(101 days)
Not Found
No
The device description details a servo-control system that adjusts ventilation based on a calculated target ventilation derived from recent average ventilation, which is a rule-based or algorithmic approach, not explicitly AI/ML. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The text explicitly states that the VPAP ADAPT SV, VPAP TX, and S9 VPAP Tx are intended to provide non-invasive ventilatory support to treat conditions such as obstructive sleep apnea and respiratory insufficiency. These are medical conditions, and providing therapy for them makes the device a therapeutic device.
No
The devices are described as "non-invasive ventilatory support" and "flow generator device designed to provide adaptive servo-ventilation therapy," indicating they are therapeutic devices for treating conditions like sleep apnea and respiratory insufficiency, not for diagnosing them. While they may measure ventilation to adjust therapy, their primary purpose is treatment delivery.
No
The device description explicitly states that the devices contain hardware components such as a blower, flow and pressure sensors, and processing electronics.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The descriptions of the VPAP devices clearly state they are "non-invasive ventilatory support" systems that deliver pressurized air to the patient via a mask and air tubing. They are treating the patient directly, not analyzing samples taken from the patient.
- The intended use is for treating sleep apnea and respiratory insufficiency. This is a therapeutic application, not a diagnostic one.
- The device descriptions focus on the mechanical aspects of delivering air pressure. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, these devices fall under the category of therapeutic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP TX is intended to be used in a clinical environment.
The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.
Product codes (comma separated list FDA assigned to the subject device)
MNS
Device Description
VPAP Adapt SV: The VPAP Adapt SV is identical to the predicate device VPAP Adapt SV (K051364), using a blower based positive pressure system. The device platform is identical to the VPAP Adapt SV (K051364) and contains a blower (motorfan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the VPAP Adapt SV are CPAP mode and Auto Servo Ventilation (ASV).
VPAP Tx: The VPAP Tx is identical to the predicate device VPAP Tx (K092186), using a blower based positive pressure system. The device platform is identical to the VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The VPAP Tx system comprises the flow generator, patient interface) and optional humidifier. Therapy modes contained in the VPAP Tx are: CPAP, Auto-titrating, Bi-level, VAuto, ASV.
S9 VPAP Tx: The S9 VPAP Tx is identical to the predicate device S9 VPAP Tx (K123511), using a blower based positive pressure system. The device platform is identical to the S9 VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The S9 VPAP Tx comprises the flow generator, patient interface) and optional humidifier. Therapy modes contained in the VPAP Tx are CPAP, Auto-titrating, Bi-level, VAuto, ASV.
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
VPAP Adapt SV: adult patients
VPAP Tx: patients weighing more than 66 lb (> 30 kg)
S9 VPAP Tx: CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg).
Intended User / Care Setting
VPAP Adapt SV: Hospital/Home
VPAP Tx: clinical environment, Hospital/Home
S9 VPAP Tx: clinical environment, Hospital/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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
VPAP Adapt SV (K051364), VPAP Tx (K092186), S9 VPAP Tx (K123511)
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.
Not Found
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
ResMed Ltd c/o Ms. Larissa D'andrea Director, Government Regulatory Affairs ReMed Corps 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K161487
Trade/Device Name: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNS Dated: August 10, 2016 Received: August 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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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 below.
510(k) Number (if known)
Device Name VPAP Adapt SV
Indications for Use (Describe)
The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
| 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) |
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 Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
Form Approved: OMB No. 0910-0120
510(k) Number (if known)
Device Name VPAP Tx
Indications for Use (Describe)
The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing.
The VPAP TX is intended to be used in a clinical environment.
| 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) |
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 Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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."
4
Indications for Use
510(k) Number (if known)
Device Name S9 VPAP Tx
Indications for Use (Describe)
The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.
| 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) |
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 Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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."
5
510(k) Summary – VPAP Adapt SV
| Required | By Section 807.92 (c) |
|---|---|
| Date Prepared | 18 May, 2016 |
| Owners Name | ResMed Ltd |
| 1 Elizabeth Macarthur Drive Bella | |
| Vista, NSW 2153, Australia | |
| Submitter | Jasjit Baveja |
- 61 2 8884 1518 (Phone)
- 61 2 8884 2000 (FAX)
Jasjit.baveja@resmed.com.au |
| Official Contact | Larissa D'Andrea
Director, Government & Regulatory Affairs ResMed
Corp
9001 Spectrum Center Boulevard San
Diego, CA 92123
+1 858 836 6837 (Phone)
+1 858 836 5519 (Fax)
Larissa.D'Andrea@resmed.com |
| Product codes | 73 MNS |
| Class
Classification Reference
Common/Usual Name
Proprietary Name | II
21 CFR 868.5895, Product Code 73 MNS
Ventilator, Continuous, Non-Life Supporting
VPAP Adapt SV |
| Predicate device(s) | VPAP Adapt SV (K051364) |
6
Reason for submission
This 510(k) is being submitted as a labelling change for the following contraindication:
ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
This contraindication is supported by SERVE-HF, which was a randomized, parallel, event-driven, international multicenter study in 1325 patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF≤45%) and moderate to severe predominant central sleep apnea. The study investigated the effects of adding ASV to guideline-based medical management on survival and cardiovascular outcomes. The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea.
Intended Use
The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory caused by central and/or mixed apneas and periodic breathing.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- Same intended use
- Same operating principle
- Similar technologies
- . Same manufacturing process
ResMed has determined that the new device has not altered the safety and effectiveness of providing non- invasive ventilatory support for treatment for patients with Obstructive Sleep Apnoea (OSA) and respiratory insufficiency caused by central and/or mixed apneas, and periodic breathing. The new device complies with the applicable requirements referenced in the FDA guidance documents:
- FDA Draft Reviewer Guidance for Ventilators (July 1995)
- FDA Reviewer Guidance for Premarket Notification Submissions (November 1993)
- FDA Reviewer's and Industry, Guidance for the content of premarket submissions for software contained in medical devices, May 1998
As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device VPAP Adapt SV (K051364)
The new device is as safe and effective as the predicate device.
Device description
The VPAP Adapt SV is identical to the predicate device VPAP Adapt SV (K051364), using a blower based positive pressure system. The device platform is identical to the VPAP Adapt SV (K051364) and contains a blower (motorfan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing.
The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.
7
Therapy modes contained in the VPAP Adapt SV are
- CPAP mode;
- Auto Servo Ventilation (ASV) ●
Therapy modes come from the predicate VPAP Adapt SV (K051364).
| Characteristic | VPAP Adapt SV (K051364) | New Device (VPAP Adapt SV) | Comments |
|---|---|---|---|
| Indication for | |||
| use | The VPAP ADAPT is intended to | ||
| provide non-invasive ventilatory | |||
| support to treat adult patients with | |||
| obstructive sleep apnea (OSA) | |||
| and Respiratory Insufficiency | |||
| caused by central and/or mixed | |||
| apneas and periodic breathing. | The VPAP ADAPT is intended to | ||
| provide non-invasive ventilatory | |||
| support to treat adult patients with | |||
| obstructive sleep apnea (OSA) and | |||
| Respiratory Insufficiency caused by | |||
| central and/or mixed apneas and | |||
| periodic breathing. | Equivalent | ||
| Only labeling change to | |||
| include contraindication | |||
| Location of use | Hospital/Home | Hospital/Home | Equivalent |
| Pressure Range and Treatment Modes | 4-13 cm H2O (CPAP) | ||
| 4-25 cm H2O (ASV) | 4-13 cm H2O (CPAP) | ||
| 4-25 cm H2O (ASV) | Equivalent | ||
| RAMP | |||
| Settings | Feature enables a slow | ||
| increase in the patient airflow | |||
| to allow the patient to fall | |||
| asleep before the device | |||
| delivers the full pressure; the | |||
| timer may be set to 0 – 45 | |||
| minute delay periods, in 5- | |||
| minutes increments | Feature enables a slow | ||
| increase in the patient airflow | |||
| to allow the patient to fall | |||
| asleep before the device | |||
| delivers the full pressure; the | |||
| timer may be set to 0 - 45 | |||
| minute delay periods, in 5- | |||
| minutes increments | Equivalent | ||
| Flow generator | |||
| operating system | Nucleus Plus | Nucleus Plus | Equivalent |
| Motor Type | Brush-less low voltage DC | Brush-less low voltage DC | Equivalent |
| Fan Type | Centrifugal | Centrifugal | Equivalent |
| Electronic | |||
| Controller | Servo-control loop | Servo-control loop | Equivalent |
| Power supply | 100-240V, 50-60Hz | 100-240V, 50-60Hz | Equivalent |
Conclusion
The VPAP Adapt SV is substantially equivalent to the predicate device, VPAP Adapt SV (K051364).
8
| 510(k) Summary -VPAP Tx | |
|---|---|
| Required | By Section 807.92 (c) |
| Date Prepared | 18 May, 2016 |
| Owners Name | ResMed Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153, Australia | |
| Submitter | Jasjit Baveja |
- 61 2 8884 1518 (Phone)
- 61 2 8884 2000 (FAX)
Jasjit.baveja@resmed.com.au |
| Official Contact | Larissa D'Andrea
Director, Government & Regulatory Affairs
ResMed Corp
9001 Spectrum Center Boulevard
San Diego, CA 92123
+1 858 836 6837 (Phone)
+1 858 836 5519 (Fax)
Larissa.D'Andrea@resmed.com |
| Product codes | 73 MNS |
| Class
Classification Reference
Common/Usual Name
Proprietary Name | II
21 CFR 868.5895, Product Code 73 MNS
Ventilator, Continuous, Non-Life Supporting
VPAP Tx |
| Predicate device(s) | VPAP Tx (K092186) |
9
Reason for submission
This 510(k) is being submitted as a labelling chanqe for the following contraindication:
ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
This contraindication is supported by SERVE-HF, which was a randomized, parallel, event-driven, international multicenter study in 1325 patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF≤45%) and moderate to severe predominant central sleep apnea. The study investigated the effects of adding ASV to quideline-based medical management on survival and cardiovascular outcomes. The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea.
Indication for Use
The VPAP Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kq) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP Tx is intended to be used in a clinical environment.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- Same intended use
- Same operating principle
- Similar technologies
- . Same manufacturing process
ResMed has determined that the new device has not altered the safety and effectiveness of treatment for patients with obstructive Sleep Apnoea (OSA), respiratory insufficiency central and/or mixed apneas, or periodic breathing who weigh more than 66 lb (>30 kg). The new 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)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device VPAP Tx (K092186).
The new device is as safe and effective as the predicate device.
Device Description
The VPAP Tx is identical to the predicate device VPAP Tx (K092186), using a blower based positive pressure system. The device platform is identical to the VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency.
The VPAP Tx system comprises the flow generator, patient interface) and optional humidifier.
10
Therapy modes contained in the VPAP Tx are:
- СРАР
- · Auto-titrating
- Bi-level
- VAuto
- . ASV
These modes come from the VPAP Tx (K092186).
| Characteristic | VPAP Tx (K092186) | New Device (VPAP Tx) | Comments |
|---|---|---|---|
| Indication for | |||
| use | The VPAP Tx is indicated for the | ||
| treatment of patients weighing | |||
| more than 66 lb (> 30 kg) with | |||
| obstructive sleep apnea (OSA), | |||
| respiratory insufficiency, central or | |||
| mixed apneas, or periodic | |||
| breathing. | |||
| The VPAP Tx is intended to be | |||
| used in a clinical environment. | The VPAP Tx is indicated for the | ||
| treatment of patients weighing more | |||
| than 66 lb (> 30 kg) with obstructive | |||
| sleep apnea (OSA), respiratory | |||
| insufficiency, central or mixed | |||
| apneas, or periodic breathing. | |||
| The VPAP Tx is intended to be used | |||
| in a clinical environment. | Equivalent | ||
| Only labeling change to | |||
| include contraindication | |||
| Location of use | Hospital/Home | Hospital/Home | Equivalent |
| Pressure Range and Treatment Modes | |||
| 4-20 cm H2O (CPAP) | 4-20 cm H2O (CPAP) | Equivalent: | |
| 4-20 cm H2O (Autoset) | 4-20 cm H2O (Autoset) | ||
| 3-30 cm H2O (Bilevel) | 3-30 cm H2O (Bilevel) | ||
| 4-25 cm H2O (VAuto) | |||
| 4-25 cm H2O (ASV) | 4-25 cm H2O (VAuto) | ||
| 4-25 cm H2O (ASV) | |||
| Flow generator | |||
| operating system | ResMed proprietary 'FG Engine' | ||
| using Diamond architecture | ResMed proprietary 'FG Engine' | ||
| using Diamond architecture | Equivalent | ||
| Motor Type | Brush-less low voltage DC | Brush-less low voltage DC | Equivalent |
| Fan Type | Centrifugal | Centrifugal | Equivalent |
| Electronic | |||
| Controller | Servo-control loop | Servo-control loop | Equivalent |
| Power supply | 100-240V, 50-60Hz | 100-240V, 50-60Hz | Equivalent |
Conclusion
The VPAP Tx is substantially equivalent to the predicate device, VPAP Tx (K092186).
11
510(k) Summary – S9 VPAP Tx
| Required | By Section 807.92 (c) |
|---|---|
| Date Prepared | 18 May, 2016 |
| Owners Name | ResMed Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153, Australia | |
| Submitter | Jasjit Baveja |
- 61 2 8884 1518 (Phone)
- 61 2 8884 2000 (FAX)
Jasjit.baveja@resmed.com.au |
| Official Contact | Larissa D'Andrea
Director, Government & Requlatory Affairs
ResMed Corp
9001 Spectrum Center Boulevard
San Diego, CA 92123
+1 858 836 6837 (Phone)
+1 858 836 5519 (Fax)
Larissa.D'Andrea@resmed.com |
| Product codes | 73 MNS |
| Class
Classification Reference
Common/Usual Name
Proprietary Name |
21 CFR 868.5895, Product Code 73 MNS
Ventilator, Continuous, Non-Life Supporting
S9 VPAP Tx |
| Predicate device(s) | S9 VPAP Tx (K123511) |
12
Reason for submission
This 510(k) is being submitted as a labelling change for the following contraindication:
ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
This contraindication is supported by SERVE-HF, which was a randomized, parallel, event-driven, international multicenter study in 1325 patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF≤45%) and moderate to severe predominant central sleep apnea. The study investigated the effects of adding ASV to quideline-based medical management on survival and cardiovascular outcomes. The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea.
Indication for Use
The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg).
The S9 VPAP Tx is intended to be used in a clinical environment.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- Same intended use ●
- Same operating principle
- . Similar technologies
- Same manufacturing process
ResMed has determined that the new device has not altered the safety and effectiveness of treatment for patients with Obstructive Sleep Apnoea (OSA), central and/or mixed apneas, or periodic breathing who weigh more than 66 lb (>30 kq).
The new device complies with the applicable requirements referenced in the FDA guidance 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)
As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device S9 VPAP Tx (K123511).
The new device is as safe and effective as the predicate device.
Device Description
The S9 VPAP Tx is identical to the predicate device S9 VPAP Tx (K123511), using a blower based positive pressure system. The device platform is identical to the S9 VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency.
The S9 VPAP Tx comprises the flow generator, patient interface) and optional humidifier.
Therapy modes contained in the VPAP Tx are
- . СРАР
- . Auto-titrating
- o Bi-level
- o VAuto
- ASV
These modes come from the S9 VPAP Tx (K123511).
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| Characteristic | S9 VPAP Tx (K123511) | New Device (S9 VPAP Tx) | Comments |
|---|---|---|---|
| Indication for | |||
| use | The S9 VPAP Tx is indicated | ||
| for the treatment and titration of | |||
| patients with obstructive sleep | |||
| apnea (OSA), respiratory | |||
| insufficiency, central or mixed | |||
| apneas, or periodic breathing. | |||
| CPAP, S, ST, T and PAC | |||
| modes are indicated for | |||
| patients weighing more than | |||
| 30lb (13 kg); all other modes | |||
| are indicated for patients | |||
| weighing more than 66lb (30 | |||
| kg). | |||
| The S9 VPAP Tx is intended to | |||
| be used in a clinical | |||
| environment. | The S9 VPAP Tx is indicated for | ||
| the treatment and titration of | |||
| patients with obstructive sleep | |||
| apnea (OSA), respiratory | |||
| insufficiency, central or mixed | |||
| apneas, or periodic breathing. | |||
| CPAP, S, ST, T and PAC modes | |||
| are indicated for patients | |||
| weighing more than 30lb (13 kg); | |||
| all other modes are indicated for | |||
| patients weighing more than | |||
| 66lb (30 kg). | |||
| The S9 VPAP Tx is intended to | |||
| be used in a clinical | |||
| environment. | Equivalent | ||
| Only labeling change | |||
| to include | |||
| contraindication | |||
| Location of use | Hospital/Home | Hospital/Home | Equivalent |
| Pressure Range and Treatment Modes | 4-20 cm H2O (CPAP) | ||
| 3-30 cm H2O (Bi-level) | |||
| 3-25 cm H2O (VAuto) | |||
| 3-30 cm H2O (ASV) | |||
| 3-30 cm H2O (ASVAuto) | 4-20 cm H2O (CPAP) | ||
| 3-30 cm H2O (Bi-level) | |||
| 3-25 cm H2O (VAuto) | |||
| 3-30 cm H2O (ASV) | |||
| 3-30 cm H2O (ASVAuto) | Equivalent: | ||
| Flow generator | |||
| operating system | Micrium uC/OS-II Software/digital | Micrium uC/OS-II Software/digital | Equivalent |
| Motor Type | Brush-less low voltage DC | Brush-less low voltage DC | Equivalent |
| Fan Type | Multiple impeller axial motor | Multiple impeller axial motor | Equivalent |
| Electronic Controller | Servo-control loop | Servo-control loop | Equivalent |
| Power supply | 100-240V, 50-60Hz | 100-240V, 50-60Hz | Equivalent |
Conclusion
The S9 VPAP Tx is substantially equivalent to the predicate device, S9 VPAP Tx (K123511).