(191 days)
Not Found
No
The description focuses on the physical components and intended use of a respiratory mask, with no mention of AI or ML capabilities.
No
The device is a mask intended to interface with ventilators for noninvasive ventilation, specifically for the treatment of respiratory insufficiency or obstructive sleep apnea. It is an accessory to a therapeutic device (ventilator) but is not therapeutic in itself.
No
The device is a mask for administering noninvasive ventilation; it is not described as analyzing or interpreting data to diagnose a condition.
No
The device description clearly describes a physical mask with different cushion configurations and sizes, headgear, and capstrap. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is a patient interface for noninvasive ventilation, used as an accessory to ventilators. This is a device used on a patient to deliver therapy, not a device used to examine specimens from a patient to diagnose or monitor a condition.
- Device Description: The description details the physical components of a mask used for ventilation, such as cushions, frame, and headgear. This aligns with a medical device used for respiratory support, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for respiratory support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This 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 alams and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>401bs/20kg) who are appropriate candidates for noninvasive ventilation.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The AF541 SE Full Face Mask is an oral-nasal full face mask that is available in two cushion configurations. The AF541 SE Full Face has two cushion configurations, an Over the Nose (OTN) cushion and an Under the Nose (UTN) cushion. The AF541 SE Full Face Mask will have interchangeable cushions that attach to a common frame. There will be four sizes available for the over the nose option (S, M, L, XL). The UTN option will have three sizes available (A, B, C). The AF541 SE will include a 4 point headgear and capstrap to allow for oral access with either headgear option.
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
patients (>40lbs/20kg)
Intended User / Care Setting
hospital/institutional environment only.
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)
Design verification tests were performed on the AF541 SE Full Face Mask. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have not raised new safety and effectiveness concerns of the device.
Performance testing was performed before and after cleaning treatments to verify that the device modifications did not raise new safety and effectiveness concerns of the subject device. Performance testing included:
- Total Mask Pressure Drop
- Total Mask Leak
- Deadspace
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.
AF531 SE Full Face Mask (K101129)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
Respironics, Inc. Ms. Shaylee Masilunas Regulatory Affairs Engineer 1001 Murry Ridge Lane Murrysville, PA 15668
Re: K150638
Trade/Device Name: AF541 SE Full Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: August 14, 2015 Received: August 17, 2015
Dear Ms. Shaylee Masilunas:
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
1
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 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.
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
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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) K150638
Device Name AF541 SE Full Face Mask
Indications for Use (Describe)
This 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 alams and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>401bs/20kg) who are appropriate candidates for noninvasive ventilation.
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:
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (Jul) 443-6740 EB
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510(k) Summary
| Date | March 9, 2015 |
|---|---|
| 510(k) Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| (724) 387-7729 | |
| (724) 387-3999 (fax) | |
| Official Contact | Shaylee Masilunas |
| Regulatory Affairs Engineer | |
| Establishment | |
| Registration # | 2518422 |
| Proprietary Name | AF541 SE Full Face Mask |
| Common/Usual Name | Mask Accessory to a Continuous Ventilator |
| Classification Panel | Anesthesiology Devices |
| Classification | |
| Reference | 21 CFR 868.5895 |
| Classification Name / | |
| Product Code | CBK - Continuous Ventilator (Anesthesiology) |
| Predicate Device(s) | AF531 SE Full Face Mask (K101129) |
Indication for Use
The AF541 SE 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 for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
4
Device Description
The AF541 SE Full Face Mask is an oral-nasal full face mask that is available in two cushion configurations. The AF541 SE Full Face has two cushion configurations, an Over the Nose (OTN) cushion and an Under the Nose (UTN) cushion. The AF541 SE Full Face Mask will have interchangeable cushions that attach to a common frame. There will be four sizes available for the over the nose option (S, M, L, XL). The UTN option will have three sizes available (A, B, C). The AF541 SE will include a 4 point headgear and capstrap to allow for oral access with either headgear option.
Similarities and Differences of the Subject Device Compared to the Predicate Devices
The AF541 SE Full Face Mask has the following similarities to the previously cleared predicate devices AF531 SE Full Face Mask (K101129):
- Similar intended use ●
- Same operating principle ●
- Similar design ●
- Similar materials
- Similar manufacturing process
The AF541 SE Full Face Mask has the following differences in the technological characteristics to the previously cleared predicate devices AF531 SE Full Face Mask (K101129):
- Patient population ●
- Patient usage type ●
- Interchangeable cushion design
- . Mask materials
Table 1: Comparison Table of Respironics AF541 EE Full Face Mask and predicate device
| Area | Predicate Device
AF531 with Standard Elbow (SE) –
Small Size (K101129) | Subject Device
AF541 SE Full Face Mask |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The AF531 SE 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
for single use in the
hospital/institutional environment | This AF541 SE 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 for single use in
the hospital/institutional environment |
5
| Area | Predicate Device
AF531 with Standard Elbow (SE) -
Small Size (K101129) | Subject Device
AF541 SE Full Face Mask |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | only. The mask is to be used on
patients 7 years or older
(>40lbs/20kg) who are appropriate
candidates for noninvasive
ventilation. | only. The mask is to be used on
patients (>40lbs/20kg) who are
appropriate candidates for noninvasive
ventilation. |
| Patient
Population | 7 years or older (>40lbs/20kg) | Similar to K101129.
(>40lbs/20kg) |
| Patient
Usage Type /
Environment
of Use | Single use in the hospital/institutional | Unchanged from K101129. |
| Product Code | CBK | Unchanged from K101129. |
| Provided
Sterile or
Non-Sterile | Non-Sterile | Unchanged from K101129. |
| Anatomical
Sites | Nose and Mouth | Unchanged from K101129. |
| Device
Design | 1. Faceplate/frame
2. Cushion
3. Elbow
4. Headgear
5. Headgear clips | 1. Frame
2. Cushion
3. Elbow
4. Headgear
5. Headgear talon clips |
| Sizes | One size - Small | Over the Nose (OTN) version has four
sizes (S, M, L, XL)
Under the Nose (UTN) version has
three sizes (A, B, C) |
6
| Component | Primary Predicate: | Subject Device: |
|---|---|---|
| Device: | Device: | |
| AF531 SE Mask - Small Size | ||
| K101129 | AF541 SE Full Face Mask | |
| Manufacturer: | Manufacturer: | |
| Respironics, Inc. | Respironics, Inc. | |
| Cushion | Silicone | Silicone |
| Frame | Polycarbonate | Polycarbonate |
| Elbow | Polycarbonate | Polypropylene |
| Headgear/Capstrap | Nylon/Spandex, Polyurethane | |
| Foam | Nylon/Spandex, Polyurethane | |
| Foam |
Table 2: Material comparison for the Respironics AF541 SE Full Face Mask and its predicate device
New materials used in this mask are classified as external communicating, tissue contact, with a contact duration C (> 30 days cumulative). The following biocompatibility tests were completed:
- Muscle Implantation Study in Rabbits 4 Weeks ●
- Muscle Implantation Study in Rabbits 12 Weeks ●
- Genotoxicity: Bacterial Reverse Mutation Study .
- . Genotoxicity: Mouse Lymphoma Assay
- . Genotoxicity: Mouse Peripheral Blood Micronucleus Study
- . Intracutaneous Injection Test
- Kligman Maximization Test
- Agar Diffusion Test (Direct Contact)
Design verification tests were performed on the AF541 SE Full Face Mask. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have not raised new safety and effectiveness concerns of the device. In summary, the device described in this submission is substantially equivalent to the predicate device.
Clinical Tests
Clinical tests were not required to demonstrate the substantial equivalence of the AF541 SE Full Face Mask. Product functionality has been adequately assessed by non-clinical tests.
Non-Clinical Tests
Performance testing was performed before and after cleaning treatments to verify that the device modifications did not raise new safety and effectiveness concerns of the subject device. Performance testing included:
- Total Mask Pressure Drop .
- Total Mask Leak ●
7
-
. Deadspace
The AF541 SE Full Face Mask has been designed per the following standards: -
. ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories
-
. ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
-
. ISO 14971 Medical devices – Application of risk management to medical devices
Conclusion
The performance and technological characteristics of the AF541 SE Full Face Mask are substantially equivalent to those of the AF531 SE Full Face Mask (K101129) and raise no new types of safety or effectiveness questions.