Who is the manufacturer of Juno VPAP ST-A?

Resmed, Ltd. filed the 510(k) submission for Juno VPAP ST-A (K153061).

What is the FDA product code for Juno VPAP ST-A?

MNS. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Juno VPAP ST-A?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Juno VPAP ST-A?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Juno VPAP ST-A

K153061 · Resmed, Ltd. · MNS · Apr 13, 2016 · Anesthesiology

Device Facts

Record ID	K153061
Device Name	Juno VPAP ST-A
Applicant	Resmed, Ltd.
Product Code	MNS · Anesthesiology
Decision Date	Apr 13, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Juno VPAP ST-A is a positive pressure ventilator for noninvasive ventilation. It uses a microprocessor-controlled blower to deliver CPAP (4-20 cmH2O) or bilevel pressures (3-30 cmH2O) via patient tubing and mask. Designed for home and hospital use by patients under clinician supervision. Features include integrated humidifier, color LCD, simple controls, and wireless data transfer. Therapy modes include CPAP, S, ST, T, PAC, and iVAPS. Device maintains 'air splint' for OSA or provides pressure support for respiratory insufficiency. Integrated alarm module monitors therapy. Clinicians use device output to adjust therapy settings; remote changes possible but discouraged in hospital settings without coordination. Benefits include effective treatment of respiratory conditions through controlled airway pressure.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including pressure, flow, pressure support, trigger/cycling, and apnea/hypopnea detection protocols compared against the predicate device. Compliance with IEC 60601-1, 60601-1-2, 60601-1-8, and 60601-1-11 standards confirmed.

Technological Characteristics

Positive pressure ventilator; brush-less low voltage DC motor; pressure range 3-30 cmH2O. Microchip STM32F405ZG microcontroller with ARM32-bit Cortex-M4 CPU. Integrated heated humidifier (HumidAir). Connectivity via SD card and integrated wireless module. Non-sterile. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-11.

Indications for Use

Indicated for patients >30lbs (13kg) with respiratory insufficiency or obstructive sleep apnoea (OSA). iVAPS mode indicated for patients >66lbs (30kg).

Regulatory Classification

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.

Predicate Devices

ResMed S9 VPAP ST-A (K113288)

Reference Devices

ResMed S9 WANDA VPAP ST (K140159)
ResMed ECO platform (K132371)

Related Devices

K113288 — VPAP ST-A · Resmed, Ltd. · Mar 29, 2012
K122324 — VPAP S-A · Resmed, Ltd. · Nov 13, 2012
K080131 — VPAP ST · Resmed, Ltd. · Apr 1, 2008
K033276 — VPAP III ST-A · Resmed, Ltd. · Jun 7, 2004
K140159 — S9 WANDA VPAP ST · Resmed, Ltd. · Jun 17, 2014

Submission Summary (Full Text)

{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 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) | {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 | 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 | {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).