(130 days)
No
The 510(k) summary describes a physical mask and its components for noninvasive ventilation, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to treat respiratory failure, respiratory insufficiency, or obstructive sleep apnea by providing a patient interface for noninvasive ventilation, which are therapeutic applications.
No
The device is a noninvasive ventilation mask, which interfaces with a ventilator to deliver positive pressure. Its purpose is to facilitate the application of therapy, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a faceplate, silicone seal, elbow, and headgear, indicating it is a hardware device.
Based on the provided information, 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 PerforMax Pediatric SE Total Face Mask is a patient interface used to deliver noninvasive ventilation. It is a physical device that connects a patient to a ventilator.
- Intended Use: The intended use is to provide a patient interface for the application of noninvasive ventilation, not to analyze biological samples.
- Device Description: The description details the physical components of the mask and its function in delivering positive pressure, not any analytical or diagnostic capabilities.
The device is a medical device, specifically a respiratory accessory, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PerforMax Pediatric SE Total 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 for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.
Product codes
CBK
Device Description
The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation when 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. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable bonnet headgear. It may be cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical highlevel disinfection process for multi-patient use.
The PerforMax Pediatric SE Total Face Mask consists of a faceplate with a bonded silicone seal for the face. A 22 mm standard elbow is connected to the elbow hub on the faceplate. The 22 mm elbow is used to connect a conventional air delivery hose between the mask and the positive airway pressure source. The bonnet headgear is connected to the mask through slots in the upper part of the frame and clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.
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
1 year or older (> 7 kg)
Intended User / Care Setting
Professional in the 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)
To demonstrate performance and functionality was unaffected as a result of these changes, extensive performance testing was completed. Testing was performed pre and post hospital/institutional cleaning and disinfection treatments. Additionally, the mask was tested for high level disinfection in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" -FDA CDRH, January 3, 2000. All patient contacting or gas path materials used in the mask have been previously cleared by the FDA or evaluated in accordance with the guidance provided by ISO 10993-1. Results from this testing demonstrate that the PerforMax Pediatric SE Total Face its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Respironics PerforMax Youth SE Total Face Mask (K092648), Respironics Small Child Profile Lite Nasal Mask (K093416)
Reference Device(s)
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
| TAB 5 | |
|---|---|
| 510(K) SUMMARY | K120639 |
| Date of Submission | 29 February 2012 |
| 510(k) Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| (724) 387-4146 | |
| (724) 387-3999 (fax) | |
| Official Contact | Michelle Brinker |
| Regulatory Affairs Manager, Patient Interface | |
| Proprietary Name | PerforMax Pediatric SE Total Face Mask |
| Common/Usual Name | Face Mask |
| Classification Name / | |
| Product Code | CBK - Ventilator, continuous, facility use |
| Predicate Device(s) | Respironics PerforMax Youth SE Total Face Mask (K092648) |
| Respironics Small Child Profile Lite Nasal Mask (K093416) | |
| JUL 10 2012 |
Device Description
The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation when 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. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable bonnet headgear. It may be cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical highlevel disinfection process for multi-patient use.
The PerforMax Pediatric SE Total Face Mask consists of a faceplate with a bonded silicone seal for the face. A 22 mm standard elbow is connected to the elbow hub on the faceplate. The 22 mm elbow is used to connect a conventional air delivery hose between the mask and the positive airway pressure source. The bonnet headgear is connected to the mask through slots in the upper part of the frame and
1
clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.
Intended Use
The PerforMax Pediatric SE Total 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 for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.
Summary of Technological Characteristics of Device Compared to the Predicate Devices
The PerforMax Pediatric SE Total Face Mask has the following similarities in the technological characteristics to the previously cleared devices (Respironics PerforMax Youth SE Total Face Mask, K092648, and Respironics Small Child Profile Lite Nasal Mask, K093416):
- Same intended use 1.
-
- Same operating principle
-
- Same technology
-
- Similar device design
- Similar physical properties 5.
- Similar materials used 6.
-
- Same scientific concepts that form the basis for the device
The PerforMax Pediatric SE Total Face Mask has the following differences in the technological characteristics to the previously cleared devices (Respironics PerforMax Youth SE Total Face Mask, K092648, and Respironics Small Child Profile Lite Nasal Mask, K093416):
-
- Faceplate and cushion have been reduced in size.
- Operating pressure range has been modified. 2.
- Mask leak specifications has been modified. 3.
- The elbow hub and headgear materials have been modified. 4.
2
Summary of the Non-Clinical Test Submitted, Referenced or Relied on in the 510(k)
To demonstrate performance and functionality was unaffected as a result of these changes, extensive performance testing was completed. Testing was performed pre and post hospital/institutional cleaning and disinfection treatments. Additionally, the mask was tested for high level disinfection in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" -FDA CDRH, January 3, 2000. All patient contacting or gas path materials used in the mask have been previously cleared by the FDA or evaluated in accordance with the guidance provided by ISO 10993-1.
Results from this testing demonstrate that the PerforMax Pediatric SE Total Face its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates.
Clinical Data
Use of face masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the PerforMax Pediatric SE Total Face Mask, as was the case with the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ms. Michelle Brinker Regulatory Affairs Manager, Patient Interface Respironics, Incorporated Sleep and Home Respiratory Group 365 Plum Industrial Court Pittsburg, Pennsylvania 15239
JUL 10 2012
Re: K120639
Trade/Device Name: PerforMax Pediatric SE Total Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 28, 2012 Received: June 29, 2012
Dear Ms. Brinker:
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 (1 vice 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. Brinker
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
PerforMax Pediatric SE Total Face Mask Device Name:
The PerforMax Pediatric SE Total 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 for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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 Device Evaluation (ODE)
L. Schuldthen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 4120639