MOVES SLC

K140049 · Thornhill Research, Inc. · BTL · May 29, 2014 · Anesthesiology

Device Facts

• Record ID: K140049
• Device Name: MOVES SLC
• Applicant: Thornhill Research, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: May 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOVES® SLC™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation. MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen. MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40 and 120kg. MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen: - Suction a. The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system. - Supplementary Oxygen b. The MOVES® SLCTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen. c. Patient Monitoring The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

Device Story

Portable, computer-controlled, electrically powered emergency transport ventilator; integrates suction pump, oxygen concentrator, and multi-parameter patient monitor. Inputs: external oxygen source or ambient air (via internal concentrator); patient physiological signals (Pulse Rate, NIBP, IBP, SpO2, Temp, Respiration Rate, CO2, O2, 12-lead ECG). Operation: provides ventilatory support, oxygen enrichment, and fluid aspiration; monitors patient status via integrated display. Used in transport/emergency settings by healthcare providers. Output: mechanical ventilation, supplemental oxygen, suction, and real-time physiological data/alarms. Clinical decision-making supported by continuous monitoring and alarm system; benefits include consolidated life-support and monitoring capabilities in a single, stretcher-mountable device.

Clinical Evidence

Bench testing only. Performance validated via EMC, environmental, shock, and vibration testing per IEC 60601-1-2, EN794-3, and MIL-STD-810F. Testing confirmed substantial equivalence in ventilator characteristics, patient monitoring, oxygen delivery, and suction performance.

Technological Characteristics

Portable, battery/AC-powered system. Materials: unspecified. Sensing: ECG, NIBP, IBP, SpO2, Temp, CO2, O2. Connectivity: standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49, IEC 60601-2-55, EN-794-3, ISO 8359, ASTM E1112-00. Software: computer-controlled ventilator and monitoring system.

Indications for Use

Indicated for adult patients (40-120kg) requiring mechanical ventilation or supplemental oxygen in transport or emergency settings. Includes suctioning of fluids/tissues from wounds or airways and monitoring of physiological parameters.

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• MOVES® (K093261)

Reference Devices

• SeQual Eclipse® 2 (K013931)

Submission Summary (Full Text)

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# Thornhill Research Inc. MOVES® SLCTM 510(k) Submission

Release Date: May 28, 2014 Section 5 - Page 1 of 4

MAY 2 9 2014

### 510(k) SUMMARY

#### SUBMITTER INFORMATION

| Company Name: | Thornhill Research Inc. |
|------------------|------------------------------------------------------------|
| Company Address: | 210 Dundas St. W, Suite 200<br>Toronto, ON, Canada M5G 2E8 |
| Company Phone: | [phone] |
| Company Fax: | [phone] |

Cliff Ansel, President Contact Person:

## DEVICE IDENTIFICATION

| Trade/Proprietary Name: | MOVES® SLCTM |
|-------------------------|------------------------------------------------------------------------------------------------------------------|
| Classification: | II |
| Generic Device Name: | Emergency and transport ventilator with suction, multi-<br>parameter patient monitoring, and Oxygen Concentrator |

#### Classification Names

| Classification Name | Product Code | Class | Regulation Number |
|-------------------------------------|--------------|-------|-------------------|
| Ventilator, Emergency and Transport | BTL | II | 21 CFR 868.5925 |
| Oxygen Concentrator | CAW | II | 21 CFR 868.5440 |
| Patient Monitoring Equipment | MWI | II | 21 CFR 870.2300 |
| Powered Suction Pump | BTA | II | 21 CFR 878.4780 |

#### DEVICE DESCRIPTION

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® device (K093261), a portable multifunction patient support and monitoring system with the following capabilities:

- . Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
- Delivery of oxygen-enriched air that may be supplied from an external oxygen . source or generated internal to the system with the on-board oxygen concentrator.
- Patient monitoring functions including the following patient parameters: Pulse . Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.

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# Thornhill Research Inc. MOVES® SLC™ 510(k) Submission

- Suction/aspirator pump for medical suction procedures where secretions, blood . and other body fluids must be removed through the application of continuous negative pressure.
The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

### INTENDED USE

The MOVES® SLC™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.

MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen.

MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40 and 120kg.

MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen:

- Suction a.
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

- Supplementary Oxygen b.
The MOVES® SLCTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

#### C. Patient Monitoring

The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

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#### SUBSTANTIAL EQUIVALENCE

The MOVES® SLCTM is of comparable type and is substantially equivalent to the following predicate devices:

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#### Comparison to Predicate Devices

MOVES® SLC™ is an upgrade to the previously cleared MOVES® device (K093261), which serves as the primary predicate device. Additional functionality has been added to SLC as follows:

- 12 Lead ECG capability .
- A 2nd temperature channel .
- A 3rd Invasive pressure channel .
- Removal of the requirement for use of the MOVES® O2 mask and replacement . with a direct output from the onboard concentrator which is equivalent to the SeQual Eclipse® 2 (K013931).

In all cases the extended indications for use or functionality are found in the identified substantially equivalent predicate devices. Furthermore, the performance specifications of MOVES® SLC™ are substantially equivalent to those of the identified predicate devices. Where differences exist, they raise no concerns about safety and efficacy.

#### Compliance to Standards and Regulations

IEC 60601-1 IEC 60601-1-2 IEC 60601-2-27 IEC 60601-2-30 IEC 60601-2-34 IEC 60601-2-49 IEC 60601-2-55 IEC 60601-2-61 EN-794-3 150 8359 ASTM E1112-00

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# Thornhill Research Inc. MOVES® SLCTM 510(k) Submission

### Summary of Performance Testing

Safety and performance testing was conducted in accordance with all referenced standards and regulations, and to validate all system requirements. EMC, environmental, and shock and vibration testing was conducted in accordance with IEC 60601-1-2, EN794-3 and MIL-STD-810F.

The results of performance testing demonstrate that the characteristics SLC are substantially equivalent to the identified predicates in terms of ventilator characteristics, patient monitoring performance, ability to delivery supplemental oxygen, and provide airway suction.

#### Determination of Substantial Equivalence

The MOVES® SLC™ system is substantially equivalent to the predicate devices. Where differences in performance or technology exist, it has been demonstrated that they do not adversely impact safety or effectiveness. In addition, SLC has been tested to comply with relevant recognized consensus safety and performance standards as well as voluntary standards (detailed above). The combination of performance verification testing and testing to applicable objective standards substantiates the claim of substantial equivalence of the SLC system.

### Conclusions:

The MOVES® SLC™ is substantially equivalent to the identified predicate devices and does not raise any new concerns of safety or efficacy.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

May 29, 2014

Thornhill Research Inc. Cliff Ansel President 210 Dundas St. W. Suite 200 Toronto, ON, Canada M5G 2E8

Re: K140049

Trade/Device Name: MOVES® SLCTM Regulation Number: 21 CFR 868.5925 Regulation Name: Powered emergency ventilator Class: II Product Codes: BTL, CAW, MWI, BTA Dated: April 24, 2014 Received: April 28, 2014

Dear Mr. Ansel:

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 - Mr. Ansel

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 [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" (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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit Sheth M.D. Clinical Deputy Director

DAGRID/ODE/CDRH FOR

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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# Thornhill Research Inc. MOVES® SLC™ 510(k) Submission

#### Indications for Use Statement

510(k) Number (if known): K140049

Device Name: MOVES® SLCTM

The MOVES® SLC™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.

MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen.

MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40kg and 120kg.

MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen:

- Suction a.
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

#### Supplementary Oxygen b.

The MOVES® SLCTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

- c. Patient Monitoring
The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

#### Operating Environment

MOVES® SLC™ is intended to be operated in a transport, or emergency setting.

#### Target Population

The intended patient population is adults who weigh between 40 and 120 kg.

AND/OR Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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