STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM

{0}------------------------------------------------ KV32671 DEC 2 0 2013 stryker Instruments ### 510(k) Summary | 510(k) Owner: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-389-3549<br>(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)<br>Dornoch Transposal Ultra System (K081047).<br>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<br>Description: | The Neptune 2 Waste Management System is a fluid waste management system<br>with smoke evacuation. It collects surgical waste fluid within a closed suction<br>system, then disposes of it through a docking station. The system is comprised of a<br>rover and a docker (also referred to as a docking station).<br><br>The Neptune 2 Rover (Model Number: 0702-001-000) is a mobile, AC-powered<br>surgical fluid waste collection device. It is intended to collect waste fluids and<br>evacuate smoke during surgical procedures.<br><br>The Neptune 2 Docking Station (Model Number: 0702-014-000) is a stationary<br>device for automated rover cleaning and waste offloading. It provides a fixed<br>connection to the hospital's water supply, sewer, and electricity.<br>The following Stryker accessories are for use with the Neptune 2 Waste<br>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<br>for Use: | The Neptune 2 Waste Management System is intended to be used in the operating<br>room, pathology, surgical centers, and doctor's offices to collect and dispose of<br>surgical fluid waste as well as collect smoke generated from electrocautery or laser<br>devices. | | | | | | | | | | | | | | | | | | | | | | Contraindications | The Neptune 2 Waste Management System is contraindicated against:<br>• Connection directly to chest tubes.<br>• Connection to closed wound drainage systems. | | | | | | | | | | | | | | | | | | | | | | Testing | The Neptune 2 Waste Management System meets the specification and<br>performance characteristics as identified in Stryker's internal design control<br>procedures. Bench testing was performed to demonstrate the performance of the<br>device. Testing was completed to verify and validate the device as outlined in the<br>device description. Testing included electrically powered suction safety, electrical<br>safety, vacuum cycling, software, smoke evacuation and filtration. Human factors<br>analysis and usability testing was performed on the user interface, labeling, and<br>training materials. | | | | | | | | | | | | | | | | | | | | | | Biocompatibility | Biocompatibility testing of the Neptune 2 Waste Management System confirmed that<br>the device meets the applicable requirements of the FDA Blue Book Memorandum<br>G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of | | | | | | | | | | | | | | | | | | | | | · {2}------------------------------------------------ | | Medical Devices Part -1: Evaluation and Testing and are biocompatible. | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial<br>Equivalence<br>(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.<br>(See attached Table 1: Device Comparison Matrix) | | Safety and<br>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<br>Associate Regulatory Affairs Analyst | | | <div> <br/> Signature </div> | | 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<br>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<br>21 CFR 878.5070 | JCX<br>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.<br>The Neptune 2 Waste Management System is contraindicated stated is the states • Connection directly so<br>hest tubes. | | 19 x 23 x 70" | swiveling hospita<br>grade caster | Rubber bumpers | urfaces of the rover vith a soft, lint-free cloth noistened with a non-<br>nstructions. Caution against using solvents, lubricants, lubricants, other chemicals,<br>brasive, hospital lisinfectant prepared ccording to the<br>Vipe the externa<br>ncluding glutaraldehyde c similar chemical<br>nanufacturer'<br>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<br>2 or 4 | Yes | | None | | 18 x 25 x 51" | swiveling hospit<br>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<br>cleansers. | Yes | T | Yes | | ntraindicat | ion<br>stem Configura | Size | Casters | Bumpers | aning instructi | red<br>lover is battery-power luring docking | of canister | Volume measuremen vith digital display | {5}------------------------------------------------ | Offloading and canister<br>cleaning accessory | Neptune 1<br>Docking Station<br>(0700-005-000) | Ultra Evac<br>Docking Station<br>UL-EV100 | Neptune 2<br>Docking Station<br>(0702-014-000) | |-----------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------| | Rover empty weight | 230 lbs | 195 lbs or 225 lbs<br>(depending on model) | 300 lbs | | Electrical isolation type | Class I, Type CF Applied<br>Part | Information not available | Class I, Type CF Applied<br>Part | | Enclosure protection | IPXO Ordinary Equipment | Information not available | IPXO Ordinary Equipment | | 120V single phase<br>electric power<br>requirements | 16 A | 4.5 A | 12 A | | Number of uses before<br>docking | Limited by fluid capacity | Limited to 2 or 4<br>procedures<br>(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<br>Docker and Insert<br>docker's gas-pump-style<br>nozzle into rover | Push rover into docker | | Waste/water connection<br>to rover | Dry-break hydraulic<br>couplings | Information not available | Dry-break hydraulic<br>couplings | | Rover-docker coupling<br>size | .875" body diameter | .625" OD | 1.325" body diameter | | Rover-docker coupling<br>orientation | Horizontal | Approximately 25° from<br>horizontal | Vertical | | Water inlet control | Solenoid valve | Solenoid valve | Solenoid valve | | Backflow prevention<br>valve | Internal | External | Internal | | Weight | 90 lbs | 100 lbs | 95 lbs | | Waste/water connection<br>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<br>regulation | Collection Canisters | Mechanical regulator | Electronic regulator | Electronic regulator | | 20 hrs | . ' •<br>" | 25 hrs | 80 hrs | |--------------------------------------------|----------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------| | Rover canister capacity | 20 L | 33 L or 52 L<br>(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<br>overfill protection | Yes | Yes | Yes | 7/8" | : | 11<br>- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | 3/8", 7/8″ | 3/8", 7/8" | | | Mechanical canister<br>overfill protection | Float-style shut-off valve<br>in rover | Hydrophobic filter<br>located in disposable<br>canister lid. | Float-style shut-off valve<br>in rover | Yes | | - | Yes | Yes | | | Volume display accuracy | $\pm 175$ mL | $\pm 150$ mL | $\pm 150$ mL, $\pm 50$ mL<br>(20 L canister, 4 L<br>canister) | ED | | ్ :: :<br>- 1 - | formation not availa | EO | | | Volume display<br>resolution | 50 mL | 10 mL | 50 mL, 20 mL<br>(20 L canister, 4 L<br>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<br>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 | --<br>: : : : : : : : : : : : : : | 375" | | | Maximum flow rate | 33 CFM | 20 CFM | 24 CFM | Single patient us | | <br>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<br> | 1-port of 4-port | | | Maximum Suction Range<br>(100% power) | 61 mm-Hg | 99 mm-Hg | 67 mm-Hg | Yes | | Yes | :-<br>. . | Yes | | | Minimum suction range<br>(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 | :<br><br>:. | Non-steril | | | Filter life indicator | Yes | Yes | Yes | | | | | | | | Variable speed settings | Infinite<br>(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 {10}------------------------------------------------ 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. {11}------------------------------------------------ Page 2 - Ms. Jump . 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 {12}------------------------------------------------ 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