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 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.

AI/ML Overview

The information provided describes the Penumbra Apollo™ System, a surgical instrument for tissue and fluid removal during endoscopic-assisted microneurosurgery. The study presented focuses on non-clinical testing to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms requiring ground truth established by experts.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents two main categories of testing: Biocompatibility and Bench-Top Testing (Design Verification). The acceptance criteria are implicitly defined by meeting established requirements and standards, and the reported performance confirms these criteria were met.

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	In vitro Cytotoxicity (MEM Elution)	Non-cytotoxic (no or mild reactivity)	Grade 2 (mild reactivity) exhibited, concluded non-cytotoxic
	Sensitization (Magnusson - Kligman Method)	No sensitization response	Grade 0 (No sensitization response) exhibited
	Irritation (Intracutaneous Reactivity)	Non-irritant (no or minimal irritation)	Grade 0.0 (saline) and 0.1 (sesame oil) exhibited, concluded non-irritant
	Systemic Toxicity (Systemic Injection (ISO))	No evidence of systemic toxicity	No evidence of systemic toxicity from sample extracts
	Material Mediated Pyrogen	Non-pyrogenic (no significant temperature rise)	No animal temperature rise ≥ 0.5°C
	Subchronic Toxicity (Subacute Toxicity)	Negative for signs of systemic toxicity	Negative for signs of systemic toxicity
	Hemocompatibility (Thrombosis)	Acceptable reaction to blood (non-thrombogenic)	Acceptable reaction to blood, concluded non-thrombogenic
	Hemocompatibility (Coagulation (PTT))	Clotting times similar to predicate device	Test article clotting times similar to predicate device, concluded acceptable coagulation response
	Hemocompatibility (Hemolysis)	Non-hemolytic (low hemolytic index)	Hemolytic index = 1.04% (direct), 0.53% (indirect); Corrected 0.23% (direct), 0.00% (indirect) - concluded non-hemolytic
	Genotoxicity (Ames Mutagenicity)	Non-mutagenic (no increased reversion or toxicity)	No zone of increased reversion or toxicity
	Genotoxicity (Mouse Lymphoma)	Non-genotoxic and non-clastogenic	Non-genotoxic and non-clastogenic
	Genotoxicity (In vivo Mouse micronucleus)	No manifestation of toxicity, erythropoietic disturbances, or significant increase in mPCE production	No manifestation of toxicity or significant increases in mPCE production
Bench-Top Testing	Disposable Component Testing:
	Tensile Test	Component bonds and connections meet or exceed minimal tensile specifications	Met or exceeded minimal tensile specifications
	Corrosion	Non-corrosive	Meets criteria as non-corrosive
	Simulated Use	Meets or exceeds simulated use testing specifications	Met or exceeded simulated use testing specifications
	Fatigue	Meets or exceeds fatigue testing specifications	Met or exceeded fatigue testing specifications
	Reusable Capital Equipment:
	IEC 60601-1 Compliance	Compliance with standard	Complies with standard
	IEC 60601-1-2 Compliance	Compliance with standard	Complies with standard
	Controls Easily Identifiable	Controls are easily identifiable by the User	Controls are easily identifiable
	Controls Validated for Usability	Validated for Usability	Validated for Usability
	Uniform Irrigation & Vibrational Energy	Supplies uniform irrigation and vibrational energy for an entire case (meets/exceeds specifications)	Meets or exceeds specifications
	Durability (Capital Equipment)	Durable piece of capital equipment	The Apollo System is a durable piece (conclusion truncated in input, but implied to meet expectation)
	Audible Noise Level	Meets audible noise specification	Meets the audible noise specification
	Canister Volume Reference Markings	Has volume reference markings	Adequately exhibits the design feature
	Canister Maximum Pressure Withstand	Withstands maximum pressure delivered by the Apollo System	Meets specifications at maximum pressure
	Canister Excess Fluid Prevention	Includes a feature to prevent excess fluid from entering the Apollo System	Adequately exhibits the design feature
Sterilization	Sterility Assurance Level (SAL)	SAL of 10-6	Achieves SAL of 10-6 (based on EN ISO 11135)
Shelf-Life	Expiration Period	12-months initially, with plans for 36-months based on further real-time testing	Established for 12-months based on 1 yr. accelerated aging test results

2. Sample Size for the Test Set and Data Provenance:

Test Set Sample Size: The document does not explicitly state the numerical sample sizes for each specific test in the biocompatibility or bench-top testing. For biocompatibility, it mentions "sample extracts," "animals," and "test article clotting times," implying plural samples were tested for each. For bench-top, it states "All testing was performed using units which were 2x sterilized." While not a precise number, this indicates multiple devices were tested after being subjected to sterilization.
Data Provenance: The studies were conducted internally by Penumbra Inc. or by contract ISO certified facilities (for sterilization). The data is non-clinical and derived from laboratory and bench-top testing, not human patient data. Therefore, there is no country of origin for patient data or retrospective/prospective classification in the usual sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to this submission. The document describes non-clinical engineering and biological testing, not a study evaluating human performance with the device or an AI algorithm requiring expert-established ground truth. The "ground truth" for these tests is based on established scientific and engineering standards (e.g., ISO 10993, IEC 60601-1, tensile strength specifications, corrosion standards).

4. Adjudication Method for the Test Set:

This information is not applicable. Since the 'test set' refers to physical devices and materials undergoing objective laboratory and bench-top measurements and observations against predefined standards, there is no need for expert adjudication in the manner of medical image interpretation or clinical outcomes. The results are quantitative measurements or qualitative observations against scientific criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The submission describes the Penumbra Apollo™ System, which is a physical surgical instrument. It is not an Artificial Intelligence (AI) device, nor does the document describe any AI-assisted components or a study involving human readers with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. As stated above, the Penumbra Apollo™ System is a physical surgical instrument and not an AI algorithm. Therefore, no standalone algorithm performance study was described or performed.

7. The type of ground truth used:

The ground truth used for these tests is based on established scientific and engineering standards and specifications.

For Biocompatibility, the ground truth refers to whether the device meets the biological safety requirements outlined in ISO 10993-1 guidelines, with conclusions drawn from standard biological assays (e.g., cytotoxic, pyrogenicity, hemolytic effects).
For Bench-Top Testing, the ground truth refers to whether the physical and mechanical properties of the device meet predefined engineering specifications and comply with relevant standards (e.g., IEC 60601-1, tensile strength limits, corrosion resistance).
For Sterilization, the ground truth is achieving a Sterility Assurance Level (SAL) of 10-6, validated according to EN ISO 11135.
For Shelf-Life, the ground truth is the maintenance of device properties over a specified period, verified through accelerated and real-time aging studies against finished goods release requirements.

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI device that requires a distinct "training set." The device development followed traditional engineering design and testing methodologies.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

Summary

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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: 510-748-3223 FAX: 510-217-6414 email: seth.schulman@Penumbrainc.com

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,State)	510(k) Number
Aesculap Aspiration Cannula	Aesculap, Inc.Center Valley, PA	K983365
Penumbra Pump MAX™	Penumbra, Inc.Alameda, CA	K122756

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1.7 Device Description:

1.8 Indications for Use:

	Aesculap AspirationCannula	Penumbra Apollo™System
510(k) No.	K983365	K132931
Classification	Class II, GWG	Class II, GWG
Materials
Wand	Polymer, Metal	Same
Tubing	N/A (Not supplied withWand)	Polymer
Canister	N/A	Polymer
Capital Equipment	N/A	General electro-medicalequipment compliantwith IEC 60601-1requirements
Sterilization	EtO	Same
Shelf-Life	36-Months	Same

Predicate Comparison 1.9

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	Aesculap AspirationCannula	Penumbra Apollo™System
Vacuum Source	Hospital based suctionsystem	System based aspirationpump
Vibration EnergySource	N/A	System based vibrationgenerator

	Penumbra PumpMAXTM	Penumbra ApolloTMSystem Pump
510(k) No.	K051758	K132931
Classification	Class II, JCX	Class II, GWG
Indication	The PenumbraAspiration Pump isintended for generalsuction use in hospitalsor clinics.	The ApolloTM System isused for the controlledaspiration of tissueand/or fluids duringsurgery of theVentricular System.The ApolloTMdisposable wand isinserted through theworking channel of aneuroendoscopic trocar.
Specifications
IEC 60601-1Compliance	Yes	SAME
IEC 60601-1-2Compliance	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 LPM0-0.8 SCFM	SAME
Fuses	Two 5 amp slow blowfuse (250 Vac)	SAME
Motor and PumpDescription	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:

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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
In vitro Cytotoxicity (MEM Elution)	Sample extracts exhibitedGrade 2 (mild reactivity)	Non-cytotoxic
Sensitization (Magnusson - Kligman Method)	Samples exhibited Grade: 0(No sensitization response)	Does not elicitsensitizationresponse
Irritation (Intracutaneous Reactivity)	Sample exhibited Grade 0.0(saline extract) and Grade 0.1(sesame oil extract)	Non-irritant
Systemic Toxicity
Systemic Injection (ISO)	No evidence of systemictoxicity from sample extracts	Does not causesystemic toxicity
Material Mediated Pyrogen	No animals had a temperaturerise ≥ 0.5°C	Non-pyrogenic
Subchronic Toxicity (Subacute Toxicity)	Negative for signs of systemictoxicity	Does not causesystemic toxicity
Hemocompatibility
Thrombosis (Dog Thrombogenicity)	Device exhibited acceptablereaction to blood	Non-thrombogenic
Coagulation (PTT)	Test article clotting timessimilar to the predicate device	Acceptablecoagulationresponse
Hematology (Hemolysis - Direct Contact)	Hemolytic index = 1.04%Corrected hemolytic index =0.23%	Non-hemolytic
Hematology (Hemolysis - Indirect (Extract)Contact)	Hemolytic index = 0.53%Corrected hemolytic index =0.00%	Non-hemolytic
Genotoxicity
Ames Mutagenicity	Tests show no zone ofincreased reversion or oftoxicity	Non-mutagenic
Mouse Lymphoma	Non-genotoxic and non-clastogenic)	Non-mutagenic

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Test	Results	Conclusions
In vivo Mouse micronucleus	No manifestation of toxicitynor biologically significanterythrpoietic disturbancesresulting in delayedmutagenesis. No biologicallysignificant increases in mPCEproduction.	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:

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Test	Methods	Conclusions
Disposable Component Testing
Tensile Test	The following deviceconnections and bondswere tested for tensilestrength:- Sonic Connector toWire- RHV to IrrigationCatheter Shaft- Proximal AspirationTubing to Y-Connector- Wand-Canister Tubingto Male SwivelConnector- Wand-Canister Tubing	Componentbonds andconnections meetor exceedminimal tensilespecifications
Corrosion	to Suction Connector- Aspiration Tubing toT-ConnectorDevice was subjected totesting to evaluate	Device meetscriteria as non-
Simulated Use	potential for corrosionDevice tested forsimulated use outputs	corrosiveDevice meets orexceedssimulated usetestingspecifications
Fatigue	Device tested for fatiguebased outputs	Device meets orexceeds fatiguetestingspecifications
Reusable Capital Equipment
IEC 60601-1	Tested Apollo Systemfor compliance withstandard	Complies withstandard
IEC 60601-1-2	Tested Apollo Systemfor compliance withstandard	Complies withstandard
The Apollo System controls shall be easilyidentifiable by the User.	Tested Apollo Systemfor usability	Controls arecasily identifiable
The Apollo System controls shall be validated forUsability	Tested Apollo Systemfor usability	Validated forUsability
The Apollo System reusable component shouldsupply uniform irrigation and vibrational energy foran entire case	Tested Apollo Systemfor functionality	Meets or exceedsspecifications tosupply uniformirrigation andvibrationalenergy for anentire case
The Apollo System will be a durable piece of capitalequipment	Tested Apollo Systemfor durability	The ApolloSystem is a
Test	Methods	Conclusions
The Apollo System should be quiet	Tested Apollo Systemfor audible noise level	The ApolloSystem meets theaudible noisespecification
The Canister should have volume referencemarkings	Verified that Canisterhas volume referencemarkings	The Canisteradequatelyexhibits thedesign feature
Canister should be able to withstand maximumpressure delivered by the Apollo System	Tested the Canister atmaximum pressure	Canister meetsspecifications atmaximumpressure
Canister lid should include a feature to preventexcess fluid from entering the Apollo System.	Verified that theCanister contains afeature to preventexcess fluids fromentering the ApolloSystem	The Canisteradequatelyexhibits thedesign feature

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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.

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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

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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

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

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Indications for Use

510(k) Number (if known): K132931

Device Name: Penumbra Apollo™ System

Indications For Use:

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

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).