(175 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 Juno VPAP ST-A System is a positive pressure device which design is based on the previously cleared ResMed S9 WANDA VPAP ST (K140159) platform. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver the prescribed positive pressure treatment to patients.
Some of the key features of the platform include: in-line power supply; fully integrated humidifier; heater controller; colour LCD and simple controls for ease of use. An integrated wireless module for data transfer/connectivity is also included (note: Remote changes in a hospital setting may not be appropriate, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's reqular care provider such that the desired therapy outcome is achieved).
Juno VPAP ST-A contains a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHyO 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 device also incorporates an Alarm function as a fully integrated module.
The therapy modes available in the Juno VPAP ST-A come from the predicate ResMed S9 VPAP ST-A (K113288). These include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS.
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 provided text does not contain detailed acceptance criteria or a study proving that the device meets these criteria in the manner you've requested (e.g., performance metrics, sample sizes, expert ground truth).
The document is a 510(k) summary for a medical device (Juno VPAP ST-A), which focuses on demonstrating substantial equivalence to a predicate device (ResMed S9 VPAP ST-A K113288), rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria.
The "Non Clinical data submitted" section (page 8) mentions "Bench test data is presented to demonstrate that the new device meets its published specifications and back-to-back testing shows substantial equivalence to the predicate device S9 VPAP ST-A (K113288)." It further states, "All bench tests confirmed that the product met the predetermined acceptance criteria. this included Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices."
However, this section does not provide specific numerical acceptance criteria values or the reported device performance against those criteria. It also doesn't describe an AI/ML-based device that would typically involve a "test set" with ground truth established by experts, MRMC studies, or standalone algorithm performance.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device assessment (bench testing for substantial equivalence of a continuous ventilator) than what your questions imply (e.g., an AI/ML diagnostic device).
Here's what can be inferred or stated based on the document's content, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot provide. The document states that bench tests confirmed the product met "predetermined acceptance criteria" for parameters like pressure, flow, pressure support, trigger and cycling, hypopnea, and apnea tests. However, the specific numerical acceptance criteria (e.g., "pressure within +/- X cmH2O") and the actual performance results are not detailed in this summary.
2. Sample sized used for the test set and the data provenance:
- Cannot provide. The document refers to "bench tests" and "back-to-back testing" against a predicate device. This is not a "test set" in the context of clinical data for an AI/ML device. There are no details on sample size, data provenance, or whether the data was retrospective or prospective, as this was not a clinical study involving patients for direct performance evaluation against ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a continuous ventilator, and its performance was evaluated through engineering bench tests, not clinical evaluation against expert-adjudicated ground truth as would be done for a diagnostic AI/ML system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication was described.
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:
- Not applicable. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware medical device (ventilator) with integrated software/firmware, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implied ground truth for bench testing: Engineering specifications and performance of the predicate device (S9 VPAP ST-A (K113288)). This is a "technical" ground truth, not a "clinical" one. The document states: "this included Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices."
8. The sample size for the training set:
- Not applicable. This document is for a hardware device, not an AI/ML model that undergoes a training phase with a specific dataset.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through bench testing against a predicate device's specifications and performance, rather than clinical study results of an AI/ML device against expert-established ground truth. Therefore, very little of the information typically sought for AI/ML device evaluation is available in this document.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
ResMed Ltd Larissa D'Andrea Director, Government & Regulatory Affairs 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K153061
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: March 9, 2016 Received: March 11, 2016
Dear Ms. 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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
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
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K153061
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the ResMed logo. The logo features a curved line made up of a series of dots that transition in color from blue to red. Below the line of dots is the company name, "ResMed," in a bold, sans-serif font.
Juno VPAP ST-A Traditional 510(k)
510(k) SUMMARY [As required by 21 CFR 807.92(c)]
- April 12th, 2016 1. Date prepared
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)(858) 836 5519 (fax)Larissa.D'Andrea@resmed.com |
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 S9 VPAP ST-A (K113288) |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transition in color from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.
4. Device description
The Juno VPAP ST-A System is a positive pressure device which design is based on the previously cleared ResMed S9 WANDA VPAP ST (K140159) platform. The device is used in a wider breathing circuit which typically comprises patient tubing and a mask (patient interface) to deliver the prescribed positive pressure treatment to patients.
Some of the key features of the platform include: in-line power supply; fully integrated humidifier; heater controller; colour LCD and simple controls for ease of use. An integrated wireless module for data transfer/connectivity is also included (note: Remote changes in a hospital setting may not be appropriate, as these setting changes may not be communicated to all hospital personnel treating the patient. Hospital staff should liaise with the patient's reqular care provider such that the desired therapy outcome is achieved).
Juno VPAP ST-A contains a Micro-processor controlled blower system that generates positive airway pressure (CPAP) between 4-20 cmHyO 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 device also incorporates an Alarm function as a fully integrated module.
The therapy modes available in the Juno VPAP ST-A come from the predicate ResMed S9 VPAP ST-A (K113288). These include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS.
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.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the ResMed logo. The logo consists of a series of dots that transition in color from blue to red, forming a curved line. Below the dots, the word "ResMed" is written in a bold, sans-serif font.
6. Comparison with previously cleared devices
| CharacteristicsIntended Use | Juno VPAP ST-A(new device) | S9 VPAP ST-A (K113288)Predicate device | S9 WANDA VPAP ST(K140159)Reference device only | Comments |
|---|---|---|---|---|
| Indications for use | The Juno VPAP ST-A isindicated to providenoninvasive ventilation forpatients weighing morethan 30lbs (13 kg) withrespiratory insufficiency orobstructive sleep apnoea(OSA).The iVAPS mode isindicated for patientsweighing more than 66lbs(30 kg).The Juno VPAP ST-A isintended for home andhospital use.The Humidifier is intendedfor single patient use inthe home environmentand re-use in ahospital/institutionalenvironment | The S9 VPAP ST-A isindicated to providenoninvasive ventilation forpatients weighing morethan 30lbs (13 kg) or morethan 66lbs (30 kg) iniVAPS mode withrespiratory insufficiency orobstructive sleep apnoea(OSA). The S9 VPAP ST-A is intended for homeand hospital use. | The S9 WANDA VPAPST is indicated for thetreatment of ObstructiveSleep Apnea (OSA) inpatients weighing morethan 66 lb (30 kg).It is intended for use in thehospital and home. | The new device has the sameintended use as the predicate S9VPAP ST-A (K113288).Equivalent |
| Environment of use | Hospital/Home | Hospital/Home | Hospital/Home | Equivalent |
| Prescription status | Prescription only | Prescription only | Prescription only | Equivalent |
| Therapies | ||||
| Modes available | • CPAP• S, ST, T• PAC• iVAPS | • CPAP• S, ST, T• PAC• iVAPS | • CPAP (w/o EPR mode)• S, ST, T• VAuto | The new device includes the sametherapy modes as the predicate S9VPAP ST-A (K113288).Equivalent |
| Pressure ranges | • 4-20 cmH2O (CPAP)• 3-30 cmH2O (bi-level) | • 4-20 cmH2O (CPAP)• 3-30 cmH2O (bi-level) | • 4-20 cm H2O (CPAP)• 4-25 cmH2O (VAuto)EPR + 3 cmH2O• 3-25 cmH2O (bi-level) | The new device operates in the samepressure ranges as the predicate S9VPAP ST-A (K113288).Equivalent |
| Ramp settings | • User selected as "Off"to 45 minutes in 5minute increments• Max Ramp time set atclinician's discretion | • User selected as "Off"to 45 minutes in 5minute increments• Max Ramp time set atclinician's discretion | • User selected as "Off"to 45 minutes in 5minute increments• Max Ramp time set atclinician's discretion | Equivalent |
| Features | ||||
| Alarms module | Yes | Yes | No | Both the new device and thepredicate S9 VPAP ST-A (K113288)include an Alarm module.Equivalent |
| Humidifier | Yes - HumidAir | Yes - H5i | Yes - HumidAir | The new device includes the lastgeneration humidifier that was firstused in S9 WANDA VPAP ST(K140159). The humidifier functionand performance is equivalent to thatof the predicate S9 VPAP ST-A(K113288).All humidifiers are intended for singlepatient use in the home environmentand re-use in a hospital/institutionalenvironmentEquivalent |
| Motor type | Brush-less low voltage DC | Brush-less low voltage DC | Brush-less low voltage DC | Equivalent |
| Operating system | Microchip STM32F405ZGmicro-controller withARM32-bit Cortex™-M4CPU | Micrium uC/OS-IISoftware/digital | Microchip STM32F405ZGmicro-controller withARM32-bit Cortex™-M4CPU | The new device includes an updatedmicro and CPU compared to thepredicate. Those components arecoming from S9 WANDA VPAP ST(K140159).Equivalent |
| Supplemental oxygen | Labeled for use withSupplemental Oxygen | Labeled for use withSupplemental Oxygen | Labeled for use withSupplemental Oxygen | Equivalent |
| Data transfer medium | • SD Card• Fully integratedwireless module | • SD Card• Optional wirelessmodule | • SD Card• Fully integratedwireless module | The new device and the predicateboth provide connectivity to ResMed'sECO platform (K132371) howeveraccess to ECO is provided via anoptional module on the predicatewhilst the new device includes thebuilt-in module previously cleared withS9 WANDA VPAP ST (K140159).Equivalent |
| Hardware platform | • Gen 10 | • Gen 9 | • Gen 10 | The new device reuses the S9WANDA VPAP ST (K140159)platform so that numerous hardwarecomponents are common with thispreviously cleared platform.Equivalent |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line made up of a series of dots that transition in color from blue to red. Below the line of dots is the word "ResMed" in a bold, italicized font.
Juno VPAP ST-A
Traditional 510(k)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.
Juno VPAP ST-A
Traditional 510(k)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the ResMed logo. The logo consists of a curved line made up of a series of dots that transition in color from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.
7. Non Clinical data submitted
Bench test data is presented to demonstrate that the new device meets its published specifications and back-to-back testing shows substantial equivalence to the predicate device S9 VPAP ST-A (K113288).
All bench tests confirmed that the product met the predetermined acceptance criteria. this included Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices.
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 data for the Juno VPAP ST-A is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases
9. Substantial Equivalence Conclusion
This submission demonstrates that the new Juno VPAP ST-A is substantially equivalent to the predicate S9 VPAP ST-A (K113288).
§ 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).