← Product Code [JCX](/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX) · K080845 # ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM (K080845) _Cardinalhealth · JCX · Apr 30, 2008 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K080845 ## Device Facts - **Applicant:** Cardinalhealth - **Product Code:** [JCX](/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX.md) - **Decision Date:** Apr 30, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4780 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** 3rd-Party Reviewed ## 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. ## Device Story System collects surgical fluid waste and small debris from surgical sites; comprises mobile unit, disposable collection disc, and stationary disposal station. Mobile unit provides vacuum source; user regulates suction via interface knob. Disposable disc features four ports and flexible liner for fluid containment. Post-procedure, mobile unit docks with disposal station in utility area; station automatically empties disc contents into hospital wastewater system and collapses disc for disposal. Used in ORs, surgical centers, and doctors' offices by clinical staff. System protects personnel from biohazard exposure and cross-contamination by utilizing single-use disposable components. Benefits include reduced risk of splash/biohazard exposure and improved cleanliness compared to reusable canister systems. ## Clinical Evidence Bench testing only. Validated vacuum operating range (0-19" Hg), fluid suction flow rates (~5 LPM), HEPA filter efficiency (99.97% at 0.3 microns), and overflow/shutoff mechanisms. Hazard analysis and software validation performed. No clinical data required. ## Technological Characteristics Powered suction pump (21 CFR 878.4780). Components: Mobile unit (AC powered, UL 60601-1 compliant), disposable collection disc (manifold and liner), and stationary disposal station. Vacuum source: On-board pump. Regulation: Knob-controlled bleeder valve. Filtration: HEPA (99.97% efficiency @ 0.3 microns). Connectivity: Mechanical docking interface between mobile unit and disposal station. ## Regulatory 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. ## Predicate Devices - Stryker Neptune Waste Management System ([K012991](/device/K012991.md)) - Neomedix Corp. Supraflow Console ([K040239](/device/K040239.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 Corporation
1500 Waukegan Road MP/WM
Mc Gaw Park, IL 60085 | |-----------------------------|-----------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | Lavenia Ford
1500 Waukegan Road MP/WM
Mc 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 and
K040239 - 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 - 2. Disposal Station - Disposable Collection Disc (hereinafter referred to as "Disposable Disc," "Collection ന 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 APR 3 0 2008 {1}------------------------------------------------ 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. {2}------------------------------------------------ . The following performance attributes were found to be acceptable for the intended use. Note tables below: | Design
Feature | Proposed Device
Cardinal
ORwellTM
Surgical Fluid
Waste Collection
and Disposal
System | Predicate Device
Stryker Neptune
Waste
Management
System (K012991) | Predicate
Device
Neomedix
Corporation,
SupraFlow
Console
(K040239) | Comments | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for
Use | The Cardinal
ORwellTM System
is intended to be
used in the
Operating Room,
Surgical Centers,
and Doctor's
Offices to collect
and dispose of
surgical fluid
waste. | 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. | The NeoMedix
SupraFlow
Console is an
aspiration pump
intended for use
in general
surgery
applications
where aspiration
of irrigation and
waste fluid from
a surgical site is
desired.
The device is not
indicated for
liposuction use. | The new device
and the
predicate
K040239 have
the same claim
of removing fluid. | | Closed
System | Protects hospital
personnel from (1)
the splashes and
inadvertent
biohazard
exposure that are
possible with
suction canister
devices and (2)
the cross-
contamination and
cleanliness issues
that are possible
with fluid
collection and
disposal systems
that utilize a
reusable
collection
chamber | Protects hospital
personnel from
splashes and
inadvertent
biohazard exposure
that is possible with
suction canister
devices | | The addition of
protecting
against cross-
contamination
and cleanliness
issues does not
raise new
questions
regarding safety. | | Fluid
Collection
Disposable | Manifold and
Collection Liner | Manifold and
Canister | | The addition of a
collection liner
for containment
of the waste fluid
does not raise
new questions
regarding safety. | | Product Code | BTA, Powered
Suction Pump | FYD, Apparatus,
Exhaust, Surgical | BTA, Powered
Suction Pump | SAME | | Design
Feature | Proposed Device
Cardinal
ORwell™
Surgical Fluid
Waste Collection
and Disposal
System | Predicate Device
Stryker Neptune
Waste
Management
System (K012991) | Predicate
Device
Neomedix
Corporation,
SupraFlow
Console
(K040239) | Comments | | FDA
Regulation,
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 | | Dimensional
differences do
not affect safety
or effectiveness | | Dimensions -
Disposal
Station | 34" width x 15"
depth x 50" height | 25" width x 22"
depth x 21.5" height
(Measured - not
specified in 510(k)) | | Dimensional
differences do
not affect safety
or effectiveness | | Mobile Unit
Electrical
Requirements | UL 60601-1
Compliant
AC Powered, 115
V, 12 Amps | UL 2601 Compliant
AC Powered. 110 V,
16 Amps | | Voltage and
amperage
differences do
not raise new
questions of
safety and
effectiveness. | | Disposal
Station
Electrical
Requirements | 115 V, 4 Amps | 120 V, 3 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 | | Flow Rate | On 100% vacuum
Fluid Flow Rate
must be $ ≥ ≥ $ 5.0
LPM | Unknown | | Requirement
met (using
water) for high
volume | | 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 | | Emergency
Back-Up Port | Yes | Yes | | SAME | | Design
Feature | Proposed Device
Cardinal
ORwell™
Surgical Fluid
Waste Collection
and Disposal
System | Predicate Device
Stryker Neptune
Waste
Management
System (K012991) | Predicate
Device
Neomedix
Corporation,
SupraFlow
Console
(K040239) | Comments | | Single Patient
Use | Single | Single or Multiple
Patients | - | The indication
for single use in
the proposed
device increases
clinician/patient
safety by not
allowing
clinicians to
leave a
contaminated
device in the OR
for prolonged
periods of time.
This change
does not raise
new questions
regarding
effectiveness. | | Canister
Capacity | 20 L | 20 L | - | SAME | | Suction Mode | Continuous | Continuous | - | SAME | | OTC or
Prescription | Prescription (RX
only) | OTC | - | Devices are
intended to be
used in
operating rooms,
surgical centers,
and doctor's
offices. | | Overflow
Prevention
Mechanism | Yes | Yes | - | SAME | | Pre-Filter | Single Use
Disposable | Single Use
Disposable | - | SAME | | Suction Inlet
Port
Dimensions | $1/4$ inch inner
diameter | 3/8 inch inner
diameter | - | Port size and
design based off
of currently
acceptable
Cardinal Health
suction canister
design | | Design
Feature | Proposed Device
Cardinal
ORwell™
Surgical Fluid
Waste Collection
and Disposal
System | Predicate Device
Stryker Neptune
Waste
Management
System (K012991) | Predicate
Device
Neomedix
Corporation,
SupraFlow
Console
(K040239) | Comments | | Principles of
Operation | • Fluid suctioned
through suction
wand into
Disposable
housed in
Mobile Unit
• Mobile Unit is
moved to
Disposal Station
and fluid
connections
engage
automatically
• Contents are
pumped out of
Mobile Unit
directly into
hospital waste
line
• Disposable is
comprised of a
suction manifold
and attached
collection liner
• Disposable
connects to
vacuum line in
mobile unit and
is housed in
cylindrical | • Fluid and smoke
are suctioned from
a wand into the
Rover
• Rover is moved to
docking station
and fluid
connections
engage
automatically
• Contents are
pumped into the
Docking Station
tank
• Fluids pumped
down a drain
• Fluid is suctioned
through a manifold
with an anti-reflux
feature
• Manifold connects
to top of a 20 L
canister on the
Rover which has a
spray head inside | | The Manifold in
the predicate
has been
augmented into
a Disposable in
the proposed
device. This
change
enhances safety
of the clinician
and patient since
all portions of the
device which
contact surgical
fluid waste will
be disposed into
red bag waste
and not left in
the OR. The
proposed
change does not
affect device
effectiveness. | {3}------------------------------------------------ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i . . : . : {4}------------------------------------------------ : : : {5}------------------------------------------------ . : 1999 - 1999 {6}------------------------------------------------ #### 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 - 2. Vacuum Level Operating Range verification that, with regulator, vacuum operating range is within spec - 3. Fluid Suction Flow Rates verification that typical worst case and maximum fluid suction flow rates are within spec - 4. HEPA Filter Efficiency and Life - verification that filter assembly is HEPA efficient and has a life of ≥ 500 hours - 5. Fluid Trap Shutoff fluid trap assembly tested for fluid ingress effectiveness - 6. 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 - 8. 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ ### 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 {9}------------------------------------------------ # 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K080845](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K080845) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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