(379 days)
The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
a. Suction
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.
b. Supplementary Oxygen
The MOVES® SLC™ 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.
The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), 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.
The provided text is a 510(k) summary for the MOVES® SLC™ medical device, which is an emergency ventilator with additional functions. This document describes the device, its indications for use, and its comparison to predicate devices to demonstrate substantial equivalence. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
Specifically, the document:
- Does not provide a clear table of acceptance criteria and reported device performance. It offers a comparison table of features and characteristics between the MOVES® SLC™ and predicate devices, including some performance specifications like frequency range, tidal volume, and SPO2 accuracy, but these are comparative, not acceptance criteria.
- Does not mention anything about sample sizes used for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This is because the device is a piece of hardware (ventilator, monitoring, suction, oxygen concentrator) and not an AI/software device that would typically involve such studies for regulatory clearance.
- Does not discuss a training set or how ground truth for a training set was established. This is irrelevant for a hardware medical device of this type.
- States that "Testing was conducted in accordance with all referenced standards and regulations, and to validate all system requirements" and a "Summary of Performance Testing" section mentions that "The results of performance testing demonstrate that the characteristics the MOVES® 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." However, it does not explicitly detail the specific performance test results against a defined set of acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on demonstrating substantial equivalence to existing predicate devices based on features, characteristics, and compliance with general medical device standards, rather than proving performance against specific acceptance criteria through clinical studies involving human readers or AI algorithms.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2017
Thornhill Research Inc. Kipton Lade CEO 210 Dundas Street West, Suite 200 Toronto, M5G 2E8 CANADA
Re: K161420
Trade/Device Name: MOVES® SLC™ Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: Class II Product Code: BTL, CAW, MWI, BTA Dated: May 5. 2017 Received: May 8, 2017
Dear Kipton Lade:
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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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 devicerelated 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 at its toll-free 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" (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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image contains a signature and a name. The signature is a complex, looping design on the left side of the image. To the right of the signature, the name "Tina Kiang-S" is written in a simple, sans-serif font. The name is stacked vertically, with "Tina" on top and "Kiang-S" below.
Tina Kiang, Ph.D. 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) K161420
Device Name MOVES® SLCTM
Indications for Use (Describe)
The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
a. Suction
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.
b. Supplementary Oxygen
The MOVES® SLC™ 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
The MOVES® SLC™ is intended to be operated in a transport and emergency setting.
Target Population
Adults and pediatric(Infant, Child, Adolescent) patients who weigh between 10kg and 120 kg.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Release Date: 05/05/2017 Section 5 - Page 1 of 7
510(k) SUMMARY
SUBMITTER INFORMATION
| Company Name: | Thornhill Research Inc. |
|---|---|
| Company Address: | 210 Dundas St. W, Suite 200 |
| Toronto, ON, Canada M5G 2E8 | |
| Company Phone: | (416) 597-1325 |
| Company Fax: | (416) 597-1330 |
Contact Person: Kipton Lade, CEO
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | MOVES® SLC™ |
|---|---|
| Classification: | II |
| Generic Device Name: | Emergency and transport ventilator with suction, multi-parameter patient monitoring, and Oxygen Concentrator |
Classification Names
| Classification Name | ProductCode | Class | RegulationNumber |
|---|---|---|---|
| Ventilator, Emergency and Transport | BTL | II | 21 CFR 868.5925 |
| Oxygen Concentrator | CAW | II | |
| Patient Monitoring Equipment | MWI | II | |
| Powered Suction Pump | BTA | II |
DEVICE DESCRIPTION
The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), 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.
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Release Date: 05/05/2017 Section 5 - Page 2 of 7
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.
INDICATIONS FOR USE
The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
a. Suction
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.
b. Supplementary Oxygen
The MOVES® SLC™ 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
The MOVES® SLC™ is intended to be operated in a transport and emergency setting.
Target Population
Adults and pediatric patients who weigh between 10kg and 120 kg.
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SUBSTANTIAL EQUIVALENCE
The MOVES® SLCTM is of comparable type and is substantially equivalent to the following predicate devices:
| Device | 510(k) # |
|---|---|
| MOVES® SLCTM (Primary Predicate) | K140049 |
| Univent 754 | K931473 |
| Viasys AVEA (Reference Device) | K062093 |
| The Medela® Vario 18 | K061205 |
| SeQual Eclipse® 2 | K013931 |
| Criticare 8100 | K012059 |
| Lifepak 15 (Reference Device) | K103567 |
| Hamilton T1 (Reference Device) | K120670 |
Comparison to Predicate Devices
The MOVES® SLC™ is an upgrade to the previously cleared MOVES® SLC™ (K140049), which serves as the primary predicate device. Additional functionality has been added to the MOVES® SLC™ as follows:
- Extension to pediatric patients >10kg included extended tidal down to 50 ml ●
- Addition of a wired external screen/controller.
- Enabling of previously disabled extended oximetry capabilities.
- Addition of a rotary control knob.
- Addition of extended oximetry parameters: hemoglobin (SpHb), total oxygen . content (SpOC), methemoglobin (SpMet), carboxyhemoglobin (SpCO) and/or pleth variability index (PVI)
| Feature/Characteristic | Modified MOVES®SLCTM | MOVES®SLCTM(K140049) | Univent 754(K931473) | Viasys AVEA(K062093)REFERENCEDEVICE |
|---|---|---|---|---|
| Environment | Transport and emergencycare | Transport andEmergency Care. | Clinical, fieldhospital, transport,aeromedical and pre-hospital (BLSthrough ATLS)environments. | Transport,Emergency Care,and Critical Care |
| Patient Population | Adults and PeditricPatients between 10 and120kg | Adults between40kg and 120kg | No restriction | Neonatal, infant,pediatric, andadults |
| Frequency | 6-40 BPM | 6-40 BPM | 1 to 150 BPM | 1-150 |
| Tidal Volume | 50 -750 ml | 100 -750 ml | Based on peak flownot exceeding 10LPM | 100 to 2500 ml(adult)25-500ml |
| Feature/Characteristic | Modified MOVES®SLCTM | MOVES®SLCTM(K140049) | Univent 754(K931473) | Viasys AVEA(K062093)REFERENCEDEVICE |
| I:E Ratio | 1:1 to 1:3 | 1:1 to 1:3 | 1:599 | Not explicitlysettable. Set byadjusting RR andinspire time. |
| PEEP | 0 to 20 cm H2O | 0 to 20 cm H2O | 1 to 20 cmH20 | 0 to 50 cm H2O |
| PSV | 0.5 to 40 cmH2O | 0.5 to 40 cmH2O | No PSV | 0-90 cmH2O |
| CPAP | No | No | No | Yes |
| APRV | Yes | No | No | Yes (alsoincluded inHamilton T1which is intendedfor transport) |
| Oxygen Supply | 15 LPM maximum flowInternal oxygenconcentrator | 15 LPM maximumflowInternal oxygenconcentrator | 50 PSI | 20 to 80 psig |
| CO2 Absorber | Extendaire (CalciumHydroxide, PotassiumHydroxide, and SodiumHydroxide) | Extendaire(CalciumHydroxide,PotassiumHydroxide, andSodium Hydroxide) | None | None |
| Airway Pressure,Display Range | End inspiratory pressure,end expiratory pressure(numeric)Airway pressure graphlabeled as Paw graph.0-99 cmH2O | End inspiratorypressure, endexpiratory pressure(numeric)Airway pressuregraph labeled asPaw graph.0-99 cmH2O | Airway PressureGraph | Peak InspiratoryPressure, endexpiratorypressure, meanairway pressure0 to 120 cmH2O |
| Electrical SourceDisplayed | Yes | Yes | Yes | Yes |
| Battery LevelDisplayed | Yes | Yes | Yes | Yes |
| Feature/Characteristic | Modified MOVES®SLCTM | MOVES®SLCTM(K140049) | Univent 754(K931473) | Viasys AVEA(K062093)REFERENCEDEVICE |
| Power Supply | 100-240 VAC 50-60Hz | 100-240 VAC 50-60Hz | 90-265 VAC, 47-440HZ | 100-240 VAC 50-60Hz dependingon supply used |
| Internal Battery | Two Lithium Polymer,>2.5 hours totaloperation time, 25.9 Vnominal(Rechargeable) | Two LithiumPolymer, >2.5hours totaloperation time, 25.9V nominal(Rechargeable) | 20-36 Volts | Internal batterybackup andoptional externalbattery 20-29 VBattery |
| Weight (Battery) | Two Batteries at 3.25 lbs | Two Batteries at3.25 lbs | 3 hours maximumoperating time usinginternal compressor. | Not separatelylisted |
| Weight | 37.5lbs (systemexcluding battery) | 37.5lbs (systemexcluding battery) | 13 lbs | 83-90 lbs |
| Dimensions (w x hx d) | 33 x 10.25 x 6.5 inches | 33 x 10.25 x 6.5inches | 8.87 x 11.5 x 4.5inches | 17 x 10.5 x 16inches |
| External Interfaces | Isolated RS232 throughcustom connector topower and communicatewith external windowsbased tablet controller | Isolated RS232through customconnector + isolated5V | None | Analog inputs(2)SVGA output |
| Monitor | Color screenExternal Windows basedtablet | Color screen | Monochrome screen | Color screenExternal VGAport to secondarymonitor |
| User Interface | Context sensitive andpermanent buttons nearscreen And rotary knobTouch screen on externaltablet. | Context sensitiveand permanentbuttons near screen. | Dials & buttons | Context sensitiveand permanentbuttons nearscreen. Touchscreen. |
| Water Trap | Separable Water trapaccessory | Water trapembedded inscrubber cartridge | NA | NA |
| Feature/Characteristic | Modified MOVES®SLCTM | MOVES®SLCTM(K140049) | Criticare8100(K012059) | LIFEPAK® 15(K103567)REFERENCEDEVICE |
| SPO2 sensitivity | Fixed | Fixed | Fixed | User selectable: Normal,High |
| SPO2 pulse raterange | 25 to 240 bpm | 25 to 240bpm | 20-300 | 25 to 240 bpm |
| SPO2 pulse rateaccuracy | +/- 3% | +/- 3% | +/-1 BMP | +/- 3 digits (during nomotion conditions)+/- 5 digits (during motionconditions) |
| Additionaloximetryparameters | Optional include hemoglobin (SpHb), total oxygen content (SpOC), methemoglobin (SpMet), carboxyhemoglobin in (SpCO) and/or pleth variability index (PVI) | None | None | Optional include hemoglobin (SpHb), total oxygen content (SpOC), methemoglobin (SpMet), carboxyhemoglobin in (SpCO) and/or pleth variability index (PVI) |
Comparison of Ventilator and User Interface Characteristics.
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Section 5 – Page 4 of 7
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Release Date: 05/05/2017
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Comparison of Oximetry between Subject and Predicate Devices
In all cases the extended indications for use or functionality are found in the identified substantially equivalent predicate devices. Furthermore, the performance specifications of the MOVES® SLC™ are substantially equivalent to those of the identified predicate devices.
Compliance to Standards and Regulations
IEC 60601-1 IEC 60601-1-2 IEC 60601-2-27 IEC 60601-2-34 IEC 60601-2-49 ISO 80601-2-30 ISO 80601-2-55 ISO 80601-2-61 EN 794-3 ISO 8359 ASTM E1112-00 IEC 62133
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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.
Summary of Performance Testing
The results of performance testing demonstrate that the characteristics the MOVES® 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. In addition, the MOVES® SLC™ has been tested to comply with relevant recognized consensus 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 MOVES® SLC™ system.
CONCLUSION
The MOVES® SLC™ is substantially equivalent to the identified predicate devices.
§ 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).