Penumbra System, Penumbra Pump MAX

K160449 · Penumbra, Inc. · NRY · May 25, 2016 · Cardiovascular

Device Facts

• Record ID: K160449
• Device Name: Penumbra System, Penumbra Pump MAX
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: May 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX. Penumbra Pump MAX The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

Device Story

Penumbra System removes thrombus from neurovasculature via continuous aspiration. Reperfusion catheter targets aspiration to thrombus; separator clears catheter lumen if blocked. System components: reperfusion catheter, separator, aspiration tubing, and Penumbra Pump MAX. Catheter introduced through guide catheter/femoral sheath, guided over guidewire to occlusion site. Pump provides vacuum (up to 29 inHg) via aspiration tubing. Used in hospitals/clinics by physicians. Output is mechanical suction; enables thrombus removal, restoring blood flow in ischemic stroke patients. Devices visible under fluoroscopy.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by leveraged biocompatibility, bench top, sterilization, stability, and animal study data from predicate devices. Additional bench testing performed for KIT packaging configuration, including visual inspection, simulated use in tortuous anatomical models, coating integrity, and leak testing; all tests passed.

Technological Characteristics

System comprises reperfusion catheters, separators, aspiration tubing, and AC-powered vacuum pump. Materials are biocompatible interventional grade; catheters feature hydrophilic coating and radiopaque markerbands. Pump provides up to 29 inHg vacuum. Sterilization via EO (catheters/tubing). Compliant with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset.

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 System ACE 64 and ACE 68 Reperfusion Catheters (K152541)
• Penumbra Pump MAX (K122756)

Reference Devices

• Penumbra System (K072718)
• Penumbra System (K090752)
• Penumbra System (K100769)
• Penumbra System (K113163)
• Penumbra System (K133317)
• Penumbra System (K142458)
• Penumbra System (K151623)
• Penumbra Pump MAX (K051758)

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

May 25, 2016

Penumbra, Inc. Mr. Richard Kimura Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502

Re: K160449

Trade/Device Name: Penumbra System and Penumbra Pump MAX Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 22, 2016 Received: April 25, 2016

Dear Mr. Richard Kimura:

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 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.

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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,

Carlos L. Pena -S/A

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) K160449

Device Name Penumbra System® and Penumbra Pump MAX

Indications for Use (Describe)

Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.

Penumbra Pump MAX The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 1 510(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 Penumbra System®.

### 1.1 Sponsor/Applicant Name and Address

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

#### 1.2 Sponsor Contact Information

Richard Kimura Regulatory Affairs Specialist Phone: [phone] FAX: [phone] Email: [e-mail]

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

April 22, 2016

### 1.4 Device Trade or Proprietary Name

Penumbra System® and Penumbra Pump MAX

#### 1.5 Device Classification

Regulatory Class: II Classification Panel: Neurology Catheter, Thrombus Retriever Classification Name: Regulation Number: 21 CFR §870.1250 Product Code: NRY

#### 1.6 Predicate Devices

| 510(k) Number/<br>Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|----------------------------------|------------------------------------------------------------|-------------------------|
| Predicate Devices | | |
| K152541[13Jan2016] | Penumbra System ACE 64 and ACE<br>68 Reperfusion Catheters | Penumbra, Inc. |
| K122756[02Oct2012] | Penumbra Pump MAX | Penumbra, Inc. |

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### 1.7 Predicate Comparison

| | Predicate Device | Subject Device |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Penumbra System | Penumbra System (including<br>Penumbra Pump MAX) |
| Predicate 510(k)<br>No. | Penumbra System : K152541 | |
| Reference 510(k)<br>No. | Penumbra System: K072718, K090752,<br>K100769, K113163, K133317,<br>K142458, K151623<br>Penumbra Pump MAX:K122756 and<br>K051758 | K160449 |
| Classification | Penumbra System: Class II, NRY<br>Penumbra Pump MAX: Class II, JCX | Class II, NRY |
| Indication for Use | Penumbra System<br>The Penumbra System is intended for<br>use in the revascularization of patients<br>with acute ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral – M1 and M2 segments,<br>basilar, and vertebral arteries) within 8<br>hours of symptom onset.<br><br>Penumbra Aspiration Pump<br>The Penumbra Pump MAX is intended<br>for general suction use in hospitals or<br>clinics. | Reperfusion Catheters and Separators<br>As part of the Penumbra System, the<br>Reperfusion Catheters and Separators<br>are indicated for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral - M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the<br>Penumbra Sterile Aspiration Tubing is<br>indicated to connect the Penumbra<br>Reperfusion Catheters to the<br>Penumbra Pump MAX.<br><br>Penumbra Pump MAX<br>The Penumbra Pump MAX is<br>indicated as a vacuum source for<br>Penumbra Aspiration Systems. |
| Reperfusion Catheter | | |
| Materials | Biocompatible, commonly utilized for<br>interventional devices | SAME |
| Coating | Hydrophilic | SAME |
| Markerband | Radiopaque | SAME |
| Guidewire<br>compatible | Yes | SAME |
| Dimensions | | |
| - OD [Maximum] | 0.051" - 0.080" [1.295mm – 2.030mm] | SAME |
| - Working Length | $125cm - 153cm$ | SAME |
| Separator | | |
| Materials | Biocompatible, commonly utilized for<br>interventional devices | SAME |
| | Predicate Device | Subject Device |
| Trade Name | Penumbra System | Penumbra System (including<br>Penumbra Pump MAX) |
| Predicate 510(k)<br>No. | Penumbra System : K152541 | |
| Reference 510(k)<br>No. | Penumbra System: K072718, K090752,<br>K100769, K113163, K133317,<br>K142458, K151623<br>Penumbra Pump MAX:K122756 and<br>K051758 | K160449 |
| Classification | Penumbra System: Class II, NRY<br>Penumbra Pump MAX: Class II, JCX | Class II, NRY |
| Dimensions | | |
| - Distal OD | 0.022" – 0.045" [0.56mm – 1.14mm] | SAME |
| - Working Length | 135cm – 155cm | SAME |
| Aspiration Tubing | | |
| Materials | Biocompatible, commonly utilized for<br>interventional devices | SAME |
| Dimensions | | |
| - ID | 0.071" – 0.110" [1.80mm – 2.80mm] | SAME |
| - Length | 112.0" [284.5cm] | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36-Months | SAME |
| Aspiration Pump | | |
| IEC 60601-1<br>Compliance | Yes | SAME |
| IEC 60601-1-2<br>Compliance | Yes | SAME |
| Voltage | 100-115 Vac/230 Vac | SAME |
| Frequency | 50 Hz/60 Hz | SAME |
| Sterilization | Non sterile | SAME |
| Shelf Life | N/A | SAME |

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### Device Description 1.8

## The Penumbra System

The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in [1.37mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As

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needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.

## The Penumbra Pump MAX

The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.

#### 1.9 Indications for Use

## Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

## Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.

## Penumbra Pump MAX

The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

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## 1.10 Leveraged Non-Clinical Data - Individual Packaged Devices

The subject and predicate devices are identical. There are no changes in the device design, materials, manufacturing, packaging and sterilization methods. Therefore, biocompatibility data, bench top data, sterilization data, and stability data from previous pre-market notifications listed in Section 1.6 are directly applicable and no additional testing was required or was performed to support the consolidation of the Penumbra System and Penumbra Pump MAX under the same product code (NRY), clarifications of the Indications for Use statements, and Instructions for Use (IFU) and Operation, Maintenance, and Service Manual revisions.

## 1.11 Non-Clinical Data - KIT Configuration

Included in this section is a brief summary of additional testing performed for the KIT configuration packaging:

- Packaging Validation Testing .
The KIT configuration met all established requirements.

# 1.11.1 Packaging Validation

The physical and mechanical properties of the KIT configuration were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:

| Attribute | Specification | Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------|
| Visual Inspection | These evaluations confirm that the units used in this<br>Design Verification testing meet all inspection<br>criteria for release of finished goods (clinically<br>acceptable) product. | | Pass |
| Simulated Use<br>(Intracranial<br>Access, Vessel<br>Access Entry<br>Performance &<br>Clot Removal) | Simulated use testing of the Catheter and Separator<br>was performed with accessory devices in an<br>anatomical model which simulated the tortuosity of<br>the neurovasculature. Devices were delivered<br>through the tortuous anatomical model to<br>evaluate the effectiveness of the devices to remove<br>clots and that the Reperfusion Catheter does not<br>collapse under vacuum. | | 100% Pass |
| Catheter Coating | Coating has not delaminated, peeled, or flaked after<br>simulated use. | | 100% Pass |
| Gross Leak | Pouch seals, pouch front, and pouch back material<br>do not leak. | | 100% Pass |

The results of the tests appropriately address the physical and mechanical performance expectations of the KIT configuration. Based on these overall results, the physical and mechanical properties of the KIT configuration devices are acceptable for the intended use and substantially equivalent to the predicate device.

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## 1.12 Leveraged Animal Study - Individual Packaged Devices and KIT Configuration

The subject and predicate devices are identical. Therefore, Animal Testing data from previous pre-market notifications listed in Section 1.6 are directly applicable and no further Animal Testing was required or was performed to support the consolidation of the Penumbra System and Penumbra Pump MAX under the same product code (NRY), clarifications in the Indications for Use statements, and IFU and Operation, Maintenance, and Service Manual revisions.

## 1.13 Summary of Substantial Equivalence

The subject Penumbra System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.