K Number
K202970
Device Name
Ventway Sparrow
Date Cleared
2021-01-29

(121 days)

Product Code
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg ( 1 1b.), who require the following types of ventilatory support: SIMV VC PS, SIMV PC PS or CPAP. The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full non-vented ventilation face mask) ventilation presets. It may be used in hospital (transport) and field environments. Models VWSP100MR and VWSP900MR may be used in a Magnetic Resonance (MR) environment up to 3 Tesla. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
Device Description
The Ventway Sparrow ventilator (a.k.a. Ventway Ventilator / Ventway System) is a portable ventilator, used for transport, in prehospital, field hospital, and hospital settings. The ventilator is suitable for non-invasive ventilation for a full non-vented ventilation face mask or for invasive ventilation via an endotracheal tube or tracheostomy. The Ventway is available in 2 models plus MR conditional use: - . VWSP-100 Civil Model - VWSP-100MR Civil Model ● - VWSP-900 Robust Model ● - VWSP-900MR Robust Model The Ventway Sparrow consists of a ventilator unit with an LCD screen and a single use patient circuit.
More Information

Not Found

No
The document describes a standard portable ventilator and its intended use, models, and performance testing. There is no mention of AI or ML capabilities in the device description, intended use, or performance studies.

Yes
The device is a ventilator intended to provide ventilatory support for individuals requiring mechanical ventilation, which directly addresses a medical condition or ailment.

No.

The device is a ventilator, which provides ventilatory support, not diagnostic information.

No

The device description explicitly states that the Ventway Sparrow consists of a "ventilator unit with an LCD screen and a single use patient circuit," indicating it is a hardware device with integrated software, not a software-only device. The performance studies also include hardware-related testing like electrical safety, biocompatibility, and MRI compatibility.

Based on the provided text, the Ventway Sparrow ventilator is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states that the device provides "continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation." This describes a device that directly supports a patient's physiological function (breathing).
  • Device Description: The description reinforces that it is a "portable ventilator" used for "transport, in prehospital, field hospital, and hospital settings." This is consistent with a life-support device.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVD devices are used in vitro (outside the body) to analyze samples. The Ventway Sparrow is used in vivo (on or in the body) to provide ventilation.
  • Performance Studies: The performance studies listed are related to the device's physical and functional performance as a ventilator (cleaning, durability, electrical safety, environmental, compliance with ventilator standards, etc.), not the analytical performance of an IVD (sensitivity, specificity, etc.).
  • Predicate Device: The predicate device listed is another ventilator (LTV® 1200 MR Conditional Ventilator), further indicating that the Ventway Sparrow falls under the category of ventilators, not IVDs.

Therefore, the Ventway Sparrow ventilator is a medical device, specifically a ventilator, but it does not meet the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg ( 1 1b.), who require the following types of ventilatory support: SIMV VC PS, SIMV PC PS or CPAP.

The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full non-vented ventilation face mask) ventilation presets. It may be used in hospital (transport) and field environments.

Models VWSP100MR and VWSP900MR may be used in a Magnetic Resonance (MR) environment up to 3 Tesla.

The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.

Product codes (comma separated list FDA assigned to the subject device)

CBK

Device Description

The Ventway Sparrow ventilator (a.k.a. Ventway Ventilator / Ventway System) is a portable ventilator, used for transport, in prehospital, field hospital, and hospital settings.

The ventilator is suitable for non-invasive ventilation for a full non-vented ventilation face mask or for invasive ventilation via an endotracheal tube or tracheostomy.

The Ventway is available in 2 models plus MR conditional use:

  • . VWSP-100 Civil Model
  • VWSP-100MR Civil Model ●
  • VWSP-900 Robust Model ●
  • VWSP-900MR Robust Model

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and pediatric patients weighing at least 5 kg (11 lb.)

Intended User / Care Setting

Intended for use by qualified, trained personnel under the direction of a physician.
It may be used in hospital (transport) and field environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing included:

  • Cleaning and Disinfection ●
  • Durability ●
  • Biocompatibility ●
  • Software Verification and Validation ●
  • Electrical Safety ●
  • Electromagnetic Compatibility
  • RFID Immunity
  • Environmental
  • ISO 80601-2-12 Medical electrical equipment Part 2-12: Particular requirements for the . safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)]
  • . ISO 10651-3: 1997 Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators
  • Comparative waveform testing
  • Conical connectors ●
  • MRI
  • Altitude ●
  • Human Factors / Usability

The results demonstrate similar performance.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083688 - LTV® 1200 MR Conditional Ventilator - Pulmonetic Systems Inc.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Inovytech Medical Solutions Ltd. % Paul Dryden Consultant c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K202970

Trade/Device Name: Ventway Sparrow Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: September 29, 2020 Received: September 30, 2020

Dear Paul Dryden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K202970

Device Name

Ventway Sparrow

Indications for Use (Describe)

The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg ( 1 1b.), who require the following types of ventilatory support: SIMV VC PS, SIMV PC PS or CPAP.

The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full non-vented ventilation face mask) ventilation presets. It may be used in hospital (transport) and field environments.

Models VWSP100MR and VWSP900MR may be used in a Magnetic Resonance (MR) environment up to 3 Tesla.

The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

3

Date Prepared:29-Jan-21
Inovytec Medical Solutions Ltd.
5 HaTidhar St.,
Raanana 4366507, Israel
Tel: +972 9 779 41 35
Official Contact:Dana Hofeller – QA&RA Manager
Submission Correspondent:Paul Dryden
ProMedic, LLC
Proprietary or Trade Name:Ventway Sparrow
Common/Usual Name:Ventilator, Continuous, Facility Use
Regulation Number:21CFR 868.5895
Regulation Code:Ventilator, Continuous, Facility Use
Product Code:CBK
Regulatory Class:II
Predicate Device:K083688 - LTV® 1200 MR Conditional Ventilator - Pulmonetic Systems Inc.

Device Description:

The Ventway Sparrow ventilator (a.k.a. Ventway Ventilator / Ventway System) is a portable ventilator, used for transport, in prehospital, field hospital, and hospital settings.

The ventilator is suitable for non-invasive ventilation for a full non-vented ventilation face mask or for invasive ventilation via an endotracheal tube or tracheostomy.

The Ventway is available in 2 models plus MR conditional use:

  • . VWSP-100 Civil Model
  • VWSP-100MR Civil Model ●
  • VWSP-900 Robust Model ●
  • VWSP-900MR Robust Model

Indications for Use:

The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lb.), who require the following types of ventilatory support: SIMV - VC (PS), SIMV-PC, or CPAP.

The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full nonvented ventilation face mask) ventilation presets. It may be used in hospitals, pre-hospital (transport) and field environments.

4

510(k) Summary Page 2 of 6

Models VWSP100MR and VWSP900MR may be used in a Magnetic Resonance (MR) environment up to 3 Tesla.

The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.

Patient Population:

Adult and pediatric patients weighing at least 5 kg (11 lb.)

Environments of use:

Hospitals, pre-hospital (transport) and field environments

Table 1 is a comparison - Subject Device vs. the Predicate, K083688 - LTV 1200.

Table1

| Technological | Ventway Sparrow
Inovytec Ltd. | Predicate - LTV 1200 MR Conditional
Ventilator Pulmonetic Systems Inc. -
K083688 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Product Code, Class | CBK, Class II | CBK, Class II |
| Indications for Use | The Ventway Sparrow ventilator is intended to
provide continuous or intermittent ventilatory
support for the care of individuals who require
mechanical ventilation. Specifically, the
ventilator is applicable for adult and pediatric
patients weighing at least 5 kg (11 lb.), who
require the following types of ventilatory
support: SIMV - VC (PS), SIMV-PC, or CPAP.

The Ventway Sparrow lung ventilator is
intended for emergency use and during
transportation. It may be used for invasive (via
an endotracheal tube and tracheostomy) or
noninvasive (full non-vented ventilation face
mask) ventilation presets. It may be used in
hospitals, pre-hospital (transport) and field
environments.

Models VWSP100MR and VWSP900MR may
be used in a Magnetic Resonance (MR)
environment up to 3 Tesla.

The ventilator is a restricted medical device
intended for use by qualified, trained personnel
under the direction of a physician. | The LTV® 1200 ventilator is intended to
provide continuous or intermittent ventilatory
support for the care of the individuals who
require mechanical ventilation. Specifically,
the ventilator is applicable for adult and
pediatric patients weighing at least 5kg (11
lbs.), who require the following types of
ventilatory support: PPV, Assist/Control,
SIMV, CPAP, or NPPV. |
| User Population | Qualified, trained personnel under the direction
of a physician. | Qualified, trained personnel under the direction
of a physician. |
| Target Population | Adults and pediatric patients weighing ≥5 kg | Adults and pediatric patients weighing ≥5 kg |
| Environment Used | Hospitals, field, transport | Institutional, home or transport settings |
| Energy Used /
Delivered | No energy delivered | No energy delivered |
| Design: | The Ventway Sparrow consists of a ventilator
unit with an LCD screen and a single use
patient circuit | The LTV® 1200 consists of a ventilator unit
with LCD displays and a reusable patient
circuit |
| Technological
Characteristic | Ventway Sparrow
Inovytec Ltd. | Predicate - LTV 1200 MR Conditional
Ventilator Pulmonetic Systems Inc. -

K083688
Mechanism of
Action
intermittent ventilatory support.
intermittent ventilatory support.
-
Components
components:
  • Ventilator
  • Patient Circuit
  • AC/DC Power Supply
  • DC/DC Power Adapter
  • Rechargeable Battery Pack
  • Non-rechargeable Battery Pack
  • Oxygen Mixer (external)
  • Oxygen enrichment kit
  • Inlet Filter | The LTV® 1200 consists of the following
    components:
  • Ventilator
  • Patient Circuit
  • AC/DC Power Adapter
  • DC/DC Power Adapter |
    | -
    Dimensions
    (HxWxD) | 2.36" x 6.5" x 6.57"
    (6.0 cm x 16.5 cm x 16.7 cm) | 3.25" x 10.5" x 13.5"
    (8.4 cm x 27 cm x 38 cm) |
    | -
    Weight | Standard version - 2.2 lbs. (1 kg)
    Robust version - 2.64 lbs. (1.2 kg) | 14.5 lbs. (6.5 kg) |
    | -
    Battery | Rechargeable: Lithium Ion
    Non-rechargeable: Li-Mn | Rechargeable: Sealed Lead Acid |
    | -
    Duration per charge | 4 hr. @ VT=500ml, 12bmp, PEEP=5cmH2O,
    FIO2=21% | 1hr @ VT=800ml, 15bmp, PEEP=5cmH2O,
    FIO2=21% |
    | -
    External power
    supply | Input: 100 - 264 VAC/ 50-60 Hz, max 1.6 A
    Output: 16-28 VDC, 120 W | Input: 100 to 250 VAC/ 50-60 Hz
    Output: 13 VDC |
    | -
    Display/User
    Interface | LCD: SPI 1.8" TFT 160x128 driver st7735,
    Rotary encoder selector integrated with push
    button | 7- segment control display, LEDs, push buttons
    and a control knob |
    | Performance | • SIMV-VC (PS) (a.k.a SIMV)
    • CPAP
    • Apnea Backup Ventilation
    • Control (Trigger sensitivity "off")
    • Assist/Control (AC)
    • SIMV-PC | • SIMV
    • CPAP
    • Apnea Backup Ventilation
    • Control (Trigger sensitivity "--")
    • Assist/Control (AC)
    • NPPV |
    | -
    Basic and Advanced
    User Modes | Yes | Yes |
    | -
    Manual Triggered
    Breath | Yes | Yes |
    | -
    Air Source | Atmospheric | Atmospheric |
    | -
    Controls | "Multi-function" control knob | Dedicated control buttons and knob |
    | -
    Monitors | PEEP, PIP ,Tidal Volume (Vt), I:E ratio,
    Breath rate (bpm), Minute Volume | PEEP, PIP, Tidal Volume (Vt), I:E Ratio,
    Breath rate (bpm), MAP, Minute Volume |
    | Settings: | | |
    | -
    Tidal Volume
    [mL/breath] | 50-2000 | 50-2000 |
    | -
    Respiratory Rate
    [bpm] | 1-60 | 5-80 |
    | -
    Inspiratory Time
    (sec) | 0.3-4 ±10% | 0.3-9.9 ±0.05 s |
    | -
    PIP Limit [cmH2O] | 11-60 ±5 | 5-100 |
    | Technological | Ventway Sparrow
    Inovytec Ltd. | Predicate - LTV 1200 MR Conditional
    Ventilator Pulmonetic Systems Inc. -
    K083688 |
    | - PEEP [cmH2O] | 0-20 | 5-20 |
    | - Supplemental
    Oxygen (FiO2) | 21% to 95% ±5 | 21% to 50% ±3
    51% to 95% ±5 |
    | - Alarms | Blower malfunction
    Tube disconnect
    Patient disconnect
    Apnea
    System recovered from a crash
    Battery empty
    Sensor disconnect
    Low respiratory rate
    High minute volume
    Low minute volume
    High inspiratory pressure
    Low inspiratory pressure
    Leak
    Inverse I:E ratio
    High temperature
    Expiratory valve blocked
    High PEEP
    Low PEEP
    High respiratory rate
    Tidal Volume Limit Reached
    Low tidal volume
    Low pressure
    Battery low
    High Voltage
    Replace filter
    Service needed
    Altitude out of range
    Unexpected Restart | Start-up Self-Test
    Circuit Disconnect
    Over Pressure/Blockage
    Apnea
    External power indicator
    Low and Empty Battery
    Detect Spontaneous Breath
    High PEEP |
    | Patient Breathing
    Circuit
    Disposable | Single limb
    Exhalation valve and PEEP valve
    User to add legally marketed non-rebreathing
    valve | Exhalation valve and PEEP valve |
    | Accessories – User
    supplied | Bacterial / Viral Filter
    HME
    Non-rebreathing Valve (22mm O.D. inlet x
    22mm I.D. outlet, resistance