(300 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a nasal mask for CPAP/bi-level therapy. There is no mention of AI, ML, or any software-based analysis or processing.
No.
The device is an accessory (an interface) for CPAP or bi-level therapy, not a therapeutic device itself.
No
Explanation: The device is a nasal mask intended to provide an interface for the application of CPAP or bi-level therapy, which is a treatment, not a diagnostic process. It does not gather information about a patient's health status to aid in diagnosis.
No
The device description clearly details physical components such as a silicone nasal cushion, mask frame, headgear, and elbow, 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:
- 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 TI Nasal Mask is a physical interface used to deliver positive airway pressure therapy directly to a patient's nose. It does not analyze any biological samples.
- Intended Use: The intended use is to provide an interface for applying CPAP or bi-level therapy, which is a treatment method, not a diagnostic test.
The description clearly indicates the device's purpose is to facilitate the delivery of air pressure for respiratory support, which falls under the category of a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The TI Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Respironics TI Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. The mask provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home (single-patient use) or cleaned by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).
The TI mask's cushion consists of a silicone nasal cushion designed to seal around the patient's nostrils. The silicone mask frame supports the cushion by connecting to the lateral ends of the cushion and resting along the sides of the patient's face up to the crown of the fabric headgear is attached through the slots on the side of the frame to support the mask fit. The elbow is inserted into the opening in the frame.
The elbow can rotate freely through 360 degrees and has a 22mm quick disconnect swivel that is used to connect the conventional air delivery hose between the mask and pressure source. The 22mm quick disconnect swivel is designed in such a way that it can also rotate freely through 360 degrees and be easily removed from the elbow.
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
Not Found
Intended User / Care Setting
single patient use in the home or multi-patient use 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)
Design verification tests were performed on the Respironics TI Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria.
Non-Clinical Tests: Extensive performance testing was performed before and after cleaning and disinfection treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
- Intentional Leak
- . Total Leak
- Deadspace Volume
- . Pressure Drop
- CO2 Rebreathing
- Cleaning and Disinfection Efficacy
- Storage
Clinical Tests: Clinical tests were not required to demonstrate the safety and effectiveness of the Respironics TI Nasal Mask. Product functionality has been adequately assessed by non-clinical tests.
Conclusion: The Respironics TI Nasal Mask has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. The Respironics TI Nasal Mask is substantially equivalent to the predicate devices.
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.
Respironics Kangaroo Nasal Mask (K122847), Respironics Simple T Nasal Mask (K121631), Innomed Technologies Nasal Aire II (K022465)
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
§ 868.5905 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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are white against a dark background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2015
Respironics, Inc. Shaylee Masilunas Regulatory Affairs Engineer 1001 Murray Ridge Lane Murrysville, PA 15668
Re: K140980
Trade/Device Name: TI Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB). Regulatory Class: II Product Code: BZD Dated: February 6, 2015 Received: February 9, 2015
Dear Ms. 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.
1
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 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/Resourcesfor You/Industry/default.htm. 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 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: December 31, 2013
See PRA Statement on last page. | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--|
| 510(k) Number (if known) | | |
| K140980 | | |
Device Name Respironics TI Nasal Mask
Indications for Use (Describe)
The TI Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital institutional environment. The mask is to be used on patients (>661bs/30kg) for whom CPAP or bi-level therapy has been prescribed.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Page 1 of 2
PSC Publishing Services (301) 443-6740 EF
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (9/13)
Page 2 of 2
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TAB 5
510(K) SUMMARY
| Date of Submission | 10 February 2015 |
|---|---|
| 510(k) Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| Official Contact | Shaylee Masilunas |
| Regulatory Affairs Engineer, Patient Interface | |
| Proprietary Name | TI Nasal Mask |
| Common/Usual Name | Nasal Mask |
| Classification Name / | |
| Product Code | 21 CFR 868.5905, Product Code BZD – Ventilator, non-continuous |
| (respirator) | |
| Predicate Device(s) | Respironics Kangaroo Nasal Mask (K122847) |
| Respironics Simple T Nasal Mask (K121631) | |
| Innomed Technologies Nasal Aire II (K022465) |
Indications for Use
The TI Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
Device Description
The Respironics TI Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. The mask provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be
5
cleaned by the patient in the home (single-patient use) or cleaned by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).
The TI mask's cushion consists of a silicone nasal cushion designed to seal around the patient's nostrils. The silicone mask frame supports the cushion by connecting to the lateral ends of the cushion and resting along the sides of the patient's face up to the crown of the fabric headgear is attached through the slots on the side of the frame to support the mask fit. The elbow is inserted into the opening in the frame.
The elbow can rotate freely through 360 degrees and has a 22mm quick disconnect swivel that is used to connect the conventional air delivery hose between the mask and pressure source. The 22mm quick disconnect swivel is designed in such a way that it can also rotate freely through 360 degrees and be easily removed from the elbow.
Substantial Equivalence
The Respironics TI Nasal Mask has the following similarities to the previously cleared predicate devices Respironics Kangaroo Nasal Mask (K122847), Respironics Simple T Nasal Mask (K121631), and Innomed Technologies Nasal Aire II (K022465):
- Same intended use
- Same operating principle
- Similar design
- . Similar materials
- . Similar manufacturing process
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| Table 1 – Material comparison for the Respironics TI Nasal Mask and its predicate devices | ||||
|---|---|---|---|---|
| Component | Primary Predicate: | |||
| Device: | ||||
| Kangaroo Nasal Mask |
Manufacturer:
Respironics, Inc.
510(k) Number:
K122847 | Secondary Predicate:
Device:
Simple T Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number:
K121631 | Additional Predicate:
Device:
Nasal Aire II
Manufacturer:
Innomed Technologies, Inc.
510(k) Number:
K022465 | Subject Device:
Device:
TI Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number:
K140980 |
| Cushion | Silicone | Silicone | | Silicone and Polycarbonate |
| Frame | Nylon/Spandex | Nylon/Spandex | | Silicone and Polycarbonate |
| Elbow and Elbow Swivel | Polycarbonate | Polycarbonate | Information not available | Polycarbonate |
| Quick-Disconnect Swivel | N/A | N/A | | Polycarbonate |
| Headgear | Polyurethane Foam, Nylon/Spandex | Nylon/Spandex | | Polyurethane Foam, Nylon/Spandex |
Table 1 – Material comparison for the Respironics TI Nasal Mask and its predicate devices
The TI Nasal Mask has the following differences in the technological characteristics to the previously cleared predicate devices Respironics Kangaroo Nasal Mask (K122847), Respironics Simple T Nasal Mask (K121631), and Nasal Aire II (K022465):
- . Cushion design modified
- . Frame and headgear design modified
- Built-in exhalation modified
- . Patient circuit connection modified
Design verification tests were performed on the Respironics TI Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.
Non-Clinical Tests
Extensive performance testing was performed before and after cleaning and disinfection treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
7
- Intentional Leak
- . Total Leak
- Deadspace Volume
- . Pressure Drop
- CO2 Rebreathing
- Cleaning and Disinfection Efficacy
- Storage
The TI Nasal Mask has been designed to meet the requirements of 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
Clinical Tests
Clinical tests were not required to demonstrate the safety and effectiveness of the Respironics TI Nasal Mask. Product functionality has been adequately assessed by non-clinical tests.
Conclusion
The Respironics TI Nasal Mask has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. The Respironics TI Nasal Mask is substantially equivalent to the predicate devices.