IntelliCart System

K172481 · Dornoch Medical Systems · JCX · Sep 14, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172481
• Device Name: IntelliCart System
• Applicant: Dornoch Medical Systems
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Sep 14, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2

Intended Use

The IntelliCart™ System is a 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.

Device Story

IntelliCart System is a self-powered suction/vacuum pump for collecting/disposing of liquid surgical waste. System comprises mobile Fluid Cart and stationary Evac Station. Cart collects patient fluids via single-use manifold and sterile suction tubing into large-volume reservoirs (up to 34L). Cart features variable vacuum (0-600 mmHg), backlit LCD touch screen for suction control/monitoring, and ConSeal tinting for visual concealment of waste. Evac Station connects to Cart to empty, clean, and disinfect canisters using bleach/enzymatic solutions, draining waste into facility drains. Used in ORs, labs, and outpatient centers by clinical staff. Closed design reduces infectious fluid exposure and red bag waste. Safety features include HEPA filtration, overflow protection, and automated disinfection cycles. System supports IV poles and smoke evacuators.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 10079-1 (suction performance), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-1-6 (usability). Testing confirmed adjustable vacuum pressure up to 600mmHg, chemical resistance of fluid paths, and efficacy of automated disinfection cycles. Software verification and validation confirmed reservoir overflow protection and safety transducer functionality.

Technological Characteristics

Closed-system suction pump; 0-600 mmHg vacuum range; 34L capacity. Powered by 120V/60Hz/15A supply. Features HEPA filtration (99.97%), backlit LCD touch interface, and automated cleaning cycles. Materials evaluated for chemical resistance. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 10079-1. Connectivity: Standalone unit with facility wall suction compatibility.

Indications for Use

Indicated for use in hospital operating rooms, pathology labs, surgical outpatient centers, and doctor's offices for the collection and disposal of liquid surgical waste in ward and general surgical applications.

Regulatory Classification

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

• IntelliCart™ System (K162421)

Submission Summary (Full Text)

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

October 5, 2017

Dornoch Medical Systems Michael Wolford Regulatory Affairs Sr. Specialist 200 West Parkway Riverside, Missouri 64150

Re: K172481

Trade/Device Name: IntelliCart System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: August 11, 2017 Received: August 16, 2017

Dear Michael Wolford:

This letter corrects our substantially equivalent letter of September 14, 2017

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.

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

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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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] 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" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, PhD 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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## Indications for Use

510(k) Number (if known) K172481

Device Name IntelliCart™ System

Indications for Use (Describe)

The IntelliCart™ System is a 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.

Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "Dornoch" in a stylized font. The letters are primarily in a light gray color, except for the "O" which is in a dark red color. Below the word "Dornoch" are the words "Medical Systems, Inc." in a smaller, light gray font.

# 510(k) Summary

| 510(k)<br>Summary | Sponsor: | Dornoch Medical Systems, Inc.<br>200 North West Parkway<br>Riverside, MO 64150<br>Establishment Registration Number: 1954182<br>Michael T. Wolford<br>Regulatory Affairs Sr. Specialist<br>Phone: [phone] |
|-------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | 8/11/2017 |
| | Trade Name: | IntelliCart™ System |
| | FDA Product<br>Code/Device<br>Common Name: | JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| | Regulation Number<br>and Description;<br>Device Classification: | 21 CFR 878.4780 – Powered suction pump; Class II |
| | Predicate Device | IntelliCart™ System (K162421) |
| | Device Description | The IntelliCart™ System is a self-powered suction / vacuum pump intended<br>to collect and dispose of liquid waste within hospital operating rooms,<br>pathology labs, surgical outpatient centers, and doctor's offices. |
| | | The IntelliCart™ System (System) consists of a Fluid Cart (Cart) and Evac<br>Station (Evac). |
| | | Carts are mobile devices used during surgery to collect patient fluids. Evacs<br>are stationary devices used to process and clean Carts. The System's closed<br>design significantly reduces employee exposure to potentially infectious<br>surgical fluids, while eliminating up to 70% of operating room red bag<br>waste. |
| | | Carts are equipped with large volume fluid reservoirs, a single regulated<br>vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF<br>00-5140-201-00) serves as the interface between a Cart's fluid reservoir and<br>sterile patient suction tubing. A Cart model equipped with a bracket to hold<br>a Smoke Evacuator is also available. |
| | Intended Use: | The IntelliCart™ System is a self-powered suction/vacuum pump intended<br>to collect and dispose of liquid waste within Hospital Operating Rooms,<br>Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices. |
| | Technological<br>Characteristics | The IntelliCart™ System is a closed self-powered suction device providing<br>various levels of suction, as selected by the user, ranging from 0-600 mmHg |

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at maximum flow volume, and collection of up to 34L of liquid surgical waste into cart canisters equipped with a viewing window for display of canister contents shown in 100ml increments. The suction cart is portable, equipped with caster type wheels with a profile able to pass through 36 inch minimum wide doorways and allows for connection to a standard 120V/60Hz/15A facility power supply and connection to facility wall suction when necessary. Cart Canisters are integrated with a window tint feature that visually restricts canister contents during transport.

The IntelliCart™ System is operated using a back lit LCD touch screen display monitor equipped with lateral adjustment capabilities and provides digital display confirmation of total fluid capacity used as well as a functional interface for suction selection/adjustment and cart cleaning.

Single use manifolds are equipped with hydrophobic filters which turn color after wash cycle is completed, giving visual indication of a manifold which must be discarded.

The Evac Station is equipped with a coupler that connects to the Suction Cart and, using compatible bleach and enzymatic solutions to break down solid waste, empties, cleans and disinfects cart canisters. After emptying and cleaning cart canisters, the Evac Station allows for draining surgical waste into facility drains.

The IntelliCart™ System can be equipped with a powered or manual IV pole, supporting up to 12,000mL of bagged fluid and allows mounting of a compatible smoke evacuation device.

#### Comparison to Predicate:

The IntelliCart"" System is substantially equivalent to the legally marketed predicate device IntelliCart'"" System in that these devices are identical in intended use, materials and design. The following tables provide a comparison between the predicate device and modified device showing similarities and differences:

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Image /page/5/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in a dark red color and the rest of the letters in a light gray color. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller, light gray font. The logo is simple and modern, with a focus on the company name.

#### System Use

| Property | Predicate Device (IntelliCartTM System<br>(K162421) | Modified Device (IntelliCartTM System) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | The IntelliCartTM System is a self-powered<br>suction/vacuum pump intended to collect and<br>dispose of liquid waste within Hospital<br>Operating Rooms, Pathology Labs, Surgical<br>Outpatient Centers, and Doctor's Offices. | Same |
| Single Use or<br>Reusable | Cart, Evac – Reusable<br>Manifold, Single Use | Same |
| Target<br>Population | Ward Use, General Surgical Application | Same |

#### System Operating Principle

| Property | Predicate Device (IntelliCart™ System) (K162421) | Modified Device (IntelliCart™ System) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Display | LCD, Backlit Touch | Same |
| Suction/Exhaust | Closed suction system with variable suction levels based<br>on user selection providing regulated vacuum from 0-<br>600mmHg using AC powered twin piston vacuum pump<br>passing through single use manifolds and into canisters. | Same |
| Filtration | HEPA Filtration 99.97% | Same |
| Cleaning | Cart Canister Processing using automated validated cycle | Cart Canister Processing using<br>automated validated cycle to<br>low level of disinfection |
| Manifold | Single Use, disposable manifold with Hydrophobic Filter | Same |
| Software | Validated Software | Same |
| Electrical<br>Requirements | (Cart) 120VAC, 60Hz, 4.75amp<br>(Evac) Same | Same |
| Portable | Locking casters and push handle allow cart to be easily<br>moved | Same |

#### System Design

| Property | Predicate Device (IntelliCartTM System (K162421)) | Modified Device (IntelliCartTM System) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Materials | No direct or indirect patient contact | Same |
| Touch Screen | LCD backlit color touch screen display | Same |
| Total Fluid Capacity | 34L | Same |
| Single Use<br>Manifold | Manifold hydrophobic filter turns blue after use,<br>indicating it must be replaced | Same |
| Suction Range | 0-600mmHg | Same |
| Footprint | 55"H x 23.5"W x 23"D | Same |
| Safety Alert | Audible and visual display for early warning of overflow<br>protection system and vacuum start up alert | Same |
| Compatible with<br>Wall Suction | Yes | Same |
| ConSeal™ Tint | Yes | Same |
| Canister Exterior<br>Graduations | Graduations marked on canister exterior provide<br>approximate visual indication of contents in 100mL<br>increments. | Same |
| IV Pole | Carts available with powered or manual IV pole, capable<br>of 12,000mL maximum fluid capacity | Same |
| External Mounting<br>of compatible<br>smoke evacuation | Yes | Same |
| HEPA Filtration | 99.97% | Same |
| Cleaning | Multiple user selected Enzymatic and Bleach cleaning<br>cycles from 3-12 minutes | Same |
| Safety Features | | |
| Feature | Predicate Device (IntelliCart™ System (K162421) | Modified Device (IntelliCart™<br>System) |
| Closed System<br>Design | Confine and contain fluids during collection and disposal | Same |
| Interactive<br>Controls | Graphical User Interface (GUI) guides user through<br>system operation | Same |
| Bleach Cycle<br>Monitoring | Continuous automatic monitoring of bleach cycle using<br>electronic sensors | Same |
| Fluid Backflow<br>Protection | Positive air gap maintained between collected fluids and<br>single-use Manifolds | Same |
| Vacuum System<br>Protection | Hydrophobic filters shut off vacuum supply when wet,<br>preventing liquids from contaminating the Cart vacuum<br>supply | Same |
| Air Exhaust<br>Protection | Replaceable HEPA rated filter | Same |
| Overflow<br>Protection | Warning to alert user when reservoir is 3000mL and<br>1500mL from full capacity – automatic shut off when<br>canisters have reached full capacity | Same |
| ES 60601-1<br>Classification | Class 1, Type B applied part (suction tubing - not supplied<br>by Zimmer Biomet) | Same |

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# Dornoch

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Image /page/7/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in "Dornoch" colored in a dark red. The rest of the letters are in a light gray color. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller font.

#### Non-Clinical Performance Data as Compared with the Predicate Device

The following performance standards are applicable to the predicate and modified devices:

| | Predetermined | Results | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------|
| Standard or Test Type | Acceptance<br>Criteria | Predicate Device<br>(IntelliCartTM<br>System (K162421) | Modified Device<br>(IntelliCartTM<br>System) |
| IEC 60601-1 Medical electrical equipment - Part<br>1: General requirements for basic safety and<br>essential performance | Yes | Pass | Pass |
| IEC 60601-1-2 Medical electrical equipment -<br>Part 1-2: General requirements for basic safety<br>and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements<br>and Tests | Yes | Pass | Pass |
| IEC 60601-1-6 Medical electrical equipment -<br>Part 1-6: General requirements for basic safety<br>and essential performance - Collateral standard:<br>Usability | Yes | Pass | Pass |
| ISO 10079-1 Medical suction equipment - Part<br>1: Electrically powered suction equipment | Yes | Pass | Pass |
| ISO 10993-1 Biological evaluation of medical<br>devices - Part 1: Evaluation and testing within a<br>risk management process | Not required - no<br>direct or indirect<br>patient contact | N/A | N/A |

#### Electrical Safety, Electromagnetic compatibility (EMC)

Medical device safety testing was conducted in accordance with IEC 60601-1 standard for safety, IEC 60601-1-2 standard for EMC. Human factors were also considered in the design of the IntelliCart™ System and testing was performed in accordance with IEC 60601-1-6 and Applying

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Image /page/8/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The logo features the word "Dornoch" in a sans-serif font, with the "O" in a dark red color and the rest of the letters in a light gray. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller font size and the same light gray color.

Human Factors and Usability Engineering to Optimize Medical Device Design, Guidance for Industry and Food and Drug Administration Staff, February 3, 2016. Critical and essential tasks were identified as part of the studies. All identified issues were managed and mitigated to an acceptable level. The IntelliCart™ System passed all electrical safety, and electromagnetic compatibility tests to predetermined acceptance criteria.

#### Software and Display Verification and Validation

Software verification and validation were performed at a systems and unit level and information supplied in accordance with guidance as recommended by FDA Guidance for Industry "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software passed all predetermined acceptance criteria including reservoir overflow protection, cart reservoir processing and low level disinfection using validated cycles, watchdog safety transducer and safety start up warning screen.

#### Mechanical Verification and Validation

#### Suction Performance

The IntelliCart™ System suction performance was designed and evaluated according to ISO 10079-1 Electrically powered suction equipment and as recommended by FDA "Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s". All critical and essential tasks were identified and mitigated through risk analysis to an acceptable level.

The IntelliCart™ System was evaluated to provide adjustable vacuum pressure as measured at the manifold port to predetermined acceptance criteria to demonstrate operation capable of providing adjustable vacuum up to 12 hours of continuous use at 600mmHg.

### Safety Features

The IntelliCart'" System was tested to predetermined acceptance criteria for Closed System Design, Interactive controls including de-bounce feature, Fluid Backflow Protection, Watchdog Safety Transducer, Wash Fluid leak free seals around covers and manifolds, and User Interface Vacuum Start Up Warning. The IntelliCart™ System met all predetermined acceptance criteria with passing results.

The IntelliCart™ fluid path was tested to predetermined acceptance criteria for chemical resistance against compatible enzymatic cleaners, bleach and Bactisure™. The IntelliCart™ met all predetermined acceptance criteria with passing results.

The IntelliCart™ System disposable manifold was tested to predetermined acceptance criteria to provide vacuum seal in the reservoir when installed. The IntelliCart™ met all acceptance criteria with passing results.

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Image /page/9/Picture/0 description: The image shows the logo for Dornoch Medical Systems, Inc. The word "Dornoch" is written in a sans-serif font, with the "O" in "Dornoch" being a dark red color, while the rest of the letters are a light gray color. Below the word "Dornoch" is the text "Medical Systems, Inc." in a smaller, light gray font.

### IV Pole Function and Support

Manual and Power IV Poles were tested to predetermined acceptance criteria for maximum bagged fluid support and automatic function (power IV pole only). The IntelliCart™ met all acceptance criteria with passing results.

#### Outer Body Shell and Fluid Capacity

The IntelliCart™ was tested to predetermined acceptance criteria for portability using casters and brakes including profile requirements to pass through standard 36″ door thresholds. The IntelliCart''' met all acceptance criteria with passing results.

IntelliCart™ was tested to predetermined acceptance criteria to include directly viewable fluid measurements, easily viewable touchscreen monitor and exterior surfaces which provide chemical resistance to standard hospital wipes. The IntelliCart™ met all acceptance criteria with passing results.

#### Fluid Reservoir Concealment

ConSeal™ technology providing concealment of canister contents was evaluated to predetermined acceptance criteria for the concealment of collected waste fluid. The IntelliCart™ met all acceptance criteria with passing results.

#### Conclusion

The subject device is substantially equivalent to the predicate device.