Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]

K142870 · Penumbra, Inc. · QEW · May 26, 2015 · Cardiovascular

Device Facts

• Record ID: K142870
• Device Name: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
• Applicant: Penumbra, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: May 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature.

Device Story

System uses aspiration to remove fresh, soft emboli and thrombi from peripheral arterial and venous vessels; includes aspiration catheter and separator. Separator breaks up clot inside catheter to facilitate aspiration. Device used in clinical settings by physicians. Output is physical removal of thrombus; clinical benefit is restoration of blood flow. System provided sterile, non-pyrogenic, single-use.

Clinical Evidence

No human clinical data. Evidence consists of biocompatibility testing (ISO 10993-1), bench-top mechanical testing (tensile, burst, flow rate, kink resistance, etc.), and an animal study. Animal study showed no vessel injury, no abnormal histology, and no significant vascular response.

Technological Characteristics

Catheter-based aspiration system. Materials: Biocompatible polymers with hydrophilic coating. Sterilization: Ethylene Oxide (EO). Shelf-life: 36 months. Design includes aspiration catheter and separator. Mechanical testing per EN ISO 10555-1:2013. No software or electronic components.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial and venous systems. Contraindicated for use in coronary or neurovascular vessels.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) (K121917)

Submission Summary (Full Text)

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Public Health Service

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

July 22, 2015

Penumbra, Inc. Michaela Mahl Senior Manager, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502

Re: K142870

Trade/Device Name: Penumbra Embolectomy Aspiration System (INDIGO™) Aspiration System) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 24, 2015 Received: April 27, 2015

Dear Ms. Mahl:

This letter corrects our substantially equivalent letter of May 26, 2015.

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. Iisting 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

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Page 2 - Michaela Mahl

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21CFR 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.

# Kenneth J. Cavanaugh -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

### 510(k) Number (if known) K142870

### Device Name

Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System)

### Indications for Use (Describe)

The Penumbra Embolectory Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Not for use in the coronaries or the neurovasculature.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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#### l 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 Embolectomy Aspiration System (INDIGO™ Aspiration System).

#### 1.1 Sponsor/Applicant Name and Address

Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA

#### 1.2 Sponsor Contact Information

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

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

May 26, 2015

#### 1.4 Device Trade or Proprietary Name

Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System)

#### 1.5 Common/Usual Name

Embolectomy Aspiration System

#### 1.6 Device Classification

Regulatory Class: I I Classification Panel: Cardiovascular Classification Name: Embolectomy catheter Regulation Number: 21 CFR § 870.5150 Product Code: DXE

#### 1.7 Predicate Devices

| 510(k) Number /<br>Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|-----------------------------------|------------------------------------------------------------------------|-------------------------|
| K121917 [19Sep2012] | Penumbra Embolectomy Aspiration System<br>(INDIGOTM Aspiration System) | Penumbra, Inc. |

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| | Penumbra Embolectomy Aspiration System<br>(INDIGOTM Aspiration System) | | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| System Name | | | |
| Device | Predicate Device | Subject Device | |
| 510(k) No. | K121917 | K142870 | |
| Classification | Class II, DXE | SAME | |
| Indication | The Penumbra Embolectomy<br>Aspiration System<br>(INDIGOTM Aspiration<br>System) is intended for the<br>removal of fresh, soft emboli<br>and thrombi from vessels of<br>the peripheral arterial system.<br>Not for use in the coronaries.<br>the venous system or the<br>neurovasculature. | The Penumbra Embolectomy<br>Aspiration System (INDIGOTM<br>Aspiration System) is intended for<br>the removal of fresh, soft emboli<br>and thrombi from vessels of the<br>peripheral arterial and venous<br>systems. Not for use in the<br>coronaries or the neurovasculature. | |
| Materials | Biocompatible, commonly<br>utilized for interventional<br>devices | SAME plus additional material<br>compositions | |
| Coating | Hydrophilic coating | SAME | |
| Effective Length | Appropriately sized for the | SAME plus shorter & longer<br>lengths | |
| Proximal OD & ID | target vasculature | SAME with larger diameters | |
| Distal OD & ID | | SAME with larger diameters | |
| Packaging Materials | Commonly used materials<br>for medical devices | SAME | |
| Packaging<br>Configuration | Individual | SAME | |
| Sterilization | EO | SAME | |
| Shelf-Life | 36 Months | SAME | |

#### 1.8 Predicate Comparison

#### 1.9 Device Description

The Penumbra Embolectomy Aspiration System's (INDIGO™ Aspiration System) fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.

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# 1.10 Indications for Use

The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature.

# 1.11 Summary of Non-Clinical Data

Included in this section are descriptions of the testing, which substantiates the safe and effective performance of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) as well as its substantial equivalence to the predicate devices:

- . Biocompatibility / Pyrogenicity
- Design Verification (Bench-Top Testing) ●
- . Animal Study

For the subject Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) all established requirements and acceptance criteria were met.

# 1.11.1 Biocompatibility Testing

Biocompatibility is established for the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) devices based on tests selected in accordance with EN ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices) for limited duration (<24 hours), external communicating devices, contacting circulating blood and limited exposure (≤ 24 hours), surface contact, skin contact devices. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. In summary the following below listed biocompatibility testing was leveraged from predicate devices. Additionally, cytotoxicity, sensitization, and irritation testing was performed on the Aspiration Tubing for the subject device.

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| Test | Method | Result |
|-------------------------------------------|----------------------------------------------|-----------------------------------------------------------------|
| Cytotoxicity | L929 MEM Elution Test | Non-Toxic |
| Sensitization | Kligman Maximization | Non-Sensitizing |
| Intracutaneous Reactivity<br>(Irritation) | Intracutaneous Injection<br>Test | Non-Irritant |
| Systemic Toxicity (Acute) | ISO Acute Systemic<br>Injection Test | Non-Toxic |
| Haemocompatibility | Complement Activation | No greater biological<br>response than<br>corresponding control |
| | Hemolysis | Non-Hemolytic |
| | Coagulation - PT | No Statistical Difference<br>from control |
| | Coagulation - PTT | No Statistical Difference<br>from control |
| | <i>In vivo</i> thrombogenicity | Non-Thrombogenic |
| Pyrogenicity | USP Material Mediated<br>Rabbit Pyrogen Test | Non-Pyrogenic |
| Genotoxicity | Mouse Lymphoma<br>Mutagenesis Assay - ISO | Non-Mutagenic |
| | Ames Test | Non-Mutagenic |
| | Micronucleus Assay - ISO | Non-Clastogenic |

# 1.11.2 Bench-top Testing

Testing was based on the design specifications, risk analysis and available guidance documents. These guidance documents include:

- . Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (FDA - 1995)
- . EN ISO 10555-1:2013 - Sterile, single-use intravascular catheters - Part 1: General Requirements

Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle.

The physical and mechanical properties of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) devices were assessed using standard test methods and pre-determined acceptance criteria. All established acceptance criteria were met. The following tests were performed:

- Visual & Dimensional Test . Friction Test .
- Pouch Seal Strength Test Flow Rate Test . .

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- Tensile Strength Test .
- Elongation Test

- . Bond Strength Test
- . Hub Air Aspiration Test
- . Burst Test
- . Particulate Test
- . Coating Integrity Test
- . Flexibility Test
- . Kink Resistance Test
- . Ovalization Resistance Test
- . Corrosion Test
- . Torsion Test
- . Simulated Use Test
- Leak Test
- Clot Removal Test ●
- . Vacuum Collapse Test
- Trackability Test ●

The results of the tests appropriately address the physical and mechanical performance expectations of the devices. This is further supported by the surgical handling and performance results reported in the in vivo study. Based on these overall results, the physical and mechanical properties of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) devices are acceptable for the intended use and substantially equivalent to the predicate devices.

# 1.11.3 Animal Study

An animal study was conducted to evaluate the safe use of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) devices. The studies concluded that:

- . No vessel injury was noted on the final angiograms following the vessel response procedure.
- . No abnormal gross or histology findings were noted in test vessel segments.
- The use of the devices resulted in no significant vascular response in these . experimental conditions.

## 1.11.4 Summary of Substantial Equivalence

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