Apollo System

K152699 · Penumbra, Inc. · GWG · Mar 17, 2016 · Neurology

Device Facts

• Record ID: K152699
• Device Name: Apollo System
• Applicant: Penumbra, Inc.
• Product Code: GWG · Neurology
• Decision Date: Mar 17, 2016
• 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 fluid during surgery of the Ventricular System or Cerebrum.

Device Story

Apollo System aids physicians in tissue/fluid removal during image-guided neurosurgery. System comprises reusable console (vacuum generation, vibrational energy, saline irrigation) and disposable rigid cannula (Wand). Wand inserts through neuro-endoscopic trocar working channel for visualization. Generator provides saline irrigation and vibrational energy to prevent Wand clogging; vacuum pump performs aspiration; collection canister stores removed material. Foot switch controls saline infusion and vibrational energy. Device used in OR by neurosurgeons; facilitates tissue/fluid removal to assist surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by literature review confirming safety/effectiveness profile and appropriateness of expanded indications.

Technological Characteristics

System includes generator, vacuum pump, collection canister, and disposable Wand. Operates via vibrational energy (21 kHz, 25 microns peak-to-peak) and saline irrigation (30 ml/min). Aspiration range 0-29 in. Hg. Powered by AC generator. Components are reusable (console) and disposable (Wand, tubing, canister).

Indications for Use

Indicated for controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

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)
• SONOTOME™ System (K990572)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

March 24, 2016

Penumbra. Inc. Ms. Mary Rose Senior Manager, Regulatory Affairs One Penumbra Place Alameda, California 94502

Re: K152699

Trade/Device Name: Apollo™ System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: February 12, 2016 Received: February 16, 2016

Dear Ms. Rose:

This letter corrects our substantially equivalent letter of March 17, 2016.

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 Actinclude requirements for annual registration. Ilisting 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

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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 yours,

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) K152699

Device Name Apollo™ System

### Indications for Use (Describe)

The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

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

| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) SUMMARY

(as required by 21 CFR 807.92)

#### 1.1 Submitter

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

Contact Person: Mary Rose, Senior Manager, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

#### Device Trade or Proprietary Name 1.2

Apollo™ System

#### Device Common/Usual or Classification Name 1.3

Endoscope, neurological (Product Code: GWG)

#### Primary Device Classification 1.4

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

#### 1.5 Predicate Devices

Apollo™ System, K132931 SONOTOME™ System, K990572

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| Table 1: Predicate Device Comparison | | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SONOTOME TM<br>System | Apollo™ System | Subject Device:<br>Apollo™ System |
| 510(k) No. | K990572 | K132931 | K152699 |
| Classification | Class II, LFL | Class II, GWG | Class II, GWG |
| Indications for<br>Use | Breakup and removal<br>of soft tissues in<br>Neurosurgery, GI and<br>affiliated organ<br>surgery, Urology,<br>General surgery,<br>Plastic and<br>reconstructive surgery,<br>Orthopedic, GYN,<br>Thoracic. | The Apollo System is<br>used for the controlled<br>aspiration of tissue<br>and/or fluid during<br>surgery of the<br>Ventricular System.<br>The Apollo Wand is<br>inserted through the<br>working channel of a<br>neuro-endoscopic<br>trocar. | The Apollo System is<br>used for the controlled<br>aspiration of tissue<br>and/or fluid during<br>surgery of the<br>Ventricular System or<br>Cerebrum. |
| Basic Operating<br>Principle | Metal tip driven by<br>ultrasound causing<br>tissue fragmentation<br>and aspiration through<br>tip. | AC power is converted<br>from the generator into<br>vibrational energy and<br>saline irrigation to the<br>distal tip of the Wand,<br>which removes tissue<br>and/or fluids through an<br>aspiration lumen. | Same as K132931<br>cleared device. |
| System Console | Self-contained with<br>ultrasonic, irrigation,<br>and aspiration<br>subsystems. | Self-contained with<br>irrigation and aspiration<br>subsystems.<br>Powered by a generator<br>and vacuum. | Same as K132931<br>cleared device. |
| Amplitude of<br>Vibration of tip | 240 microns, peak to<br>peak | 25 microns, peak to<br>peak | Same as K132931<br>cleared device. |
| Vibration<br>Frequency | 20 kHz | 21 kHz | Same as K132931<br>cleared device. |
| Irrigation Flow<br>Rate | 10-400 ml/min | 30 ml/min | Same as K132931<br>cleared device. |
| Aspiration | 5-15 in. Hg | 0-29 in. Hg | Same as K132931<br>cleared device. |
| Disposable | ● Surgical Tips | ● Wand | |
| Table 1: Predicate Device Comparison | | | |
| | SONOTOME ™ System | Apollo™ System | Subject Device:<br>Apollo™ System |
| components | • Suction trap,<br>• Irrigation/suction tubing set | • Collection Canister, filter and pump-canister tubing<br>• Irrigation Tubing | |
| Power requirements | 105-130 v a-c, 60Hz, 500 watts | 100-115V (60Hz), 100V (50Hz) | Same as K132931 cleared device. |

#### 1.6 Predicate Comparison

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#### 1.7 Device Description:

The Apollo System is designed to aid a physician in the removal of tissue and/or fluids during image-guided neurosurgery. The reusable components have three functions; 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 be image-guided, such as passing through the working channel of various neuro-endoscope trocars, allowing visualization of the procedure. To aid in tissue and/or fluid removal, the Apollo Generator provides the saline irrigation and vibrational energy to the Wand to ensure the Wand does not become clogged. Aspiration of the tissue and/or fluid is performed by the Apollo Vacuum Pump. Any tissue and/or fluid removed is collected in the Apollo Collection Canister. Activation of saline infusion and vibrational energy is controlled by the Apollo Foot Switch.

#### Indications for Use: 1.8

The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.

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#### 1.9 Summary of Non-clinical Data

A literature review was conducted to substantiate the safe and effective performance of the Apollo System, as well as its substantial equivalence to the predicate devices. Current literature was reviewed in relationship to device indications. Review concluded the revised indication for use is appropriate. Additionally, revised labeling was found to have a safety and effectiveness profile that is similar to the predicate devices.

## 1.10 Summary of Substantial Equivalence

The Apollo System was found to have a safety and effectiveness profile that is similar to the predicate devices.