Penumbra System (Modified 110 Aspiration Tubing)

K182522 · Penumbra, Inc. · NRY · Oct 12, 2018 · Cardiovascular

Device Facts

• Record ID: K182522
• Device Name: Penumbra System (Modified 110 Aspiration Tubing)
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Oct 12, 2018
• Decision: SESE
• Submission Type: Special
• 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 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA ) or who fail IV t-PA therapy are candidates for treatment. Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. 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 Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Device Story

Penumbra System removes thrombus from neurovasculature via continuous aspiration. System components include Reperfusion Catheters, Separators, 3D Revascularization Device, Aspiration Pump, and Aspiration Tubing. Subject device is modified 110 Aspiration Tubing (PST4) connecting catheter to pump. Physician (interventional neuroradiologist) operates system in clinical setting. Catheter introduced via guide catheter/sheath to occlusion; pump provides vacuum; flow switch on tubing allows physician to control aspiration. Separator clears catheter lumen if blocked. Output is thrombus removal; clinical benefit is revascularization of occluded vessels. Modified tubing features single-piece construction and updated flow switch assembly; maintains compatibility with existing pump/catheter components.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993), dimensional/visual inspection, suction connector/luer compatibility, vacuum leak testing, flow control switch cycling, and tensile strength testing.

Technological Characteristics

Aspiration tubing assembly; materials include polyurethane, nylon, polycarbonate, acetal, and PVC. Single-piece construction. EO sterilized. 36-month shelf life. Connects to vacuum pump via press-fit suction connector and rotating luer. Flow switch controls aspiration. Dimensions: 0.110 in ID, 0.188 in OD, 100 in length.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, and vertebral arteries) within 8 hours of symptom onset. Candidates include patients ineligible for or failing IV t-PA therapy.

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 – 110 Aspiration Tubing (K151623)
• Penumbra System - 3D Revascularization Device (K162901)
• Penumbra System – Reperfusion Catheters JET 7 (K173761)

Reference Devices

• Indigo Aspiration System – Advanced 110 Aspiration Tubing (K180939)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 12, 2018

Penumbra, Inc. Micaela Victoria Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502

Re: K182522

Trade/Device Name: Penumbra System (Modified 110 Aspiration Tubing) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: September 11, 2018 Received: September 13, 2018

Dear Micaela Victoria:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Xiaolin Zheng -S

for 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) K182522

Device Name Penumbra System (Modified 110 Aspiration Tubing)

### Indications for Use (Describe)

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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA ) or who fail IV t-PA therapy are candidates for treatment.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

### 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 Aspiration Pump.

Penumbra Aspiration Pump The Penumbra Aspiration Pump 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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Image /page/3/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 "P" is stylized with a horizontal line extending from the right side of the "P" to the edge of the circle. The logo is simple and modern.

#### 510(k) Summary - K182522 1

(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® with modified 110 Aspiration Tubing.

#### 1.1 Sponsor/Applicant Name and Address

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

#### 1.2 Sponsor Contact Information

Micaela Victoria Regulatory Affairs Specialist II Phone: [phone] FAX: [phone] Email: [e-mail]

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

October 09, 2018

#### 1.4 Device Trade or Proprietary Name

Penumbra System® (Modified 110 Aspiration Tubing)

#### 1.5 Device Classification

| Regulatory Class: | II |
|-----------------------|-----------------------|
| Classification Panel: | Neurology |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR §870.1250 |
| Product Code: | NRY |

#### 1.6 Predicate and Reference Devices

| 510(k) Number / Clearance Date | Name of Device | Name of Manufacturer |
|------------------------------------|-----------------------------------------------|---------------------------------------------------------------|
| Predicate Device | | |
| K151623 cleared on August 6, 2015 | Penumbra System – 110 Aspiration Tubing | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
| Additional Predicate Devices | | |
| K162901 cleared on April 20, 2017 | Penumbra System - 3D Revascularization Device | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
| K173761 cleared on August 17, 2018 | Penumbra System – Reperfusion Catheter JET 7 | |

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Image /page/4/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written 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.

| Reference Device | | |
|---------------------------------|--------------------------------------------------------------|---------------------------------------------------------------|
| K180939 cleared on May, 3, 2018 | Indigo Aspiration System – Advanced 110<br>Aspiration Tubing | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |

#### 1.7 Predicate Comparison

| | Predicate Device | Subject Device1 | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Trade Name | Penumbra System | SAME | |
| 510(k) No. | K151623 [Primary Predicate] | K182522 | |
| Classification | Class II, NRY | SAME | |
| Indication for Use | The Penumbra System / Penumbra System<br>MAX are intended for use in the<br>revascularization of patients with acute<br>ischemic stroke secondary to intracranial large<br>vessel occlusive disease (within the internal<br>carotid, middle cerebral - M1 and M2<br>segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset.<br>The Penumbra System is intended for use in<br>the revascularization of patients with acute<br>ischemic stroke secondary to intracranial large<br>vessel occlusive disease (within the internal<br>carotid, middle cerebral - M1 and M2<br>segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset. The<br>Reperfusion Catheters ACE 64 and ACE 68 | Penumbra Reperfusion Catheters and<br>Separators<br>As part of the Penumbra System, the<br>Reperfusion Catheters and Separators are<br>indicated for use in the revascularization<br>of patients with acute ischemic stroke<br>secondary to intracranial large vessel<br>occlusive disease (within the internal<br>carotid, middle cerebral - M1 and M2<br>segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset.<br>Patients who are ineligible for<br>intravenous tissue plasminogen activator<br>(IV t-PA) or who fail IV t-PA therapy are<br>candidates for treatment. | |
| | are intended for use in revascularization<br>within the Internal Carotid Artery (ICA)<br>within 8 hours of symptom onset. | Penumbra 3D Revascularization Device<br>As part of the Penumbra System, the<br>Penumbra 3D Revascularization Device<br>is indicated for use in the<br>revascularization of patients with acute<br>ischemic stroke secondary to intracranial<br>large vessel occlusive disease (within the<br>internal carotid, middle cerebral – M1<br>and M2 segments) within 8 hours of<br>symptom onset. Patients who are<br>ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or who<br>fail IV t-PA therapy are candidates for<br>treatment.<br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the<br>Penumbra Sterile Aspiration Tubing is<br>indicated to connect the Penumbra | |
| | Predicate Device | Subject Device1 | |
| Trade Name | Penumbra System | SAME | |
| 510(k) No. | K151623 [Primary Predicate] | K182522 | |
| Classification | Class II, NRY | SAME | |
| | | Reperfusion Catheters to the Penumbra<br>Aspiration Pump. | |
| | | Penumbra Aspiration Pump | |
| | | The Penumbra Aspiration Pump is<br>indicated as a vacuum source for<br>Penumbra Aspiration Systems. | |
| Aspiration Tubing | | | |
| | Current 110 Aspiration Tubing | Modified 110 Aspiration Tubing | |
| Tubing Inner<br>Diameter (ID) | 0.110 in | SAME | |
| Tubing Outer<br>Diameter (OD) | 0.188 in | SAME | |
| Overall Length | 112.0 in | 100.0 in | |
| Distal Length | 7.0 in | N/A (Single Piece Construction) | |
| Materials | | | |
| Tubing Material | Polyurethane & Nylon | SAME | |
| Rotating Male<br>Luer | Polycarbonate with EPDM OR Silicone O-<br>Ring | SAME | |
| Tubing/Luer Joint<br>Adhesive | Cyclohexanone | SAME | |
| Female Luer | Polycarbonate | N/A | |
| Suction Connector<br>Material | Polyvinylchloride (PVC) | SAME | |
| Tubing/Suction<br>Connector Joint<br>Adhesive | Loctite | Cyclohexanone | |
| Flow Control<br>Switch Body<br>Material | Polycarbonate | SAME | |
| Flow Control<br>Switch Slider<br>Material | Acetal | Acetal | |
| Flow Control<br>Switch Slider<br>Material Pin | Acetal | Nylon | |
| Collar | ABS | N/A | |
| Valve | Silicone | N/A | |
| "ON" Logo | Polyolefin | Heat Stamp Foil | |
| "OFF" Logo | Polyolefin | Heat Stamp Foil | |
| | | Predicate Device | Subject Device1 |
| Trade Name | Penumbra System | | SAME |
| 510(k) No. | K151623 [Primary Predicate] | | K182522 |
| Classification | Class II, NRY | | SAME |
| Packaging<br>Materials | Pouch | Polyester/Polyethylene/Tyvek® | Nylon/ADH/HDPE/Tyvek® |
| | Display<br>Box | SBS Paperboard | SAME |
| | Label Stock | Label stock | SAME |
| Sterilization | EO | | SAME |
| Shelf Life | 36 months | | SAME |

l The Penumbra System Reperfusion Catheters, Separators, and Aspiration Pumps are unchanged and remain identical to those of the currently cleared Penumbra System (K162901, K173761, and K180008,).

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Image /page/5/Picture/0 description: The image shows the word "Penumbra" in a bold, red font. To the right of the word is a circular logo, also in red, with a white "P" inside. The logo is simple and modern, and the overall design is clean and professional.

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Image /page/6/Picture/0 description: The image shows the logo for Penumbra, Inc., a healthcare company. The word "Penumbra" is written in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside of it. The logo is simple and modern, and the red color is eye-catching.

#### Device Description 1.8 -

The Penumbra System is intended for the removal of thrombus from the neuro vasculature using continuous aspiration. Intended users for this device are physicians who have received appropriate training in interventional neuroradiology and the treatment of acute ischemic stroke.

The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. 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 or largerfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As 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 Aspiration Pump, 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 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under

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Image /page/7/Picture/0 description: The image shows the Penumbra company logo. The logo consists of the word "Penumbra" in a red, sans-serif font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the left side of the letter to the edge of the circle.

fluoroscopy.

The Penumbra Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Penumbra Reperfusion Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for PST1, 0.088 in [2.24mm] for PST2, and 0.110 in [2.79mm] for PST3 and PST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices. The Modified 110 Aspiration Tubing (PST4) is the subject device for this submission (K182522).

#### 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

## Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

## 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 Aspiration Pump.

### Penumbra Aspiration Pump

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

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Image /page/8/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a red circle with a white "P" inside of it. A white line extends from the left side of the "P" to the right side of the word "Penumbra".

## 1.10 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 substantial equivalence of the device follows.

Included in this section are summary descriptions of the testing which substantiates the performance of the subject Penumbra System with modified 110 Aspiration Tubing as well as its substantial equivalence to the predicate device:

- Biocompatibility .
- Design Verification (Bench-Top Testing) ●
- Shelf Life ●
- Sterilization ●
- Packaging ●

The subject Penumbra System with modified 110 Aspiration Tubing met all established requirements.

## 1.10.1 Biocompatibility

Biocompatibility testing…