(232 days)
The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA).
The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg).
The Juno VPAP ST-A is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
The subject device Juno VPAP ST-A retains all the same hardware, technologies and manufacturing characteristics as previously cleared in K153061. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver a prescribed positive airway pressure treatment to patients.
Some of the kev features of the device include an in-line power supply: fully integrated humidifier: alarms module; heater controller; colour LCD and simple controls for ease of use. The device also allows data transfer/connectivity via an integrated wireless module (When used in a hospital setting, remote changes may not be appropriate for certain patients, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's regular care provider such that the desired therapy outcome is achieved).
Juno VPAP ST-A utilizes a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHJO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmH2O for the treatment respiratory insufficiency.
The therapy modes available in the Juno VPAP ST-A include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. In this subject device now features an optional "AutoEPAP" function on iVAPS mode. AutoEPAP automatically adjusts EPAP pressure (within set values) in response to flow limitations of the upper airway.
Juno VPAP ST-A is intended to be used under the conditions and purposes indicated in the labelling provided with the product.
It is a prescription device, supplied non-sterile.
The document describes the Resmed Juno VPAP ST-A device (K161492), which is an update to a previously cleared device (K153061). The key change in the subject device is the addition of an optional "AutoEPAP" function to the iVAPS therapy mode.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, suitability for market is based on demonstrating substantial equivalence to the predicate device (Juno VPAP ST-A, K153061) and demonstrating that the new AutoEPAP algorithm provides equivalent therapy to the fixed EPAP setting of the predicate.
The reported device performance is that the AutoEPAP iVAPS therapy mode was as efficacious as iVAPS with fixed EPAP in terms of several clinical metrics.
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from Clinical Data) |
|---|---|
| Equivalence in maintaining upper airway patency | AutoEPAP iVAPS was as efficacious as iVAPS with fixed EPAP. |
| Equivalence in Apnea-Hypopnea Index (AHI) | Equivalent |
| Equivalence in Oxygen Desaturation Index (ODI) | Equivalent |
| Equivalence in Blood Oxygen Saturation (SPO2) | Equivalent |
| Equivalence in Transcutaneous Carbon Dioxide (PtcCO2) | Equivalent |
| Equivalence in Sleep Quality | Equivalent |
| No serious adverse events or complications | No serious adverse events or complications related to the study device were recorded. |
| Compliance with relevant standards and specifications | The subject device meets all requirements of the Juno VPAP ST-A System Specification and complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, FDA Draft Reviewer Guidance for Ventilators, and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not explicitly stated. The document mentions "patients with respiratory insufficiency" but does not provide the number of participants.
- Data provenance: Not explicitly stated, but the study was a "clinical trial" which implies prospective data collection. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As this is a study evaluating the clinical efficacy of a ventilator mode, the "ground truth" would be established by direct physiological measurements and clinical assessments rather than expert review of images or data.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC study was not done. This device is a ventilator, not an AI-assisted diagnostic tool that would typically involve human readers interpreting data or images. The study focuses on the direct efficacy of the ventilator's automated function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical trial described appears to be a standalone performance evaluation of the AutoEPAP iVAPS algorithm. It directly compares the efficacy of the new automated algorithm with the fixed EPAP mode, which also functions automatically (without real-time human intervention during therapy delivery).
7. The Type of Ground Truth Used
The ground truth was established using physiological measurements and clinical outcomes data such as:
- Apnea-Hypopnea Index (AHI)
- Oxygen Desaturation Index (ODI)
- Blood Oxygen Saturation (SPO2)
- Transcutaneous Carbon Dioxide (PtcCO2)
- Sleep Quality (presumably based on polysomnography or other clinical assessments)
8. The Sample Size for the Training Set
The document describes a clinical trial (double-blinded, randomized, crossover study) which evaluates the performance of the implemented algorithm. It does not mention a separate "training set" in the context of an AI/machine learning model development lifecycle. The AutoEPAP algorithm would have been developed and internally validated by the manufacturer, but the specific details of its training data (if any for a machine learning component) are not provided. The clinical trial serves as the validation or test set for the device's efficacy.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" in the machine learning sense is not explicitly discussed. For the clinical trial (validation data), the ground truth was established through direct physiological measurements and clinical assessments as listed in point 7.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Resmed Ltd % Larissa D'Andrea Director, Government & Regulatory Affairs Resmed Corp. 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K161492
Trade/Device Name: Juno VPAP ST-A Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNS Dated: December 16, 2016 Received: December 19, 2016
Dear Larissa D'Andrea:
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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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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Indications for Use
510(k) Number (if known) K161492
Device Name Juno VPAP ST-A
Indications for Use (Describe)
The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA).
The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg).
The Juno VPAP ST-A is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY [As required by 21 CFR 807.92(c)]
-
- Date prepared January 13, 2017
2. Applicant information
| Company Name/Owner | ResMed Ltd1 Elizabeth Macarthur DriveBella Vista NSW 2153 Australia |
|---|---|
| Submitter Name | Mr. Jean-Nicolas BoudaudRegulatory Affairs Manager+61 2 88841000 (phone)+61 2 88842004 (fax)Jean.boudaud@resmed.com.au |
| Correspondent Details/Official Contact | Ms. Larissa D'AndreaDirector, Government & Regulatory Affairs9001 Spectrum Center BlvdSan Diego CA 92123 USA(858) 836 6837 (phone)Larissa.D'Andrea@resmed.comMr. Jean-Nicolas BoudaudRegulatory Affairs Manager+61 2 88841000 (phone)+61 2 88842004 (fax)Jean.boudaud@resmed.com.au |
3. Device details and substantial equivalence claim [807.92(a)(3)]
| Trade/Device Names | Juno VPAP ST-A |
|---|---|
| Device Common Name | Ventilator, continuous, non-life supporting |
| Regulation Number | 21 CFR §868.5895 |
| Regulation Name | Anesthesiology devices, Continuous Ventilator |
| Regulatory Class | Class II |
| Product Code | MNS |
| Predicate Device | ResMed Juno VPAP ST-A (K153061) |
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4. Device description
The subject device Juno VPAP ST-A retains all the same hardware, technologies and manufacturing characteristics as previously cleared in K153061. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver a prescribed positive airway pressure treatment to patients.
Some of the kev features of the device include an in-line power supply: fully integrated humidifier: alarms module; heater controller; colour LCD and simple controls for ease of use. The device also allows data transfer/connectivity via an integrated wireless module (When used in a hospital setting, remote changes may not be appropriate for certain patients, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's regular care provider such that the desired therapy outcome is achieved).
Juno VPAP ST-A utilizes a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHJO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmH2O for the treatment respiratory insufficiency.
The therapy modes available in the Juno VPAP ST-A include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. In this subject device now features an optional "AutoEPAP" function on iVAPS mode. AutoEPAP automatically adjusts EPAP pressure (within set values) in response to flow limitations of the upper airway.
Juno VPAP ST-A is intended to be used under the conditions and purposes indicated in the labelling provided with the product.
It is a prescription device, supplied non-sterile.
5. Indications For Use
The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA).
The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg).
The Juno VPAP ST-A is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
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Predicate comparison 6.
| Characteristics | Juno VPAP ST-A(Subject device) | Juno VPAP ST-A(Predicate device - K153061) | Comments |
|---|---|---|---|
| Intended Use | |||
| Indications for use | The Juno VPAP ST-A isindicated to providenoninvasive ventilation forpatients weighing more than30lbs (13 kg) with respiratoryinsufficiency or obstructivesleep apnoea (OSA). | The Juno VPAP ST-A isindicated to provide noninvasiveventilation for patients weighingmore than 30lbs (13 kg) withrespiratory insufficiency orobstructive sleep apnoea(OSA). | Same intended use - Equivalent |
| The iVAPS mode is indicatedfor patients weighing more than66lbs (30 kg). | The iVAPS mode is indicatedfor patients weighing more than66lbs (30 kg). | ||
| The Juno VPAP ST-A isintended for home and hospitaluse. | The Juno VPAP ST-A isintended for home and hospitaluse. | ||
| The Humidifier is intended forsingle patient use in the homeenvironment and re-use in ahospital/institutionalenvironment | The Humidifier is intended forsingle patient use in the homeenvironment and re-use in ahospital/institutionalenvironment | ||
| Environment of use | Hospital/Home | Hospital/Home | Same environment of use - Equivalent |
| Prescription status | Prescription only | Prescription only | Same prescription status - Equivalent |
| Therapies | |||
| Modes available | • CPAP• S, ST, T• PAC• iVAPS with optionalAutoEPAP | • CPAP• S, ST, T• PAC• iVAPS with fixed EPAP only | The subject device includes the same therapy modesas the predicate. An optional "AutoEPAP" function isadded on the iVAPS mode. The role of AutoEPAP is toautomatically adjust EPAP pressure (within a set min-max range) in order to maintain upper airway patency.Data is provided to demonstrate that the new algorithm |
| provides equivalent therapy to set fixed EPAP. | |||
| Equivalent | |||
| Pressure ranges | • 4-20 cmH2O (CPAP)• 3-30 cmH2O (bi-level)o AutoEPAP: 3-25 cmH2O | • 4-20 cmH2O (CPAP)• 3-30 cmH2O (bi-level)o Fixed EPAP: 3-25 cmH2O | The subject device operates within the same pressureranges as the predicate in all modes. |
| On the iVAPS (Bi-level mode), the range of adjustmentfor the new AutoEPAP feature is the same as with fixedEPAP, hence the same as the predicate. | |||
| Equivalent | |||
| Ramp settings | • User selected as “Off” to 45minutes in 5 minuteincrements• Max Ramp time set atclinician's discretion | • User selected as “Off” to 45minutes in 5 minuteincrements• Max Ramp time set atclinician's discretion | Same ramp settings - Equivalent |
| Features | |||
| Alarms module | Yes | Yes | Same integrated alarms module - Equivalent |
| Humidifier | Yes | Yes | Same integrated humidifier - Equivalent |
| Motor type | Brush-less low voltage DC | Brush-less low voltage DC | Same motor - Equivalent |
| Operating system | Microchip STM32F405ZGmicro-controller with ARM32-bitCortex™-M4 CPU | Microchip STM32F405ZGmicro-controller with ARM32-bitCortex™-M4 CPU | Same operating system - Equivalent |
| Supplemental oxygen | Labeled for use withSupplemental Oxygen | Labeled for use withSupplemental Oxygen | Same use with supplemental oxygen - Equivalent |
| Data transfer medium | • SD Card• Fully integrated wirelessmodule | • SD Card• Fully integrated wirelessmodule | Same data transfer and connectivity mediums -Equivalent |
| Hardware platform | • Gen 10 | • Gen 10 | Same hardware - Equivalent |
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7. Non Clinical data submitted
Bench test data is presented to demonstrate that the subject device meets all requirements of the Juno VPAP ST-A System Specification. For the new AutoEPAP algorithm, this includes characterization of the ventilator's response to a breathing machine that simulates patients flow limitations and apnoeas.
The Juno VPAP ST-A has also been tested to the relevant FDA consensus standards and other applicable requirements passing all test protocols. The Juno VPAP ST-A with and without the integrated heated humidifier (HumidAir) was designed and tested according to:
- . IEC 60601-1:2005+AMD1:2012, Medical electrical equipment - Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-1-8:2006, Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
The device complies with the applicable requirements referenced in the FDA quidance documents:
- FDA Draft Reviewer Guidance for Ventilators (July 1995) .
- FDA Guidance for the Content of Premarket Submissions for Software Contained in ● Medical Devices (May 11, 2005)
8. Clinical data
Clinical trial data is provided to demonstrate that the added AutoEPAP iVAPS algorithm performed as expected in maintaining upper airway patency in patients with respiratory insufficiency. The data relates to a double-blinded, randomised, crossover study comparing the efficacy of the AutoEPAP iVAPS therapy mode with the fixed EPAP iVAPS mode (as previously used on the predicate).
In patients with respiratory insufficiency, the trial demonstrated that therapy with AutoEPAP iVAPS was as efficacious as iVAPS with fixed EPAP in terms of AHI, ODI, SPO2, PtcCO2 and sleep quality.
No serious adverse events or complications related to the study device were recorded.
9. Substantial Equivalence Conclusion
This submission demonstrates that the subject device is substantially equivalent to the predicate Juno VPAP ST-A (K153061).
§ 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).