(146 days)
No
The description focuses on standard microprocessor-controlled blower systems and therapy modes, with no mention of AI or ML algorithms for decision-making or adaptation beyond pre-defined rules. The performance studies rely on bench testing and comparison to a predicate device with unchanged treatment algorithms.
Yes
The device is indicated for the treatment of Obstructive Sleep Apnea (OSA), which is a medical condition, and it delivers Continuous Positive Airway Pressure (CPAP) to maintain an "air splint" for treatment. This indicates it is a therapeutic device designed to directly treat a medical condition.
No
The device is indicated for the treatment of Obstructive Sleep Apnea (OSA) by generating Continuous Positive Airway Pressure (CPAP) to maintain an "air splint." It does not mention any function for diagnosing OSA.
No
The device description explicitly lists hardware components such as an inline power supply, integrated humidifier, tubing, color LCD, controls, and a micro-processor controlled blower system. It is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea (OSA) by providing positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a system that generates and delivers air pressure to the patient's airway. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies described are bench tests simulating breathing patterns and verifying the device's ability to deliver the intended therapy. There is no mention of studies involving the analysis of biological samples or diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to treat a condition by providing mechanical support to the airway.
N/A
Intended Use / Indications for 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.
Product codes
73 BZD, BZD
Device Description
S9 WANDA VPAP ST System is similar to the predicate device (S9 VPAP ST (K102513)). Key features include: inline power supply; integrated humidifier; tubing; colour LCD; and simple controls. The S9 WANDA VPAP ST contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 3-25 cmHzO as required to maintain an "air splint" for treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The S9 WANDA VPAP ST flow generator includes the same therapy modes as the S9 VPAP ST system (K102513) predicate device. These base therapy modes include:
- CPAP and CPAP with expiratory pressure relief (EPR) modes the device delivers a continuous positive airway pressure throughout the therapy session
- Bilevel mode the flow generator augments any breath initiated by the patient by detecting the onset of inspiration or expiration and delivering the set Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP)
- VAuto mode - the mean air-way pressure (between IPAP and EPAP) will alter based upon breathing events
The functional characteristics of the S9 WANDA VPAP ST system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.
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
Not Found
Intended User / Care Setting
hospital and home.
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
Bench testing included testing the performance of each therapy mode which included:
- Pressure stability
- Response to apneas
- Response to flow limitations and snore.
- Reporting of Closed Airway Detection (CAD)
A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding to provide the therapy mode pressure. The clinical Pass/Fail requirements are traced to the S9 WANDA VPAP ST System Specification and to the predicate device's performance.
Summary of Performance Studies
Bench testing alone is sufficient to demonstrate Substantial Equivalence. Treatment algorithms remain unchanged from the predicate device (K102513).
Side-by-Side bench testing was performed to verify that the S9 WANDA VPAP ST met the requirements of the S9 WANDA VPAP ST System Specification, and compare the results to the predicate device [(S9 VPAP ST (K102513)].
This bench testing included testing the performance of each therapy mode which included:
- Pressure stability
- Response to apneas
- Response to flow limitations and snore.
- Reporting of Closed Airway Detection (CAD)
A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding to provide the therapy mode pressure. The clinical Pass/Fail requirements are traced to the S9 WANDA VPAP ST System Specification and to the predicate device's performance.
This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST.
Humidifier output for more than 8 hours 12.0mg/L @ 20cm H2O (50 L/min). The difference is not clinically significant and acceptance criteria was met (refer to bench testing (section 18)).
Key Metrics
Not Found
Predicate Device(s)
S9 VPAP ST (K102513)
Reference Device(s)
EasyCare Online (K132371)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
JUN 1 7 2014
510(k) Summary - S9 WANDA VPAP ST
Required By section 807.92 (c)
16th June, 2014
Date Prepared Owners Name
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista, NSW 2153, Australia Submitter Greg Dockar + 61 2 8884 2157 (Phone) + 61 2 8884 2004 (FAX)
Official Contact
Mr Jim Cassi - Vice President - Quality Assurance Americas ResMed Corp.
9001 Spectrum Center Boulevard,
San Diego, CA 92123
- 1 (858) 836 6081 (Phone)
+1 (858) 836 5519 (FAX)
Classification Reference
(21 CFR 868.5905 Product code 73 BZD)
Product Code 73 BZD
Class ll
Common/Usual Name
Non continuous ventilator (IPPB).
Proprietary Name S9 WANDA VPAP ST
Predicate Device(s)
S9 VPAP ST (K102513)
Reason for submission
New Device
1
Indication for 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.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device ((S9 VPAP ST (K102513)),
- Same intended use .
- Same operating principle .
- . Similar technologies
- Same manufacturing process .
The S9 WANDA VPAP ST retains the same operating/technologies/manufacturing characteristics cleared in the S9 VPAP ST (K102513). The main differences between the S9 WANDA VPAP ST and the predicate device (S9 VPAP ST) include: the interface of the flow generator with the humidifier: updated operating system: minor material changes; and the addition of wireless data transfer.
Design and Verification activities were performed on the S9 WANDA VPAP ST device as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. The S9 WANDA VPAP ST complies with the applicable requirements referenced in the FDA guidance documents:
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- FDA Draft Guidance for Industry and FDA Staff Design Considerations for Devices Intended for Home . Use - Document Issued on: December 12, 2012
- FDA Draft Guidance document "Radio Frequency Wireless Technology in Medical Devices Guidance for . Industry and Food and Drug Administration Staff" - Document Issued on: August 13, 2013
- Reviewer Guidance for Premarket Notification Submissions, ARDB, CDRH, FDA, November 1993. .
Clinical Testing
Bench testing alone is sufficient to demonstrate Substantial Equivalence. Treatment algorithms remain unchanged from the predicate device (K102513).
Non-Clinical Testing
Side-by-Side bench testing was performed to verify that the S9 WANDA VPAP ST met the requirements of the S9 WANDA VPAP ST System Specification, and compare the results to the predicate device [(S9 VPAP ST (K102513)].
This bench testing included testing the performance of each therapy mode which included:
- . Pressure stability
- Response to apneas �
- Response to flow limitations and snore. .
- Reporting of Closed Airway Detection (CAD) ●
A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding to provide the therapy mode pressure. The clinical Pass/Fail requirements are traced to the S9 WANDA VPAP ST System Specification and to the predicate device's performance.
This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST
2
Standards Testing
The S9 WANDA VPAP ST has been tested to appropriate standards and other applicable requirements. TThe S9 WANDA VPAP ST with integrated heated humidifier was designed and tested according to:
- IEC 60601-1:2005. Medical electrical equipment Part 1: General requirements for safety Medical . electrical equipment - General requirements for basic safety and essential performance
- IEC 60601-1-11 Edition 1.0: 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. (General)
- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 62304:2006 Medical device software Software life cycle processes ●
- IEC 62366:2007 Medical devices Application of usability engineering to medical devices .
- ISO 8185:2007 Respiratory tract humidifiers for medical use -- Particular requirements for . respiratory humidification systems
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the . risk management process
Biocompatibility Testing
Materials used in the construction of components that contact the heated humidified gas pathway are classified as permanent "external communicating devices" (with tissue/bone/dentin). The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1 were:
- ISO 10993-3 Genotoxicity, .
- ISO 10993-5 Cytotoxicity, ●
- ISO 10993-6 Implantation and .
- · ISO 10993-10 Sensitization & Irritation.
Testing for particulate matter and volatiles demonstrated compliance to EPA requirements.
Device Description
S9 WANDA VPAP ST System is similar to the predicate device (S9 VPAP ST (K102513)). Key features include: inline power supply; integrated humidifier; tubing; colour LCD; and simple controls. The S9 WANDA VPAP ST contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 3-25 cmHzO as required to maintain an "air splint" for treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The S9 WANDA VPAP ST flow generator includes the same therapy modes as the S9 VPAP ST system (K102513) predicate device. These base therapy modes include:
- CPAP and CPAP with expiratory pressure relief (EPR) modes the device delivers a continuous positive . airway pressure throughout the therapy session
- Bilevel mode the flow generator augments any breath initiated by the patient by detecting the onset of . inspiration or expiration and delivering the set Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP)
- . VAuto mode - the mean air-way pressure (between IPAP and EPAP) will alter based upon breathing events
The functional characteristics of the S9 WANDA VPAP ST system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.
3
Characteristics (differences) between predicate and new device
| Characteristic | Predicate S9 VPAP ST (K102513) | New Device (S9 WANDA VPAP ST) | Comments |
|---|---|---|---|
| Indication for use | The S9 VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The S9 VPAP ST is intended for use in the hospital and home. | 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. | Equivalent |
| Simplified - Intent of IFU remains unchanged | |||
| Performance | |||
| Flow Generator operating system/controller | Micrium uC/OS-II | ||
| Software/digital | Microchip: | ||
| STM32F405ZG micro-controller with ARM 32-bit Cortex™-M4 CPU | |||
| Software/digital | Equivalent: | ||
| Updated micro in line with latest technologies for micro-controller chip-sets and CPU appropriate for processing power needed for this device. | |||
| Flow generator weight | 1.7lb | 2.5lb | Equivalent |
| Includes humidifier internal to the Flow Generator (combined weight of humidifier and flow generator) | |||
| Dimensions H x W x D (inches) | Flow generator unit: | ||
| 3.4 x 5.5 x 6.0 | Flow generator unit: | ||
| 4.5 x 9.6 x 6.0 | Equivalent | ||
| Accounts for inclusion of the humidifier with larger width | |||
| Data transfer medium | SD Card | SD Card | |
| Wireless | Equivalent: | ||
| Wireless data transfer is equivalent to EasyCare Online (K132371). EasyCare Online is indicated for compatibility with ResMed therapy devices |
「
Flow Generator comparison
| Characteristic | Predicate S9 VPAP ST with H5i (K102513) | S9 WANDA VPAP ST Humidifier | Comments |
|---|---|---|---|
| Indication for use | Indicated for the | ||
| humidification of the air | |||
| delivered from ResMed | |||
| compatible CPAP therapy | |||
| devices | — | Equivalent: | |
| Humidifier is completely | |||
| integrated- separate manual is | |||
| no longer required. Relevant | |||
| information is included in the | |||
| User Guide. Refer to Appendix I | |||
| Humidifier Performance | |||
| Humidifier output for | |||
| more than 8 hours | 12.7mg/L @ 20cm H2O (50 | ||
| L/min) | 12.0mg/L @ 20cm H2O (50 | ||
| L/min) | Equivalent: | ||
| The difference is not clinically | |||
| significant and acceptance criteria | |||
| was met (refer to bench testing | |||
| (section 18)). | |||
| Size | 96 mm (H) x 145 mm (W) x | ||
| 153 mm (L) | N/A | Equivalent | |
| Humidifier is now internal to the | |||
| Therapy Device | |||
| Weight | 0.55 kg (including Docking | ||
| station) | N/A | Equivalent | |
| Humidifier is now internal to the | |||
| Therapy Device |
The differences between the predicate [(S9 VPAP ST (K102513)] and S9 WANDA VPAP ST does not raise new questions of safety or effectiveness. .
.
4
Conclusion
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- September 19.
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The S9 WANDA VPAP ST is substantially equivalent to the predicate device [(S9 VPAP ST (K102513)].
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5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement around the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
June 17, 2014
ResMed Ltd. Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Blvd. San Diego, CA 92123
Re: K140159
Trade/Device Name: S9 WANDA VPAP ST Regulation Number: 21 CFR 868.5905 Regulation Name: Non Continuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 6, 2014 Received: May 12, 2014
Dear Mr. Cassi:
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.
6
Page 2 - Mr. Cassi
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Teiashri Purohit-Sheth, M.D. Clinical Deputy Director
..
Teiashri Purohit-Sheth, M.D. 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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name S9 WANDA VPAP ST
Indications for Use (Describe)
The S9 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apies (OSA) in patients weighing more than 66 Ib (30 kg). It is intended for use in the hospital and home.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | ||
|---|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | ||
| Anya C. Harry -S | ||
| 2014.06.16 | ||
| 21:57:14 -04'00' | ||
| FORM FDA 3881 (1/14) | Page 1 of 2 | PSC Publishing Services (301) 443-6740 |
8
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