The ORwell™ Fluid Collection and Disposal System is intended to be used in the Operating Rooms, Surgical Centers, and Doctors' Offices to collect and dispose of fluid waste.

Device Description

The ORwell™ Fluid Collection and Disposal System consists of three (3) components:

Mobile Unit
Disposal Station
Disposable Collection Disc (hereinafter referred to as "Disposable Disc," "Collection Disc," or "Disc")

The Mobile Unit is a portable unit that provides its own source of vacuum and houses the Disposable Collection Disc which is used to collect fluid waste and small debris from the surgical site. The amount of suction can be regulated by the end user via the simple user interface on the Mobile Unit.

The Disposable Collection Disc is a single use disposable that collects fluid waste from the surgical procedure. It has four ports to allow for the collection of fluid from various instruments during the procedure. Additionally, the Disc features an attached flexible liner in which collected fluid is contained.

The Disposal Station is a stationary unit located in a utility area plumbed with water inlet and outlet lines. After the surgical procedure, the Mobile Unit is moved to the utility area where it interfaces with and locks into the Disposal Station. After the Mobile Unit is locked into place, the Disposal Station automatically empties the Collection Disc, sending the surgical fluid waste into the hospital's waste water system. The evacuation process also collapses the Disc to allow for easy disposal.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the ORwell™ Fluid Collection and Disposal System. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove the device meets them in the context of, for example, a diagnostic AI or imaging device.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of regulatory submission and information provided.

However, I can extract the acceptance criteria (referred to as "performance attributes" in the document) and the reported device performance from the provided text as it relates to the comparison with predicate devices.

1. A table of acceptance criteria and the reported device performance:

The document describes "performance attributes" that were found acceptable for the intended use and compares them to predicate devices. It also outlines specific testing for the ORwell system.

Design Feature / Acceptance Criteria	Predicate Device Performance (Stryker Neptune K012991)	Proposed Device Performance (ORwell™ Fluid Collection and Disposal System)	Comments / Proof of Meeting Criteria
Indications for Use	Collect and dispose of surgical fluid waste, and collect smoke.	Intended to collect and dispose of surgical fluid waste.	The new device and the predicate K040239 have the same claim of removing fluid. Removal of smoke evacuation feature does not raise new risks.
Closed System	Protects hospital personnel from splashes and biohazard exposure.	Protects hospital personnel from splashes, biohazard exposure, cross-contamination, and cleanliness issues.	The addition of protecting against cross-contamination and cleanliness issues does not raise new questions regarding safety.
Fluid Collection Disposable	Manifold and Canister	Manifold and Collection Liner	The addition of a collection liner for containment of waste fluid does not raise new questions regarding safety.
Product Code	FYD, Apparatus, Exhaust, Surgical (K012991) / BTA, Powered Suction Pump (K040239)	BTA, Powered Suction Pump	SAME (compared to K040239)
FDA Regulation, 21 CFR	878.5070 (K012991) / 878.4780 (K040239)	878.4780	SAME (compared to K040239)
Dimensions - Mobile Unit	18" width x 25" depth x 51" height	23" width x 28" depth x 47" height	Dimensional differences do not affect safety or effectiveness.
Dimensions - Disposal Station	25" width x 22" depth x 21.5" height	34" width x 15" depth x 50" height	Dimensional differences do not affect safety or effectiveness.
Mobile Unit Electrical Requirements	UL 2601 Compliant, AC Powered, 110 V, 16 Amps	UL 60601-1 Compliant, AC Powered, 115 V, 12 Amps	Voltage and amperage differences do not raise new questions of safety and effectiveness.
Disposal Station Electrical Requirements	120 V, 3 Amps	115 V, 4 Amps	Voltage and amperage differences do not raise new questions of safety and effectiveness.
Suction Source	On-Board Pump	On-Board Pump	SAME
Mobile Unit Vacuum Range	0-19" Hg	0-19" Hg	SAME. Testing: "Vacuum Level Operating Range verification that, with regulator, vacuum operating range is within spec" was performed. Results: "Vacuum level operating range was found to be the same at 0" – 19" Hg".
Flow Rate (Fluid Suction)	Approximately 4.9 LPM (at maximum)	On 100% vacuum must be ≥ 5.0 LPM	Requirement Met: "Requirement met (using water) for high volume." Also, "maximum fluid suction flow rate was found to be comparable with ORwell™ performing at approximately 5 liters/minute and the predicate at approximately 4.9 liters/minute."
Vacuum Regulator	Knob-Controlled Bleeder Valve	Knob-Controlled Bleeder Valve	SAME
Fluid Suction Filter	HEPA, 99.97% efficiency @ 0.3 microns	HEPA, 99.97% efficiency @ 0.3 microns	SAME. Testing: "HEPA Filter Efficiency and Life - verification that filter assembly is HEPA efficient and has a life of ≥ 500 hours" was performed.
Emergency Back-Up Port	Yes	Yes	SAME
Single Patient Use	Single or Multiple Patients	Single Patient Use	The indication for single use increases clinician/patient safety by not allowing contaminated devices to be left in the OR for prolonged periods. This change does not raise new questions regarding effectiveness.
Canister Capacity	20 L	20 L	SAME
Suction Mode	Continuous	Continuous	SAME
OTC or Prescription	OTC	Prescription (RX only)	Devices are intended to be used in operating rooms, surgical centers, and doctor's offices.
Overflow Prevention Mechanism	Yes	Yes	SAME. Testing: "Overflow Valve Fluid Ingress overflow valve tested for fluid ingress effectiveness" was performed.
Pre-Filter	Single Use Disposable	Single Use Disposable	SAME
Suction Inlet Port Dimensions	3/8 inch inner diameter	1/4 inch inner diameter	Port size and design based off of currently acceptable Cardinal Health suction canister design.
Principles of Operation	Fluid and smoke suctioned; mobile unit docks for disposal; contents pumped into tank/drain.	Fluid suctioned; mobile unit docks for disposal; contents pumped directly into hospital waste line; disposable includes collection liner.	The manifold in the predicate has been augmented into a disposable in the proposed device. This enhances safety.
"Almost Full" Sensor	Not specified		Testing: "verification that light illuminates and audible alarm sounds at the appropriate pre-determined level" was performed.
Fluid Trap Shutoff	Not specified		Testing: "fluid trap assembly tested for fluid ingress effectiveness" was performed.
Disposal Station Valve Drip Prevention	Not specified		Testing: "verification that no dripping results after the fluid disposal process" was performed.
Disposal Port Valve Opening Pressure	Not specified		Testing: "verification that the valve will prevent user from being exposed to biohazards" was performed.
Instructions for Use	Not specified		Testing: "ORwell™ system tested for safe operation when being used per instructions for use" was performed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is primarily engineering performance testing to demonstrate equivalence, not clinical testing with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes technical/engineering performance testing, not diagnostic accuracy based on expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no human interpretation or ground truth adjudication described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is a fluid collection and disposal system, not an AI-powered diagnostic tool.

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

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the engineering performance tests would be the established engineering specifications, standards, and comparison data from the predicate device. For example, the "ground truth" for the vacuum range is 0-19" Hg, and the device was tested to verify it met this. The "ground truth" for filter efficiency is HEPA standard (99.97% @ 0.3 microns).

8. The sample size for the training set

This information is not applicable as the device is an electro-mechanical system, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is an electro-mechanical system, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized graphic element above the company name. The graphic element is composed of several curved lines that intersect, creating a sense of movement and connection.

Medical Products and Services 1500 Waukegan Road McGraw Park, IL 60085 847.473.1500 tel 847.785.2461 fax

www.cardinal.com

SMDA REQUIREMENTS - K080845

510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS ORwell™ Fluid Collection and Disposal System

Manufacturer:	Cardinal Health Corporation1500 Waukegan Road MP/WMMc Gaw Park, IL 60085
Regulatory Affairs Contact:	Lavenia Ford1500 Waukegan Road MP/WMMc Gaw Park, IL 60085
Telephone Number:	(847) 785-3323
Date summary Prepared:	March 5, 2008
Trade Name:	ORwell™ Fluid Collection and Disposal System
Classification:	Class II per 21 CFR § 878.4780
Classification Name:	Powered Suction Pump
Predicate Device:	K012991 - Stryker Neptune Waste Management System andK040239 - Neomedix Corp. Supraflow Console

Description:

The Disposal Station is a stationary unit located in a utility area. The ORwell™ Fluid Collection and Disposal System consists of three (3) components:

1. Mobile Unit
1. Disposal Station
Disposable Collection Disc (hereinafter referred to as "Disposable Disc," "Collection ന Disc," or "Disc")

APR 3 0 2008

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Disposal Station automatically empties the Collection Disc, sending the surgical fluid waste into the hospital's waste water system. The evacuation process also collapses the Disc to allow for easy disposal.

Intended Use:

The ORwell™ Fluid Collection and Disposal System is intended to be used in the Operating Rooms, Surgical Centers and Doctors' Offices to collect and dispose of fluid waste.

Substantial Equivalence

The ORwell™ Fluid Collection and Disposal System is substantially equivalent to the Neptune Waste Management System in that:

Intended use is a subset of that of the Neptune Waste Management System. ー Removal of the smoke evacuation feature limits use within the currently cleared indications of the predicate device. This change does not raise new risks to the patient or clinician, nor is there any significant effect on the device's safety or effectiveness with respect to surgical fluid collection.
Performance attributes and safety components are substantially equivalent to the l predicate
- Vacuum range is the same as predicate 트
- I Both devices regulate vacuum via a knob-controlled bleeder valve
- . Both devices assure HEPA quality exhaust
- 트 Both devices contain an overflow prevention mechanism
The ORwell™ System differentiates from the predicate in that its collection vessel is | a single use disposable component. This requires the user to dispose of all components that have come in contact with surgical fluid waste between procedures, limiting likelihood of cross-contamination. This key feature change increases the safety of the device and has no adverse effect on substantial equivalence.

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The following performance attributes were found to be acceptable for the intended use.

Note tables below:

DesignFeature	Proposed DeviceCardinalORwellTMSurgical FluidWaste Collectionand DisposalSystem	Predicate DeviceStryker NeptuneWasteManagementSystem (K012991)	PredicateDeviceNeomedixCorporation,SupraFlowConsole(K040239)	Comments
Indications forUse	The CardinalORwellTM Systemis intended to beused in theOperating Room,Surgical Centers,and Doctor'sOffices to collectand dispose ofsurgical fluidwaste.	The Neptune WasteManagementSystem is intendedto be used in theOperating Room,Surgical Centersand Doctor's Officesto collect anddispose of surgicalfluid waste as wellas collect smokegenerated fromelectrocautery orlaser devices.	The NeoMedixSupraFlowConsole is anaspiration pumpintended for usein generalsurgeryapplicationswhere aspirationof irrigation andwaste fluid froma surgical site isdesired.The device is notindicated forliposuction use.	The new deviceand thepredicateK040239 havethe same claimof removing fluid.
ClosedSystem	Protects hospitalpersonnel from (1)the splashes andinadvertentbiohazardexposure that arepossible withsuction canisterdevices and (2)the cross-contamination andcleanliness issuesthat are possiblewith fluidcollection anddisposal systemsthat utilize areusablecollectionchamber	Protects hospitalpersonnel fromsplashes andinadvertentbiohazard exposurethat is possible withsuction canisterdevices		The addition ofprotectingagainst cross-contaminationand cleanlinessissues does notraise newquestionsregarding safety.
FluidCollectionDisposable	Manifold andCollection Liner	Manifold andCanister		The addition of acollection linerfor containmentof the waste fluiddoes not raisenew questionsregarding safety.
Product Code	BTA, PoweredSuction Pump	FYD, Apparatus,Exhaust, Surgical	BTA, PoweredSuction Pump	SAME
DesignFeature	Proposed DeviceCardinalORwell™Surgical FluidWaste Collectionand DisposalSystem	Predicate DeviceStryker NeptuneWasteManagementSystem (K012991)	PredicateDeviceNeomedixCorporation,SupraFlowConsole(K040239)	Comments
FDARegulation,21 CFR	878.4780	878.5070	878.4780	SAME
Dimensions -Mobile Unit	23" width x 28"depth x 47" height	18" width x 25"depth x 51" height		Dimensionaldifferences donot affect safetyor effectiveness
Dimensions -DisposalStation	34" width x 15"depth x 50" height	25" width x 22"depth x 21.5" height(Measured - notspecified in 510(k))		Dimensionaldifferences donot affect safetyor effectiveness
Mobile UnitElectricalRequirements	UL 60601-1CompliantAC Powered, 115V, 12 Amps	UL 2601 CompliantAC Powered. 110 V,16 Amps		Voltage andamperagedifferences donot raise newquestions ofsafety andeffectiveness.
DisposalStationElectricalRequirements	115 V, 4 Amps	120 V, 3 Amps		Voltage andamperagedifferences donot raise newquestions ofsafety andeffectiveness.
SuctionSource	On-Board Pump	On-Board Pump		SAME
Mobile UnitVacuumRange	0-19" Hg	0-19" Hg		SAME
Flow Rate	On 100% vacuumFluid Flow Ratemust be $ ≥ ≥ $ 5.0LPM	Unknown		Requirementmet (usingwater) for highvolume
VacuumRegulator	Knob-ControlledBleeder Valve	Knob-ControlledBleeder Valve		SAME
Fluid SuctionFilter	HEPA, 99.97%efficiency @ 0.3microns	HEPA, 99.97%efficiency @ 0.3microns		SAME
EmergencyBack-Up Port	Yes	Yes		SAME
DesignFeature	Proposed DeviceCardinalORwell™Surgical FluidWaste Collectionand DisposalSystem	Predicate DeviceStryker NeptuneWasteManagementSystem (K012991)	PredicateDeviceNeomedixCorporation,SupraFlowConsole(K040239)	Comments
Single PatientUse	Single	Single or MultiplePatients	-	The indicationfor single use inthe proposeddevice increasesclinician/patientsafety by notallowingclinicians toleave acontaminateddevice in the ORfor prolongedperiods of time.This changedoes not raisenew questionsregardingeffectiveness.
CanisterCapacity	20 L	20 L	-	SAME
Suction Mode	Continuous	Continuous	-	SAME
OTC orPrescription	Prescription (RXonly)	OTC	-	Devices areintended to beused inoperating rooms,surgical centers,and doctor'soffices.
OverflowPreventionMechanism	Yes	Yes	-	SAME
Pre-Filter	Single UseDisposable	Single UseDisposable	-	SAME
Suction InletPortDimensions	$1/4$ inch innerdiameter	3/8 inch innerdiameter	-	Port size anddesign based offof currentlyacceptableCardinal Healthsuction canisterdesign
DesignFeature	Proposed DeviceCardinalORwell™Surgical FluidWaste Collectionand DisposalSystem	Predicate DeviceStryker NeptuneWasteManagementSystem (K012991)	PredicateDeviceNeomedixCorporation,SupraFlowConsole(K040239)	Comments
Principles ofOperation	• Fluid suctionedthrough suctionwand intoDisposablehoused inMobile Unit• Mobile Unit ismoved toDisposal Stationand fluidconnectionsengageautomatically• Contents arepumped out ofMobile Unitdirectly intohospital wasteline• Disposable iscomprised of asuction manifoldand attachedcollection liner• Disposableconnects tovacuum line inmobile unit andis housed incylindrical	• Fluid and smokeare suctioned froma wand into theRover• Rover is moved todocking stationand fluidconnectionsengageautomatically• Contents arepumped into theDocking Stationtank• Fluids pumpeddown a drain• Fluid is suctionedthrough a manifoldwith an anti-refluxfeature• Manifold connectsto top of a 20 Lcanister on theRover which has aspray head inside		The Manifold inthe predicatehas beenaugmented intoa Disposable inthe proposeddevice. Thischangeenhances safetyof the clinicianand patient sinceall portions of thedevice whichcontact surgicalfluid waste willbe disposed intored bag wasteand not left inthe OR. Theproposedchange does notaffect deviceeffectiveness.

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1999 - 1999

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Summary of Testing:

The ORwell™ Fluid Collection and Disposal System is substantially equivalent to the predicate device. The testing consisted of all testing identified in the FDA's Guidance Document for Powered Suction Pumps, September 30, 1998 and Premarket Submission for Software Contained in Medical Device. A hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operations. The ORwell™ Fluid Collection and Disposal System has no direct patient contact therefore, biocompatibility testing is not applicable. A detailed list of testing is provided with test protocols and reports.

The following testing was completed on the ORwell™ System:

1. "Almost Full" Sensor – verification that light illuminates and audible alarm sounds at the appropriate pre-determined level
1. Vacuum Level Operating Range verification that, with regulator, vacuum operating range is within spec
1. Fluid Suction Flow Rates verification that typical worst case and maximum fluid suction flow rates are within spec
1. HEPA Filter Efficiency and Life - verification that filter assembly is HEPA efficient and has a life of ≥ 500 hours
1. Fluid Trap Shutoff fluid trap assembly tested for fluid ingress effectiveness
1. Overflow Valve Fluid Ingress overflow valve tested for fluid ingress effectiveness
Instructions for Use ORwell™ system tested for safe operation when being used 7 per instructions for use
1. Disposal Station Valve Drip - verification that no dripping results after the fluid disposal process
ல் Disposal Port Valve Opening Pressure – verification that the valve will prevent user from being exposed to biohazards

Performance Data

The ORwell™ Fluid Collection and Disposal System was tested against the predicate for vacuum level operating range and fluid suction flow rate. Vacuum level operating range was found to be the same at 0" – 19" Hg and maximum fluid suction flow rate was found to be comparable with ORwell™ performing at approximately 5 liters/minute and the predicate at approximately 4.9 liters/minute.

Conclusions Drawn from Testing

Data from testing demonstrates that the performance of the ORwell™ Fluid Collection and Disposal System is similar and substantially equivalent to that of Stryker's currently commercially available Neptune Waste Management System.

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Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The seal is simple and iconic, representing the department's role in promoting health and well-being in the United States.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health % Underwriters Laboratories, Inc. Mr. Ned Devinc 333 Pfingsten Road Northbrook, Illinois 60062-2096

APR 3 0 2008

Re: K080845

Trade/Device Name: Orwell™ Fluid Collection and Disposal System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: April 16, 2008 Received: April 17, 2008

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Ned Devine

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systeros at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ¥0808 ¥5

Device Name: ORwell™ Fluid Collection and Disposal System Indications for Use:

The ORwell™ Fluid Collection and Disposal System is intended to be used in the Operating Rooms, Surgical Centers, and Doctors' Offices to collect and dispose of fluid waste.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use X (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Net RP Qgl for mxm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_ _ 080895

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.