(175 days)
ResMed S9 VPAP ST-A (K113288)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard positive pressure ventilation technology and a microprocessor-controlled blower system, without mentioning any AI/ML components or algorithms.
Yes.
The device's intended use is to provide noninvasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea, indicating it is used for medical treatment.
No
The device is a positive pressure device for treatment of respiratory insufficiency or obstructive sleep apnea, not for diagnosis.
No
The device description clearly outlines hardware components such as a blower system, integrated humidifier, heater controller, LCD, and wireless module, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Juno VPAP ST-A is a positive pressure ventilation device. It delivers air pressure to a patient's airway to assist with breathing. This is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is to provide noninvasive ventilation for patients with respiratory insufficiency or obstructive sleep apnoea (OSA). This is a treatment, not a diagnostic test.
- Device Description: The description details a blower system, pressure delivery, and therapy modes. These are all related to providing respiratory support, not analyzing biological samples.
The text does not mention any analysis of biological samples or diagnostic testing. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNS
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.
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
patients weighing more than 30lbs (13 kg)
patients weighing more than 66lbs (30 kg)
Intended User / Care Setting
home and hospital use
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)
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.
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.
ResMed S9 VPAP ST-A (K113288)
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.
S9 WANDA VPAP ST (K140159)
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
§ 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).
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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
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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)
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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 Ltd
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153 Australia |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name | Mr. Jean-Nicolas Boudaud
Regulatory Affairs Manager
+61 2 88841000 (phone)
+61 2 88842004 (fax)
Jean.boudaud@resmed.com.au |
| Correspondent Details/
Official Contact | Ms. Larissa D'Andrea
Director, Government & Regulatory Affairs
9001 Spectrum Center Blvd
San 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) |
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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.
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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
| Characteristics
Intended 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 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 S9 VPAP ST-A is
indicated to provide
noninvasive ventilation for
patients weighing more
than 30lbs (13 kg) or more
than 66lbs (30 kg) in
iVAPS mode with
respiratory insufficiency or
obstructive sleep apnoea
(OSA). The S9 VPAP ST-
A is intended for home
and hospital use. | The S9 WANDA VPAP
ST is indicated for the
treatment of Obstructive
Sleep Apnea (OSA) in
patients weighing more
than 66 lb (30 kg).
It is intended for use in the
hospital and home. | The new device has the same
intended use as the predicate S9
VPAP 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 same
therapy modes as the predicate S9
VPAP 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 same
pressure ranges as the predicate S9
VPAP ST-A (K113288).
Equivalent |
| Ramp settings | • User selected as "Off"
to 45 minutes in 5
minute increments
• Max Ramp time set at
clinician's discretion | • User selected as "Off"
to 45 minutes in 5
minute increments
• Max Ramp time set at
clinician's discretion | • User selected as "Off"
to 45 minutes in 5
minute increments
• Max Ramp time set at
clinician's discretion | Equivalent |
| Features | | | | |
| Alarms module | Yes | Yes | No | Both the new device and the
predicate S9 VPAP ST-A (K113288)
include an Alarm module.
Equivalent |
| Humidifier | Yes - HumidAir | Yes - H5i | Yes - HumidAir | The new device includes the last
generation humidifier that was first
used in S9 WANDA VPAP ST
(K140159). The humidifier function
and performance is equivalent to that
of the predicate S9 VPAP ST-A
(K113288).
All humidifiers are intended for single
patient use in the home environment
and re-use in a hospital/institutional
environment
Equivalent |
| | | | | |
| Motor type | Brush-less low voltage DC | Brush-less low voltage DC | Brush-less low voltage DC | Equivalent |
| Operating system | Microchip STM32F405ZG
micro-controller with
ARM32-bit Cortex™-M4
CPU | Micrium uC/OS-II
Software/digital | Microchip STM32F405ZG
micro-controller with
ARM32-bit Cortex™-M4
CPU | The new device includes an updated
micro and CPU compared to the
predicate. Those components are
coming from S9 WANDA VPAP ST
(K140159).
Equivalent |
| Supplemental oxygen | Labeled for use with
Supplemental Oxygen | Labeled for use with
Supplemental Oxygen | Labeled for use with
Supplemental Oxygen | Equivalent |
| Data transfer medium | • SD Card
• Fully integrated
wireless module | • SD Card
• Optional wireless
module | • SD Card
• Fully integrated
wireless module | The new device and the predicate
both provide connectivity to ResMed's
ECO platform (K132371) however
access to ECO is provided via an
optional module on the predicate
whilst the new device includes the
built-in module previously cleared with
S9 WANDA VPAP ST (K140159).
Equivalent |
| Hardware platform | • Gen 10 | • Gen 9 | • Gen 10 | The new device reuses the S9
WANDA VPAP ST (K140159)
platform so that numerous hardware
components are common with this
previously cleared platform.
Equivalent |
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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)
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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)
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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).