(118 days)
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.
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.
The provided text describes a 510(k) submission for a medical device, the ADVANTAGE SERIES® Non-vented (NV) Full Face Mask. The submission focuses on its substantial equivalence to predicate devices and results from non-clinical performance testing.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Conformance to design specifications | Passed the specified test criteria. |
| Interconnection to patient circuit compliant with international standards | Passed the specified test criteria. |
| Environmental testing | Passed the specified test criteria. |
| Dead Space | Passed the specified test criteria. |
| Pressure vs. Flow | Passed the specified test criteria. |
| Leak Allowance | Passed the specified test criteria. |
| Cleaning | Passed the specified test criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for each test conducted during the "non-clinical performance testing." It only states that the device "was tested under various conditions using the Cardinal Health design control process." The data provenance is internal to Cardinal Health, and it is a retrospective evaluation of the device's design parameters through bench testing, not involving human subjects or real-world data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The non-clinical performance testing appears to be objective bench testing against established specifications and international standards (e.g., ISO 5356-1 for interconnection). Therefore, "ground truth" in the traditional sense (e.g., expert consensus on medical images) is not applicable here. The "ground truth" would be the successful adherence to engineering specifications and performance benchmarks.
4. Adjudication Method for the Test Set
This information is not applicable as the testing described is non-clinical performance testing against objective criteria, not a subjective evaluation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical medical mask, not an AI-powered diagnostic or assistive technology. The study described is bench testing of the mask's physical performance characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical mask for non-invasive ventilation, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance testing was based on established design specifications, international standards (e.g., ISO 5356-1), and pre-defined test criteria for physical device performance.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The "design control process" refers to the engineering and development process, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
{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 92887Phone: (714) 283-8472Fax: (714) 283-8472 | ||
|---|---|---|---|
| Contact Person | Andre von Mullerphone/fax: (714) 292-9464email: andre.vonmuller@cardinalhealth.com | ||
| EstablishmentRegistrationNumber | 2050001 | ||
| Date prepared | June 4, 2008 | ||
| Name of the device | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask | ||
| Common/usualname | Mask for use with ventilator (continuous, facility use) | ||
| Classification | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is classified asa Class II device under the following classification code: | ||
| ProductCode | CFR Section | Panel | |
| CBK | 21 CFR 868.5895 | Anesthesiology | |
| Reason for thesubmission | This is a new device to be marketed by Cardinal Health 207, Inc. | ||
| Substantiallyequivalent device | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is substantiallyequivalent to the following device:➤ Image3 SE Disposable Full Face Mask (K023135). | ||
| THE ADVANTAGE SERIES® Non-vented (NV) Full Face has the followingsimilarities to the predicate device:➤ Same intended use➤ Same technology | |||
| Labeling for the predicate device to which substantial equivalence has beenclaimed is included in Section 21 of this 510(k) submission. | |||
| Device Description. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask provides aseal around the nose and mouth such that pressure from a positive pressuresource is directed into the patient's nose and mouth. It is held in place with anadjustable headgear. The design consists of latex-free silicone cushionconnected to a molded polycarbonate frame with an elbow that can swivel360°. The elbow shall have an interconnection mating with the tubing from thepositive 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 patientsrequiring pressures up from 3 to 40 cmH2O. This mask can be used with arange 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}------------------------------------------------
| IntendedUse/Indications forUse | mechanism to adequately remove exhaled gases as well as a safety valvethat opens to atmosphere to provide room air in the event of loss of supplypressure. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask isfunctionally similar to Cardinal Health Advantage Series Full Face mask(K043382) except that it does not have the anti-asphyxia or an exhalationport. Due to the fact that this is a non-vented mask, there is a need for aseparate mechanism to remove exhaled gases. Reference Section 22 of thissubmission for a drawing of the mask. |
|---|---|
| IntendedUse/Indications forUse | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is intended toprovide a patient interface for application of noninvasive ventilation. The maskis to be used as an accessory to ventilators which have adequate alarms andsafety systems for ventilator failure, and which are intended to administerCPAP 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 adultpatients (> 30 kg), who are appropriate candidates for noninvasive ventilationand use in a hospital/institutional environment. | |
| Comparison oftechnologicalcharacteristicsbetween devices. | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is functionallysimilar to the Cardinal Health Advantage Series Full Face mask (K043382)except that it does not have the anti-asphyxia or an exhalation port. It isconstructed from the same materials as the Advantage Series Full FaceMask. |
| THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is substantiallyequivalent to the Image3 SE Disposable Full Face Mask (K023135). Acomparison of the Advantage Full-Face Non-Vented (NV) Mask to the Image3SE Disposable Full Face Mask has been provided in Section 12 of this 510(k)submission. | |
| Summary ofnon-clinicalperformancetesting. | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask was testedunder various conditions using the Cardinal Health design control process toevaluate 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 clinicalperformanceexperience. | THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask was notsubjected 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 thepredicate devices, demonstrate that the device is as safe, as effective, andperforms as well as or better than the predicate devices. The intended use ofthe ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is the same asthe 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/
Page 1 of 1
K081670 Advantage Series Non-Vented (NV) Full Face Mask -- Response to FDA
§ 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).