The Neptune 3 Waste Management System is intended to be used in the operating room, pathology, surgical centers and doctor's offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.

Device Description

The Neptune 3 Waste Management System provides fluid waste management, fluid volume measurement and surgical smoke evacuation capabilities and is also equipped with a motorized IV pole. The Stryker Neptune 3 Rover (Model Number 0703-001-000) is a mobile device used to suction and collect waste fluids and evacuate smoke during surgical procedures. The Stryker Neptune 3 Rover collects surgical waste fluid within a closed suction system and is paired with a compatible Stryker Neptune 2 Docking Station (0702-014-000) to facilitate disposal.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Neptune 3 Waste Management System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or significant improvements through complex clinical trials typically associated with AI/ML devices or new drug applications.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance for an AI/ML or diagnostic accuracy study.
Sample sizes used for test sets specifically for diagnostic performance.
Data provenance (country of origin, retrospective/prospective) for a clinical test set.
Number of experts used to establish ground truth or their qualifications.
Adjudication methods for ground truth.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
Standalone algorithm performance.
The type of ground truth used (expert consensus, pathology, outcome data) for a diagnostic output.
Sample size for training sets.
How ground truth for training data was established.

Instead, the document details non-clinical performance data to support substantial equivalence. The acceptance criteria described are for engineering and functional performance tests of the device, not diagnostic accuracy.

Here's an overview of the acceptance criteria and study types relevant to this document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering Focus):

The document states that the Neptune 3 Waste Management System met all identified acceptance criteria for each test, demonstrating passing results. The specific numerical acceptance criteria are not detailed in this public summary, but the type of performance evaluated is listed.

Performance Test	Acceptance Criteria (Implied)	Reported Performance
Electrical Safety & EMC	Compliance with IEC 60601-1 and IEC 60601-1-2 standards	Device complies with IEC 60601-1 and IEC 60601-1-2 (including RF wireless).
Software V&V	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Major level of concern)	Software verification and validation testing was conducted and documentation provided as recommended.
Suction Performance	Ability to quickly aspirate fluids, worst-case simulated use	Met all identified acceptance criteria, demonstrating passing results.
ISO 10079-1 (Suction Safety)	Compliance with minimum safety and performance for medical/surgical suction equipment	Met all identified acceptance criteria, demonstrating passing results.
Smoke Blower Performance	Predetermined acceptance criteria for minimum/maximum flow rates	Met all identified acceptance criteria, demonstrating passing results.
IV Pole Performance	Predetermined acceptance criteria for extension/retraction times	Met all identified acceptance criteria, demonstrating passing results.
Docking Performance	Compatibility with Neptune 2 Docking Station, waste off-load after worst-case use	Met all identified acceptance criteria, demonstrating passing results.
ULPA Filtration	Compliance with IEST-RP-CC007 under worst-case flow/vacuum	Met identified acceptance criteria, demonstrating passing results.
Human Factors Evaluation	Compliance with FDA's "Applying Human Factors and Usability Engineering..." and IEC 62366-1	Human factors analysis and usability testing was performed in support of SE.

2. Sample Size for Test Set and Data Provenance:

This information is not applicable in the context of the provided document. The tests conducted are functional and engineering performance tests on the device itself, not clinical studies involving patient data or diagnostic output. The "test set" here refers to the specific test conditions or units used in engineering verification.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable. Ground truth for these engineering tests would be established by validated test methods and instrumentation, not by expert human interpretation of medical images or conditions.

4. Adjudication Method for Test Set:

This information is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not conducted. This type of study is relevant for evaluating the impact of AI systems on human diagnostic performance, which is not the purpose of this 510(k) submission for a fluid waste management system.

6. Standalone Algorithm Performance:

No. This device does not feature a diagnostic algorithm; thus, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for the performance claims in this document is based on engineering standards, predetermined functional specifications, and validated test methodologies. For example:

Electrical safety is proven against IEC standards.
Suction performance is measured against specified flow rates and vacuum levels.
Filtration is evaluated against established particle penetration standards (IEST-RP-CC007).

8. Sample Size for Training Set:

This information is not applicable. This device is not an AI/ML device that requires a training set of data. The "training" of this device involves its manufacturing and calibration according to specifications, not data-driven machine learning.

9. How Ground Truth for Training Set was Established:

This information is not applicable.

Summary

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

April 25, 2016

Stryker Corporation Division: Stryker Instruments Kim Wiersema Staff Regulatory Affairs Specialist 4100 E. Milham Ave Kalamazoo, Michigan 49001

Re: K153407

Trade/Device Name: Neptune 3 Waste Management System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX, FYD Dated: March 23, 2016 Received: March 24, 2016

Dear Kim Wiersema:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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,

Tejashri Purohit-Sheth, M.D.

Teiashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153407

Device Name

Neptune 3 Waste Management System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Prepared: 22 April 2016

I. SUBMITTER

Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 Phone: 269-323-7700

Contact: Kim Wiersema

II. DEVICE

Name of Device:	Neptune 3 Waste Management System
Common/Usual Name:	Portable suction and smoke evacuation device
Regulation Numbers:	21 CFR 878.4780 and 21 CFR 878.5070
Regulation Name:	Powered Suction PumpApparatus, exhaust, surgical
Regulatory Class:	II
Product Codes:	JCX and FYD
III. PREDICATE DEVICE
Predicate Device	Stryker Neptune 2 Rover, K132671
Reference Devices	Dornoch Ultra Suction System, K133786Buffalo Filter Porta Plumesafe, K924732Valleylab OptiMumm Smoke Evacuator System, K980915

IV. DEVICE DESCRIPTION

Stryker Neptune 2 Manifolds:Product Code: JCX510k: K132671	Component providing an interface between the Rover andsuction tubing along with backflow prevention. May alsoincorporate specimen collection capability (modeldependent).
Fluid Suction High EfficiencyParticulate Air (HEPA) Filter:Product Code: JCX510k: K132671	Component providing filtration of air drawn out of the fluidcollection canister.

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Smoke Evacuation Ultra LowPenetration Air (ULPA) Filter:Product Code: FYD510k: K132671	Component providing filtration of evacuated smoke and air asit passes through the Rover. The filter also provides aninterface to connect smoke evacuation accessories (1/4 inch,3/8 inch, or 7/8 inch).
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V. INDICATIONS FOR USE

CONTRAINDICATIONS

The Neptune 3 Waste Management System is contraindicated against:

Connection directly to chest tubes.
. Connection to closed wound drainage systems.

The Indications for Use are identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following table identifies technological characteristics shared between the Predicate and Subject device:

	Predicate Device	Subject Device
Indications for Use	Intended to be used in the operatingroom, pathology, surgical centers, anddoctor's offices to collect and dispose ofsurgical fluid waste, as well as, collectsmoke generated from electrocautery orlaser devices.	Same
Contraindications	Contraindicated against• Connection directly to chest tubes.• Connection to closed wound drainagesystems.	Same
For use with	• Neptune 2 Docking Station• Neptune 2 Manifolds• Stryker HEPA & ULPA Filters• Compatible Smoke Evacuationaccessories• Compatible suction tubing andaccessories	Same
Patient Contact	No direct or indirect patient contact	Same

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	Predicate Device	Subject Device
Materials of Construction	Steel, aluminum, glass, insulation, TPE, thermoplastics, printed circuit board assemblies and electronic/wiring componentsHEPA, ULPA and carbon filter media	Same
Energy Used	120VAC, 60Hz, 12 A	Same
Electrical Isolation Type	Class I, Type CF Applied Part	Same
Electrical Safety & EMC	Tested and compliant with IEC 60601-1, IEC 60601-1-2	Same
Design Features	Suction Characteristics Continuous suction Two independently operated suction levels Electronic regulator Electric pump HEPA filtration (exhaust) Low, Medium, High Vacuum Range Indicators Fluid Collection 24L collection capacity 2 canisters: 1 @ 20L, 1 @ 4L Fluid volume measurement Smoke Evacuation ULPA filtration Voltage-controlled motor Adjustable in 10% increments Manual and Automatic Modes 80 hour filter life IV Pole 4 hooks, powered actuation	Same

The following differences between the subject and predicate device were considered in relation to the substantial equivalence determination:

Disposables management the Neptune 3 Rover incorporates RFID technology to ● authenticate and track manifold use.
The Neptune 3 Rover incorporates a touchscreen display
. The Neptune 3 Rover has a higher maximum suction setting
The Neptune 3 Rover incorporates a 4L canister illumination feature ●
. The available smoke evacuation power range of the Neptune 3 Rover is expanded and provides a wider range of smoke evacuation flow rates

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Stryker Neptune 3 Rover. Testing included assessment of RF wireless performance. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.

Mechanical Testing

Suction Performance

Rover fluid suction flow rate was evaluated simulating an emergent situation when clinicians might need to quickly aspirate fluids to provide surgical site visibility as well as worst case simulated use. Neptune 3 Waste Management System met all identified acceptance criteria, demonstrating passing results.

ISO 10079-1 Electrically-powered suction safety

The Rover was evaluated against the minimum safety and performance requirements for medical and surgical suction equipment as defined in this international standard. Neptune 3 Waste Management System met all identified acceptance criteria, demonstrating passing results.

Smoke Blower Performance

Smoke evacuation minimum and maximum flow rates were evaluated against predetermined acceptance criteria. Neptune 3 Waste Management System met all identified acceptance criteria, demonstrating passing results.

IV Pole Performance

IV pole extension and retraction times were evaluated against predetermined acceptance criteria. Neptune 3 Waste Management System met all identified acceptance criteria, demonstrating passing results.

Docking Performance

Evaluation of the Neptune 3 Rover compatibility with the Neptune 2 Docking Station included demonstration of waste off-load after worst-case clinical use conditions. The Neptune 3

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Waste Management System met all identified acceptance criteria, demonstrating passing results.

ULPA Filtration

Evaluation of the Neptune 3 Rover compatibility with the Neptune 2 ULPA filter included evaluation of UPLA rating in accordance with IEST-RP-CC007 under worst case flow and vacuum conditions. Neptune 3 Waste Management System met identified acceptance criteria, demonstrating passing results.

Human Factors Evaluation

Human factors analysis and usability testing was performed in support of the Substantial Equivalence determination and in accordance with FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and IEC 62366-1 "Medical Devices - Application of Usability Engineering to Medical Devices."

Biocompatibility

Biocompatibility data is not required to support a Substantial Equivalence determination as the Neptune 3 Rover is identical to the predicate device in that there are no components with direct or indirect patient contact.

Animal Study

Not Applicable - data from animal studies was not provided to support the Substantial Equivalence determination. Animal studies are not required to demonstrate safety or feasibility of the Neptune 3 Rover.

Clinical Studies

Not Applicable - data from clinical studies was not provided to support the Substantial Equivalence determination. Clinical studies are not required to demonstrate safety or feasibility of the Neptune 3 Rover.

VIII. CONCLUSIONS

The differences that exist between the Neptune 3 Rover and its predicate do not raise different questions of safety or effectiveness. The results of non-clinical performance testing demonstrate that the Neptune 3 Rover will perform as intended and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.