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.

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.
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.

AI/ML Overview

The provided text is a 510(k) summary for the Thornhill Research Inc. MOVES® SLC™ medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and study designs (like sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies) that would be present in a submission establishing de novo safety and effectiveness for a novel device or AI algorithm.

The document mainly describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices and compliance with relevant standards.

Here's a breakdown of the information available in the document regarding acceptance criteria and performance, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The "Summary of Performance Testing" section states:

"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."

And the "Determination of Substantial Equivalence" section reiterates:

"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 acceptance criteria, implicitly, are that the device's performance characteristics for ventilation, patient monitoring, oxygen delivery, and suction must be substantially equivalent to those of its predicate devices and comply with all referenced standards and regulations.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. The testing mentioned is "performance testing" and likely refers to engineering, bench, and potentially animal testing, rather than human clinical trials with specific patient sample sizes. The provenance of any data (country, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable/provided. The document describes a medical device (ventilator, monitor, concentrator, suction pump), not an AI algorithm requiring expert-established ground truth on a test set (e.g., for image classification or diagnosis).

4. Adjudication Method for the Test Set

This information is not applicable/provided for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically performed for AI-powered diagnostic aids where the impact on human reader performance is being evaluated.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The MOVES® SLC™ is a hardware medical device with integrated software/control. It is not an "algorithm only" device in the sense of a standalone AI diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in this context. The performance testing refers to the overall device's functionality.

7. The Type of Ground Truth Used

Given that this is a hardware device primarily demonstrating substantial equivalence and compliance with standards, the "ground truth" would be established through a combination of:

Engineering specifications and measurements: Comparing output parameters (e.g., ventilator pressures, flow rates, oxygen concentration, monitoring accuracy) against known physical standards or the specifications of predicate devices.
Performance against predicate device specifications: Ensuring that the MOVES® SLC™ meets or exceeds the demonstrated performance of its predicate devices for the various functions.
Compliance with recognized consensus standards: Meeting the benchmarks set by standards like IEC 60601 series, EN-794-3, ISO 8359, and ASTM E1112-00.

There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" in the context of this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable/provided. The MOVES® SLC™ is not described as a device that uses machine learning or an AI algorithm that requires a "training set" of data. Its control system and functionalities are based on established engineering principles and algorithms, not data-driven machine learning models that are "trained."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided as there is no mention of a training set for an AI algorithm.

Summary

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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 200Toronto, ON, Canada M5G 2E8
Company Phone:	(416) 597-1325
Company Fax:	(416) 597-1330

Cliff Ansel, President Contact Person:

DEVICE IDENTIFICATION

Trade/Proprietary Name:	MOVES® SLCTM
Classification:	II
Generic Device Name:	Emergency and transport ventilator with suction, multi-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

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 (800) 638-2041 or (301) 796-7100 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

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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Regulation Number and Section

§ 868.5925 Powered emergency ventilator.

(a)
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.(b)
Classification. Class II (performance standards).