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.

AI/ML Overview

The document provided is a 510(k) Premarket Notification from the FDA regarding the "Ventway Sparrow" ventilator. It is a regulatory document and does not contain a study that proves the device meets specific acceptance criteria.

Instead, it details the device's indications for use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to a predicate device (LTV® 1200 MR Conditional Ventilator).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document. The document primarily focuses on demonstrating that the Ventway Sparrow is "substantially equivalent" to an already cleared device, K083688, based on similar intended use and technological characteristics, and that it has undergone various non-clinical performance and safety tests.

There is no mention of:

A table of acceptance criteria and reported device performance.
Sample sizes for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for a ground truth test set.
A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
A standalone algorithm performance study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance claims.
Sample size for a training set or how ground truth for a training set was established.

The "Performance" section within Table 1 lists various ventilatory modes and settings, but these are descriptions of the device's capabilities, not acceptance criteria for a study demonstrating performance. The non-clinical testing listed primarily covers safety, electrical, environmental, and engineering standards compliance.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K202970

Device Name

Ventway Sparrow

Indications for Use (Describe)

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)

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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.

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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 SparrowInovytec Ltd.	Predicate - LTV 1200 MR ConditionalVentilator Pulmonetic Systems Inc. -K083688
Characteristic
Product Code, Class	CBK, Class II	CBK, Class II
Indications for Use	The Ventway Sparrow ventilator is intended toprovide continuous or intermittent ventilatorysupport for the care of individuals who requiremechanical ventilation. Specifically, theventilator is applicable for adult and pediatricpatients weighing at least 5 kg (11 lb.), whorequire the following types of ventilatorysupport: SIMV - VC (PS), SIMV-PC, or CPAP.The Ventway Sparrow lung ventilator isintended for emergency use and duringtransportation. It may be used for invasive (viaan endotracheal tube and tracheostomy) ornoninvasive (full non-vented ventilation facemask) ventilation presets. It may be used inhospitals, pre-hospital (transport) and fieldenvironments.Models VWSP100MR and VWSP900MR maybe used in a Magnetic Resonance (MR)environment up to 3 Tesla.The ventilator is a restricted medical deviceintended for use by qualified, trained personnelunder the direction of a physician.	The LTV® 1200 ventilator is intended toprovide continuous or intermittent ventilatorysupport for the care of the individuals whorequire mechanical ventilation. Specifically,the ventilator is applicable for adult andpediatric patients weighing at least 5kg (11lbs.), who require the following types ofventilatory support: PPV, Assist/Control,SIMV, CPAP, or NPPV.
User Population	Qualified, trained personnel under the directionof a physician.	Qualified, trained personnel under the directionof 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 ventilatorunit with an LCD screen and a single usepatient circuit	The LTV® 1200 consists of a ventilator unitwith LCD displays and a reusable patientcircuit
TechnologicalCharacteristic	Ventway SparrowInovytec Ltd.	Predicate - LTV 1200 MR ConditionalVentilator Pulmonetic Systems Inc. -K083688
-Mechanism ofAction	The Ventway Sparrow provides continuous orintermittent ventilatory support.	The LTV® 1200 provides continuous orintermittent ventilatory support.
-Components	The Ventway Sparrow consists of the followingcomponents:- 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 followingcomponents:- 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 IonNon-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 powersupply	Input: 100 - 264 VAC/ 50-60 Hz, max 1.6 AOutput: 16-28 VDC, 120 W	Input: 100 to 250 VAC/ 50-60 HzOutput: 13 VDC
-Display/UserInterface	LCD: SPI 1.8" TFT 160x128 driver st7735,Rotary encoder selector integrated with pushbutton	7- segment control display, LEDs, push buttonsand 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 AdvancedUser Modes	Yes	Yes
-Manual TriggeredBreath	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 SparrowInovytec Ltd.	Predicate - LTV 1200 MR ConditionalVentilator Pulmonetic Systems Inc. -K083688
- PEEP [cmH2O]	0-20	5-20
- SupplementalOxygen (FiO2)	21% to 95% ±5	21% to 50% ±351% to 95% ±5
- Alarms	Blower malfunctionTube disconnectPatient disconnectApneaSystem recovered from a crashBattery emptySensor disconnectLow respiratory rateHigh minute volumeLow minute volumeHigh inspiratory pressureLow inspiratory pressureLeakInverse I:E ratioHigh temperatureExpiratory valve blockedHigh PEEPLow PEEPHigh respiratory rateTidal Volume Limit ReachedLow tidal volumeLow pressureBattery lowHigh VoltageReplace filterService neededAltitude out of rangeUnexpected Restart	Start-up Self-TestCircuit DisconnectOver Pressure/BlockageApneaExternal power indicatorLow and Empty BatteryDetect Spontaneous BreathHigh PEEP
Patient BreathingCircuitDisposable	Single limbExhalation valve and PEEP valveUser to add legally marketed non-rebreathingvalve	Exhalation valve and PEEP valve
Accessories – Usersupplied	Bacterial / Viral FilterHMENon-rebreathing Valve (22mm O.D. inlet x22mm I.D. outlet, resistance < 0.5 cmH2O)	Bacterial / Viral FilterHME
Standards Met	IEC 60601-1IEC 60601-1-2IEC 60601-1-12ISO 80601-2-12IEC 62304EN 1789RTCA DO-160GRFID AIM7351731ASTM F2119 - 3 Tesla	IEC 601-1IEC 68-2-27IEC 68-2-6IEC 68-2-34MIL-STD-810E
TechnologicalCharacteristic	Ventway SparrowInovytec Ltd.	Predicate - LTV 1200 MR ConditionalVentilator Pulmonetic Systems Inc. -K083688
Biocompatibility	Externally communicating, tissue, prolongeddurationISO 10993-5ISO 10993-10ISO 18562-2ISO 18562-3	Externally communicating, tissue, prolongedduration
Human Factors /Usability	Preformed with the identified user group

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510(k) Summary

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510(k) Summary Page 4 of 6

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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

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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.

Regulation Number and Section

§ 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).