriovenous<br>fistulae<br>• Arterial and venous<br>embolizations in the<br>peripheral<br>vasculature | SAME | SAME |
| Materials/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 Reference |
| Introducer Sheath | Polypropylene, PET | High Density<br>Polyethylene, PET | SAME as Reference |
| Dimensions/Shape | | | |
| Coil Shape | Complex | Complex, Helical | Wave (two dimensional<br>shape) |
| Coil Length | 1 - 60 cm | SAME | 2 - 60 cm |
| Coil Primary Diameter | 0.022 in. max | 0.0135 in. max | SAME as Predicate |
| Other | | | |
| Device Packaging | As specified in<br>K141134 | SAME | SAME |
| Sterilization | Ethylene Oxide (EO) | SAME | SAME |
| Pyrogenicity<br>(Coil/Pusher) | < 2.15 EU/device | SAME | SAME |
| Pyrogenicity<br>(Detachment Handle) | < 20 EU/device | SAME | SAME |
| Shelf-Life (Coil/Pusher<br>assembly) | 8 years | 5 years | SAME as Reference |
| Shelf-Life (Detachment<br>Handle) | 3 years | 5 years | SAME as Predicate |

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## 1.11 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 POD Packing Coil. Design Verification (Bench-Top Testing) was performed on the subject device as a part of the design control activities. The subject POD Packing Coil met all established requirements.

## 1.11.1 Bench-top Testing

Design Verification testing was conducted to evaluate the physical and mechanical properties of the POD Packing Coil and demonstrate substantial equivalence to predicate. The following tests were performed and all tests passed:

| Attribute | Specification | Results |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Dimensional/Visual<br>Inspection | Confirm the dimensions of the units meet all<br>product specifications. | 100%<br>Pass |
| Fatigue Resistance | The Coil retains its secondary shape after being<br>cycled into / out of the 0.025 in. ID microcatheter. | 100%<br>Pass |
| Torsional Resistance | Minimum value per specification | 100%<br>Pass |
| Friction through a 0.025<br>in. ID microcatheter –<br>Pull & Push | Maximum value per specification | 100%<br>Pass |
| Simulated Use Flow<br>Model Testing | Simulated use testing of POD Packing Coil with<br>accessory devices in an anatomical model which<br>simulated the tortuosity of the neurovasculature.<br>Devices were delivered through the model to<br>evaluate the effectiveness of the devices to<br>embolize targeted vasculature. | 100%<br>Pass |
| Distal System Tensile<br>Test | Minimum per specification | 100%<br>Pass |

### 1.11.2 Biocompatibility Testing

Biocompatibility testing previously performed on the predicate device and reference device substantiates the biocompatibility of the subject device POD Packing Coil. 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

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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 | ISO Intracutaneous (Intradermal) | Non-Irritant | |
| Reactivity) | Injection Test | | |
| 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 | 14 day / 14 dose Repeat Dose study | Non-Toxic | |
| Toxicity | | | |
| Hemo-compatibility | | | |
| In Vitro Hemolysis | ASTM Method (Extraction & Direct | Non-Hemolytic | |
| | Contact) | | |
| Dog Thrombogenicity | Thrombogenicity Study in Dogs - ISO | Non-Thrombogenic | |
| Coagulation | PT and PTT Test | Non-Thrombogenic | |
| | | No greater | |
| Complement Activation | C3a and SC5b-9 through Enzyme | biological response | |
| | Assay | than corresponding | |
| | | control | |
| Genotoxicity | | | |
| Mouse Lymphoma | ISO In Vitro Mouse Lymphoma | Non-Mutagenic | |
| Ames Mutagenicity | Salmonella typhimurium Reverse | Non-Mutagenic | |
| | Mutation Assay (Ames Test) | | |
| In Vivo Mouse<br>ISO In Vivo Mouse Micronucleus | | Non-Mutagenic | |
| Micronucleus | Assay | | |

The leveraged non-clinical testing substantiates that the POD Packing Coil is noncytotoxic, non-sensitizing, non-irritating, non-toxic, non-mutagenic, non-mutagenic, nongenotoxic, non-hemolytic, and non-thrombogenic.

## 1.12 Summary of Substantial Equivalence

The subject device POD Packing Coil device is substantially equivalent to the predicate device POD System. The subject device has identical intended use as the predicate device. The subject device and the predicate devices differ slightly in regards to minor technological variations, while maintaining the same fundamental scientific technology.

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However, these differences do not raise different questions of safety and effectiveness. The device testing described in Section 1.11 demonstrate the subject device is substantially equivalent to the predicate device in regards to operating principle, fundamental technology and device performance.