(354 days)
No
The 510(k) summary describes a physical mask for non-invasive ventilation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The document states that the mask is "intended to provide an interface for application of non-invasive ventilation" and to be "used with positive airway pressure devices." It also explicitly mentions "compatible therapy device" and "CPAP therapy device," indicating that the mask itself is not the therapy device but rather an accessory to it.
No
Explanation: The device is described as a mask intended for non-invasive ventilation, acting as an interface for the application of positive airway pressure. Its purpose is to deliver therapy, not to diagnose a condition.
No
The device description clearly describes a physical mask with components like a cushion, fabric frame, adjustable headgear, and an adjustment dial, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a nasal mask intended to provide an interface for non-invasive ventilation. It delivers positive airway pressure to the patient's nose.
- Lack of Sample Analysis: There is no mention of the device collecting or analyzing any biological samples from the patient. Its function is purely mechanical, facilitating the delivery of air pressure.
Therefore, this device falls under the category of a respiratory support device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.
Product codes
BZD
Device Description
The Simple T Pediatric Nasal Mask is intended to be used with positive airway pressure devices. For use of this mask with a CPAP therapy device, the patient population is limited by the intended use of the device (e.g. > 30 kg). In other words, this mask can be used with a variety of therapy devices which may have their own limitations on patient population. If the therapy device itself is limited to patients greater than 10 kg (e.g. 30 kg), then the use of this mask does not expand the intended use of that therapy device.
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 a fabric frame and an adjustable headgear. The cushion contains an adjustment dial that can be engaged to reduce minor leaks around the nose. The mask may be cleaned in the home (single-patient use) or reprocessed by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose
Indicated Patient Age Range
Patients greater than 10kg/22lbs (>10kg/22lbs)
Intended User / Care Setting
single patient use in the home and 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 Simple T Pediatric Nasal Mask. 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.
Performance testing was performed before and after reprocessing treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
- Intentional Leak
- Total Mask Leak
- Mask Deadspace
- Pressure Drop
- CO2 Rebreathing
- Performance Post Cleaning, Disinfection and Sterilization
- Cleaning and Disinfection Validation Testing
- Storage
Clinical tests were not required to demonstrate the safety and effectiveness of the Simple T Pediatric Nasal Mask. Product functionality has been adequately assessed by non-clinical tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 three human profiles facing right, layered on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
Respironics, Inc. Shaylee Masilunas Regulatory Affairs Engineer 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K151120
Trade/Device Name: Simple T Pediatric Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 2, 2015 Received: March 4, 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.
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
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number (if known) | |
| Device Name | Simple T Pediatric Nasal Mask |
| Indications for Use (Describe) | |
| This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight. | |
| Type of Use (Select one or both, as applicable) | |
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect |
of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Psblishing Survices (JUI) 443-6740 ED
3
TAB 6
510(K) SUMMARY
| 510(k) Owner | Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|---------------------------------------|---------------------------------------------------------------------------------------------------|
| Official Contact | Shaylee Masilunas
Regulatory Affairs Engineer, Patient Interface |
| Establishment Registration # | 2518422 |
| Proprietary Name | Simple T Pediatric 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 Simple T Youth Nasal Mask (K140268)
Respironics Profile Lite Small Child (K093416) |
| Reference Device | Respironics Trilogy 200 (K093416) |
Indications for Use
This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.
Device Description
The Simple T Pediatric Nasal Mask is intended to be used with positive airway pressure devices. For use of this mask with a CPAP therapy device, the patient population is limited by the intended use of the device (e.g. > 30 kg). In other words, this mask can be used with a variety of therapy devices which may have their own limitations on patient population. If the therapy device itself is limited to patients
4
greater than 10 kg (e.g. 30 kg), then the use of this mask does not expand the intended use of that therapy device.
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 a fabric frame and an adjustable headgear. The cushion contains an adjustment dial that can be engaged to reduce minor leaks around the nose. The mask may be cleaned in the home (single-patient use) or reprocessed by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).
Substantial Equivalence
The Simple T Pediatric Nasal Mask has the following similarities to the previously cleared predicate devices Respironics Simple T Youth Nasal Mask (K140268) and Respironics Profile Lite Small Child mask (K093416):
- Same operating principle
- Similar intended use
- . Similar materials
- Similar design
- Similar manufacturing process
The following modifications have been made to the previously cleared predicate devices Respironics Simple T Youth Nasal Mask (K140268) and Respironics Profile Lite Small Child mask (K093416) for the Simple T Pediatric Nasal Mask:
- . The intended use population was modified to include patients greater than 10kg/22lbs
- . An existing warning was converted to a contraindication to align with the definition of a contraindication. The language of that statement was revised to reflect standardized terminology.
- . The mask components were modified for sizing. The cushion was modified to include a leak adjustment dial.
5
Table 1 – Technological characteristics comparison of the Simple T Pediatric Nasal Mask and its predicate devices
| Intended Use | Primary Predicate:
Device:
Simple T Youth
K140268
Manufacturer:
Respironics, Inc.
The Simple T Youth Nasal Mask | Secondary Predicate:
Device:
Profile Lite Small Child K093416
Manufacturer:
Respironics, Inc.
The Small Child Profile Lite | Subject Device:
Device:
Simple T Pediatric Nasal Mask
Manufacturer:
Respironics, Inc.
This mask is intended to provide an |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | is intended to provide an
interface for Continuous Positive
Airway Pressure (CPAP) or bi-
level therapy. | Nasal Mask and Softcap are
intended to provide an
interface when used with CPAP
or bi-level therapy. | interface for application of non-
invasive ventilation to patients. |
| Patient
Population | Patients 7 years or older (>40
lbs/18kg) | Profile Lite Small Child Mask:
Patients 1 year or older (>7 kg)
Trilogy 200 Ventilator: Patients
at least 5kg/11lbs | Patients greater than 10kg/22lbs
(>10kg/22lbs) |
| Environment of
Use | Home or Hospital/
Institutional Environment | Home or Hospital/
Institutional Environment | Unchanged from K140268,
K093416 |
| Patient Usage
Type | Single patient reuse or multi-
patient use | Single Patient Use | Unchanged from K140268 |
| Provided Sterile
or Non-Sterile | Non-Sterile | Non-Sterile | Unchanged from K140268,
K093416 |
| Anatomical Sites | Nose | Nose | Unchanged from K140268,
K093416 |
| Device Design | 1. Nasal cushion
2. Frame
3. Elbow with built-in exhalation
device
4. Tubing with 15mm to 22mm
swivel connector
5. Headgear | 1. Nasal cushion
2. Faceplate
3. Elbow with built-in
exhalation device
4. Tubing with 15mm to 22mm
swivel connector.
5. Headgear | Unchanged from K140268
- Nasal Cushion with Dial
- Frame
- Elbow with built-in exhalation
device - Tubing with 15 mm to 22 mm
swivel connector. - Headgear |
| Cushion | Silicone sealing cushion that fits
around the nose. | Encapsulated gel cushion that
fits around the nose. | Similar to K140268
The cushion contains an
adjustment dial. |
| Cushion Sizes | 3 sizes | 1 size | 2 sizes |
| Frame Design | The frame stabilizes the cushion
on the nose and allows
clearance of facial features.
Four slots exist for insertion of
headgear tabs. | The faceplate and forehead
arm secure the cushion to the
face. Four slots exist for
insertion of headgear tabs. | Unchanged from K140268 |
| Exhalation device
design | No separate exhalation device is
required. 18 exhalation ports
are integrated. | No separate exhalation device
is required. Two exhalation
ports are integrated. | Unchanged from K140268 |
| Tubing | 15 mm tubing | 15 to 22 mm tubing | Unchanged from K140268 |
6
| Primary Predicate: | Secondary Predicate: | Subject Device: | |
|---|---|---|---|
| Device: | Device: | Device: | |
| Simple T Youth | |||
| K140268 | Profile Lite Small Child K093416 | Simple T Pediatric Nasal Mask | |
| Manufacturer: | |||
| Respironics, Inc. | Manufacturer: | ||
| Respironics, Inc. | Manufacturer: | ||
| Respironics, Inc. | |||
| General | |||
| headgear design | Four point headgear with hook | ||
| and loop tabs for attaching to | |||
| frame. | Four point bonnet with hook | ||
| and loop tabs for attaching to | |||
| frame. | Unchanged from K140268 | ||
| Patient Circuit | |||
| Connection | 22 mm swivel connector | 22 mm swivel connector | Unchanged from K140268 and |
| K093416 |
7
| Primary Predicate: | Secondary Predicate: | Subject Device: | |
|---|---|---|---|
| Device: | Device: | Device: | |
| Simple T Youth | Profile Lite Small Child K093416 | Simple T Pediatric Nasal Mask | |
| K140268 | |||
| Manufacturer: | Manufacturer: | ||
| Manufacturer: | Respironics, Inc. | Respironics, Inc. | |
| Component | Respironics, Inc. | ||
| Cushion | Silicone | Gel encapsulated in urethane | Silicone |
| Frame | Polyurethane Foam, Nylon | Polycarbonate | Polyurethane Foam, Nylon |
| Elbow and | Polycarbonate | Polycarbonate | Polycarbonate |
| Swivel | |||
| Tubing | Thermoplastic Elastomer | Ethylene Vinyl Acetate | Thermoplastic Elastomer |
| Headgear | Polyurethane Foam, | ||
| Nylon/Spandex | Nylon and Lycra | Polyurethane Foam, | |
| Nylon/Spandex |
Table 2 – Material comparison for the Simple T Pediatric Nasal Mask and its predicate devices
Design verification tests were performed on the Simple T Pediatric Nasal Mask. 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
Performance testing was performed before and after reprocessing treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
- Intentional Leak
- . Total Mask Leak
- . Mask Deadspace
- . Pressure Drop
- CO2 Rebreathing
- Performance Post Cleaning, Disinfection and Sterilization
- Cleaning and Disinfection Validation Testing
- Storage
The Simple T Pediatric Nasal Mask has been designed to meet the requirements of the following standards:
8
- 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 Simple T Pediatric Nasal Mask. Product functionality has been adequately assessed by non-clinical tests.
Conclusion
The performance and technological characteristics of the Simple T Pediatric Nasal Mask are substantially equivalent to those of the Simple T Youth Nasal Mask (K140268) and the Profile Lite Small Child (K093416). The differences described above do not raise new questions of safety and effectiveness.