(147 days)
Not Found
No
The document describes a physical medical device (a face mask) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections explicitly state "Not Found".
No
The device is a mask accessory for ventilators used in the treatment of respiratory conditions and obstructive sleep apnea; it does not directly provide therapy but interfaces with a therapeutic device.
No.
The device is a full face mask intended to provide a patient interface for non-invasive ventilation, acting as an accessory to ventilators. Its purpose is to deliver therapy (CPAP or positive pressure ventilation), not to diagnose a condition.
No
The device description clearly states it consists of physical components like a silicone cushion and polycarbonate faceplate, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for providing a patient interface for noninvasive ventilation. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details the physical components of the mask and its use as an accessory to ventilators. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does none of that.
The device is a medical device used in the treatment of respiratory conditions, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The small size AF531 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 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
Product codes
CBK
Device Description
The Respironics AF531 SE Full Face Mask consists of a silicone cushion, polycarbonate faceplate with a standard elbow with no exhalation, requiring the use of a separate exhalation device. This mask is an accessory for use with ventilators in the hospital/institutional environment only. The small size AF531 SE Full Face Mask will be used on patients 7 years or older (> 40 lbs/20kg).
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
7 years or older (>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)
The modified device has been performance tested with passing results. Test protocols including pressure performance, waveform performance, triggering, cycling and alarm functionality testing along with the results of these tests are provided in Tab 8 of this submission.
The small size AF531 SE Full Face Mask was performance tested and verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Respironics PerforMax SE Total Face Mask (K072588/K092648)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY OF SAFETY & EFFECTIVENE
Date of Submission
510(k) Owner
TAB 3
April 21, 2010
Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
Official Contact
Zita Yurko Director, Regulatory Affairs (724) 387-4120 (724) 882-4120 (cell) (724) 387-4216 (fax)
Anesthesiology Devices
Proprietary Name
Common/Usual Name Face mask
Class II Device Classification
Classification Panel
Product Code CBK - Continuous ventilator
Respironics PerforMax SE Total Face Mask (K072588/K092648) Predicate Devices
Respironics AF531 SE Full Face Mask
Draft labeling can be found in Tab 5 Labeling
- Modified device Reason for submission
Device Description
The Respironics AF531 SE Full Face Mask consists of a silicone cushion, polycarbonate faceplate with a standard elbow with no exhalation, requiring the use of a separate exhalation device. This mask is an accessory for use with ventilators in the hospital/institutional environment only. The small size AF531 SE Full Face Mask will be used on patients 7 years or older (> 40 lbs/20kg).
Intended Use
The small size AF531 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
1
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 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
Predicate Comparison
Comparison of the AF531 SE Full Face Mask (modified mask) with the predicate Respironics PerforMax SE Total Face Mask (K072588/K092648);
- . The intended use and the environment of use is the same. Both masks are for the hospital/institutional use only on patients 7 years or older and > 40lbs/20kg.
- Both masks contain a silicone cushion, polycarbonate faceplate and standard elbow, . requiring the use of an additional exhalation device. The same elbow is on both masks.
- . Both masks use the same headgear (Four Points Headgear design) and headgear attachment clips. The CapStrap headgear may also be used with the AF531 mask.
- The difference between the modified device and the Respironics PerforMax SE Total Face . Mask predicate is the shape of the faceplate and cushion. The modified device is a full face mask with a faceplate and cushion covering the nose and mouth, whereas the predicate device is a total face mask with a faceplate and cushion covering the nose, mouth and eyes.
The modified device has been performance tested with passing results. Test protocols including pressure performance, waveform performance, triggering, cycling and alarm functionality testing along with the results of these tests are provided in Tab 8 of this submission.
Substantial Equivalence
The AF531 SE Full Face Mask has the following similarities to the previously cleared predicate device:
- O Same intended use.
- o Same operating principle.
- D Same technology.
- D Same manufacturing process.
There is no change to the intended use, operating principle, technology or manufacturing process for the AF531 SE Full Face Mask. The small size AF531 SE Full Face Mask was performance tested
2
.
and verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.
Respironics has followed the FDA's Guidance for Industry and FDA Staff document "pre-market assessment of pediatric medical devices" and applied the principle of FDA's Least Burdensome Approach to demonstrate the Substantial Equivalence of the mask.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Respironics, Incorporated Ms. Zita A. Yurko Director, Regulatory Affairs Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
SEP 1 32010
Re: K101129
Trade/Device Name: AF531 SE Full Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 12, 2010 Received: August 18, 2010
Dear Ms. Yurko:
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.
4
Page 2- Ms. Yurko
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica]Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jm. I. D. So. A.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
· Radiological Health
Enclosure
5
Page_1_of_1
Indications for Use
K/01129
SEP 1 3 2010
510(k) Number (if known):
Device Name: AF531 SE Full Face Mask
The small size AF531 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 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devide Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101129