Penumbra System ACE 64 and ACE 68 Reperfusion Catheters

K152541 · Penumbra, Inc. · NRY · Jan 13, 2016 · Cardiovascular

Device Facts

• Record ID: K152541
• Device Name: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Jan 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Penumbra System is intended 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.

Device Story

The Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are neurovascular catheters used to aspirate thrombus from occluded vessels. The device is used in conjunction with an aspiration pump. The catheter is navigated to the site of occlusion; vacuum pressure is applied via the pump to aspirate the thrombus. The procedure is performed by a physician in a clinical setting. The device facilitates revascularization, potentially improving clinical outcomes for patients suffering from acute ischemic stroke. The catheters are single-use, sterile, and non-pyrogenic.

Clinical Evidence

No clinical data. Evidence consists of GLP animal testing in a porcine vascular model evaluating vascular response to aspiration in a 'wedged' position. Results showed no significant vessel response on contrast angiography and no significant pathological findings on gross necropsy or histopathology.

Technological Characteristics

Catheters feature proximal hubs (Grilamid), stainless steel strain relief, and distal extrusions (Pellethane, Tecoflex, Pebax). Reinforcement includes stainless steel and NiTi coils. Coated with proprietary SRDX Harmony. Dimensions: 0.068-0.084 inch ID/OD. Sterilized via EO. Standalone device used with aspiration pump.

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 (K142458)

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

January 13, 2016

Penumbra, Inc. Ms. Michaela Mahl, MSBE Senior Manager Regulatory Affairs One Penumbra Place Alameda, California 94502

Re: K152541

Trade/Device Name: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 11, 2015 Received: December 14, 2015

Dear Ms. Michaela Mahl:

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,

# Michael J. Hoffmann -A

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) K152541

Device Name

Penumbra System® ACE 64 and ACE 68 Reperfusion Catheters

Indications for Use (Describe)

The Penumbra System is intended 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 ACE 64 and ACE 68 Reperfusion Catheters .

#### 1.1 Sponsor/Applicant Name and Address

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

#### 1.2 Sponsor Contact Information

Michaela Mahl Senior Manager, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

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

December 11, 2015

#### 1.4 Device Trade or Proprietary Name

Penumbra System® ACE 64 and ACE 68 Reperfusion Catheters

#### Device Classification 1.5

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

#### 1.6 Predicate Devices

| 510(k) Number / Clearance<br>Date | Name of Predicate Device | Name of Manufacturer |
|-----------------------------------|-------------------------------------------------------------|---------------------------------------------------------------|
| K142458 / 22May2015 | Penumbra System® ACE 64 and<br>ACE 68 Reperfusion Catheters | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |

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#### 1.7 Predicate Comparison

| System Name | Predicate<br>Reperfusion Catheters | | Subject<br>Reperfusion Catheters | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | ACE 64 | ACE 68 | ACE 64 | ACE 68 |
| Device Name | ACE 64 | | ACE 68 | |
| 510(k) No. | K142458 | | SAME | |
| Classification | Class II, NRY | | SAME | |
| Indication | The Penumbra System is intended for<br>use in the revascularization of patients<br>with acute ischemic stroke secondary<br>to 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. The Reperfusion Catheters ACE<br>64 and ACE 68 are intended for use in<br>revascularization within the Internal<br>Carotid Artery (ICA) within 8 hours of<br>symptom onset. | | The Penumbra System is intended for<br>use in the revascularization of patients<br>with acute ischemic stroke secondary<br>to 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. | |
| Materials | | | | |
| Proximal hub | Grilamid (TR55-LX) | SAME | SAME | SAME |
| Strain Relief [Hub Sleeve] | Grilamid (TR55) | SAME | SAME | |
| Strain Relief | Stainless Steel, 304 | SAME | SAME | |
| ID Band | Polyolefin, PET yellow [black ink] | SAME | SAME | |
| Catheter Shaft | | | | |
| Distal Extrusions | Pellethane 80A, Tecoflex 80A,<br>Tecoflex 80A/Pebax 35D, Pebax 35D,<br>Pebax 35D/40D Blend, Pebax 40D,<br>Pebax 40D/55D Blend, Pebax 55D,<br>Pebax 63D | | SAME | |
| Proximal Extrusions | Pebax 55D, Pebax<br>72D, Vestamid | Pebax 55D/72D<br>Blend, Pebax<br>72D, Vestamid | SAME | SAME |
| Proximal Coil<br>Reinforcement | SS flat (0.0015 in x<br>0.006 in) and SS<br>round (0.0025 in) | SS flat (0.0015<br>in x 0.006 in)<br>and NiTi round<br>(0.0025 in) | SAME | SAME |
| Extrusion Colorants | Clear/ Natural or Purple | SAME | SAME | |
| Tip Shape | Straight | | SAME | |
| Markerband | C-cut Pt/Ir band | | SAME | |
| Coating | SRDX Harmony (proprietary) | | SAME | |
| Dimensions | | | | |
| Proximal OD | 0.084 in Max | 0.084 in Max | SAME | SAME |
| Proximal ID | 0.068 in Min | 0.068 in Min | SAME | SAME |
| Distal OD | 0.080 in Max | 0.084 in Max | SAME | SAME |
| Distal ID | 0.064 in Min | 0.068 in Min | SAME | SAME |
| Effective Length | 115, 120, 125, 127, 132 cm | | SAME | |
| Coating Length | 30 cm | | SAME | |
| Accessories | | | | |
| System Name | Predicate<br>Reperfusion Catheters | | Subject<br>Reperfusion Catheters | |
| Device Name | ACE 64 | ACE 68 | ACE 64 | ACE 68 |
| Rotating Hemostasis Valve | Polycarbonate, silicone o-ring | | SAME | |
| Shaping Mandrel | 0.038in OD | | SAME | |
| Packaging Materials | | | | |
| Pouch | Polyester/Polyethylene/<br>Tyvek® | | SAME | |
| Packaging Hoop | Polyethylene | | SAME | |
| Packaging Card | Polyethylene | | SAME | |
| Display Carton | SBS Paperboard | | SAME | |
| Packaging Configuration | Individual | | SAME | |
| Sterilization | EO | | SAME | |
| Shelf-Life | 36 Months | | SAME | |

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#### Device Description 1.8

The Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are components to the currently available Penumbra System. The Penumbra System ACE AC 64 and ACE 68 Reperfusion Catheters are used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

#### 1.9 Indications for Use

The Penumbra System is intended 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.

# 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 devices follows.

Included in this section is a summary description of the testing, which substantiates the performance of the subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters as well as its substantial equivalence to the predicate devices:

- · Design Validation (GLP Animal Testing)
The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters met all established requirements.

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# 1.10.1 Animal Study

The safety and performance of the ACE 64 and ACE 68 Reperfusion Catheters, when "wedged" in a vessel and using maximum aspiration, was evaluated in the accepted porcine vascular model. The purpose of this study was to evaluate the Reperfusion Catheter ACE aspiration vascular response when "wedged" within a swine artery. Safety of the test articles was assessed by consideration of the acute and chronic vascular response. Vascular response was assessed by contrast angiography and by gross necropsy and histopathology of associated vasculature performed by the Sponsor Pathologist.

The study concluded that:

- . No significant vessel response was noted on the contrast angiograms following the aspiration treatment with the test article in a wedged position.
- No significant pathological findings were identified during the gross or . histopathological evaluation.

# 1.10.2 Leveraged Non-Clinical Data

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 the predicate devices (K142458) are directly applicable and no additional testing is required or was performed.

# 1.11 Summary of Substantial Equivalence

The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.