(175 days)
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.
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.
The provided text describes a medical device, the VOCSN Unified Respiratory System, and its various components, along with comparisons to predicate devices and adherence to performance standards. However, it does not describe a study involving an AI algorithm's performance or human reader improvements. Therefore, I cannot provide details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies, as these elements are not present in the document.
Instead, the document focuses on the VOCSN Unified Respiratory System's regulatory submission (510(k)) to the FDA, demonstrating its substantial equivalence to previously cleared medical devices. This involves non-clinical performance testing against user and product requirements and compliance with international standards.
I will structure the answer based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):
The acceptance criteria are generally framed as compliance with specific international and FDA guidance standards, as well as meeting internal User Requirements and Product Requirements Specifications. The "reported device performance" is essentially the statement that the device is compliant with these standards and requirements, and that verification/validation testing was successfully completed. Specific quantitative performance targets are not always explicitly stated in the summary but are implied by compliance with the referenced standards.
Ventilation Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 80601-2-12 (Critical care ventilators) | Compliant |
| ASTM F1246 (Home care ventilators) | Compliant |
| ISO 5356-1 (Conical connectors) | Compliant |
| ISO 80601-2-55 (Respiratory gas monitors) | Compliant |
| ISO 27427 (Nebulizing system) | Compliant |
| ISO 5367 (Breathing sets and connectors) | Compliant |
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-2 (Electromagnetic compatibility) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| Biocompatibility (VOC analysis, particulate matter, CO2, CO, Ozone) | Compliant |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, bacterial reverse mutation genotoxicity, chemical characterization with risk assessment for gas pathway with humidification/aerosolized meds) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Oxygen Concentrator Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 80601-2-69 (Oxygen concentrators) | Compliant |
| ISO 80601-2-67 (Oxygen conserving equipment) | Compliant |
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-2 (Electromagnetic compatibility) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Cough Assist Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Suction Component:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| FDA Guidance Document for Powered Suction Pump 510(k)s | Compliant |
| ISO 10079-1 (Electrically powered suction equipment) | Compliant |
| IEC 60601-1 (Medical electrical equipment) | Compliant |
| IEC 60601-1-11 (Medical devices for home use) | Compliant |
| IEC 60601-1-8 (Alarm system) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Heated Wire Patient Circuit Accessory:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 10993-1 (Biological Evaluation) | Compliant |
| ISO 8185 (Respiratory tract humidifiers for medical use) | Compliant |
| ISO 5356-1 (Conical connectors) | Compliant |
| ISO 5367 (Breathing sets and connectors) | Compliant |
| IEC 60601-1 (Medical Electrical Equipment) | Complies with applicable parts |
| Condensate control over wide range | Demonstrated |
| Resistance to airflow (ISO 8185 / ISO 5367) | Compliant |
| Patient leakage current (IEC 60601-1) | Compliant |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Bacteria Filter Accessory:
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance |
|---|---|
| ISO 5356-1 (Conical connectors) | Compliant |
| 99.99% BFE & VFE Filtration efficiency | Achieved |
| Resistance @ 30 lpm (0.4 cmH2O) | Achieved |
| Biocompatibility (as listed in Ventilation section) | Compliant |
| User Requirements Document | Performance validated |
| Product Requirements Specification | System performance verified |
Regarding AI-specific questions:
The provided document describes a physical medical device (VOCSN Unified Respiratory System), not an AI algorithm. Therefore, the following information is not present in the text:
- Sample size used for the test set and the data provenance: Not applicable as no AI test set is described. The device performance was validated and verified through simulated use conditions and testing against various standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device validation and verification typically involve engineering and clinical experts during the design and testing phases, but not specifically for establishing "ground truth" in the context of an AI model's performance.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for AI-assisted human reading tasks, which is not the subject of this document.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" here is compliance with engineering specifications and regulatory standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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
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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
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510(k) Summary
| Date Prepared | April 6, 2017 |
|---|---|
| Sponsor | Ventec Life Systems, Inc.19021 120th Ave. NE, Suite 101Bothell, WA 98011Tel: 425-686-1750 |
| Contact Information | Joseph CipolloneVP Quality & Regulatory19021 120th Ave. NE, Suite 101Bothell, WA 98011Tel: 909-213-3691jcipollone@venteclife.com |
| Device Proprietary Name: | VOCSN Unified Respiratory System |
| Common name | Mechanical ventilator / Oxygen concentrator / Cough assist / Suction pump |
| Primary Classification andProduct Code | Mechanical ventilator• Classification number 21 CFR 868.5895• Class II• Code: CBK - Continuous Ventilator, Facility Use |
| Subsequent Product Codesof Additional IntegratedFunctions | Mechanical ventilator• Code: NOU - Continuous Ventilator, Home UseOxygen concentrator• Code: CAW - Portable oxygen generatorCough Assist• Code: NHJ - Noncontinuous ventilator (IPPB)Suction Pump• Code: BTA - Powered suction pumpHeated Patient Circuits• Code: BZE - Heater, Breathing System, W/Wo ControllerBacteria Filter• Code: CAH - Filter, Bacterial, Breathing Circuit |
| Primary Predicate DeviceInformation: | Mechanical ventilator componentRespironics Trilogy Series Ventilator (K111610) |
| Reference Predicate DeviceInformation: | Mechanical ventilator componentCareFusion Palmtop Ventilator PTV-8 & -10 (K070594)CareFusion LTV 1200 Ventilator (K060647) |
| Oxygen concentrator componentOmni 3 (eQuinox) Oxygen System (K120785) | |
| Cough Assist componentRespironics Cough Assist T70 (K121955) | |
| Suction Pump componentPrecision Medical Easy Go Vac PM66 (K140179) | |
| Heated Patient CircuitsRespironics (Philips) Disposable Heated Wire Circuits (K110398) | |
| Bacteria FilterRespironics (Philips) Bacteria Filter PN 342077 - Supplied by KingSystems 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.
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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.
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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 intermittentventilatory support invasive and non-invasive ped through adult ≥ 5 kg home, hospital, institutionaland transport settings,including portableapplications | continuous or intermittentventilatory support invasive and non-invasive ped through adult ≥ 5 kg home, hospital, and mobileapplications. | Substantially EquivalentEquivalent except the Trilogydoes not specify transportsettings. The secondarypredicate Palmtop ventilatorspecifies transport use. |
| FDA ProductCode | 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 EquivalentEquivalentVOCSN Bi-level mode isequivalent to Trilogy (S/T)and (T) modes withappropriate settings ofpatient 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.Equivalent to secondary predicate Palmtop ventilator.Reference Tab 5, TPR-00049,TPR-00050 and TPR-00055for test results | |
| Significantbreath controlparameters | 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 blowerworking in conjunction withvalves and transducers underthe control of a microprocessorto provide breath delivery. | Conventional radial blowerworking in conjunction withvalves and transducers underthe control of a microprocessorto 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 withadditional hard keys | LCD screen with hard keys | Substantially EquivalentThe Palmtop ventilator(K070594) includes a touchscreen |
| Characteristic | VOCSN | Predicate, Trilogy (K111610) | Comparison |
| Nebulizer | Provides pneumatic drive toexternal OEM 6 L/min nebulizer | No nebulizer drive provided | Substantially EquivalentThe alternate predicatePalmtop ventilator provides apneumatic drive to anexternal OEM 6 L/minnebulizer |
| Power | AC, DC, and internal battery | AC, DC, and internal battery | Equivalent |
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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 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 oxygenconcentrator is intended for theadministration of supplementaloxygen | The administration ofsupplemental oxygen. |
| FDA ProductCode | 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 concentrationprocess. |
| User Interface | LCD touch screen withadditional 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 inconjunction with a cough assistvalve under the control of amicroprocessor | Radial blower working inconjunction with two coughassist valves under the controlof a microprocessor |
| User Interface | LCD touch screen withadditional 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 |
{14}------------------------------------------------
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) DisposableHeated Wire Circuits (K110398) |
|---|---|---|
| Operatingprinciple | Connects ventilator to patient connection. Passive circuit uses a fixed leak forexhalation 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 foruse with a humidifier. |
| Classification | Class II | Class II |
| Product Code | BZE | BZE |
| Intended use | The patient circuit is intended to be used only with theVOCSN Unified Respiratory System which is intended toprovide continuous or intermittent ventilatory support for the care ofindividuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatricthrough adult patients weighing at least 5 kg. It isintended for use in home, hospital, institutional andtransport settings, including portable applications. | Intended to provide warmed and/or humidified breathinggases before they enter the patient's airway. The disposableheated wire circuit is indicated for use by a single adult orpediatric patient in the home,hospital, and or institutional setting. It may be used for bothinvasive and non-invasive ventilation |
| Humidifiercompatibility | Fisher Paykel HC550 &MR850 humidifiers | HC500 |
| Reuseable | Single patient use | Single patient use |
| Heating mode | Applied voltage throughheating wires. | Applied voltage through heatingwires. |
| Sterility | Non-Sterile | Non-Sterile |
| Materials | Compliant with ISO 10993-1Biological Evaluation | Compliant with ISO 10993-1Biological 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 mlAdult: approx. 703 mlCompliant with ISO 5367 | Not stated, claims compliance with ISO 5367 |
| Exhalation valve type | Passive Option - fixed orifice typeActive Option - Piloted diaphragm type | Passive Option - fixed orifice typeActive Option - Piloted diaphragm type |
| Enthalpy | Per ISO 8185 | Not stated |
| Condensate performance | The VOCSN circuit was demonstrated to control condensate over a wide range of patient ventilation conditions. | Not stated. |
| ISO-5367Breathing tubes | Complies | Complies |
| ISO-8185Respiratory humidification systems | Complies as applied to breathing circuits | Complies as applied to breathing circuits |
| ISO-60601-1Medical Electrical Equipment | Complies with applicable parts as specified in ISO 8185 | Complies with applicable parts |
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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 |
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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) BacteriaFilter PN 342077 - Supplied byKing Systems under (K973797) |
|---|---|---|
| Classification | Class II | Class II |
| Product Code | CAH | CAH |
| Intended use | To be used only as part ofthe VOCSN integratedrespiratory care system toreduce bacterial/viraltransmissions between thepatient and equipment. | It is designed to reducebacterial/viral transmissionsbetween the patient andequipment. |
| Operatingprinciple | Electrostatic | Electrostatic |
| Filtrationefficiency | 99.99% BFE & VFE | 99.99% BFE & VFE |
| ApproximateVolume (ml) | 31 | 74 |
| Connectors | 22 mm conical, compliantwith ISO 5356-1 ConicalConnectors | 22 mm conical |
| Resistance @ 30lpm | 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.
§ 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).