APOLLO SYSTEM

K132931 · Penumbra, Inc. · GWG · Jan 17, 2014 · Neurology

Device Facts

• Record ID: K132931
• Device Name: APOLLO SYSTEM
• Applicant: Penumbra, Inc.
• Product Code: GWG · Neurology
• Decision Date: Jan 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apollo™ System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The Apollo™ disposable wand is inserted through the working channel of a neuroendoscopic trocar.

Device Story

Apollo System is a surgical instrument for tissue/fluid removal during endoscopic-assisted microneurosurgery. System comprises reusable capital equipment (vacuum pump, vibration generator) and disposable wand (rigid cannula). Operation: vacuum aspiration draws tissue/fluid into wand lumen; internal vibrational wire agitates to prevent clogging; saline irrigation facilitates transport. Used in OR by trained neurosurgeons. Output is physical removal of target tissue/fluid. Benefits include reduced clogging compared to standard suction aspiration. System integrates vacuum generation, vibrational energy, and irrigation into a single device workflow.

Clinical Evidence

No clinical data. Evidence consists of bench-top testing (tensile, corrosion, simulated use, fatigue, durability, audible noise, canister pressure/volume) and biocompatibility testing (ISO 10993: cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, genotoxicity).

Technological Characteristics

System includes reusable pump/generator and disposable wand/tubing. Materials: Polymer and metal. Energy: Vacuum and vibrational energy. Compliance: IEC 60601-1, IEC 60601-1-2. Sterilization: EtO (disposables). Connectivity: Standalone capital equipment. Software: None described.

Indications for Use

Indicated for controlled aspiration of tissue and/or fluids during surgery of the Ventricular System in patients undergoing neuroendoscopic procedures.

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

• Aesculap Aspiration Cannula (K983365)
• Penumbra Pump MAX™ (K122756)

Submission Summary (Full Text)

{0}------------------------------------------------

K132 931

JAN 1 7 2014

### 510(k) SUMMARY l

(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 Apollo™ System.

### Sponsor/Applicant Name and Address 1.1

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

### Sponsor Contact Information 1.2

Seth A. Schulman Director, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

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

December 13, 2013

#### 1.4 Device Trade or Proprietary Name

Apollo™ System

### Device Common/Usual or Classification Name 1.5

Endoscope, neurological (Product Code: GWG, 21 CFR §882.1480)

### Identification of the Legally Marketed Devices to which Equivalence is Being 1.6 Claimed:

| Name of Predicate Device | Name of Manufacturer (Town,<br>State) | 510(k) Number |
|-----------------------------|---------------------------------------|---------------|
| Aesculap Aspiration Cannula | Aesculap, Inc.<br>Center Valley, PA | K983365 |
| Penumbra Pump MAX™ | Penumbra, Inc.<br>Alameda, CA | K122756 |

{1}------------------------------------------------

### 1.7 Device Description:

The Apollo System is a two component surgical instrument designed to aid a physician in the removal of tissue and/or fluids during endoscopic-assisted microneurosurgery. The reusable component has three functions. These functions are vacuum generation, generation of vibrational energy, and saline irrigation. The disposable component, "the Wand" is a rigid cannula to remove tissue and/or fluid with the assistance of vibrational energy and aspiration. The disposable wand is designed to pass through the working channel of various neuro-endoscope trocars allowing visualization of the procedure. The method of action of removal is first vacuum aspiration, which draws the tissue and/or fluid into the lumen of the wand. Next, a vibrational wire is agitated inside the lumen of the wand facilitating movement of any tissue and/or fluid that may otherwise clog the lumen. Saline irrigation has the purpose of providing additional fluid to transport the tissue through the cannula. The irrigation and inner vibration wire components of the disposable wand provide an improvement over existing methods of suction aspiration through a cannula in that the use of the Apollo wand can prevent clogging. Intended users for this device are physicians who have received appropriate training in endoscopicassisted microneurosurgery.

#### 1.8 Indications for Use:

The Apollo™ System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The Apollo™ disposable wand is inserted through the working channel of a neuroendoscopic trocar.

| | Aesculap Aspiration<br>Cannula | Penumbra Apollo™<br>System |
|-------------------|---------------------------------|------------------------------------------------------------------------------------|
| 510(k) No. | K983365 | K132931 |
| Classification | Class II, GWG | Class II, GWG |
| Materials | | |
| Wand | Polymer, Metal | Same |
| Tubing | N/A (Not supplied with<br>Wand) | Polymer |
| Canister | N/A | Polymer |
| Capital Equipment | N/A | General electro-medical<br>equipment compliant<br>with IEC 60601-1<br>requirements |
| Sterilization | EtO | Same |
| Shelf-Life | 36-Months | Same |

#### Predicate Comparison 1.9

{2}------------------------------------------------

| | Aesculap Aspiration<br>Cannula | Penumbra Apollo™<br>System |
|----------------------------|----------------------------------|-------------------------------------|
| Vacuum Source | Hospital based suction<br>system | System based aspiration<br>pump |
| Vibration Energy<br>Source | N/A | System based vibration<br>generator |

| | Penumbra Pump<br>MAXTM | Penumbra ApolloTM<br>System Pump |
|-------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K051758 | K132931 |
| Classification | Class II, JCX | Class II, GWG |
| Indication | The Penumbra<br>Aspiration Pump is<br>intended for general<br>suction use in hospitals<br>or clinics. | The ApolloTM System is<br>used for the controlled<br>aspiration of tissue<br>and/or fluids during<br>surgery of the<br>Ventricular System.<br>The ApolloTM<br>disposable wand is<br>inserted through the<br>working channel of a<br>neuroendoscopic trocar. |
| Specifications | | |
| IEC 60601-1<br>Compliance | Yes | SAME |
| IEC 60601-1-2<br>Compliance | Yes | SAME |
| Voltage | 100-115Vac / 230 Vac | SAME |
| Frequency | 50 Hz / 60 Hz | SAME |
| Vacuum Range | 0-29 inHg (0-98.2 kPa) | SAME |
| Flow Rate | 0-23 LPM<br>0-0.8 SCFM | SAME |
| Fuses | Two 5 amp slow blow<br>fuse (250 Vac) | SAME |
| Motor and Pump<br>Description | Oil-less, rotating pump | SAME |
| Sterilization | Non-Sterile | SAME |
| Shelf-Life | N/A | SAME |

## 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 safety and effectiveness of the device follows.

Included in this section are descriptions of the testing's, which substantiates the safe and effective performance of the Apollo™ System as well as its substantial equivalence to the predicate devices:

{3}------------------------------------------------

- Biocompatibility .
- Design Verification (Bench-Top Testing) .

The subject Apollo™ System components met all established requirements.

## 1.10.1 Biocompatibility Testing

Biocompatibility tests conducted with Penumbra Apollo™ System were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for a blood contacting permanent implant device. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

| Test | Results | Conclusions |
|--------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------|
| <i>In vitro</i> Cytotoxicity (MEM Elution) | Sample extracts exhibited<br>Grade 2 (mild reactivity) | Non-cytotoxic |
| Sensitization (Magnusson - Kligman Method) | Samples exhibited Grade: 0<br>(No sensitization response) | Does not elicit<br>sensitization<br>response |
| Irritation (Intracutaneous Reactivity) | Sample exhibited Grade 0.0<br>(saline extract) and Grade 0.1<br>(sesame oil extract) | Non-irritant |
| Systemic Toxicity | | |
| Systemic Injection (ISO) | No evidence of systemic<br>toxicity from sample extracts | Does not cause<br>systemic toxicity |
| Material Mediated Pyrogen | No animals had a temperature<br>rise ≥ 0.5°C | Non-pyrogenic |
| Subchronic Toxicity (Subacute Toxicity) | Negative for signs of systemic<br>toxicity | Does not cause<br>systemic toxicity |
| Hemocompatibility | | |
| Thrombosis (Dog Thrombogenicity) | Device exhibited acceptable<br>reaction to blood | Non-<br>thrombogenic |
| Coagulation (PTT) | Test article clotting times<br>similar to the predicate device | Acceptable<br>coagulation<br>response |
| Hematology (Hemolysis - Direct Contact) | Hemolytic index = 1.04%<br>Corrected hemolytic index =<br>0.23% | Non-hemolytic |
| Hematology (Hemolysis - Indirect (Extract)<br>Contact) | Hemolytic index = 0.53%<br>Corrected hemolytic index =<br>0.00% | Non-hemolytic |
| Genotoxicity | | |
| Ames Mutagenicity | Tests show no zone of<br>increased reversion or of<br>toxicity | Non-mutagenic |
| Mouse Lymphoma | Non-genotoxic and non-<br>clastogenic) | Non-mutagenic |

{4}------------------------------------------------

| Test | Results | Conclusions |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| <i>In vivo</i> Mouse micronucleus | No manifestation of toxicity<br>nor biologically significant<br>erythrpoietic disturbances<br>resulting in delayed<br>mutagenesis. No biologically<br>significant increases in mPCE<br>production. | Non-mutagenic |

In summary, non-clinical testing found the Penumbra Apollo™ System to be biocompatible according to the requirements of ISO 10993. Additionally, the product was found to be non-pyrogenic. The physical, mechanical and performance testing of the Penumbra Apollo™ System demonstrate that the product is substantially equivalent to the currently marketed predicate devices.

## 1.10.2 Bench-top Testing

The physical, mechanical and performance testing of the Apollo™ System components demonstrates that the devices are substantially equivalent to the currently marketed predicate devices:

Design Verification testing was conducted to evaluate the physical and mechanical properties of the Apollo™ System components. All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements. The tests performed on the Apollo™ System components included:

{5}------------------------------------------------

| Test | Methods | Conclusions |
|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Disposable Component Testing | | |
| Tensile Test | The following device<br>connections and bonds<br>were tested for tensile<br>strength:<br>- Sonic Connector to<br>Wire<br>- RHV to Irrigation<br>Catheter Shaft<br>- Proximal Aspiration<br>Tubing to Y-Connector<br>- Wand-Canister Tubing<br>to Male Swivel<br>Connector<br>- Wand-Canister Tubing | Component<br>bonds and<br>connections meet<br>or exceed<br>minimal tensile<br>specifications |
| Corrosion | to Suction Connector<br>- Aspiration Tubing to<br>T-Connector<br>Device was subjected to<br>testing to evaluate | Device meets<br>criteria as non- |
| Simulated Use | potential for corrosion<br>Device tested for<br>simulated use outputs | corrosive<br>Device meets or<br>exceeds<br>simulated use<br>testing<br>specifications |
| Fatigue | Device tested for fatigue<br>based outputs | Device meets or<br>exceeds fatigue<br>testing<br>specifications |
| Reusable Capital Equipment | | |
| IEC 60601-1 | Tested Apollo System<br>for compliance with<br>standard | Complies with<br>standard |
| IEC 60601-1-2 | Tested Apollo System<br>for compliance with<br>standard | Complies with<br>standard |
| The Apollo System controls shall be easily<br>identifiable by the User. | Tested Apollo System<br>for usability | Controls are<br>casily identifiable |
| The Apollo System controls shall be validated for<br>Usability | Tested Apollo System<br>for usability | Validated for<br>Usability |
| The Apollo System reusable component should<br>supply uniform irrigation and vibrational energy for<br>an entire case | Tested Apollo System<br>for functionality | Meets or exceeds<br>specifications to<br>supply uniform<br>irrigation and<br>vibrational<br>energy for an<br>entire case |
| The Apollo System will be a durable piece of capital<br>equipment | Tested Apollo System<br>for durability | The Apollo<br>System is a |
| Test | Methods | Conclusions |
| The Apollo System should be quiet | Tested Apollo System<br>for audible noise level | The Apollo<br>System meets the<br>audible noise<br>specification |
| The Canister should have volume reference<br>markings | Verified that Canister<br>has volume reference<br>markings | The Canister<br>adequately<br>exhibits the<br>design feature |
| Canister should be able to withstand maximum<br>pressure delivered by the Apollo System | Tested the Canister at<br>maximum pressure | Canister meets<br>specifications at<br>maximum<br>pressure |
| Canister lid should include a feature to prevent<br>excess fluid from entering the Apollo System. | Verified that the<br>Canister contains a<br>feature to prevent<br>excess fluids from<br>entering the Apollo<br>System | The Canister<br>adequately<br>exhibits the<br>design feature |

{6}------------------------------------------------

All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the Apollo™ System components are acceptable for the intended use and substantially equivalent to the predicate devices.

### 1.10.3 Sterilization

The Penumbra Apollo™ System contains several components. The following table identifies which components are sterile or non-sterile. None of the Penumbra Apollo™ System components can be end-user sterilized.

| Component | Sterility |
|------------|-------------|
| Wand | Sterile |
| Tubing | Sterile |
| Canister | Non-Sterile |
| Generator | Non-Sterile |
| Pump | Non-Sterile |
| I.V. Pole | Non-Sterile |
| Footswitch | Non-Sterile |

| Table 1: Component Sterility | | | | | = |
|------------------------------|--|--|--|--|---|
|------------------------------|--|--|--|--|---|

The Penumbra Apollo™ System disposable wands and tubing are packaged and submitted to a contract ISO certified facility for the sterilization of medical devices.

{7}------------------------------------------------

The EtO validation and routine sterilization process of the Penumbra Apollo™ System disposable wands and tubing is based on EN ISO 11135' ensuring a Sterility Assurance Level (SAL) of 10-6.

### 1.10.4 Shelf-Life

The expiration period for the Penumbra Apollo™ System disposable wands and tubing are currently established for 12-months based on 1 yr. accelerated aging test results. The shelf life protocol specifies a test regimen using both accelerated and confirmatory realtime testing methodologies to enable Penumbra to extend the shelf life as additional data becomes available. Upon successful completion of the protocol, Penumbra will maintain a 36-month shelf life for the product.

Penumbra Apollo™ System disposable wands and tubing used in the shelf life studies were produced according to approved production procedures. Acceptance criteria were based on the sterile finished goods testing requirements. All devices used in the shelf-life studies completed 2x sterilization processes prior to test initiation. Packaging materials (both primary and secondary) were tested to validate their properties over the intended shelf life.

## 1.10.5 Summary of Substantial Equivalence

The Apollo™ System components are substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.

EN ISO 11135: 2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 17, 2014

Penumbra, Inc. % Mr. Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502

Re: K132931

> Trade/Device Name: Penumbra Apollo™ System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: December 13, 2013 Received: December 18, 2013

Dear Mr. Schulman:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{9}------------------------------------------------

Page 2 - Mr. Seth A. Schulman

,……

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Joyce M. Whang -S

for Carlos L. Peña, Ph.D., M.S. . Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

## Indications for Use

510(k) Number (if known): K132931

Device Name: Penumbra Apollo™ System

Indications For Use:

The Apollo™ System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The Apollo™ disposable wand is inserted through the working channel of a neuroendoscopic trocar.

V Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of 1