(115 days)
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.
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 provided text describes the Stryker® Neptune 2 Waste Management System, a fluid waste management system with smoke evacuation, submitted for 510(k) clearance. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific acceptance criteria through a comparative study with a ground truth established by experts.
Therefore, many of the requested elements (e.g., specific acceptance criteria, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not explicitly detailed in this 510(k) summary. The summary primarily relies on bench testing and comparison to predicate devices to establish safety and effectiveness.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of explicit, quantitative acceptance criteria that the device was tested against and then reports its performance against those criteria in a "study" as one might expect for a new diagnostic or AI-driven insights device. Instead, the "Testing" section states:
"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."
The "Table 1: Device Comparison Matrix" provides comparative specifications against predicate devices, implying that performance within a similar range or meeting similar functional attributes to the predicates would be considered acceptable. Below is a table summarizing key performance characteristics (rather than explicit acceptance criteria with pass/fail thresholds) of the Neptune 2 and its predicates, as presented in the document.
| Feature / Performance Characteristic | Stryker® Neptune 2 (Reported Performance) | Predicate Device 1 (Stryker® Neptune Waste Management System) | Predicate Device 2 (Dornoch Transposal Ultra System) | Predicate Device 3 (Valleylab OptiMumm Smoke Evacuator System) |
|---|---|---|---|---|
| General | ||||
| Classification | II | II | II | II |
| Product Code | JCX, FYD | FYD, JCX | JCX | FYD |
| Rover Empty Weight | 300 lbs | 230 lbs | 195 lbs or 225 lbs (depending on model) | 230 lbs (from Neptune 1, similar category) |
| Electrical Isolation Type | Class I, Type CF Applied Part | Class I, Type CF Applied Part | Information not available | Class I, Type CF Applied Part (from Neptune 1, similar category) |
| Enclosure Protection | IPXO Ordinary Equipment | IPXO Ordinary Equipment | Information not available | IPXO Ordinary Equipment (from Neptune 1, similar category) |
| 120V Single-phase Electric Power Requirements | 12 A | 16 A | 4.5 A | 3 A |
| Number of Uses Before Docking | Limited by fluid capacity | Limited by fluid capacity | Limited to 2 or 4 procedures | Limited by fluid capacity (from Neptune 1, similar category) |
| User Display | LCD screen | LCD screen | LCD screen | Digital display (smoke evacuator) / LCD screen (from Neptune 1) |
| Suction / Fluid Waste Management | ||||
| Canister Vacuum Level Regulation | Electronic regulator | Mechanical regulator | Electronic regulator | Electronic regulator (from Neptune 1, similar category) |
| Rover Canister Capacity | 24 L | 20 L | 33 L or 52 L (depending on model) | 24 L (from Neptune 1, similar category) |
| Canister Graduation Label | Yes | Yes | Yes | Yes |
| Electronic Canister Overfill Protection | Yes | Yes | Yes | Yes |
| Mechanical Canister Overfill Protection | Float-style shut-off valve in rover | Float-style shut-off valve in rover | Hydrophobic filter located in disposable canister lid | Float-style shut-off valve in rover (from Neptune 1, similar category) |
| Volume Display Accuracy | ±150 mL (20L), ±50 mL (4L) | ±175 mL | ±150 mL | ±150 mL (from Neptune 1, similar category) |
| Volume Display Resolution | 50 mL (20L), 20 mL (4L) | 50 mL | 10 mL | 50 mL (from Neptune 1, similar category) |
| Max Suction Range (100% power) | 67 mm-Hg | 61 mm-Hg | 99 mm-Hg | 61 mm-Hg (from Neptune 1, similar category) |
| Min Suction Range (20% power) | 34 mm-Hg | 0 mm-Hg | 12 mm-Hg | 0 mm-Hg (from Neptune 1, similar category) |
| Smoke Evacuation | ||||
| Filtration Efficiency | ULPA | HEPA | ULPA | HEPA |
| Maximum Flow Rate | 24 CFM | 33 CFM | 20 CFM | 33 CFM (from Neptune 1, similar category) |
| Minimum Flow Rate | 21 CFM | 0 CFM | 3 CFM | 0 CFM (from Neptune 1, similar category) |
| Variable Speed Settings | 9 | Infinite (continuous rotary dial) | 5 | Infinite (from Neptune 1, similar category) |
| Pre-filter | Multi-use disposable | Single-use disposable | Single-use disposable | Single-use disposable (from Neptune 1, similar category) |
| Filter Life Indicator | Yes | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states "Bench testing was performed...Testing was completed to verify and validate the device." However, specific sample sizes (e.g., number of test articles, number of test runs) for each component of the bench testing (electrical safety, vacuum cycling, smoke evacuation, filtration, software, human factors) are not detailed.
- Data Provenance: The testing was conducted internally by Stryker. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, as this is a device for fluid and smoke management, not an AI or diagnostic device that typically uses patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the 510(k) summary. This type of detail is typically associated with studies for diagnostic devices or AI algorithms where expert consensus establishes a "ground truth" against which device performance is measured (e.g., presence or absence of a disease). For a waste management system, the "ground truth" is typically defined by engineering specifications and functional testing (e.g., vacuum pressure achieved, fluid volume collected, smoke particles filtered).
4. Adjudication Method for the Test Set
This is not applicable and not provided in the 510(k) summary for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic devices or AI algorithms when interpreted by multiple human readers, often comparing performance with and without AI assistance. This device is a surgical waste management system and does not involve human interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm-only study was not done because this is a physical medical device. It does not employ an "algorithm" in the sense of a software component making diagnostic or analytical decisions. Its performance is related to its mechanical and electrical functions.
7. The Type of Ground Truth Used
The "ground truth" for this device would be defined by engineering specifications, regulatory standards (e.g., electrical safety, biocompatibility), and functional performance targets (e.g., flow rates, vacuum levels, filtration efficiency, fluid capacity). The device was tested to verify it met these internal specifications and regulatory requirements. The biocompatibility testing specifically referenced ISO-10993 standards.
8. The Sample Size for the Training Set
This is not applicable and not provided. "Training set" refers to data used to train machine learning algorithms. The Neptune 2 is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/ML algorithm for this device.
{0}------------------------------------------------
KV32671
DEC 2 0 2013
stryker
Instruments
510(k) Summary
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, 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}------------------------------------------------
| DeviceDescription: | The Neptune 2 Waste Management System is a fluid waste management systemwith smoke evacuation. It collects surgical waste fluid within a closed suctionsystem, then disposes of it through a docking station. The system is comprised of arover and a docker (also referred to as a docking station).The Neptune 2 Rover (Model Number: 0702-001-000) is a mobile, AC-poweredsurgical fluid waste collection device. It is intended to collect waste fluids andevacuate smoke during surgical procedures.The Neptune 2 Docking Station (Model Number: 0702-014-000) is a stationarydevice for automated rover cleaning and waste offloading. It provides a fixedconnection to the hospital's water supply, sewer, and electricity.The following Stryker accessories are for use with the Neptune 2 WasteManagement 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® | |||||||||||||||||||||
| Indicationsfor Use: | The Neptune 2 Waste Management System is intended to be used in the operatingroom, pathology, surgical centers, and doctor's offices to collect and dispose ofsurgical fluid waste as well as collect smoke generated from electrocautery or laserdevices. | ||||||||||||||||||||
| 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 andperformance characteristics as identified in Stryker's internal design controlprocedures. Bench testing was performed to demonstrate the performance of thedevice. Testing was completed to verify and validate the device as outlined in thedevice description. Testing included electrically powered suction safety, electricalsafety, vacuum cycling, software, smoke evacuation and filtration. Human factorsanalysis and usability testing was performed on the user interface, labeling, andtraining materials. | ||||||||||||||||||||
| Biocompatibility | Biocompatibility testing of the Neptune 2 Waste Management System confirmed thatthe device meets the applicable requirements of the FDA Blue Book MemorandumG95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of |
·
{2}------------------------------------------------
| Medical Devices Part -1: Evaluation and Testing and are biocompatible. | |
|---|---|
| SubstantialEquivalence(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 andEffectiveness: | 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 JumpAssociate 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: DU100Quad: 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 878.478021 CFR 878.5070 | JCXFYD | 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 sohest tubes. | 19 x 23 x 70" | swiveling hospitagrade 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 theVipe the externancluding glutaraldehyde c similar chemicalnanufacturer'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 mode2 or 4 | Yes | ||
| None | 18 x 25 x 51" | swiveling hospitgrade 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 simcleansers. | Yes | T | Yes | |
| ntraindicat | ionstem Configura | Size | Casters | Bumpers | aning instructi | redlover is battery-power luring docking | of canister | Volume measuremen vith digital display |
{5}------------------------------------------------
| Offloading and canistercleaning accessory | Neptune 1Docking Station(0700-005-000) | Ultra EvacDocking StationUL-EV100 | Neptune 2Docking 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 AppliedPart | Information not available | Class I, Type CF AppliedPart |
| Enclosure protection | IPXO Ordinary Equipment | Information not available | IPXO Ordinary Equipment |
| 120V single phaseelectric powerrequirements | 16 A | 4.5 A | 12 A |
| Number of uses beforedocking | Limited by fluid capacity | Limited to 2 or 4procedures(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 toDocker and Insertdocker's gas-pump-stylenozzle into rover | Push rover into docker |
| Waste/water connectionto rover | Dry-break hydrauliccouplings | Information not available | Dry-break hydrauliccouplings |
| Rover-docker couplingsize | .875" body diameter | .625" OD | 1.325" body diameter |
| Rover-docker couplingorientation | Horizontal | Approximately 25° fromhorizontal | Vertical |
| Water inlet control | Solenoid valve | Solenoid valve | Solenoid valve |
| Backflow preventionvalve | Internal | External | Internal |
| Weight | 90 lbs | 100 lbs | 95 lbs |
| Waste/water connectionto facility | Quick disconnect fittings | Information not available | Quick disconnect fittings |
{6}------------------------------------------------
Neptune docking
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{7}------------------------------------------------
| Canister vacuum levelregulation | 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 canisteroverfill protection | Yes | Yes | Yes | 7/8" | : | 11- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | 3/8", 7/8″ | 3/8", 7/8" | |
| Mechanical canisteroverfill protection | Float-style shut-off valvein rover | Hydrophobic filterlocated in disposablecanister lid. | Float-style shut-off valvein rover | Yes | - | Yes | Yes | ||
| Volume display accuracy | $\pm 175$ mL | $\pm 150$ mL | $\pm 150$ mL, $\pm 50$ mL(20 L canister, 4 Lcanister) | ED | ్ :: :- 1 - | formation not availa | EO | ||
| Volume displayresolution | 50 mL | 10 mL | 50 mL, 20 mL(20 L canister, 4 Lcanister) | 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 | ્રﺔ 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 |
: :
:
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| 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
.
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
§ 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.