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.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document is a 510(k) premarket notification decision letter from the FDA for the Apollo™ System. It primarily focuses on:

Regulatory classification and history: K152699, Class II, Neurological Endoscope (Product Code GWG).
Indications for Use: Controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
Predicate devices: K132931 (Apollo™ System) and K990572 (SONOTOME™ System).
Device description and comparison to predicates: Outlines operating principles, system console, amplitude and frequency of vibration, irrigation flow rate, aspiration, and disposables.
Non-clinical data summary: States a literature review was conducted to substantiate safe and effective performance and substantial equivalence, along with the appropriateness of the revised indication for use and labeling.
Summary of Substantial Equivalence: Concludes the device has a similar safety and effectiveness profile to predicate devices.

The document does not contain details about specific performance metrics, clinical trials, or validation studies using specific datasets that would include the information you've requested.

Summary

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

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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

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)

X 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."

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

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: 510-748-3346 FAX: 510-217-6414 email: mrose@Penumbrainc.com

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

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

Table 1: Predicate Device Comparison
	SONOTOME TMSystem	Apollo™ System	Subject Device:Apollo™ System
510(k) No.	K990572	K132931	K152699
Classification	Class II, LFL	Class II, GWG	Class II, GWG
Indications forUse	Breakup and removalof soft tissues inNeurosurgery, GI andaffiliated organsurgery, Urology,General surgery,Plastic andreconstructive surgery,Orthopedic, GYN,Thoracic.	The Apollo System isused for the controlledaspiration of tissueand/or fluid duringsurgery of theVentricular System.The Apollo Wand isinserted through theworking channel of aneuro-endoscopictrocar.	The Apollo System isused for the controlledaspiration of tissueand/or fluid duringsurgery of theVentricular System orCerebrum.
Basic OperatingPrinciple	Metal tip driven byultrasound causingtissue fragmentationand aspiration throughtip.	AC power is convertedfrom the generator intovibrational energy andsaline irrigation to thedistal tip of the Wand,which removes tissueand/or fluids through anaspiration lumen.	Same as K132931cleared device.
System Console	Self-contained withultrasonic, irrigation,and aspirationsubsystems.	Self-contained withirrigation and aspirationsubsystems.Powered by a generatorand vacuum.	Same as K132931cleared device.
Amplitude ofVibration of tip	240 microns, peak topeak	25 microns, peak topeak	Same as K132931cleared device.
VibrationFrequency	20 kHz	21 kHz	Same as K132931cleared device.
Irrigation FlowRate	10-400 ml/min	30 ml/min	Same as K132931cleared device.
Aspiration	5-15 in. Hg	0-29 in. Hg	Same as K132931cleared device.
Disposable	● Surgical Tips	● Wand
Table 1: Predicate Device Comparison
	SONOTOME ™ System	Apollo™ System	Subject Device:Apollo™ System
components	• Suction trap,• Irrigation/suction tubing set	• Collection Canister, filter and pump-canister tubing• 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

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

1.7 Device Description:

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.

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

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.

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).