Predicate Devices

Reference Devices

K070594, K060647, K120785, K121955, K140179, K110398, K973797

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on combining conventional therapies.

Therapeutic

Yes
The device is described as a "mechanical ventilator which combines additional conventional therapies into a single device" for individuals who "require mechanical ventilation." It provides "continuous or intermittent ventilatory support," "supplemental oxygen," and aids in "airway fluid removal" and "clearing secretions effectively," all of which are therapeutic functions.

Diagnostic

No

Explanation: The device is described as a "mechanical ventilator" and its intended use is to provide "continuous or intermittent ventilatory support." It also includes therapies like oxygen concentration, cough assist, and suction. These are all therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or predict a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mechanical ventilator which combines additional conventional therapies into a single device," including oxygen, cough assist, and suction. This indicates it is a hardware device with integrated software, not a software-only medical device. The testing described also includes biocompatibility and comparative waveform testing, which are typical for hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided text, the VOCSN Unified Respiratory System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device that provides respiratory support, oxygen, cough assist, and suction directly to a patient. These are all in vivo (within a living organism) functions.
Device Description: The description reinforces that it's a mechanical ventilator with additional therapies applied to the patient.
Lack of IVD Indicators: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening. The testing described (biocompatibility, waveform testing) is related to the device's performance and safety in direct contact with the patient's respiratory system.

Therefore, the VOCSN Unified Respiratory System is a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.

The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

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

CBK, NOU, CAW, NHJ, BTA, BZE, CAH

Device Description

The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction.

The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.

Ventilation: The ventilator function of the VOCSN device is a conventional positive pressure ventilator that supplies volume breaths, pressure breaths, and spontaneous breath types are incorporated into the following traditional modes of ventilation: Assist Control, SIMV (Synchronized Intermittent Mandatory Ventilation), Bi-Level. The VOCSN uses a conventional radial blower working in conjunction with valves and transducers under the control of a microprocessor to provide breath delivery. Oxygen is provided to the patient from the internal concentrator, or from external sources. The ventilator is connected to the patient via one of three available circuits: an active circuit, a passive circuit, or a mouthpiece circuit. An optional Secretion Trap can be placed between the patient connection and the patient circuit to collect liquids to help prevent obstructing the patient circuit. The VOCSN provides a conventional alarm and monitoring package to alert users to hazard conditions. A central user interface provides adjustment of the controls and display of monitored data. The VOCSN is a portable device that can be operated from common AC and DC supply power sources, as well as internal batteries.

Oxygen Concentrator: An optional internal oxygen concentrator can be selected to provide oxygen to the patient. Oxygen from the internal oxygen concentrator is delivered as a pulse dose via a tube directly to the patient interface. The oxygen is separated from the nitrogen in room air using a conventional Pressure Swing Adsorption (PSA) oxygen concentration process. The system consists of a reciprocating compressor, sieve bed, and valves under the control of the microprocessor system. As part of the VOCSN system it uses the central user interface and can be operated from common AC and DC supply power sources, as well as internal batteries. The VOCSN provides an alarm and monitoring package to alert users to hazard conditions.

Cough Assist: The Cough Assist option clears secretions from the lungs by applying positive pressure (insufflation) to the airway followed by a sudden negative pressure (exsufflation). This creates a high expiratory flow, simulating a natural cough. The device attaches to standard patient interfaces using the VOCSN patient circuits. The VOCSN uses a conventional radial blower working in conjunction with a cough assist valve under the control of a microprocessor to provide the insufflation cough phases. The cough assist function is integral to the ventilator and is connected to the patient via the patient circuit. The VOCSN provides an alarm and monitoring package to alert users to hazard conditions.

Suction: The VOCSN includes an optional integrated suction function and detachable VLS suction canister. If enabled, Suction therapy can be initiated at any time during Ventilation or Cough therapy, to help remove secretions from the patient airway or patient circuit. When enabled, the Cough+Suction feature activates both therapies simultaneously to help remove secretions from the patient airway and/or patient circuit. Suction will begin at the start of the first Cough therapy insufflation, and run throughout the configured number of Cough Cycles plus an additional 30 seconds. The VOCSN suction function uses a conventional reciprocating piston pump working in conjunction with a selector valve under the control of a microprocessor to provide the negative pressure. Suction is routed to the canister, and a suction tube connects the suction catheter to the canister. The VOCSN provides an alarm and monitoring package to alert users to hazard conditions.

Heated Wire Patient Circuit Accessory: The VOCSN system includes a heated patient circuit accessory to connect the ventilator to the patient connection. The circuits are single patient use pediatric & adult heated patient circuits, with a passive or active exhalation valve. Passive circuits use a fixed leak for exhalation. Active circuits use a piloted diaphragm valve for exhalation control. The VOCSN heated wire patient circuits are to be used only with the VOCSN Unified Respiratory System.

Bacteria Filter Accessory: The VOCSN system includes a bacteria filter accessory connected between the VOCSN and the patient circuit. The filter is intended to reduce bacterial/viral transmissions between the patient and equipment. The VOCSN bacteria filter is to be used only with the VOCSN Unified Respiratory System.

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

pediatric through adult patients weighing at least 5 kg

Intended User / Care Setting

It is intended for use in home, hospital, institutional and transport settings, including portable applications.

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)

The company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility and comparative waveform testing. Biocompatibility testing of breathing gases comprised evaluation of volatile organic compounds (VOC), particulate matter, carbon dioxide, carbon monoxide and ozone. Biocompatibility testing of the gas pathway in contact with humidification or aerosolized medications additionally included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, bacterial reverse mutation genotoxicity, and chemical characterization with risk assessment. These tests demonstrated that the VOCSN ventilator is compliant with the user and product requirements.

For the Oxygen Concentrator, the company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN oxygen concentrator is compliant with the user and product requirements.

For Cough Assist, the company completed validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

For Suction, the company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

For Heated Wire Patient Circuit Accessory, the company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

For the Bacteria Filter Accessory, the company completed testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

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.

K111610

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.

K070594, K060647, K120785, K121955, K140179, K110398, K973797

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

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 7, 2017

Ventec Life Systems, Inc. Joseph Cipollone VP Quality & Regulatory 19021 120th Ave Ne Suite 101 Bothell, Washington 98011

Re: K162877

Trade/Device Name: VOCSN Unified Respiratory System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, NOU, CAW, NHJ, BTA, BZE, CAH Dated: March 8, 2017 Received: March 10, 2017

Dear Mr. Cipollone:

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.

1

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Image /page/1/Picture/8 description: The image contains a signature followed by the name "Tina Kiang". There is a number 8 above a dash and the number 5. The signature is illegible and appears to be a series of loops and curves.

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

2

Section 4: Indications for Use Statement

510(k) Number: K162877

Device Name: VOCSN Unified Respiratory System

Indications for Use:

The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.

The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

Prescription Use ___X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Form #3881, Indications for Use is included in Tab 9

3

510(k) Summary

Date Prepared	April 6, 2017
Sponsor	Ventec Life Systems, Inc.
19021 120th Ave. NE, Suite 101
Bothell, WA 98011
Tel: 425-686-1750
Contact Information	Joseph Cipollone
VP Quality & Regulatory
19021 120th Ave. NE, Suite 101
Bothell, WA 98011
Tel: 909-213-3691
jcipollone@venteclife.com
Device Proprietary Name:	VOCSN Unified Respiratory System
Common name	Mechanical ventilator / Oxygen concentrator / Cough assist / Suction pump
Primary Classification and
Product Code	Mechanical ventilator
• Classification number 21 CFR 868.5895
• Class II
• Code: CBK - Continuous Ventilator, Facility Use
Subsequent Product Codes
of Additional Integrated
Functions	Mechanical ventilator
• Code: NOU - Continuous Ventilator, Home Use
Oxygen concentrator
• Code: CAW - Portable oxygen generator
Cough Assist
• Code: NHJ - Noncontinuous ventilator (IPPB)
Suction Pump
• Code: BTA - Powered suction pump
Heated Patient Circuits
• Code: BZE - Heater, Breathing System, W/Wo Controller
Bacteria Filter
• Code: CAH - Filter, Bacterial, Breathing Circuit
Primary Predicate Device
Information:	Mechanical ventilator component
Respironics Trilogy Series Ventilator (K111610)
Reference Predicate Device
Information:	Mechanical ventilator component
CareFusion Palmtop Ventilator PTV-8 & -10 (K070594)
CareFusion LTV 1200 Ventilator (K060647)
	Oxygen concentrator component
Omni 3 (eQuinox) Oxygen System (K120785)
	Cough Assist component
Respironics Cough Assist T70 (K121955)
	Suction Pump component
Precision Medical Easy Go Vac PM66 (K140179)
	Heated Patient Circuits
Respironics (Philips) Disposable Heated Wire Circuits (K110398)
	Bacteria Filter
Respironics (Philips) Bacteria Filter PN 342077 - Supplied by King
Systems under (K973797)

4

Indications for Use (VOCSN Unified Respiratory System)

The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and noninvasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.

The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

Discussion of Differences in the Indications for Use from the Primary Predicate Device

The VOCSN and primary predicate Trilogy ventilator have substantially equivalent indications for use with regard to the ventilation therapy, except that the VOCSN is indicated for transport settings whereas the Trilogy is not intended for use as a transport ventilator. This additional use setting is equivalent to a secondary predicate that is identified.

The indications for use statement of the VOCSN encompasses additional intended uses for oxygen concentrator, cough assist, and suction pump therapies that are not available in the Trilogy ventilator. These therapies are complementary adjunct therapies to the ventilation therapy, for which secondary predicates are identified.

5

The Trilogy ventilator indicates an optional Oximetry Interface Kit that is not indicated in the VOCSN indications for use. Oximetry is an ancillary therapy that is not critical to the therapeutic benefit of the ventilation, oxygen concentration, cough assist and suction therapies provided by VOCSN.

Device Description Overview

The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction.

The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.

6

Ventilation

Description

The ventilator function of the VOCSN device is a conventional positive pressure ventilator that supplies volume breaths, pressure breaths, and spontaneous breath types are incorporated into the following traditional modes of ventilation:

. Assist Control
SIMV (Synchronized Intermittent Mandatory Ventilation)
Bi-Level

The VOCSN uses a conventional radial blower working in conjunction with valves and transducers under the control of a microprocessor to provide breath delivery. Oxygen is provided to the patient from the internal concentrator, or from external sources. The ventilator is connected to the patient via one of three available circuits: an active circuit, a passive circuit, or a mouthpiece circuit. An optional Secretion Trap can be placed between the patient connection and the patient circuit to collect liquids to help prevent obstructing the patient circuit. The VOCSN provides a conventional alarm and monitoring package to alert users to hazard conditions.

A central user interface provides adjustment of the controls and display of monitored data. The VOCSN is a portable device that can be operated from common AC and DC supply power sources, as well as internal batteries.

Substantial Equivalence

The intended use, performance, and technology of the ventilator system have been compared to predicate devices, the Trilogy Series Ventilator (K111610), and the Palmtop Ventilator PTV-8 & -10 (K070594). A summary table of key characteristics compared to the predicate device(s) is shown below.

Characteristic	VOCSN	Predicate, Trilogy (K111610)	Comparison
Intended Use	continuous or intermittent
ventilatory support invasive and non-invasive ped through adult ≥ 5 kg home, hospital, institutional
and transport settings,
including portable
applications	continuous or intermittent
ventilatory support invasive and non-invasive ped through adult ≥ 5 kg home, hospital, and mobile
applications.	Substantially Equivalent
Equivalent except the Trilogy
does not specify transport
settings. The secondary
predicate Palmtop ventilator
specifies transport use.
FDA Product
Code	NOU, CBK	NOU, CBK	Equivalent
Characteristic	VOCSN	Predicate, Trilogy (K111610)	Comparison
Modes of ventilation	Spontaneous Bi-Level	Spontaneous ventilation (S) Spontaneous ventilation with timed back-up (S/T)
Timed ventilation (T)	Substantially Equivalent

Equivalent

VOCSN Bi-level mode is
equivalent to Trilogy (S/T)
and (T) modes with
appropriate settings of
patient trigger |
| | Assist/Control-Pressure Assist/Control-Volume SIMV-Pressure SIMV-Volume | Pressure A/C (Palmtop ventilator K070594) Volume A/C (Palmtop ventilator K070594) Pressure SIMV (Palmtop ventilator K070594) Volume SIMV (Palmtop ventilator K070594) | Equivalent to the secondary predicate Palmtop ventilator.

Equivalent to the secondary predicate Palmtop ventilator.

Equivalent to secondary predicate Palmtop ventilator.

Reference Tab 5, TPR-00049,
TPR-00050 and TPR-00055
for test results |
| Significant
breath control
parameters | Breath Rate PEEP/EPAP Pressure/Pressure Control/
IPAP Inspiratory Time Sigh Tidal volume FIO2 | Breath Rate PEEP/EPAP Pressure/Pressure Control/
IPAP Inspiratory Time Sigh Tidal volume FIO2 | Substantially Equivalent |
| Core technology | Conventional radial blower
working in conjunction with
valves and transducers under
the control of a microprocessor
to provide breath delivery. | Conventional radial blower
working in conjunction with
valves and transducers under
the control of a microprocessor
to provide breath delivery. | Substantially Equivalent |
| Circuits | Single limb with active exh. valve Single limb with passive exh. valve Single limb with mouthpiece | Single limb with active exh. valve Single limb with passive exh. valve Single limb with mouthpiece | Equivalent |
| Circuit Interfaces | Invasive and non-invasive | Invasive and non-invasive | Equivalent |
| User Interface | LCD touch screen with
additional hard keys | LCD screen with hard keys | Substantially Equivalent
The Palmtop ventilator
(K070594) includes a touch
screen |
| Characteristic | VOCSN | Predicate, Trilogy (K111610) | Comparison |
| Nebulizer | Provides pneumatic drive to
external OEM 6 L/min nebulizer | No nebulizer drive provided | Substantially Equivalent
The alternate predicate
Palmtop ventilator provides a
pneumatic drive to an
external OEM 6 L/min
nebulizer |
| Power | AC, DC, and internal battery | AC, DC, and internal battery | Equivalent |

7

8

The company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility and comparative waveform testing. Biocompatibility testing of breathing gases comprised evaluation of volatile organic compounds (VOC), particulate matter, carbon dioxide, carbon monoxide and ozone. Biocompatibility testing of the gas pathway in contact with humidification or aerosolized medications additionally included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, bacterial reverse mutation genotoxicity, and chemical characterization with risk assessment. These tests demonstrated that the VOCSN ventilator is compliant with the user and product requirements.

The product is compliant with and has been verified to the following standards:

Critical care ventilators	ISO 80601-2-12
Home care ventilators	ASTM F1246
Anesthetic and respiratory equipment -- Conical connectors	ISO 5356-1
Respiratory gas monitors	ISO 80601-2-55
Nebulizing system	ISO 27427
Breathing sets and connectors	ISO 5367
Medical electrical equipment	IEC 60601-1
Electromagnetic compatibility	IEC 60601-1-2
Medical devices for home use	IEC 60601-1-11
Alarm system	IEC 60601-1-8

9

Oxygen Concentrator

Description

An optional internal oxygen concentrator can be selected to provide oxygen to the patient. Oxygen from the internal oxygen concentrator is delivered as a pulse dose via a tube directly to the patient interface.

The oxygen is separated from the nitrogen in room air using a conventional Pressure Swing Adsorption (PSA) oxygen concentration process. The system consists of a reciprocating compressor, sieve bed, and valves under the control of the microprocessor system. As part of the VOCSN system it uses the central user interface and can be operated from common AC and DC supply power sources, as well as internal batteries. The VOCSN provides an alarm and monitoring package to alert users to hazard conditions.

Substantial Equivalence

The intended use, performance, and technology of the oxygen concentrator system have been compared to the Omni 3 (eQuinox) Oxygen System (K120785) predicate device. A summary table of key characteristics compared to the predicate device is shown below.

Characteristic	VOCSN	Predicate, Omni 3 (K120785)
Intended Use	The integral oxygen
concentrator is intended for the
administration of supplemental
oxygen	The administration of
supplemental oxygen.
FDA Product
Code	CAW	CAW
Oxygen %	Nominal 90 %	Nominal 90 %
Modes	• Pulse Dose	• Pulse Dose
• Continuous
Core technology	Pressure Swing Adsorption (PSA)
oxygen concentration process.	Pressure Swing Adsorption
(PSA) oxygen concentration
process.
User Interface	LCD touch screen with
additional hard keys	LCD screen with hard keys
Power	AC, DC, and internal battery	AC, DC, and internal battery

Performance Testing (non-clinical)

The company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN oxygen concentrator is compliant with the user and product requirements.

The oxygen concentrator option is compliant with and has been tested to the following standards:

Oxygen concentrators

150 80601-2-69

10

Oxygen conserving equipment	ISO 80601-2-67
Medical electrical equipment	IEC 60601-1
Electromagnetic compatibility	IEC 60601-1-2
Medical devices for home use	IEC 60601-1-11
Alarm system	IEC 60601-1-8

11

Cough Assist

Description

The Cough Assist option clears secretions from the lungs by applying positive pressure (insufflation) to the airway followed by a sudden negative pressure (exsufflation). This creates a high expiratory flow, simulating a natural cough. The device attaches to standard patient interfaces using the VOCSN patient circuits.

The VOCSN uses a conventional radial blower working in conjunction with a cough assist valve under the control of a microprocessor to provide the insufflation cough phases. The cough assist function is integral to the ventilator and is connected to the patient via the patient circuit.

The VOCSN provides an alarm and monitoring package to alert users to hazard conditions.

Substantial Equivalence

The intended use, performance, and technology of the cough assist system have been compared to the Cough Assist T70 (K121955) predicate device. A summary table of key characteristics compared to the predicate device is shown below.

Characteristic	VOCSN	Cough Assist T70 (K121955)
Intended Use	Mechanically ventilated patient unable to cough or clear secretions effectively pediatric through adult ≥ 5 kg invasive and non-invasive home, hospital, institutional and transport settings, including portable applications	patient unable to cough or clear secretions effectively. adult or pediatric patients used with facemask, mouthpiece, endotracheal, or tracheostomy tube. hospital, institutional environment, or in the home.
FDA Product Code	NHJ	NHJ
Significant control parameters	Breath Sync Exsufflation Pressure Exsufflation Time Insufflation Rise Time Insufflation Time Pause Time	Cough Trak Exsufflation Pressure Exsufflation Time Inhale Flow (controls rise time) Insufflation Time Pause Time

12

Characteristic	VOCSN	Cough Assist T70 (K121955)
Core technology	Radial blower working in
conjunction with a cough assist
valve under the control of a
microprocessor	Radial blower working in
conjunction with two cough
assist valves under the control
of a microprocessor
User Interface	LCD touch screen with
additional hard keys	LCD screen with hard keys
Power	AC, DC, and internal battery	AC, DC, and internal battery

The company completed validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

The cough assist option is compliant with and has been verified to the following standards:

Medical electrical equipment	IEC 60601-1
Medical devices for home use	IEC 60601-1-11
Alarm system	IEC 60601-1-8

13

Suction

Description

The VOCSN includes an optional integrated suction function and detachable VLS suction canister. If enabled, Suction therapy can be initiated at any time during Ventilation or Cough therapy, to help remove secretions from the patient airway or patient circuit.

When enabled, the Cough+Suction feature activates both therapies simultaneously to help remove secretions from the patient airway and/or patient circuit. Suction will begin at the start of the first Cough therapy insufflation, and run throughout the configured number of Cough Cycles plus an additional 30 seconds.

The VOCSN suction function uses a conventional reciprocating piston pump working in conjunction with a selector valve under the control of a microprocessor to provide the negative pressure. Suction is routed to the canister, and a suction tube connects the suction catheter to the canister.

The VOCSN provides an alarm and monitoring package to alert users to hazard conditions.

Substantial Equivalence

The intended use, performance, and technology of the suction function have been compared to the Precision Medical Easy Go Vac PM66 (K140179) predicate device. A summary table of key characteristics compared to the predicate device is shown below.

Characteristic	VOCSN	Easy Go Vac PM66 (K140179)
Intended Use	intended for airway fluid removal and oral/pharyngeal hygiene. home, hospital, institutional and transport settings, including portable applications	provides a portable, AC/DC powered medical vacuum source. It is intended for use in the homecare / healthcare environments
FDA Product Code	BTA	BTA
Vacuum Control	-50 to -300 mmHg	-50 to -533 mmHg
Core technology	reciprocating piston pump working in conjunction with a selector valve under the control of a microprocessor	reciprocating piston pump working in conjunction with a vacuum regulator and mechanical gage
User Interface	LCD touch screen with additional hard keys	Manual physical controls
Power	AC, DC, and internal battery	AC, DC, and internal battery

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The company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

The suction option is compliant with and has been tested to the following standards:

FDA Guidance Document for Powered Suction Pump 510(k)s
Electrically powered suction equipment	ISO 10079-1
Medical electrical equipment	IEC 60601-1
Medical devices for home use	IEC 60601-1-11
Alarm system	IEC 60601-1-8

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Heated Wire Patient Circuit Accessory

Description

The VOCSN system includes a heated patient circuit accessory to connect the ventilator to the patient connection. The circuits are single patient use pediatric & adult heated patient circuits, with a passive or active exhalation valve. Passive circuits use a fixed leak for exhalation. Active circuits use a piloted diaphragm valve for exhalation control. The VOCSN heated wire patient circuits are to be used only with the VOCSN Unified Respiratory System.

| Feature | VOCSN | Respironics (Philips) Disposable
Heated Wire Circuits (K110398) |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
principle | Connects ventilator to patient connection. Passive circuit uses a fixed leak for
exhalation port. Active circuit uses a piloted diaphragm valve for exhalation control.
Includes heated wire for use with a humidifier. | Connects ventilator to patient connection. Passive circuit uses a fixed leak for exhalation port.
Active circuit uses a piloted diaphragm valve for exhalation control. Includes heated wire for
use with a humidifier. |
| Classification | Class II | Class II |
| Product Code | BZE | BZE |
| Intended use | The patient circuit is intended to be used only with the
VOCSN Unified Respiratory System which is intended to
provide continuous or intermittent ventilatory support for the care of
individuals who require mechanical ventilation. It may be used in invasive and non-
invasive applications. The VOCSN is intended for pediatric
through adult patients weighing at least 5 kg. It is
intended for use in home, hospital, institutional and
transport settings, including portable applications. | Intended to provide warmed and/or humidified breathing
gases before they enter the patient's airway. The disposable
heated wire circuit is indicated for use by a single adult or
pediatric patient in the home,
hospital, and or institutional setting. It may be used for both
invasive and non-invasive ventilation |
| Humidifier
compatibility | Fisher Paykel HC550 &
MR850 humidifiers | HC500 |
| Reuseable | Single patient use | Single patient use |
| Heating mode | Applied voltage through
heating wires. | Applied voltage through heating
wires. |
| Sterility | Non-Sterile | Non-Sterile |
| Materials | Compliant with ISO 10993-1
Biological Evaluation | Compliant with ISO 10993-1
Biological Evaluation |
| Breathing gases | Air and supplemental oxygen | Air and supplemental oxygen |
| Feature | VOCSN | Respironics (Philips) Disposable Heated Wire Circuits (K110398) |
| Tube diameter | Adult: 22 MM Pediatric 15 mm | Adult: 22 MM Pediatric 15 mm |
| Tube length | 1.85 M | 1.8 m |
| Tube connectors | 22 mm conical Compliant with ISO-5356-1 Conical connectors | 22 mm conical Compliant with ISO-5356-1 Conical connectors |
| Heating wire | Resistive, encased | Resistive, encased |
| Wire resistance (ohms) | 16 | 30 |
| Rated power | 60 watts | Not stated |
| Patient Leakage current | Compliant with the requirements of IEC 60601-1 | Claims compliance with IEC 60601-1 |
| Resistance to airflow | Complaint with ISO 8185 | Complaint with ISO 5367 |
| Tube volume | Pediatric: approx. 326 ml
Adult: approx. 703 ml
Compliant with ISO 5367 | Not stated, claims compliance with ISO 5367 |
| Exhalation valve type | Passive Option - fixed orifice type

Active Option - Piloted diaphragm type | Passive Option - fixed orifice type

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The company completed Validation testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

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The heated wire patient circuit accessory is compliant with and has been tested to the following standards:

Biological Evaluation	ISO 10993-1
Respiratory tract humidifiers for medical use	ISO 8185
Conical connectors	ISO 5356-1
Breathing sets and connectors	ISO 5367

18

Bacteria Filter Accessory

Description

The VOCSN system includes a bacteria filter accessory connected between the VOCSN and the patient circuit. The filter is intended to reduce bacterial/viral transmissions between the patient and equipment. The VOCSN bacteria filter is to be used only with the VOCSN Unified Respiratory System.

| Feature | VOCSN | Respironics (Philips) Bacteria
Filter PN 342077 - Supplied by
King Systems under (K973797) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II |
| Product Code | CAH | CAH |
| Intended use | To be used only as part of
the VOCSN integrated
respiratory care system to
reduce bacterial/viral
transmissions between the
patient and equipment. | It is designed to reduce
bacterial/viral transmissions
between the patient and
equipment. |
| Operating
principle | Electrostatic | Electrostatic |
| Filtration
efficiency | 99.99% BFE & VFE | 99.99% BFE & VFE |
| Approximate
Volume (ml) | 31 | 74 |
| Connectors | 22 mm conical, compliant
with ISO 5356-1 Conical
Connectors | 22 mm conical |
| Resistance @ 30
lpm | 0.4 cmH2O | 0.7 cmH2O |

Performance Testing (non-clinical)

The company completed testing to validate performance against the User Requirements Document under simulated use conditions, and test reports were generated summarizing the test results. Verification testing was completed to verify system performance against the Product Requirements Specification, and test reports were generated summarizing the test results. This testing included biocompatibility testing, as listed in the Ventilation section. These tests demonstrated that the VOCSN is compliant with the user and product requirements.

The bacteria filter accessory is compliant with and has been tested to the following standards:

Conical connectors

ISO 5356-1

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Conclusion

The indications for use, performance characteristics, and core technology of the VOCSN are substantially equivalent to the predicate devices. Extensive validation and verification testing has demonstrated that the device is compliant with the product requirements and relevant regulatory standards. The information provided supports the claim that the device is substantially equivalent to predicate devices.