Ventway Sparrow

K202970 · Inovytech Medical Solutions , Ltd. · CBK · Jan 29, 2021 · Anesthesiology

Device Facts

• Record ID: K202970
• Device Name: Ventway Sparrow
• Applicant: Inovytech Medical Solutions , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 (11 lb.), 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 Story

Portable ventilator for invasive/non-invasive support; used in hospital, transport, and field environments by qualified personnel. Inputs: atmospheric air; user-set parameters (Tidal Volume, Rate, PEEP, FiO2). Operation: blower-based positive pressure delivery; controlled via rotary encoder/push-button interface with 1.8" TFT LCD display. Outputs: mechanical ventilation; real-time monitoring of PEEP, PIP, Tidal Volume, I:E ratio, Breath rate, Minute Volume. Alarms: extensive set including disconnect, apnea, pressure, and battery alerts. Benefits: provides life-sustaining respiratory support in mobile/emergency settings; MR-conditional models (VWSP100MR/VWSP900MR) allow use in 3 Tesla MRI environments. Healthcare providers use output data to adjust ventilation settings and monitor patient status.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via cleaning/disinfection, durability, biocompatibility (ISO 10993-5/10, ISO 18562-2/3), electrical safety (IEC 60601-1), EMC, RFID immunity, environmental testing, and adherence to ISO 80601-2-12 and ISO 10651-3. Comparative waveform testing and human factors/usability studies performed.

Technological Characteristics

Blower-based positive pressure ventilator. Materials: biocompatible (ISO 10993/18562). Power: AC/DC, rechargeable Li-Ion or non-rechargeable Li-Mn batteries. Interface: 1.8" TFT LCD (160x128, ST7735 driver) with rotary encoder. Connectivity: standalone. MR-conditional (ASTM F2119) up to 3 Tesla. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-12, ISO 80601-2-12, IEC 62304, EN 1789, RTCA DO-160G.

Indications for Use

Indicated for adult and pediatric patients weighing ≥5 kg requiring mechanical ventilation (SIMV-VC, SIMV-PC, or CPAP) in emergency, transport, hospital, or field environments. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• LTV® 1200 MR Conditional Ventilator (K083688)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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: [phone] |
| 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.

| Table | 1 |
|-------|---|
| | |

| Technological | Ventway Sparrow<br>Inovytec Ltd. | Predicate - LTV 1200 MR Conditional<br>Ventilator Pulmonetic Systems Inc. -<br>K083688 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Product Code, Class | CBK, Class II | CBK, Class II |
| Indications for Use | The Ventway Sparrow ventilator is intended to<br>provide continuous or intermittent ventilatory<br>support for the care of individuals who require<br>mechanical ventilation. Specifically, the<br>ventilator is applicable for adult and pediatric<br>patients weighing at least 5 kg (11 lb.), who<br>require the following types of ventilatory<br>support: SIMV - VC (PS), SIMV-PC, or CPAP.<br><br>The Ventway Sparrow lung ventilator is<br>intended for emergency use and during<br>transportation. It may be used for invasive (via<br>an endotracheal tube and tracheostomy) or<br>noninvasive (full non-vented ventilation face<br>mask) ventilation presets. It may be used in<br>hospitals, pre-hospital (transport) and field<br>environments.<br><br>Models VWSP100MR and VWSP900MR may<br>be used in a Magnetic Resonance (MR)<br>environment up to 3 Tesla.<br><br>The ventilator is a restricted medical device<br>intended for use by qualified, trained personnel<br>under the direction of a physician. | The LTV® 1200 ventilator is intended to<br>provide continuous or intermittent ventilatory<br>support for the care of the individuals who<br>require mechanical ventilation. Specifically,<br>the ventilator is applicable for adult and<br>pediatric patients weighing at least 5kg (11<br>lbs.), who require the following types of<br>ventilatory support: PPV, Assist/Control,<br>SIMV, CPAP, or NPPV. |
| User Population | Qualified, trained personnel under the direction<br>of a physician. | Qualified, trained personnel under the direction<br>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 /<br>Delivered | No energy delivered | No energy delivered |
| Design: | The Ventway Sparrow consists of a ventilator<br>unit with an LCD screen and a single use<br>patient circuit | The LTV® 1200 consists of a ventilator unit<br>with LCD displays and a reusable patient<br>circuit |
| Technological<br>Characteristic | Ventway Sparrow<br>Inovytec Ltd. | Predicate - LTV 1200 MR Conditional<br>Ventilator Pulmonetic Systems Inc. -<br>K083688 |
| -<br>Mechanism of<br>Action | The Ventway Sparrow provides continuous or<br>intermittent ventilatory support. | The LTV® 1200 provides continuous or<br>intermittent ventilatory support. |
| -<br>Components | The Ventway Sparrow consists of the following<br>components:<br>- Ventilator<br>- Patient Circuit<br>- AC/DC Power Supply<br>- DC/DC Power Adapter<br>- Rechargeable Battery Pack<br>- Non-rechargeable Battery Pack<br>- Oxygen Mixer (external)<br>- Oxygen enrichment kit<br>- Inlet Filter | The LTV® 1200 consists of the following<br>components:<br>- Ventilator<br>- Patient Circuit<br>- AC/DC Power Adapter<br>- DC/DC Power Adapter |
| -<br>Dimensions<br>(HxWxD) | 2.36" x 6.5" x 6.57"<br>(6.0 cm x 16.5 cm x 16.7 cm) | 3.25" x 10.5" x 13.5"<br>(8.4 cm x 27 cm x 38 cm) |
| -<br>Weight | Standard version - 2.2 lbs. (1 kg)<br>Robust version - 2.64 lbs. (1.2 kg) | 14.5 lbs. (6.5 kg) |
| -<br>Battery | Rechargeable: Lithium Ion<br>Non-rechargeable: Li-Mn | Rechargeable: Sealed Lead Acid |
| -<br>Duration per charge | 4 hr. @ VT=500ml, 12bmp, PEEP=5cmH2O,<br>FIO2=21% | 1hr @ VT=800ml, 15bmp, PEEP=5cmH2O,<br>FIO2=21% |
| -<br>External power<br>supply | Input: 100 - 264 VAC/ 50-60 Hz, max 1.6 A<br>Output: 16-28 VDC, 120 W | Input: 100 to 250 VAC/ 50-60 Hz<br>Output: 13 VDC |
| -<br>Display/User<br>Interface | LCD: SPI 1.8" TFT 160x128 driver st7735,<br>Rotary encoder selector integrated with push<br>button | 7- segment control display, LEDs, push buttons<br>and a control knob |
| Performance | • SIMV-VC (PS) (a.k.a SIMV)<br>• CPAP<br>• Apnea Backup Ventilation<br>• Control (Trigger sensitivity "off")<br>• Assist/Control (AC)<br>• SIMV-PC | • SIMV<br>• CPAP<br>• Apnea Backup Ventilation<br>• Control (Trigger sensitivity "--")<br>• Assist/Control (AC)<br>• NPPV |
| -<br>Basic and Advanced<br>User Modes | Yes | Yes |
| -<br>Manual Triggered<br>Breath | Yes | Yes |
| -<br>Air Source | Atmospheric | Atmospheric |
| -<br>Controls | "Multi-function" control knob | Dedicated control buttons and knob |
| -<br>Monitors | PEEP, PIP ,Tidal Volume (Vt), I:E ratio,<br>Breath rate (bpm), Minute Volume | PEEP, PIP, Tidal Volume (Vt), I:E Ratio,<br>Breath rate (bpm), MAP, Minute Volume |
| Settings: | | |
| -<br>Tidal Volume<br>[mL/breath] | 50-2000 | 50-2000 |
| -<br>Respiratory Rate<br>[bpm] | 1-60 | 5-80 |
| -<br>Inspiratory Time<br>(sec) | 0.3-4 ±10% | 0.3-9.9 ±0.05 s |
| -<br>PIP Limit [cmH2O] | 11-60 ±5 | 5-100 |
| Technological | Ventway Sparrow<br>Inovytec Ltd. | Predicate - LTV 1200 MR Conditional<br>Ventilator Pulmonetic Systems Inc. -<br>K083688 |
| - PEEP [cmH2O] | 0-20 | 5-20 |
| - Supplemental<br>Oxygen (FiO2) | 21% to 95% ±5 | 21% to 50% ±3<br>51% to 95% ±5 |
| - Alarms | Blower malfunction<br>Tube disconnect<br>Patient disconnect<br>Apnea<br>System recovered from a crash<br>Battery empty<br>Sensor disconnect<br>Low respiratory rate<br>High minute volume<br>Low minute volume<br>High inspiratory pressure<br>Low inspiratory pressure<br>Leak<br>Inverse I:E ratio<br>High temperature<br>Expiratory valve blocked<br>High PEEP<br>Low PEEP<br>High respiratory rate<br>Tidal Volume Limit Reached<br>Low tidal volume<br>Low pressure<br>Battery low<br>High Voltage<br>Replace filter<br>Service needed<br>Altitude out of range<br>Unexpected Restart | Start-up Self-Test<br>Circuit Disconnect<br>Over Pressure/Blockage<br>Apnea<br>External power indicator<br>Low and Empty Battery<br>Detect Spontaneous Breath<br>High PEEP |
| Patient Breathing<br>Circuit<br>Disposable | Single limb<br>Exhalation valve and PEEP valve<br>User to add legally marketed non-rebreathing<br>valve | Exhalation valve and PEEP valve |
| Accessories – User<br>supplied | Bacterial / Viral Filter<br>HME<br>Non-rebreathing Valve (22mm O.D. inlet x<br>22mm I.D. outlet, resistance < 0.5 cmH2O) | Bacterial / Viral Filter<br>HME |
| Standards Met | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-12<br>ISO 80601-2-12<br>IEC 62304<br>EN 1789<br>RTCA DO-160G<br>RFID AIM7351731<br>ASTM F2119 - 3 Tesla | IEC 601-1<br>IEC 68-2-27<br>IEC 68-2-6<br>IEC 68-2-34<br>MIL-STD-810E |
| Technological<br>Characteristic | Ventway Sparrow<br>Inovytec Ltd. | Predicate - LTV 1200 MR Conditional<br>Ventilator Pulmonetic Systems Inc. -<br>K083688 |
| Biocompatibility | Externally communicating, tissue, prolonged<br>duration<br>ISO 10993-5<br>ISO 10993-10<br>ISO 18562-2<br>ISO 18562-3 | Externally communicating, tissue, prolonged<br>duration |
| Human Factors /<br>Usability | Preformed with the identified user group | |

{5}------------------------------------------------

# 510(k) Summary

{6}------------------------------------------------

### 510(k) Summary Page 4 of 6

{7}------------------------------------------------

### 510(k) Summary Page 5 of 6

### Substantial Equivalence Discussion

The Ventway Sparrow has the same intended use and similar technological characteristics and principles of operation as the predicate LTV 1200, K083688.

### 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. It may be used for invasive or noninvasive ventilation presets. It may be used in hospital (transport) and field environments.

This is similar to the predicate.

### Technological Characteristics

Both devices have blower-based technology to provide positive pressure and have applicable alarms and sensors to maintain performance within their specifications.

### Non-clinical Testing

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

{8}------------------------------------------------

### 510(k) Summary Page 6 of 6

The results demonstrate similar performance.

# Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.