(169 days)
Not Found
No
The description details a servo-controlled system that adjusts pressure based on real-time measurements and recent averages, which is a form of automated control but does not explicitly mention or describe the use of AI or ML algorithms for learning or complex pattern recognition beyond simple averaging and feedback loops. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for the treatment of various sleep apnea conditions and delivers positive airway pressure and adaptive servo-ventilation therapy to stabilize a patient's ventilation, which classifies it as a therapeutic device.
No.
The device is indicated for the treatment of sleep apnea and periodic breathing, not for diagnosis. It provides adaptive servo-ventilation therapy to stabilize a patient's ventilation.
No
The device description explicitly states it is a "blower based positive pressure system" and includes components like a "flow generator, patient tubing, mask (patient interface) and humidifier," indicating it is a hardware device with integrated software for control.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The descriptions clearly state that these devices are "blower based positive pressure systems" designed to provide "adaptive servo-ventilation therapy (ASV)" by generating controlled positive airway pressure. They work by directly interacting with the patient's airway to treat sleep apnea and related conditions.
- Intended Use: The intended use is for the "treatment of patients" with specific sleep disorders. This is a therapeutic function, not a diagnostic one based on analyzing biological samples.
The devices described are therapeutic medical devices used to manage respiratory conditions during sleep. They do not perform in vitro testing.
N/A
Intended Use / Indications for Use
The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.
The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It 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 VPAP Adapt is indicated for the treatment of patients weighing more than 66lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The S9 VPAP Adapt is identical to the predicate device S9 VPAP Adapt (K102586), using a blower based positive pressure system with an integrated heated humidfier and heater controller. The device platform is identical to the S9 VPAP Adapt (K102586) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The S9 VPAP ADAPT is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the S9 VPAP Adapt are: CPAP mode; CPAP with EPR; Auto Servo Ventilation (ASV).
The VPAP Adapt is identical to the predicate device (K113801), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the VPAP Adapt are CPAP, ASV, and ASVAuto.
The AirCurve 10 ASV is identical to the predicate device, S9 Greenhills (K140279), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 Greenhills (K140279) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The AirCurve 10 ASV is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV mode) or (ASVAuto mode) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average minute ventilation. It then adjusts the degree of pressure support to servo-control the ventilation to at least equal the target ventilation. The same is true for ASVAuto mode except the EPAP is adjusted to address any obstructive apneas detected. Therapy modes contained in the AirCurve 10 ASV are CPAP, ASV, and ASVAuto. They are: CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session; ASV mode the device automatically adjusts pressure support in response to the patient's recent average minute ventilation; and ASVAuto mode the device automatically adjusts pressure support in response to the patient's recent average minute ventilation and EPAP level for OSA events.
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 66 lb (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)
As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device.
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.
S9 VPAP Adapt (K102586), VPAP Adapt (K113801), S9 Greenhills (K140279)
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
§ 868.5905 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
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 and Regulatory Affairs ResMed Corp 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K160822
Trade/Device Name: S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD 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. Isting 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 S9 VPAP ADAPT
Indications for Use (Describe)
The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.
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 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."
FORM FDA 3881 (8/14)
3
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 AirCurve 10 ASV
Indications for Use (Describe)
The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 Ib (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It 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)
| 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
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."
4
Indications for Use
510(k) Number (if known)
Device Name VPAP Adapt
Indications for Use (Describe)
The VPAP Adapt is indicated for the treatment of patients weighing more than 66lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use.
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 Drug 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."
5
510(k) Summary – S9 VPAP Adapt
| Required | By Section 807.92 (c) |
|---|---|
| Date Prepared | 18 March, 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 BZD |
| Class
Classification Reference
Common/Usual Name
Proprietary Name | 21 CFR 868.5905, Product Code 73 BZD
Non continuous ventilator (IPPB)
S9 VPAP Adapt |
| Predicate device(s) | S9 VPAP Adapt (K102586) |
6
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 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 S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.
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 CPAP treatment for patients with Obstructive Sleep Apnoea (OSA), central and/or mixed appeas, or periodic breathing who weigh more than 66 lb (>30 kg). The new device complicable requirements referenced in the FDA guidance documents:
- . FDA Reviewer Guidance for Premarket Notification Submissions (November 1993)
- 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 Adapt (K102586)
The new device is as safe and effective as the predicate device.
Device description
The S9 VPAP Adapt is identical to the predicate device S9 VPAP Adapt (K102586), using a blower based positive pressure system with an integrated heated humidfier and heater controller. The device platform is identical to the S9 VPAP Adapt (K102586) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmHJO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The S9 VPAP ADAPT is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures instantaneous ventilation,
7
and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the S9 VPAP Adapt are:
- . CPAP mode;
- CPAP with EPR .
- Auto Servo Ventilation (ASV) ●
Therapy modes come from the predicate S9 VPAP Adapt (K102586).
The functional characteristics of the S9 VPAP Adapt system include all the clinician and user friendly features of the predicate device.
| Characteristic | S9 VPAP Adapt (K102586) | New Device (S9 VPAP Adapt ) | Comments |
|---|---|---|---|
| Indication for | |||
| use | The S9 VPAP Adapt is indicated | ||
| for the treatment of patients | |||
| weighing more than 66 lb (30kg) | |||
| with obstructive sleep apnea | |||
| (OSA), central and/or mixed | |||
| apneas, or periodic breathing. | |||
| The S9 VPAP Adapt is intended | |||
| for home and hospital use. | The S9 VPAP Adapt is indicated | ||
| for the treatment of patients | |||
| weighing more than 66 lb (30kg) | |||
| with obstructive sleep apnea | |||
| (OSA), central and/or mixed | |||
| apneas, or periodic breathing. | |||
| The S9 VPAP Adapt is intended | |||
| for home and hospital use. | 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) | |||
| 3-25 cm H2O (ASV) | 4-20 cm H2O (CPAP) | ||
| 3-25 cm H2O (ASV) | 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 | Equivalent |
| System
Components | > Flow generator
Integrated humidifier (5i)
Mask, air tubing and heated
tubing | > Flow generator
Integrated humidifier (5i)
Mask, air tubing and heated
tubing | Equivalent |
| Power supply | 100-240V, 50-60Hz | 100-240V, 50-60Hz | Equivalent |
| Flow generator
weight | 1.7lb | 1.7lb | Equivalent |
| Dimensions H x
W x D (inches) | Flow generator unit:
3.4 x 5.5 x 6.0 | Flow generator unit:
3.4 x 5.5 x 6.0 | Equivalent |
8
| Characteristic | S9 VPAP Adapt (K102586) | New Device (S9 VPAP Adapt ) | Comments |
|---|---|---|---|
| Supplemental | |||
| oxygen | Labeled for use with | ||
| supplemental oxygen | Labeled for use with supplemental | ||
| oxygen | Equivalent |
Conclusion
The S9 VPAP Adapt is substantially equivalent to the predicate device, S9 VPAP Adapt (K102586).
9
510(k) Summary – VPAP Adapt
| Required | By Section 807.92 (c) |
|---|---|
| Date Prepared | 18 March, 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 BZD |
| Class
Classification Reference
Common/Usual Name
Proprietary Name | 21 CFR 868.5905, Product Code 73 BZD
Non continuous ventilator (IPPB)
VPAP Adapt |
| Predicate device(s) | VPAP Adapt (K113801) |
10
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 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.
Indication for Use
The VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use
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 CPAP treatment for patients with Obstructive Sleep Apnoea (OSA), central and/or mixed apneas, or periodic breathing who weigh more than 66 lb (>30 kg). The new device complicable requirements referenced in the FDA guidance documents:
- FDA Reviewer Guidance for Premarket Notification Submissions (November 1993) ●
- 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 VPAP Adapt (K113801).
The new device is as safe and effective as the predicate device.
Device Description
The VPAP Adapt is identical to the predicate device (K113801), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that qenerates controlled positive airway pressure between 3-25 cmH2O as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and
11
calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.
Therapy modes contained in the VPAP Adapt are
- СРАР .
- ASV ●
- ASVAuto .
The CPAP and ASV therapy modes come from the VPAP Adapt (K113801).
The functional characteristics of the VPAP Adapt system includes all the clinician and user friendly features of the predicate device.
| Characteristic | VPAP Adapt (K113801) | New Device (VPAP Adapt) | Comments |
|---|---|---|---|
| Indication for | |||
| use | The VPAP Adapt is indicated for | ||
| the treatment of patients | |||
| weighing more than 66 lb (30 | |||
| kg) with obstructive sleep apnea | |||
| (OSA), central and/or mixed | |||
| apneas, or periodic breathing. It | |||
| is intended for home and | |||
| hospital use. | The VPAP Adapt is indicated for | ||
| the treatment of patients weighing | |||
| more than 66 lb (30 kg) with | |||
| obstructive sleep apnea (OSA), | |||
| central and/or mixed apneas, or | |||
| periodic breathing. It is intended for | |||
| home and hospital use. | 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) | |||
| 3-25 cm H2O (ASV) | |||
| 3-25 cm H2O (ASVAuto) | 4-20 cm H2O (CPAP) | ||
| 3-25 cm H2O (ASV) | |||
| 3-25 cm H2O (ASVAuto) | 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 | Equivalent |
| System
Components | > Flow generator
Integrated humidifier (5i)
Mask, air tubing and heated
tubing | > Flow generator
Integrated humidifier (5i)
Mask, air tubing and heated
tubing | Equivalent |
| Power supply | 100-240V, 50-60Hz | 100-240V, 50-60Hz | Equivalent |
| Flow generator
weight | 1.7lb | 1.7lb | Equivalent |
| Dimensions H x
W x D (inches) | Flow generator unit:
3.4 x 5.5 x 6.0 | Flow generator unit:
3.4 x 5.5 x 6.0 | Equivalent |
| Characteristic | VPAP Adapt (K113801) | New Device (VPAP Adapt) | Comments |
| Supplemental
oxygen | Labeled for use with
supplemental oxygen | Labeled for use with supplemental
oxygen | Equivalent |
12
Conclusion
The VPAP Adapt is substantially equivalent to the predicate devices, VPAP Adapt (K113801).
13
510(k) Summary – AirCurve 10 ASV
| Required | By Section 807.92 (c) |
|---|---|
| Date Prepared | 18 March, 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 BZD |
| Class | II |
| Classification Reference | 21 CFR 868.5905, Product Code 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB) |
| Proprietary Name | AirCurve 10 ASV |
| Predicate device(s) | S9 Greenhills (K140279) |
14
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 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.
Indication for Use
The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It 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.
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 CPAP/Bilevel treatment for patients with Obstructive Sleep Apnoea (OSA), 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 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 for Industry and FDA Staff Radio Frequency Wireless Technology in Medical Devices ● - Document Issued on: August 13, 2013
- Reviewer Guidance for Premarket Notification Submissions, ARDB, CDRH, FDA, November 1993. .
As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device S9 Greenhills (K140279).
The new device is as safe and effective as the predicate device.
15
Device Description
The AirCurve 10 ASV is identica to the predicate device, S9 Greenhills (K140279), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 Greenhills (K140279) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The AirCurve 10 ASV is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV mode) or (ASVAuto mode) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average minute ventilation. It then adjusts the degree of pressure support to servo-control the patilation to at least equal the target ventilation. The same is true for ASVAuto mode except the EPAP is adjusted to address any obstructive apneas detected.
Therapy modes contained in the AirCurve 10 ASV are CPAP, ASV, and ASVAuto. They are:
- . CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session;
- ASV mode the device automatically adjusts pressure support in response to the patient's recent average . minute ventilation; and
- ASVAuto mode the device automatically adjusts pressure support in response to the patient's recent ● average minute ventilation and EPAP level for OSA events.
The functional characteristics of the AirCurve 10 ASV 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.
The functional characteristics of the system include all the clinician and user friendly features of the predicate device S9 Greenhills (K140279).
| Characteristic | S9 Greenhills (K140279) | New Device (AirCurve 10 ASV) | Comments |
|---|---|---|---|
| Indication for | |||
| use | The S9 Greenhills is indicated | ||
| for the treatment of patients | |||
| weighing more than 66 lb (30 | |||
| kg) with obstructive sleep | |||
| apnea (OSA), central and/or | |||
| mixed apneas, or periodic | |||
| breathing. It 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 AirCurve 10 ASV device is | ||
| indicated for the treatment of | |||
| patients weighing more than 66 lb | |||
| (30 kg) with obstructive sleep apnea | |||
| (OSA), central and/or mixed | |||
| apneas, or periodic breathing. It 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. | Equivalent | ||
| Marketed name change | |||
| only | |||
| Only labeling change to | |||
| include contraindication | |||
| Location of use | Hospital/Home | Hospital/Home | Equivalent |
16
| Characteristic | S9 Greenhills (K140279) | New Device (AirCurve 10 ASV) | Comments |
|---|---|---|---|
| Pressure Range and Treatment Modes | |||
| 4-20 cm H2O (CPAP) | 4-20 cm H2O (CPAP) | Equivalent: | |
| 3-25 cm H2O (ASV) | 3-25 cm H2O (ASV) | ||
| 3-25 cm H2O (ASVAuto) | 3-25 cm H2O (ASVAuto) | ||
| 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 | Equivalent | ||
| System Components | Flow generator | ||
| Humidifier | |||
| Mask, air tubing and | |||
| heated tubing | Flow generator | ||
| Humidifier | |||
| Mask, air tubing and heated | |||
| tubing | Equivalent | ||
| Power supply | 100-240V, 50-60Hz | 100-240V, 50-60Hz | Equivalent |
| Flow generator | |||
| weight | 2.5lb | 2.5lb | Equivalent |
| Dimensions H x | |||
| W x D (inches) | Flow generator unit: | ||
| 4.5 x 9.6 x 6.0 | Flow generator unit: | ||
| 4.5 x 9.6 x 6.0 | Equivalent | ||
| Supplemental | |||
| oxygen | Labeled for use with | ||
| supplemental oxygen | Labeled for use with supplemental | ||
| oxygen | Equivalent |
Conclusion
The AirCurve 10 ASV is substantially equivalent to the predicate device, S9 Greenhills (K140279).