Artemis Neuro Evacuation Device

K171332 · Penumbra, Inc. · GWG · Aug 14, 2017 · Neurology

Device Facts

• Record ID: K171332
• Device Name: Artemis Neuro Evacuation Device
• Applicant: Penumbra, Inc.
• Product Code: GWG · Neurology
• Decision Date: Aug 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.

Device Story

Artemis Neuro Evacuation Device is a surgical instrument for image-guided neurosurgery; aids removal of tissue/fluid from Ventricular System or Cerebrum. Device consists of a wand with a rigid hypotube containing an integrated wire. Operates via vacuum aspiration generated by an external Penumbra Aspiration Pump; rotational energy is provided by an internal 1.5V DC motor powered by a lithium-ion battery in the handle. Rotational energy facilitates movement of material to prevent lumen clogging. Used by trained physicians in clinical settings. Output is the physical removal of tissue/fluid; healthcare provider visualizes procedure via image guidance. Benefits include efficient evacuation of intracranial material during surgery.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility (ISO 10993), design verification (packaging, dimensional, dynamic vacuum, simulated use, tensile/torque), and electrical safety (IEC 60601-1 series). All tests passed.

Technological Characteristics

Materials: Polymer and metal (304 stainless steel hypotube). Energy: Vacuum aspiration (external pump) and rotational energy (internal 1.5V DC motor, Li-ion battery). Dimensions: 26.1-27.0 cm length. Connectivity: Standalone wand connected to external pump via tubing. Sterilization: Gamma irradiation (ISO 11137, ISO 11737). Electrical safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366.

Indications for Use

Indicated for controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in patients undergoing image-guided neurosurgery.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Apollo System (K132931)
• Apollo System (K152699)

Reference Devices

• Penumbra Embolectomy Aspiration System (INDIGO Aspiration System) (K160533)
• Penumbra System and Penumbra Pump MAX (K160449)

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

August 14. 2017

Penumbra, Inc. Mary Rose Director, Regulatory Affairs One Penumbra Place Alameda, California 94502

Re: K171332

Trade/Device Name: Artemis Neuro Evacuation Device Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: July 14, 2017 Received: July 17, 2017

Dear Ms. Rose:

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 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) K171332

Device Name ArtemisTM Neuro Evacuation Device

Indications for Use (Describe)

The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.

Penumbra Aspiration Pump:

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Image /page/3/Picture/0 description: The image shows the word "Penumbra" in a bold, red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern. The word "Penumbra" is the main focus of the image.

#### 510(k) SUMMARY 1

(as required by 21 CFR 807.92)

#### Sponsor/Applicant Name and Address 1.1

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

#### Sponsor Contact Information 1.2

Mary Rose Director, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

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

July 14, 2017

#### Device Trade or Proprietary Name 1.4

Artemis™ Neuro Evacuation Device

#### Device Common/Usual or Classification Name 1.5

Endoscope, neurological (Product Code: GWG)

#### Primary Device Classification 1.6

| Regulatory Class: | II |
|-----------------------|-------------------------|
| Classification Panel: | Neurology |
| Classification Name: | Endoscope, neurological |
| Regulation Number: | 21 CFR 882.1480 |
| Product Code: | GWG |

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Image /page/4/Picture/0 description: The image contains the word "Penumbra" in a red, sans-serif font. To the right of the word is a circular logo, also in red, with a white "P" shape inside. The logo is simple and modern, complementing the clean typography of the wordmark.

#### Predicate Devices 1.7

| 510(k)<br>Number | Clearance<br>Date | Name of Predicate Device | Name of<br>Manufacturer |
|-------------------|-------------------|------------------------------------------------------------------------|-------------------------|
| K132931 | 01/17/14 | Apollo System | Penumbra, Inc. |
| K152699 | 03/17/16 | Apollo System | Penumbra, Inc. |
| Reference Devices | | | |
| K160533 | 05/24/16 | Penumbra Embolectomy Aspiration System<br>(INDIGOTM Aspiration System) | Penumbra, Inc. |
| K160449 | 05/25/16 | Penumbra System® and Penumbra Pump MAX | Penumbra, Inc. |

#### 1.8 Predicate Comparison

| | Apollo™ System | Subject Device:<br>Artemis™ Neuro Evacuation<br>Device |
|-----------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------|
| 510(k) No. | K132931, K152699 | K171332 |
| Classification | Class II, GWG | Class II, GWG |
| Intended Use | Used for the controlled | SAME |
| | aspiration of tissue and/or | |
| | fluid during surgery of the | |
| | Ventricular System or | |
| | Cerebrum. | |
| Aspiration Control | Fingertip controlled via | SAME |
| | vacuum regulator hole on | |
| | Wand handle. | |
| Mechanism of Action | Vacuum Aspiration aided by<br>Vibrational Energy | Vacuum Aspiration aided by<br>Rotational Energy |
| Power Source for<br>Mechanism of Action | Apollo Generator | Primary Cell Lithium Ion<br>Battery, 1.5 Volt DC Motor<br>contained within the handle |
| Aspiration Source | Apollo Pump | Penumbra Aspiration Pump |
| Wand Hypotube | 304 Stainless Steel | SAME |
| Wand Materials | Polymer, Metal | SAME |
| Wand Dimensions | L: 27.0 cm – 28.0 cm | L: 26.1 cm - 27.0 cm |
| | ID: 0.060″ — 0.088″ | ID: 00.048″ — 0.100″ |
| | OD: 0.072″ — 0.101″ | OD: 00.058″ — 0.109″ |
| Aspiration Tubing | Polymer | SAME |
| Material | | |

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| | Apollo™ System | Subject Device:<br>Artemis™ Neuro Evacuation<br>Device |
|---------------------------------|--------------------------|--------------------------------------------------------|
| Aspiration Tubing<br>Dimensions | OD: 0.188"<br>ID: 0.088" | OD: 0.263"<br>ID: 0.163" |
| Single Use or<br>Reusable | Single Use | SAME |
| Sterilization | EO | Gamma |
| Shelf-Life | 12-Months - Wand | SAME |
| Aspiration Pump | Apollo System Pump | Penumbra 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 |
| Maximum Vacuum | 29 inHg | SAME |
| Maximum Flow rate | 0.8 SCFM | SAME |

#### 1.9 Device Description

The Artemis™ Neuro Evacuation Device, is a surgical instrument designed to aid a physician in the removal of tissue and/or fluid during image-guided neurosurgery. The Artemis Wand has two functions. These functions are control and transfer of aspiration and generation of rotational energy. Aspiration is generated by a Penumbra Aspiration Pump, which the Artemis Wand connects to through its flexible tubing. The Artemis Wand has a rigid hypotube containing a wire to facilitate removing tissue and/or fluid with the assistance of rotational energy and aspiration.

The Artemis Wand is designed to be image-guided, allowing visualization of the procedure. The method of removal is vacuum aspiration, which draws the tissue and/or fluid into the lumen of the Wand hypotube. The integrated wire is fully contained within the lumen of the Wand hypotube, and has rotational capability facilitating movement of any tissue and/or fluid that may otherwise clog the hypotube lumen.

Intended users for this device are physicians who have received appropriate training in image-guided neurosurgery.

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### 1.10 Indications for Use

The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.

### Penumbra Aspiration Pump:

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

### 1.11 Summary of Non-clinical Data

Included in this section is a description of the testing, which substantiates the safe and effective performance of the subject Artemis™ Neuro Evacuation Device as well as its substantial equivalence to the predicate device:

- Biocompatibility .
- Design Verification (Bench-Top Testing) ●
- EMC ●
- Sterilization
- . Shelf-life

### 1.11.1 Biocompatibility

Biocompatibility testing was performed on the subject Artemis™ Neuro Evacuation Device. Tests were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) and FDA Guidance. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

| Test | Method | Conclusions |
|----------------------------------------------|------------------------------------------------|-----------------|
| In vitro Cytotoxicity | MEM Elution Test | Non-toxic |
| Sensitization (Magnusson-<br>Kligman Method) | ISO Guinea Pig Maximization Sensitization Test | Non-sensitizing |

The following tests were performed based contact type and duration:

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| Test | Method | Conclusions |
|-------------------------------------------------|-------------------------------------------------|------------------|
| Irritation (Intracutaneous<br>Reactivity (ISO)) | ISO Tests for Irritation and Skin Sensitization | Non-irritant |
| Systemic Toxicity | | |
| Systemic Injection (ISO) | ISO Acute Systemic Injection Test | Non-toxic |
| Material Mediated Pyrogen | ISO Materials-Mediated Rabbit Pyrogen Test | Non-pyrogenic |
| Hemocompatibility | | |
| Thrombosis (Dog<br>Thrombogenicity) | Thrombogenicity Study in Dogs - ISO | Non-Thrombogenic |
| Coagulation (PT) | Prothrombin Time (PT) Test | Non-hemolytic |
| Coagulation (PTT) | Partial Thromboplastin Time (PTT) Test | Non-hemolytic |
| Hematology (Hemolysis) -<br>Direct Contact | ASTM Hemolysis (Direct Contact Method) | Non-hemolytic |
| Hematology (Hemolysis) -<br>Indirect Contact | ASTM Hemolysis (Extract Method) | Non-hemolytic |
| Genotoxicity | | |
| Ames Mutagenicity | Ames Test | Non-mutagenic |
| In vivo Mouse micronucleus | ISO In Vivo Mouse Micronucleus Assay | Non-mutagenic |

The non-clinical testing found the Penumbra Artemis™ Neuro Evacuation Device to be biocompatible according to EN ISO 10993 requirements. Therefore, Penumbra Artemis™ Neuro Evacuation Device is substantial equivalent to the predicate device.

# 1.11.2 Bench-Top Testing

Design Verification testing was conducted to evaluate the physical and mechanical properties of the Artemis™ Neuro Evacuation Device and demonstrate substantial equivalence to predicate. The following tests were successfully performed:

| Test | Test Method Summary | Results |
|------------------------------------|-----------------------------------------------------------------------------------------------------|--------------|
| Packaging Inspection | Confirm the packaging outputs meet all product<br>specifications. | 100%<br>Pass |
| Dimensional / Visual<br>Inspection | Confirm the dimensions / visual outputs meet all<br>product specifications. | 100%<br>Pass |
| Dynamic Vacuum<br>Testing | Wand can sustain maximum vacuum and transfer<br>vacuum to distal tip of wand. | 100%<br>Pass |
| Simulated Use | Evaluate the effectiveness of the device to generate<br>rotational energy to remove simulated clot. | 100%<br>Pass |

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| Tensile/Torque | All components are tested to ensure connections/joints meet all product specifications. | 100% |
|-------------------------|-------------------------------------------------------------------------------------------------|------|
| | | Pass |
| Electric Safety Testing | Compliant to requirements of IEC 60601-1 (3rd Ed.),<br>IEC 60601-1-2, 60601-1-6, and IEC 62366. | 100% |
| | | Pass |

Design Verification (Bench-Top Testing) found the Penumbra Artemis™ Neuro Evacuation Device to meet all design inputs. Therefore, Penumbra Artemis™ Neuro Evacuation Device is substantially equivalent to the predicate device.

### 1.11.3 Sterilization

The Artemis™ Neuro Evacuation Device was validated for gamma irradiation sterilization to a 6-log sterility assurance utilizing the VDmax25 sterilization validation in accordance with ISO 11137 and ISO 11737.

### 1.11.4 Shelf Life

The Artemis™ Neuro Evacuation Device has a 12-month Shelf-life

### 1.12 Summary of Substantial Equivalence

The subject Artemis™ Neuro Evacuation Device is equivalent to the predicate Apollo System™. The subject device has an identical intended use as the predicate device. The subject device and predicate device differ slightly in regards to technological and material variations. 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 equivalent to the predicate device in regards to operating principle fundamental technology, materials, and device performance.