(288 days)
The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.
The SleepWeaver Advance Pediatric Nasal CPAP Mask serves as a mechanism for connecting a pediatric patient between 2 and 7 years of age for whom PAP therapy has been prescribed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has a tubing swivel connector which is compatible with the industry standard 22 mm air tubing. Air is supplied to the mask by a therapy device. The patient inhales air from the mask and exhales into the mask where continuous airflow from the therapy device purges the exhaled carbon dioxide from the mask through the mask exhalation holes. The SleepWeaver Advance Pediatric Nasal CPAP Mask can be used in the home environment (single-patient use) or the hospital/institutional environment (single-patient use). The mask features a cloth cushion made of a blue polyester fabric with a polyester / nylon / lycra / polyurethane interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is a 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be removed by unwrapping the white medical tape for cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for cleaning and replacement. The SleepWeaver Advance Pediatric Nasal CPAP Mask product also offers an optional accessory: the Feather Weight tube. The optional SleepWeaver FeatherWeight tube may be used with this mask, but it remains outside the scope of this submission as it has been previously cleared by its inclusion in K120757. The Feather Weight tube is an 18" plastic extension tube compliant to ISO 5356-1 and ISO 5367 that connects between the SleepWeaver Advance Pediatric Nasal CPAP Mask and standard CPAP tubing.
The provided document is a 510(k) premarket notification for a medical device called the "SleepWeaver Advance Pediatric Nasal CPAP Mask." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where an AI-driven device's performance is compared against human readers or specific acceptance criteria for AI output.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, stand-alone performance, training set sample size, how ground truth for training set was established) are not applicable to this type of submission. The device described is a physical medical device (a CPAP mask), not an AI/ML-driven software device.
However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Testing Summary" and "Technological Characteristics" sections, as these effectively serve as the performance evaluation for this type of device.
Acceptance Criteria and Reported Device Performance
Device: SleepWeaver Advance Pediatric Nasal CPAP Mask (K151683)
Predicate Device: ResMed Ltd., Pixi Pediatric Mask (K102224)
| Acceptance Criteria / Performance Metric | Predicate Device (ResMed Pixi Pediatric Mask) Performance | SleepWeaver Advance Pediatric Nasal CPAP Mask Performance | Equivalence Narrative / Compliance |
|---|---|---|---|
| Intended Use | To provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy for patients between 2 and 7 years of age. Single-patient re-use in home/hospital environment. | To provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy for patients between 2 and 7 years of age. Single-patient use in home/hospital environment. | Same. |
| Patient Population | Pediatric patients between 2 and 7 years of age. | Pediatric patients between 2 and 7 years of age. | Same. |
| Therapy Pressure Range | 3 to 20 cm H2O | 4 - 20 cm H2O | Proposed device range is within predicate range. |
| Sizing | 1 size | 1 size | Both sized to accommodate intended population. |
| Physical Dead Space | 101.7 mL | 130 mL | Higher than predicate, but performance testing (CO2 rebreathing tests under ISO 17510-2) confirms no CO2 build-up due to exhalation holes. |
| Resistance (Pressure Drop) | 0.8 cm H2O at 50 L/min; 3.1 cm H2O at 100 L/min | 0.4 cm H2O at 50 L/min; 1.0 cm H2O at 100 L/min | Lower than predicate, which is considered preferential. |
| Carbon Dioxide Washout Profile | Not available (Predicate) | Amount of CO2 being rebreathed < 20% max allowable increase under normal conditions (4, 5, and 10 cm H2O). | The SleepWeaver Pediatric meets ISO 17510-2. |
| Leak Rate | Pressure (cm H2O) 3: 18 L/min 7: 28 L/min 12: 36 L/min 16: 43 L/min 20: 49 L/min | Pressure (cm H2O) 4: 14 L/min 5: 16 L/min 10: 25 L/min 15: 33 L/min 20: 40 L/min | Lower than predicate. Its leak rate is greater than patient exhalation per minute, and it passed CO2 rebreathing tests under ISO 17510-2. |
| A-weighted Sound Levels | Not available (Predicate) | Sound Power Level: 26 dBA; Sound Pressure Level at 1m: 18 dBA | Not applicable (no predicate data for comparison). |
| Biocompatibility | ISO 10993-1 compliant materials | Materials used in legally marketed devices (SleepWeaver Advance Nasal CPAP Mask (K092362), SleepWeaver Elan Nasal CPAP Mask (K120757), and SleepWeaver Anew Full Face Mask CPAP (K130481)). | Materials are biocompatible and in use in other cleared devices. |
Study Details (as applicable to a physical medical device submission)
-
Sample size used for the test set and the data provenance:
- Specific human subject sample sizes for each test are not explicitly stated. The "Fit evaluation and anthropometric analysis" implies human subjects were used, but the number is not provided.
- The "CO2 rebreathing testing per ISO 17510-2" and "Fixed leak rate per ISO 17510-2" were likely conducted in a lab setting using test lungs or simulated breathing circuits rather than human subjects for the core performance metrics.
- Data provenance: Primarily bench-top testing, not clinical trial data from specific countries.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is a physical device, and the "ground truth" is established by compliance with engineering standards (like ISO 17510-2) and direct measurements from bench-top tests, rather than expert interpretation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical data, which is not the primary basis of this submission.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-driven device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-driven device. The "standalone" performance is the device's measured physical characteristics on a test bench.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this medical device consists of established engineering standards (e.g., ISO 17510-2 for CO2 rebreathing), physical measurements (e.g., dead space, resistance, leak rate), and biocompatibility testing results.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set.
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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 to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
Circadiance, LLC % Pooja Roychoudhury Operation Manager Regulatory & Quality Solutions, LLC 2790 Mosside Blvd, Suite 800 Monroeville, Pennsylvania 15146
Re: K151683
Trade/Device Name: SleepWeaver Advance Pediatric Nasal CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 1, 2016 Received: March 3, 2016
Dear Ms. Roychoudhury:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151683
Device Name
SleepWeaver Advance Pediatric Nasal CPAP Mask
Indications for Use (Describe)
The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.
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)
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)
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510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Circadiance, LLC 1300 Rodi Road, Turtle Creek, PA 15145 Phone: (724) 858-2837 Facsimile: (412) 202-4583 Contact Person: David Groll, CEO, David.Groll@Circadiance.com
Date Originally Prepared: June 19, 2015 Date Revised: April 5, 2016
Name of Device and Name/Address of Sponsor
SleepWeaver Advance Pediatric Nasal CPAP Mask
Common or Usual Name
Vented Nasal Mask
Classification Name
Accessory to Non-Continuous Ventilator, Class II, 21 CFR 868.5905, Product Code: BZD
Predicate Devices
ResMed Ltd., Pixi Pediatric Mask (K102224)
Indications for Use
The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.
Description of Device
The SleepWeaver Advance Pediatric Nasal CPAP Mask serves as a mechanism for connecting a pediatric patient between 2 and 7 years of age for whom PAP therapy has been prescribed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has a tubing swivel connector which is compatible with the industry standard 22 mm air tubing.
Air is supplied to the mask by a therapy device. The patient inhales air from the mask and exhales into the mask where continuous airflow from the therapy device purges the exhaled carbon dioxide from the mask through the mask exhalation holes.
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The SleepWeaver Advance Pediatric Nasal CPAP Mask can be used in the home environment (single-patient use) or the hospital/institutional environment (single-patient use).
The mask features a cloth cushion made of a blue polyester fabric with a polyester / nylon / lycra / polyurethane interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is a 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be removed by unwrapping the white medical tape for cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for cleaning and replacement.
The SleepWeaver Advance Pediatric Nasal CPAP Mask product also offers an optional accessory: the Feather Weight tube. The optional SleepWeaver FeatherWeight tube may be used with this mask, but it remains outside the scope of this submission as it has been previously cleared by its inclusion in K120757. The Feather Weight tube is an 18" plastic extension tube compliant to ISO 5356-1 and ISO 5367 that connects between the SleepWeaver Advance Pediatric Nasal CPAP Mask and standard CPAP tubing.
Technological Characteristics
The SleepWeaver Advance Pediatric Nasal CPAP Mask consists of a cloth cushion, headgear, and a swivel connector. Table 1 is provided below which lists additional technological characteristics for the SleepWeaver Advance Pediatric Nasal CPAP Mask as well as a comparison of the described feature to the predicate device.
| Feature | Proposed Device:SleepWeaver AdvancePediatric Nasal CPAP Mask | Predicate Device: ResMed PixiPediatric Mask (K102224) | Equivalence Narrative |
|---|---|---|---|
| IntendedUse | The SleepWeaver AdvancePediatric Nasal Mask is intendedto provide an interface fornoninvasive Positive AirwayPressure (PAP) ventilationtherapy. This mask is intendedfor single-patient use in the homeand single-patient use in thehospital / institutionalenvironment. This mask is to beused on patients between 2 and7 years of age. | The Pixi Pediatric Mask channelsairflow noninvasively to a patient from acontinuous positive airway pressure(CPAP) or bilevel device.The Pixi Pediatric Mask is:To be used by children aged●between 2 and 7 for whomcontinuous positive airwaypressure (CPAP) or bileveltherapy has been prescribed.Intended for single-patient re-use●in the home environment andsingle-patient re-use in thehospital/ institutional environment. | Same |
| Contra-indications | None | None | Same |
| ProductCode | BZD | BZD | Same |
| Environmentof Use | Hospital, Home | Hospital, Home | Same |
| PatientPopulation | Pediatric patients between 2 and7 years of age | Pediatric patients between 2 and 7years of age | Same |
| Use Case(s) | Single Patient Use | Single Patient Use | Same |
| Components/Accessories | Headgear, Mask, Interface,Swivel Connector, FeatherWeight Tube (Optional) | Headgear, Mask frame, Frame nodes,Mask socket, Short tube assembly,Elbow, Plug tether, Plug, Cushion, Vent,Cushion shoulder, Pressure port, Topheadgear strap and buckle, Middleheadgear strap and buckle, Lowerheadgear strap and buckle, Quickrelease clip, Lower headgear arms, 22mm Swivel | The SleepWeaver Pediatric andpredicate ResMed Pixi both havea nasal mask, adjustableheadgear, an interface swivelconnection, and a tube assembly.The SleepWeaver Pediatric maskis manufactured from clothwhereas the ResMed Pixi maskhas a silicone cushion and aplastic stability feature. TheSleepWeaver Pediatric Mask issupported by performance testing;thus it can be concluded that theSleepWeaver Advance PediatricNasal CPAP Mask, is substantiallyequivalent to the predicate device,the ResMed Pixi Pediatric Mask, inregards to this comparison. |
| Design | Image: SleepWeaver Pediatric Mask | Image: ResMed Pixi Pediatric Mask | The SleepWeaver Pediatric Maskand predicate ResMed Pixi areboth nasal CPAP masks withadjustable headgear. TheSleepWeaver Pediatric mask ismanufactured from cloth whereasthe ResMed Pixi mask has asilicone cushion and a plasticstability feature. TheSleepWeaver Pediatric Mask issupported by performance testing;thus it can be concluded that theSleepWeaver Advance PediatricNasal CPAP Mask, is substantiallyequivalent to the predicate device,the ResMed Pixi Pediatric Mask, inregards to this comparison. |
| Materials | Headgear: Nylon,Elastane, PolyurethaneMask: Blue PolyesterInterface: Polyester, Nylon,Lycra, PolyurethaneSwivel Connector: Polycarbonate | Information not available | The SleepWeeaver Pediatric Maskand headgear are made ofmaterials used in legally marketeddevices (SleepWeaver AdvanceNasal CPAP Mask (K092362),SleepWeaver Elan Nasal CPAPMask (K120757), andSleepWeaver Anew Full FaceMask CPAP (K130481)) and thepredicate ResMed Pixi is made ofplastic and silicone. TheSleepWeaver Pediatric Mask usesbiocompatible materials; thus itcan be concluded that theSleepWeaver Advance PediatricNasal CPAP Mask, is substantiallyequivalent to the predicate device,the ResMed Pixi Pediatric Mask, inregards to this comparison. |
| TherapyPressureRange | $4 - 20 cm H_2O$ | $3 to 20 cm H_2O$ | The SleepWeaver Pediatric has atherapy range from $4 to 20 cm$$H_2O$ whereas he ResMed Pixi hasa therapy range from $3 to 20 cm$$H_2O$ . Since the SleepWeaverPediatric therapy range is withinthe therapy range for the ResMed |
Table 1: Technological Characteristics and Comparison to the Predicate
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| Pixi, it can be concluded that theSleepWeaver Advance PediatricNasal CPAP Mask, is substantiallyequivalent to the predicate device,the ResMed Pixi Pediatric Mask, inregards to this comparison. | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sizing | 1 size | 1 size | SleepWeaver Pediatric andResMed Pixi are both sized toaccommodate the intended patientpopulation. | ||||||||||||||||||||||||
| PhysicalDead Space | 130 mL | 101.7 mL | The dead space for theSleepWeaver Pediatric is largerthan the predicate ResMed Pixi;however, since the SleepWeaverPediatric mask has exhalationholes and seams that enablecontinuous purging of the volumeof air around the periphery of themask, it prevents CO2 build-up.This is supported by theperformance testing since themask has passed the rebreathingtests under ISO 17510-2. Thus itcan be concluded that theSleepWeaver Advance PediatricNasal CPAP Mask, is substantiallyequivalent to the predicate device,the ResMed Pixi Pediatric Mask, inregards to this comparison. | ||||||||||||||||||||||||
| A-weightedSoundlevels | Sound Power Level:26 dBA;Sound Pressure Level at 1m:18 dBA | Not available | Not applicable | ||||||||||||||||||||||||
| Resistance(pressuredrop) | 0.4 cm H2O at 50 L/min;1.0 cm H2O at 100 L/min | 0.8 cm H2O at 50 L/min;3.1 cm H2O at 100 L/min | The resistance for theSleepWeaver Pediatric is lowerthan the predicate ResMed Pixi;however, a lower pressure dropmay be considered preferential asthe patient will receive therapycloser to the intended pressure.Thus it can be concluded that theSleepWeaver Advance PediatricNasal CPAP Mask, is substantiallyequivalent to the predicate device,the ResMed Pixi Pediatric Mask, inregards to this comparison. | ||||||||||||||||||||||||
| CarbonDioxideWashoutProfile | The amount of CO2 beingrebreathed by the patient in allscenarios listed in ISO 17510-2:2009 is less than the maximumallowable percentage increaseunder normal conditions (20% for4, 5, and 10 cm H2O). | Not available | The SleepWeaver Pediatric meetsISO 17510-2. | ||||||||||||||||||||||||
| Leak Rate | Pressure(cm H2O) Flow(L/min) 4 14 5 16 10 25 15 33 20 40 | Pressure(cm H2O) Flow(L/min) 3 18 7 28 12 36 16 43 20 49 | The leak rate is lower than thepredicate ResMed Pixi. Since theleak rate of the SleepWeaverPediatric mask is greater than apatient would exhale per minuteand the SleepWeaver Pediatricmask passed the rebreathing testsunder ISO 17510-2, it can beconcluded that the SleepWeaverAdvance Pediatric Nasal CPAPMask, is substantially equivalent to |
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| the predicate device, the ResMedPixi Pediatric Mask, in regards tothis comparison. | |||
|---|---|---|---|
| AppliedStandards | ISO 14971, ISO 10993-1, 10993-5, ISO 10993-10, ISO 5356-1,IEC 62366, ISO 5367, ISO17510-2 | ISO 10993-1 | Not applicable |
Non-Clinical Testing Summary:
Bench top testing for the SleepWeaver Advance Pediatric Nasal CPAP Mask included the following tests or evaluations:
- . Product performance;
- Fixed leak rate per ISO 17510-2; O
- Resistance to flow per ISO 17510-2; O
- o CO2 rebreathing testing per ISO 17510-2:
- Physical dead space; and O
- O Headgear attachment;
- Reliability/Cleaning:
- Fit evaluation and anthropometric analysis; and ●
- Simulated use case;
- . Biocompatibility:
- Patient contact Duration: Permanent o
- Gas Pathway (External Communicating) Components: Swivel connector, O mask body material, nasal interface, and internal surface of the oral interface. The materials in these components have been used in legally marketed devices (SleepWeaver Advance Nasal CPAP Mask (K092362), SleepWeaver Elan Nasal CPAP Mask (K120757), and SleepWeaver Anew Full Face Mask CPAP (K130481)).
- Surface Contact (Skin) Components: Headgear/mask wings and external o surface of the oral interface. The materials in these components have been used in legally marketed devices (SleepWeaver Advance Nasal CPAP Mask (K092362), SleepWeaver Elan Nasal CPAP Mask (K120757), and SleepWeaver Anew Full Face Mask CPAP (K130481)).
The packaging of the SleepWeaver Advance Pediatric Nasal CPAP mask uses the same packaging and is stored in the same way as other legally marketed devices (SleepWeaver Advance Nasal CPAP Mask (K092362)).
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Clinical Data
Use of the SleepWeaver Advance Pediatric Nasal CPAP Mask is supported by bench testing and is sufficient to demonstrate substantial equivalence to the ResMed Pixi Pediatric Mask.
Substantial Equivalence (Conclusion)
The new device, the SleepWeaver Advance Pediatric Nasal CPAP Mask, is substantially equivalent to the predicate device, the ResMed Pixi Pediatric Mask (K102224):
- . it has the same intended use;
- it has the same patient population;
- . it has similar technological characteristics;
- it has similar performance characteristics; and
- it does not raise new questions of safety and effectiveness ●
Thus it can be concluded that the SleepWeaver Advance Pediatric Nasal CPAP Mask, is substantially equivalent to the predicate device, the ResMed Pixi Pediatric Mask.
§ 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).