(118 days)
No
The description focuses on the physical design and function of a respiratory mask, with no mention of AI or ML capabilities.
Yes
The device is intended to treat respiratory failure, respiratory insufficiency, or obstructive sleep apnea by applying noninvasive ventilation, which are therapeutic medical conditions.
No
The device is a full face mask intended to provide a patient interface for noninvasive ventilation, specifically for the application of CPAP or positive pressure ventilation. It is an accessory to ventilators, not a diagnostic tool itself.
No
The device description clearly details physical components like a silicone cushion, polycarbonate frame, and elbow, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is a physical interface used to deliver positive pressure ventilation to a patient. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for providing a patient interface for noninvasive ventilation, not for diagnostic testing.
Therefore, this device falls under the category of a medical device used for treatment/support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The mask is disposable and for single patient use. It is for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation and use in a hospital/institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask provides a seal around the nose and mouth such that pressure from a positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable headgear. The design consists of latex-free silicone cushion connected to a molded polycarbonate frame with an elbow that can swivel 360°. The elbow shall have an interconnection mating with the tubing from the positive pressure device. The interconnection shall conform to ISO 5356-1 (EN1281-1) with a 22mm female connector that can also swivel through 360°. This mask can be used to deliver positive pressure therapy to patients requiring pressures up from 3 to 40 cmH2O. This mask can be used with a range of devices that provide a low level of pressure and that have a mechanism to adequately remove exhaled gases as well as a safety valve that opens to atmosphere to provide room air in the event of loss of supply pressure. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is functionally similar to Cardinal Health Advantage Series Full Face mask (K043382) except that it does not have the anti-asphyxia or an exhalation port. Due to the fact that this is a non-vented mask, there is a need for a separate mechanism to remove exhaled gases. Reference Section 22 of this submission for a drawing of the mask.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adult patients (> 30 kg)
Intended User / Care Setting
Hospital/institutional environment
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)
THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask was tested under various conditions using the Cardinal Health design control process to evaluate design parameters. Testing included:
• Conformance to design specifications
• Interconnection to patient circuit compliant with international standards
• Environmental testing
• Dead Space
• Pressure vs. Flow
• Leak Allowance
• Cleaning
The mask passed the specified test criteria.
THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask was not subjected to human clinical studies to validate the performance of the 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.
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.
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
6081670
510(k) Summary
510(k) Summary as required by 21 CFR § 807.92
| 510(k) Submitter: | Cardinal Health 207, Inc.
Yorba Linda, CA 92887
Phone: (714) 283-8472
Fax: (714) 283-8472 | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------|
| Contact Person | Andre von Muller
phone/fax: (714) 292-9464
email: andre.vonmuller@cardinalhealth.com | | |
| Establishment
Registration
Number | 2050001 | | |
| Date prepared | June 4, 2008 | | |
| Name of the device | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask | | |
| Common/usual
name | Mask for use with ventilator (continuous, facility use) | | |
| Classification | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is classified as
a Class II device under the following classification code: | | |
| | Product
Code | CFR Section | Panel |
| | CBK | 21 CFR 868.5895 | Anesthesiology |
| Reason for the
submission | This is a new device to be marketed by Cardinal Health 207, Inc. | | |
| Substantially
equivalent device | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is substantially
equivalent to the following device:
➤ Image3 SE Disposable Full Face Mask (K023135). | | |
| | THE ADVANTAGE SERIES® Non-vented (NV) Full Face has the following
similarities to the predicate device:
➤ Same intended use
➤ Same technology | | |
| | Labeling for the predicate device to which substantial equivalence has been
claimed is included in Section 21 of this 510(k) submission. | | |
| | Device Description. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask provides a
seal around the nose and mouth such that pressure from a positive pressure
source is directed into the patient's nose and mouth. It is held in place with an
adjustable headgear. The design consists of latex-free silicone cushion
connected to a molded polycarbonate frame with an elbow that can swivel
360°. The elbow shall have an interconnection mating with the tubing from the
positive pressure device. The interconnection shall conform to ISO 5356-1
(EN1281-1) with a 22mm female connector that can also swivel through 360°.
This mask can be used to deliver positive pressure therapy to patients
requiring pressures up from 3 to 40 cmH2O. This mask can be used with a
range of devices that provide a low level of pressure and that have a | | |
K081670 Advantage Series Non-Vented (NV) Full Face Mask – Response to FDA
1
| Intended
Use/Indications for
Use | mechanism to adequately remove exhaled gases as well as a safety valve
that opens to atmosphere to provide room air in the event of loss of supply
pressure. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is
functionally similar to Cardinal Health Advantage Series Full Face mask
(K043382) except that it does not have the anti-asphyxia or an exhalation
port. Due to the fact that this is a non-vented mask, there is a need for a
separate mechanism to remove exhaled gases. Reference Section 22 of this
submission for a drawing of the mask. |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for
Use | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is intended to
provide a patient interface for application of noninvasive ventilation. The mask
is to be used as an accessory to ventilators which have adequate alarms and
safety systems for ventilator failure, and which are intended to administer
CPAP or positive pressure ventilation for treatment of respiratory failure,
respiratory insufficiency, or obstructive sleep apnea. |
| | The mask is disposable and for single patient use. It is for use on adult
patients (> 30 kg), who are appropriate candidates for noninvasive ventilation
and use in a hospital/institutional environment. |
| Comparison of
technological
characteristics
between devices. | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is functionally
similar to the Cardinal Health Advantage Series Full Face mask (K043382)
except that it does not have the anti-asphyxia or an exhalation port. It is
constructed from the same materials as the Advantage Series Full Face
Mask. |
| | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is substantially
equivalent to the Image3 SE Disposable Full Face Mask (K023135). A
comparison of the Advantage Full-Face Non-Vented (NV) Mask to the Image3
SE Disposable Full Face Mask has been provided in Section 12 of this 510(k)
submission. |
| Summary of
non-clinical
performance
testing. | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask was tested
under various conditions using the Cardinal Health design control process to
evaluate design parameters. Testing included:
• Conformance to design specifications
• Interconnection to patient circuit compliant with international standards
• Environmental testing
• Dead Space
• Pressure vs. Flow
• Leak Allowance
• Cleaning |
| | The mask passed the specified test criteria. |
| Summary of clinical
performance
experience. | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask was not
subjected to human clinical studies to validate the performance of the device. |
| Conclusion | The bench performance data of the ADVANTAGE SERIES® Non-vented (NV)
Full Face Mask, when compared to the data and/or claims made on the
predicate devices, demonstrate that the device is as safe, as effective, and
performs as well as or better than the predicate devices. The intended use of
the ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is the same as
the predicate device. No new questions of safety or effectiveness are raised. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 9 2008
Mr. Andre von Muller Senior Regulatory Affairs Engineer Cardinal Health 207, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887
Re: K081670
Trade/Device Name: ADVANTAGE SERIES® Non-vented (NV) Full Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 26, 2008 Received: September 29, 2008
Dear Mr. von Muller:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. von Muller
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. Samuels find mr forell
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ....................................................................................................................................................
Device Name: ADVANTAGE SERIES® Non-vented (NV) Full Face Mask
Indications for Use: The ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The mask is disposable and for single patient use. It is for use on adult patients (>30 kg) who are appropriate candidates for noninvasive ventilation and use in a hospital/institutional environment.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE IN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lan Aims
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K08/
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K081670 Advantage Series Non-Vented (NV) Full Face Mask -- Response to FDA