Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a fluid waste management system with smoke evacuation and does not mention any AI or ML capabilities.

Therapeutic

No
The device collects surgical fluid waste and smoke; it does not directly treat or restore health in a patient.

Diagnostic

No

The device description and intended use clearly state that the Neptune 2 Waste Management System is for collecting and disposing of surgical fluid waste and smoke. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components (rover and docker) that are integral to the device's function of collecting and disposing of surgical fluid waste and smoke. The performance studies also include testing related to electrical safety, vacuum cycling, and smoke evacuation and filtration, which are hardware-dependent functions.

IVD (In Vitro Diagnostic)

Based on the provided information, the Neptune 2 Waste Management System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to collect and dispose of surgical fluid waste and collect smoke generated during surgical procedures. This is a physical process of waste management and smoke evacuation, not a diagnostic test performed on biological samples in vitro (outside the body).
Device Description: The device description focuses on the mechanical aspects of fluid collection, disposal, and smoke evacuation. It describes a closed suction system, a rover, and a docking station for cleaning and offloading. There is no mention of analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Using reagents or assays

The Neptune 2 Waste Management System is a medical device used in surgical settings for waste management and smoke evacuation, which are supportive functions during procedures, not diagnostic ones.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Neptune 2 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.

Product codes (comma separated list FDA assigned to the subject device)

JCX, FYD

Device Description

The Neptune 2 Waste Management System is a fluid waste management system with smoke evacuation. It collects surgical waste fluid within a closed suction system, then disposes of it through a docking station. The system is comprised of a rover and a docker (also referred to as a docking station).

The Neptune 2 Rover (Model Number: 0702-001-000) is a mobile, AC-powered surgical fluid waste collection device. It is intended to collect waste fluids and evacuate smoke during surgical procedures.

The Neptune 2 Docking Station (Model Number: 0702-014-000) is a stationary device for automated rover cleaning and waste offloading. It provides a fixed connection to the hospital's water supply, sewer, and electricity.
The following Stryker accessories are for use with the Neptune 2 Waste Management System:
Model Number Product Name
0700-001-026 Neptune Docking Detergent
0702-020-000 Neptune 2 4-Port Manifold
0702-020-001 Neptune 2 Specimen Collection 4-Port
0702-025-000 Neptune 2 Single-Port Manifold
0702-034-000 Fluid Suction HEPA Filter
0702-040-000 Smoke Evacuator ULPA Filter
0702-045-023 Smoke (Evacuator) Tubing, 3/8 inch x 10 feet
0700-026-000 Smoke (Evacuator) Tubing, 7/8 inch x 10 feet
0702-045-027 PenAdapt®

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor's offices.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was performed to demonstrate the performance of the device. Testing was completed to verify and validate the device as outlined in the device description. Testing included electrically powered suction safety, electrical safety, vacuum cycling, software, smoke evacuation and filtration. Human factors analysis and usability testing was performed on the user interface, labeling, and training materials.
Biocompatibility testing of the Neptune 2 Waste Management System confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Stryker® Neptune Waste Management System (K012991), Dornoch Transposal Ultra System (K081047), Valleylab OptiMumm Smoke Evacuator System (K980915)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

KV32671

DEC 2 0 2013

stryker

Instruments

510(k) Summary

| 510(k) Owner: | Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, MI 49001
(p) 269-389-3549
(f) 269-389-5412 |
|-------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Jump |
| Registration No.: | 1811755 |
| Trade Name: | Stryker® Neptune 2 Waste Management System |
| Common Name: | Portable suction and smoke evacuation device |

Classification Name and Regulation Number	Primary Product Code
-------------------------------------------	----------------------

Product Code	Device	Regulation Number	Class
JCX	apparatus, suction, ward use, portable, ac-powered	21 CFR 872.4780	II

	Secondary Product Code
--	------------------------

Product Code	Device	Regulation Number	Class
FYD	apparatus, exhaust, surgical	21 CFR 878.5070	II

| Predicate Devices: | Stryker® Neptune Waste Management System (K012991)
Dornoch Transposal Ultra System (K081047).
Valleylab OptiMumm Smoke Evacuator System (K980915) |

--------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------

4100 E. Milham Avenue
Kalamazoo. MI 49001
t: 269 323 7700 1: 269 389 5412
www.sstryker.com

1

| Device
Description: | The Neptune 2 Waste Management System is a fluid waste management system
with smoke evacuation. It collects surgical waste fluid within a closed suction
system, then disposes of it through a docking station. The system is comprised of a
rover and a docker (also referred to as a docking station).

The Neptune 2 Rover (Model Number: 0702-001-000) is a mobile, AC-powered
surgical fluid waste collection device. It is intended to collect waste fluids and
evacuate smoke during surgical procedures.

The Neptune 2 Docking Station (Model Number: 0702-014-000) is a stationary
device for automated rover cleaning and waste offloading. It provides a fixed
connection to the hospital's water supply, sewer, and electricity.
The following Stryker accessories are for use with the Neptune 2 Waste
Management System: | | | | | | | | | | | | | | | | | | | | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | Model Number Product Name 0700-001-026 Neptune Docking Detergent 0702-020-000 Neptune 2 4-Port Manifold 0702-020-001 Neptune 2 Specimen Collection 4-Port 0702-025-000 Neptune 2 Single-Port Manifold 0702-034-000 Fluid Suction HEPA Filter 0702-040-000 Smoke Evacuator ULPA Filter 0702-045-023 Smoke (Evacuator) Tubing, 3/8 inch x 10 feet 0700-026-000 Smoke (Evacuator) Tubing, 7/8 inch x 10 feet 0702-045-027 PenAdapt® | | | | | | | | | | | | | | | | | | | | |
| Indications
for Use: | The Neptune 2 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. | | | | | | | | | | | | | | | | | | | | |
| Contraindications | The Neptune 2 Waste Management System is contraindicated against:
• Connection directly to chest tubes.
• Connection to closed wound drainage systems. | | | | | | | | | | | | | | | | | | | | |
| Testing | The Neptune 2 Waste Management System meets the specification and
performance characteristics as identified in Stryker's internal design control
procedures. Bench testing was performed to demonstrate the performance of the
device. Testing was completed to verify and validate the device as outlined in the
device description. Testing included electrically powered suction safety, electrical
safety, vacuum cycling, software, smoke evacuation and filtration. Human factors
analysis and usability testing was performed on the user interface, labeling, and
training materials. | | | | | | | | | | | | | | | | | | | | |
| Biocompatibility | Biocompatibility testing of the Neptune 2 Waste Management System confirmed that
the device meets the applicable requirements of the FDA Blue Book Memorandum
G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of | | | | | | | | | | | | | | | | | | | | |

·

2

	Medical Devices Part -1: Evaluation and Testing and are biocompatible.
Substantial
Equivalence
(SE) Rationale:	The Neptune 2 Waste Management System, when compared to its predicates, has an equivalent intended use, protocols for use, mode of operation, technological characteristics and performance specifications.
(See attached Table 1: Device Comparison Matrix)
Safety and
Effectiveness:	Based upon the comparison to the predicate devices, the Stryker Neptune 2 Waste Management System is substantially equivalent to the predicate devices.
Submitted by:	Michelle Jump
Associate Regulatory Affairs Analyst

     Signature                                                                                                                                                                                                                             |

| Date Submitted: | December 20, 2013 |

3

4100 E. Milham Avenue
Kalamazoo, Mi 49001
1: 269 323 7700 f: 269 389 5412
www.siryker.com

stryker

Instruments

Stryker Neptune 2

Covidien (Valleylab)

Dornoch Transposal

Stryker Neptune 1

able 1: Device Comparison Matri

Model Number	Clearance	Classification	Regulation	Product Code	Indications for Use
Rover: 0700-010-00	510k	II	21 CFR 878.5070	FYD	The Neptune Waste Management system is intended to be used in the Operating Room, 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.
Duo: DU100
Quad: QD100	K012991	II	21 CFR 878.4780	JCX	The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
OptiMumm: 945 102 097	K081047	II	21 CFR 878.5070	FYD	The Indications for Use of the Valleylab OptiMumm Smoke Evacuator system are for the removal of smoke and incidental fluids produced during electrosurgery and/or laser surgery. The removal of smoke from the surgical site improves visibility and reduces potential health hazards associated with surgical smoke.
Rover: 0702-010-000	K980915	II	21 CFR 878.4780
21 CFR 878.5070	JCX
FYD	The Neptune 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.
	Pending	II

4

| lest toose. Connection to closed ound drainage systems.
The Neptune 2 Waste Management System is contraindicated stated is the states • Connection directly so
hest tubes. | | 19 x 23 x 70" | swiveling hospita
grade caster | Rubber bumpers | urfaces of the rover vith a soft, lint-free cloth noistened with a non-
nstructions. Caution against using solvents, lubricants, lubricants, other chemicals,
brasive, hospital lisinfectant prepared ccording to the
Vipe the externa
ncluding glutaraldehyde c similar chemical
nanufacturer'
cleaners | No | と | Yes |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------|-----------------------------------|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------|----------------------------------------|
| None | | | | . :: , ' | .5 - | . " | | |
| None | | 24" x 24" x 55" or 23" x 33" x 33" x 55" depending on mode | swiveling caster | lastic bumper | | No | epending on mode
2 or 4 | Yes |
| None | | 18 x 25 x 51" | swiveling hospit
grade casters | Rubber bumper | Wipe the surfaces of the Restitio and the criation and the station and the station and the stations and the count of the count of the world coultions codes of cides to on sim
cleansers. | Yes | T | Yes |
| ntraindicat | ion
stem Configura | Size | Casters | Bumpers | aning instructi | red
lover is battery-power luring docking | of canister | Volume measuremen vith digital display |

5

| Offloading and canister
cleaning accessory | Neptune 1
Docking Station
(0700-005-000) | Ultra Evac
Docking Station
UL-EV100 | Neptune 2
Docking Station
(0702-014-000) |
|-----------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------|
| Rover empty weight | 230 lbs | 195 lbs or 225 lbs
(depending on model) | 300 lbs |
| Electrical isolation type | Class I, Type CF Applied
Part | Information not available | Class I, Type CF Applied
Part |
| Enclosure protection | IPXO Ordinary Equipment | Information not available | IPXO Ordinary Equipment |
| 120V single phase
electric power
requirements | 16 A | 4.5 A | 12 A |
| Number of uses before
docking | Limited by fluid capacity | Limited to 2 or 4
procedures
(depending on model) | Limited by fluid capacity |
| User display | LCD screen | LCD screen | LCD screen |
| User interaction to dock | Push rover into docker | Push Rover adjacent to
Docker and Insert
docker's gas-pump-style
nozzle into rover | Push rover into docker |
| Waste/water connection
to rover | Dry-break hydraulic
couplings | Information not available | Dry-break hydraulic
couplings |
| Rover-docker coupling
size | .875" body diameter | .625" OD | 1.325" body diameter |
| Rover-docker coupling
orientation | Horizontal | Approximately 25° from
horizontal | Vertical |
| Water inlet control | Solenoid valve | Solenoid valve | Solenoid valve |
| Backflow prevention
valve | Internal | External | Internal |
| Weight | 90 lbs | 100 lbs | 95 lbs |
| Waste/water connection
to facility | Quick disconnect fittings | Information not available | Quick disconnect fittings |

6

Neptune docking

etergent (0700-00)
xed rubber pa 0 - 480 mm-H 23″ x 23″ x 16 igital displa
(mm-Hg) nfrared Sprinkle НЕРА 3 A Yes Yes Yes Yes Yes ನ . ---ﺎﺭﻳﺲ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ … .. 、『 ్ ప్ర ﺃ ﺍﻟ : : . . ﻳﻮ . ・ ﻨﻪ : : .............................................................................................................................................................................. 。 : ・・・・
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ . . . . . .. . :: : . ormation not availab tra Enzyme (UL-EZ20
ectrical contac 4 - 700 mm-Hj 0" x 16" x 28 igital display
(mm-Hg) Sprinkler HEPA 15 A Yes Yes Yes Yes No ਨ ters with adjustab
extensions Neptune docking
tergent (0700-00)
4 - 483 mm-H Analog gauge
mm-Hg, in-Hg, in-Hg 5" x 20" x 22 Sprinkle nfrarec HEPA Yes 3 A Yes Yes Yes (દડ I nister cleaning meth ectromagnet for
olding rover to docke cuum limit adjustab multaneous levels cuum control ranj ptional wall suctio Rinses canister with
facility water cker dimension cuum Syster 20V single phas
ectric power
equirements offloads waste to
anitary sewer Canister cleaning
Jetergent uction filtration
fficiency anister vacuun ocker support over-Docker
ommunication ndicator uction orts

ction 005

7

| Canister vacuum level
regulation | Collection Canisters | Mechanical regulator | Electronic regulator | Electronic regulator | | 20 hrs | . ' •
" | 25 hrs | 80 hrs |
|--------------------------------------------|----------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------|
| Rover canister capacity | 20 L | 33 L or 52 L
(depending on model) | 24 L | Yes | | | ત્વ જિડ | Yes | |
| Canister graduation label | Yes | Yes | Yes | T | ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ | . | I | రా | |
| Electronic canister
overfill protection | Yes | Yes | Yes | 7/8" | : | 11

- - - - | 3/8", 7/8″ | 3/8", 7/8" | |
        | Mechanical canister
        overfill protection | Float-style shut-off valve
        in rover | Hydrophobic filter
        located in disposable
        canister lid. | Float-style shut-off valve
        in rover | Yes | | - | Yes | Yes | |
        | Volume display accuracy | $\pm 175$ mL | $\pm 150$ mL | $\pm 150$ mL, $\pm 50$ mL
        (20 L canister, 4 L
        canister) | ED | | ్ :: :
1 - | formation not availa | EO | |
| Volume display
resolution | 50 mL | 10 mL | 50 mL, 20 mL
(20 L canister, 4 L
canister) | SO 10993-1 | . . | ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | 50 10993 | 20 10993- | |
| Lighted canister contents | No | Yes | No | | | | | | |
| Smoke Evacuator | | | | fertica | | 45 degree | ્ર
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | forizonta | |
| Filtration efficiency | HEPA | ULPA | ULPA | 375" | | x .320" and 1x .37 | --
: : : : : : : : : : : : : : | 375" | |
| Maximum flow rate | 33 CFM | 20 CFM | 24 CFM | Single patient us | |
ingle patient us | | Single patient | |
| Minimum flow rate | 0 CFM | 3 CFM | 21 CFM | 1-port o 4-port | | 3-port | ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
| 1-port of 4-port | |
| Maximum Suction Range
(100% power) | 61 mm-Hg | 99 mm-Hg | 67 mm-Hg | Yes | | Yes | :-
. . | Yes | |
| Minimum suction range
(20% power) | 0 mm-Hg | 12 mm-Hg | 34 mm-Hg | 4.7 oz | | 3.1 oz | | 1.6 oz | |
| Pre-filter | Single-use disposable | Single-use disposable | Multi-use disposable | on-sterile | | lon-steril | :

:. | Non-steril | |
| Filter life indicator | Yes | Yes | Yes | | | | | | |
| Variable speed settings | Infinite
(continuous rotary dial) | 5 | 9 | Yes | | Yes | | Yes | |
| ectric motor-drive | | formation not availa | | ectric motor-driv | | | | | |
| て | | ਟ | | t | | | | | |

: :

:

8

9

Travel	Maximum height from floor	Environmental Conditions
		Operation Temp	Operation Humidity	Operation Barometric Pressure	Storage / Transportation
29 in	89 in	10 - 40°C	30 - 75%	700 - 1060 hPa	-20 - 40°C
Information not available	Information not available	10 - 40°C	30 - 75%	700 - 1060 hPa	-20 - 40°C
32 in	102 in	Information not available	Information not available	Information not available	Information not available
		10 - 40°C	30 - 75%	700 - 1060 hPa	-20 - 40°C
		Storage / Transportation Humidity	Storage / Transportation Barometric Pressure
		10 - 75%	500 - 1060 hPa
		10 - 75%	500 - 1060 hPa
		Information not available	Information not available
		10 - 75%	500 - 1060 hPa

. ﺑ

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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with outstretched arms, representing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is printed in black and white.

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

December 20, 2013

Stryker Corporation Michelle Jump, RAC, M.S. Regulatory Affairs Associate Analyst 4100 E. Milham Ave, KALAMAZOO MI 49001

Re: K132671

Trade/Device Name: Neptune 2 Waste Management System Regulation Number: 21 CFR 872.4780 Regulation Name: Apparatus, suction, ward use, portable, ac-powered Regulatory Class: II Product Code: JCX, FYD Dated: November 14, 2013 Received: November 15, 2013

Dear Ms. Jump:

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.

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Page 2 - Ms. Jump

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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 forth in 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 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

Sincerely yours,

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/11/Picture/7 description: The image contains a signature and some text. The text reads "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The signature is illegible.

Erin I. Keith, M.S. Acting 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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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ Stryker® Neptune 2

Indications for Use

ﺮ ﺍﻟﻤﻌﺎﺩﻟﺔ ﻣﻮﺍﺩ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﻠﺘﻤﻴﺔ -

The Neptune 2 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

and/or

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Glaverie -S 2013.12.17 18:13:45 -05'0