(123 days)
Not Found
No
The 510(k) summary describes a physical nasal mask and its components for CPAP/bi-level therapy. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties, cleaning/disinfection, and biocompatibility.
Yes
Explanation: The device is a nasal mask intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy, which are recognized therapeutic interventions for conditions like sleep apnea.
No
Explanation: The device is a nasal mask intended to provide an interface for CPAP or bi-level therapy, meaning it is a therapeutic device for delivering air pressure, not for diagnosing conditions.
No
The device description clearly outlines physical components such as a silicone nasal cushion, 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:
- Intended Use: The intended use is to provide an interface for CPAP or bi-level therapy, which is a therapeutic intervention for respiratory conditions. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical mask and its components used to deliver positive airway pressure. It does not mention any components or processes related to analyzing biological samples.
- No mention of biological samples: The entire description focuses on the physical function of the mask and its connection to a pressure source. There is no mention of collecting, analyzing, or interacting with biological specimens like blood, urine, or tissue.
- Performance Studies: The performance studies focus on the mask's functionality, cleaning/disinfection efficacy, and biocompatibility, all of which are relevant to a therapeutic device, not an IVD.
Therefore, the Simple T Nasal Mask is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Simple T Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospitalinstitutional environment. This mask is to be used on patients greater than 66lbs /30kg.
Product codes
BZD
Device Description
The Simple T Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It 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 a frame and adjustable headgear. The mask components may be cleaned by the patient in the home or disinfected by the professional in the hospital/institutional environment (multi-patient use). The fabric headgear and frame may be cleaned by low-level disinfection processes (multi-patient use).
The design consists of a silicone nasal cushion designed to fit over the patient's nose. The cushion is connected to a nasal cushion support (frame) that rests along the sides of the patient's face and supports the cushion. The frame is covered in a fabric material for comfort purposes. An elbow is connected at the frame via a snap lock attachment feature. The fabric headgear is connected to the mask through slots in the frame. The nasal cushion and elbow are designed in such a way that it can be easily removed from the frame for cleaning or replacement purposes.
The elbow is attached to 15mm tubing that is fitted at the end with a 22mm swivel connector. This fitting is used to connect conventional air delivery hose between the mask and pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees.
The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose, face
Indicated Patient Age Range
patients greater than 66 lbs /30 kg
Intended User / Care Setting
single-patient reuse in the home and multi-patient, multi-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)
To demonstrate performance and functionality was unaffected as a result of these changes, performance testing was completed. Testing was performed pre and post cleaning and disinfection freatments. Additionally, cleaning and disinfection efficacy testing was performed to ensure that the mask could be disinfected, in accordance with AAMI TIR No. 12-2010, AAMI TIR 30-2011, 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. A biocompatibility assessment in accordance with ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing was completed for all skin-contacting materials.
Results from this testing concluded that the verification testing performed verified that the Simple T Mask meets 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 Simple T Nasal Mask (K120145), Respironics GoLife Nasal Mask (K110008)
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
2012
| Date of Submission | 30 May 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 | Simple T Nasal Mask |
| Common/Usual Name | Nasal Mask |
| Classification Name / | |
| Product Code | BZD - Ventilator, non-continuous (respirator) |
| Classification / Regulation | |
| Number | Class II - 21 CFR 868.5905 |
| Predicate Device(s) | Respironics Simple T Nasal Mask (K120145) |
| Respironics GoLife Nasal Mask (K110008) |
Device Description
The Simple T Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It 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 a frame and adjustable headgear. The mask components may be cleaned by the patient in the home or disinfected by the professional in the hospital/institutional environment (multi-patient use). The fabric headgear and frame may be cleaned by low-level disinfection processes (multi-patient use).
The design consists of a silicone nasal cushion designed to fit over the patient's nose. The cushion is connected to a nasal cushion support (frame) that rests along the sides of the patient's face and supports
1
the cushion. The frame is covered in a fabric material for comfort purposes. An elbow is connected at the frame via a snap lock attachment feature. The fabric headgear is connected to the mask through slots in the frame. The nasal cushion and elbow are designed in such a way that it can be easily removed from the frame for cleaning or replacement purposes.
The elbow is attached to 15mm tubing that is fitted at the end with a 22mm swivel connector. This fitting is used to connect conventional air delivery hose between the mask and pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees.
The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.
Indications for Use
The Simple T Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospitalinstitutional environment. This mask is to be used on patients greater than 66lbs /30kg.
Summary of Technological Characteristics of Device Compared to the Predicate Device
The Simple T Nasal Mask has the following similarities in the technological characteristics to the previously cleared device (Simple T, K120145):
- . Same intended use
- . Same operating principle
- . Same technology
- l Same cushion, elbow, and swivel materials used
- Similar device design and physical properties ■
- Same scientific concepts that form the basis for the device i
The Simple T Nasal Mask has the following differences in the technological characteristics to the previously cleared device (Simple T, K120145): *
- . Usage of the Simple T Nasal Mask is being expanded from single patient use in the home or hospital/institutional environment to also include multi-patient use in the hospital/institutional
2
environment. The secondary predicate for this submission, GoLife Nasal Mask (K110008), is intended for single patient reuse in the home or multi-patient, multi-use in the hospital/institutional environment.
- Design modification to cushion
- Design modification to frame
- Design modification to exhalation device .
- Design modification to headgear 1
- Modification of frame and headgear materials
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, performance testing was completed. Testing was performed pre and post cleaning and disinfection freatments. Additionally, cleaning and disinfection efficacy testing was performed to ensure that the mask could be disinfected, in accordance with AAMI TIR No. 12-2010, AAMI TIR 30-2011, 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. A biocompatibility assessment in accordance with ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing was completed for all skin-contacting materials.
Results from this testing concluded that the verification testing performed verified that the Simple T Mask meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates.
Clinical Data
Use of nasal 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 Simple T Nasal Mask, as was the case with the predicate devices.
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Respironics, Incorporated
Ms. Michelle Brinker
Regulatory Affairs Manager, Patient Interface
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668
Re: K121631
Trade/Device Name: Simple T Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 7, 2012 Received: September 10, 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 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.
OCT
5 2012
4
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,
F. Pelletier
F. Smith Jr.
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
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Page 1 of_1
Indications for Use
510(k) Number (if known): ر
Device Name: ___Simple T Nasal Mask
The Simple T-Nasal-Mask-is-intended-to-provide-an-interface-for-Gontinuous-Positive-Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.
Over-The-Counter Use _ Use Prescription AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Af. Rache
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: