(68 days)
No
The device description focuses on the physical components and design modifications of a face mask for respiratory therapy, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a mask that provides an interface for the application of therapy, but it is not the therapeutic device itself.
No
The device is described as an interface for applying CPAP or BiPAP therapy, which are forms of treatment, not diagnostic procedures.
No
The device description clearly details physical components like a faceplate, cushion, headgear, and valves, 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:
- Intended Use: The intended use is to "provide an interface for application of Respironics CPAP or BiPAP therapy to patients." This describes a device used to deliver therapy, not to perform diagnostic testing on biological samples.
- Device Description: The description details a mask designed to fit over the face and connect to a CPAP or BiPAP machine. It focuses on the physical interface and its components for delivering air pressure. There is no mention of collecting or analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to diagnose diseases, monitor conditions, or screen for health issues. This device does none of those things.
The device is clearly an interface for respiratory therapy, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Total Face Mask is intended to provide a single-patient-use interface for adult patients (>30 kg) receiving Respironics CPAP or BiPAP therapy.
The Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients.
Product codes
BZD
Device Description
The Total Face Mask is intended to provide a single-patient-use interface for adult patients (>30 kg) receiving Respironics CPAP or BiPAP therapy. The mask (Figure 1) fits over the entire face, with the rim of the mask framing the face along the hairline and jawline. The mask consists of a polycarbonate faceplate and a thin silicone cushion that folds inward, creating a flap on the inner perimeter of the mask to improve seal. The faceplate has four Velcro® hooks to which the headgear tabs attach.
The modified faceplate (Figure 2) is smaller, rounder, and has a streamlined profile. (Predicate mask is larger, primarily round, with the exception of the eye area, which is squared off.) Modified mask volume is smaller at 1550 ml. (Predicate volume is 2300 ml.) Modified mask cushion material is silicone. (Predicate cushion is urethane.)
Modified faceplate (Figure 2) has a nosepiece with 22-mm entrainment valve, whose accessory swivel connects to patient circuit. (Predicate faceplate has a 22-mm elbow, to which patient circuit is connected.) Entrainment valve opens to ambient air if pressure should cease. (Predicate requires use of a non-rebreathing valve (NRV).) Two built-in exhalation ports are located on the nosepiece. (Predicate's ports are located on the mask.) Nosepiece has one pressure pickoff port. (Predicate elbow has two.) The headgear consists of Velcro® straps. (Predicate headgear is a cap with Velcro straps.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
adult patients (>30 kg)
Intended User / Care Setting
For single patient use in the home or 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)
Design verification tests were performed on the Total Face Mask as a result of the risk analysis assessment, and acceptance criteria were met. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Total Face Mask (K925920)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
TACHMENT 4
SUMMARY OF SAFETY & EFFE
| Official Contact | David J. Vanella
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - noncontinuous ventilator |
| Common/Usual Name | nasal mask |
| Proprietary Name | Respironics® Total™ Face Mask |
| Predicate Device | Total Face Mask (K925920) |
| Reason for submission | Modified design; modified materials |
Substantial Equivalence
The modified mask has the following similarities to the previously cleared predicate device:
- 0 Same intended use.
- ପ Same operating principle.
- Same technology.
- O Same manufacturing process.
Design verification tests were performed on the Total Face Mask as a result of the risk analysis assessment, and acceptance criteria were met. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the mask described in this submission is substantially equivalent to the predicate device.
The modified mask complies with the applicable standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993.
1
Device Description/Intended Use
The Total Face Mask is intended to provide a single-patient-use interface for adult patients (>30 kg) receiving Respironics CPAP or BiPAP therapy. The mask (Figure 1) fits over the entire face, with the rim of the mask framing the face along the hairline and jawline. The mask consists of a polycarbonate faceplate and a thin silicone cushion that folds inward, creating a flap on the inner perimeter of the mask to improve seal. The faceplate has four Velcro® hooks to which the headgear tabs attach.
Image /page/1/Figure/4 description: The image contains two figures of a Respironics Total Face Mask. Figure 1 shows the face mask being worn with headgear and flexible tubing. Figure 2 shows the face mask with the total face mask faceplate, entrainment valve, accessory swivel, exhalation ports, pressure pickoff port cap, and headgear hooks.
The modified faceplate (Figure 2) is smaller, rounder, and has a streamlined profile. (Predicate mask is larger, primarily round, with the exception of the eye area, which is squared off.) Modified mask volume is smaller at 1550 ml. (Predicate volume is 2300 ml.) Modified mask cushion material is silicone. (Predicate cushion is urethane.)
Modified faceplate (Figure 2) has a nosepiece with 22-mm entrainment valve, whose accessory swivel connects to patient circuit. (Predicate faceplate has a 22-mm elbow, to which patient circuit is connected.) Entrainment valve opens to ambient air if pressure should cease. (Predicate requires use of a non-rebreathing valve (NRV).) Two built-in exhalation ports are located on the nosepiece. (Predicate's ports are located on the mask.) Nosepiece has one pressure pickoff port. (Predicate elbow has two.) The headgear consists of Velcro® straps. (Predicate headgear is a cap with Velcro straps.)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550
K992969 Re : Total Face Mask Regulatory Class: II (two) Product Code: 73 BZD October 8, 1999 Dated: Received: October 12, 1999
Dear Mr. Vanella:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. David J. Vanella
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Jeanne M. Wentworth for;
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K992969
Device Name: Respironics® Total™ Face Mask
Intended Use/Indications for Use
The Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients.
Environment of Use/Patient Population
For single patient use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30 kg) for whom CPAP or BiPAP therapy has been prescribed using a Respironics CPAP or BiPAP system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K 992969 |