(288 days)
The F&P Eson™ 2 Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level therapy. The F&P Eson™ 2 Nasal Mask is intended for single patient adult (≥ 66lb (30kg)) use in the home and for multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Eson™ 2 Nasal Mask is a non-invasive patient interface with a silicone seal which covers around the nose of a patient held in place by adjustable headgear straps.
The mask connects to a single breathing tube via a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Eson™ 2 Nasal Mask is a prescription only device, provided in a non-sterile state.
An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring (previously covered by K121597 F&P Eson Nasal Mask).
This document describes a 510(k) premarket notification for the F&P Eson™ 2 Nasal Mask, which is a non-invasive patient interface for CPAP or Bi-level therapy. The purpose of the submission is to demonstrate substantial equivalence to a predicate device, the Eson™ Nasal Mask (K121597).
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies, formatted to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly list "acceptance criteria" in a separate table for performance metrics in the same way one might find for an AI medical device. Instead, it compares the F&P Eson™ 2 Nasal Mask to its predicate device and states conformance to relevant standards. The "Comments" column in the comparison tables serves as an implicit acceptance of the observed performance relative to the predicate or standard.
| Feature | Implicit Acceptance Criteria / Standard | Predicate Device (K121597) Performance | F&P Eson™ 2 Nasal Mask Performance | Device Meets Criteria? |
|---|---|---|---|---|
| Classification Regulation | 21 CFR §868.5905 | 868.5905 | 868.5905 | Yes (Identical) |
| Product Code | BZD (Anaesthesiology) | BZD | BZD | Yes (Identical) |
| Indications for Use | Substantially equivalent to predicate, adult patient population (>= 30kg) | For individuals requiring CPAP or Bi-Level therapy, adult (single/multiple patient use) | For individuals requiring CPAP or Bi-Level therapy, adult (>= 66lb (30kg)) (single/multiple patient use) | Yes (Substantially equivalent with minor clarification) |
| Resistance to Flow | Conformance with ISO 17510-2 | With diffuser: 0.14 ± 0.1cmH2O @ 50L/min, 0.65 ± 0.1cmH2O @ 100L/minWithout diffuser: 0.15 ± 0.1cmH2O @ 50L/min, 0.62 ± 0.1cmH2O @ 100L/min | With diffuser: 0.19 ± 0.1cmH2O @ 50L/min, 0.80 ± 0.1cmH2O @ 100L/minWithout diffuser: 0.17 ± 0.1cmH2O @ 50L/min, 0.73 ± 0.1cmH2O @ 100L/min | Yes (In conformance with ISO 17510-2 despite higher values) |
| Dead Space | Conformance with ISO 17510-2 | Small: 61 cc, Medium: 67 cc, Large: 79 cc | Small: 69 cc, Medium: 86 cc, Large: 98 cc | Yes (In conformance with ISO 17510-2 despite higher values) |
| Pressure Range | Allowable pressure range | 4 to 25cmH2O | 4 to 30 cmH2O | Yes (Higher allowable pressure is acceptable) |
| Sound Emissions | Sound power level < 25 dBA | With diffuser: 30 dBA (power), 22 dBA (pressure)Without diffuser: 32 dBA (power), 24 dBA (pressure) | With diffuser: 21.3 dBA (power), 13.3 dBA (pressure)Without diffuser: 31.4 dBA (power), 23.4 dBA (pressure) | Yes (Quieter with diffuser, overall acceptable) |
| Biocompatibility | Conformance with ISO 10993 | (Implied compliant) | Differences in materials from predicate underwent cytotoxicity, sensitization and extractables and leachables testing to demonstrate biocompatibility as per ISO 10993. | Yes (Demonstrated) |
| Transportation & Storage | Perform as intended, no deformation, sufficient CO2 removal, no lint, no odor, intact packaging | (Not explicitly stated but implied compliant for predicate) | No visible deformations, sufficiently removed CO2, no visible lint, no offensive odor, packaging intact. | Yes |
| Automatic High-Level Disinfection | Minimum 6 log reduction | (Not explicitly stated but implied compliant for predicate) | Achieved minimum 6 log reduction. | Yes |
| Thermal Disinfection | Effective disinfection at specified cycles (75°C for 30min, 80°C for 10min, 90°C for 1min) | (Not explicitly stated but implied compliant for predicate) | Able to be thermally disinfected through predetermined cycles. | Yes |
| Carbon Dioxide Flushing | Meet minimum flush rate | (Not explicitly stated but implied compliant for predicate) | Sufficiently flushed carbon dioxide at a suitable rate under worst-case. | Yes |
| Shelf Life Assessment | Retain structural integrity; very remote risk of degradation within 10 years | (Not explicitly stated but implied compliant for predicate) | Materials have well-known, stable properties, very remote risk of degradation within 10 years. | Yes |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This submission does not involve an AI device and thus does not refer to "test sets" in the context of machine learning model evaluation. The non-clinical tests performed (e.g., resistance to flow, dead space, sound emissions, disinfection, shelf life, CO2 flushing) are likely in-house laboratory tests on a representative number of device samples. The document does not specify the exact sample sizes for these tests or the country of origin of the data, but it implies the testing was conducted by Fisher & Paykel Healthcare based in New Zealand. These were likely prospective tests conducted for the purpose of this submission.
3. 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. As this is not an AI device, there is no "ground truth" establishment by experts in the context of image interpretation or similar AI applications. Performance is measured using objective engineering and laboratory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI device submission requiring adjudication of expert interpretations for a test set.
5. 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 a medical device (nasal mask), not an AI diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device. The device itself is the "standalone" component being evaluated functionally.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the F&P Eson™ 2 Nasal Mask's performance is established by objective engineering and laboratory measurements against recognized international standards (ISO 17510-2, ISO 10993-1) and internal functional specifications. For biocompatibility, the ground truth is adherence to the toxicological profiles defined by ISO 10993. For disinfection, the ground truth is achieving a specified log reduction of microorganisms.
8. The sample size for the training set
Not applicable. This is not an AI device and does not involve training data sets.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device and does not involve training data sets or their ground truth establishment.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles 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
September 20, 2016
Fisher&Paykel Amelia Ortiz Regulatory Affairs Specialist 15 Maurice Paykel Place, EastTamaki P O Box 14 348. Panmure Auckland 2013, New Zealand
Re: K153505
Trade/Device Name: F&P Eson™ 2 Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 17, 2016 Received: August 22, 2016
Dear Ms. Ortiz:
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 801and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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as set forth in 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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,
Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K153505
Device Name F&P Eson™ 2 Nasal Mask
Indications for Use (Describe)
The F&P Eson™ 2 Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level therapy. The F&P Eson™ 2 Nasal Mask is intended for single patient adult (≥ 661b (30kg)) use in the home and for multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.
| 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) |
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510(k) Summary
Image /page/3/Picture/4 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, and the word "Healthcare" is on the bottom line. A horizontal line separates the two lines of text. The text is in a dark blue font.
15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person/Author | Amelia Ortiz |
|---|---|
| Co-Author/Reviewer | Sue Cho, Ryan Bormann |
| Date prepared | 21 September 2016 |
| Contact details | Address: 15 Maurice Paykel PlacePaykel BuildingEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100Fax: +64 9 574 0158 |
| Trade name | F&P Eson™ 2 Nasal Mask |
| Common name | Nasal Mask |
| Classification name | Non Continuous Ventilator (IPPB)Class II (21 CFR §868.5905)Product code BZD (Anaesthesiology) |
| Predicate device | Eson™ Nasal Mask (K121597) |
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Device Description
The F&P Eson™ 2 Nasal Mask is a non-invasive patient interface with a silicone seal which covers around the nose of a patient held in place by adjustable headgear straps.
The mask connects to a single breathing tube via a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Eson™ 2 Nasal Mask is a prescription only device, provided in a non-sterile state.
An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring (previously covered by K121597 F&P Eson Nasal Mask).
Indications for Use
The F&P Eson™ 2 Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level therapy. The F&P Eson™ 2 Nasal Mask is intended for single patient adult (≥ 66lb (30kg)) use in the home and for multiple patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
Technological Characteristics Comparison
The F&P Eson™ 2 Nasal Mask has the following similarities to the previously cleared predicate Eson™ Nasal Mask (K121597):
- -Substantially equivalent intended use with same patient population and operating environment.
- -Same mode of operation whereby both masks deliver gases through the nose.
- -Same breathing tube connection mechanism via a 22mm connector.
- -Same RollFit™ seal mechanism where the silicone seal rolls back and forward on the bridge of the nose.
- -Both new and the predicate device headgear are designed to attach at the same four points on the mask frame.
The key differences to the predicate device are that the F&P Eson™ 2 Nasal Mask:
- Has colour cues (VisiBlue™) added to swivel, frame, seal, and headgear components to aid in reassembly and orientation of the mask.
- Provide a simpler diffuser system whereby the diffuser mat and the cover have been integrated into a single component and is washable.
- -Has a detachable elbow to aid in mask cleaning and disinfection.
- -Has a headgear which allows over the head fitting of the mask.
- -Has a notch mechanism for crown strap headgear adjustment, removing the need of a headgear buckle piece for adjustment.
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| Feature | F&P Eson™ 2Nasal Mask | Predicate Device:Eson™ NasalMask (K121597) | Comment |
|---|---|---|---|
| ClassificationRegulation | 868.5905 | 868.5905 | Identical |
| Product Code | BZD | BZD | Identical |
| Indications for Use | The F&P Eson 2Nasal Mask isintended to beused by individualswho have beendiagnosed by aphysician asrequiring CPAP orBi-Level therapy.The F&P Eson 2Nasal Mask isintended for singlepatient adult ( $≥$ 66lb(30kg)) use in thehome and formultiple patientadult use in thehospital or otherclinical settingwhere properdisinfection of thedevice can occurbetween patientuses. | The F&P EsonNasal Mask isintended to beused by individualswho have beendiagnosed by aphysician asrequiring CPAP orBi-Level Ventilatortreatment. TheF&P Eson NasalMask is intendedfor Single PatientAdult Use in thehome and MultiplePatient Adult Usein the hospital orother clinicalsetting whereproper disinfectionof the device canoccur betweenpatient uses. | The indications for usebetween F&P Eson 2 NasalMask and Eson Nasal Maskare identical, with theaddition of a weightspecification for adultpatients $≥$ 66lb (30kg). |
| Patient Population | Adult | Adult | Identical |
| OperatingEnvironment | Home, hospital orother clinicalsetting | Home, hospital orother clinicalsetting | Identical |
| Mask Availability | Prescription only | Prescription only | Identical |
| Breathing Circuit | Single inspiratorytube | Single inspiratorytube | Identical |
| Exhalation Vent(Exhaust holes) | Exhalation vent inthe form of clusterof holes located onthe elbow. | Exhalation vent inthe form of clusterof holes located onthe elbow. | Substantially equivalent |
| Feature | F&P Eson™ 2 Nasal Mask | Predicate Device:Eson™ Nasal Mask (K121597) | Comment |
| Reusability between multiple patients | Reusable (Multi-Patient Use) – validated high-level thermal disinfection method available for cleaning between patient use | Reusable (Multi-Patient Use) – validated high-level thermal disinfection method available for cleaning between patient use | Identical |
| Face Coverage | Seal around the nose | Seal around the nose | Identical |
| Number of Seal Sizes | 3 sizes – small, medium, and large. | 3 sizes – small, medium, and large. | Identical |
| Accessories | Oxygen / Pressure Port Adaptor (900HC452) | Oxygen / Pressure Port Adaptor (900HC452) | Identical |
| Breathing Tube connection to Mask | 22mm conical connector | 22mm conical connector | Identical |
| Facial Seal Design | RollFit™ seal design which self-adjusts by rolling back and forward on the bridge of the nose. | RollFit™ seal design which self-adjusts by rolling back and forward on the bridge of the nose. | Identical |
| Diffuser | Washable one piece design with integrated diffuser mat and cover. | Two piece design consisting of diffuser cover and replacement only diffuser mat/filter. | Substantially equivalent.Function and mechanism of the diffuser component are identical.F&P Eson™ 2 Nasal Mask diffuser was modified to be washable and the number of components were reduced. |
| Elbow Design | Removable elbow | Permanently attached elbow | F&P Eson™ 2 Nasal Mask elbow modified to be removable for ease of cleaning. |
| Feature | F&P Eson™ 2Nasal Mask | Predicate Device:Eson™ NasalMask (K121597) | Comment |
| Headgear Design | Six headgear straps. Four attachment points on the mask frame. Notch mechanism for crown headgear strap adjustment. | Six headgear straps. Four attachment points on mask frame. Buckle adjustment mechanism for crown headgear straps. | Different in design - crown headgear strap modified to eliminate the need of a buckle piece for adjustment.The modification has not significantly altered the way in which the headgear interacts with the patient or the connection points on the mask. The adjustment points on the headgear for the patient remain the same as the predicate. |
| Mask Fitting | Using headgear clips located on the bottom headgear strap. By loosening of bottom headgear straps. Over the head | Using headgear clips located on the bottom headgear strap. By loosening of bottom headgear straps. | F&P Eson™ 2 Nasal Mask provides an additional method of fitting the mask to the predicate – over the head. |
| Mask ElbowDesign(ball elbow) | Removable | Non-removable | F&P Eson™ 2 Nasal Mask elbow modified to be removable to aid in cleaning and disinfection of the mask. |
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| Feature | F&P Eson™ 2Nasal Mask | Predicate Device:Eson™ NasalMask (K121597) | Comment |
|---|---|---|---|
| Resistance toFlow | With diffuser:Pressure drop through mask @ 50L/min:0.19 ± 0.1cmH2O Pressure drop through mask @ 100L/min:0.80 ± 0.1cmH2O Without diffuser: Pressure drop through mask @ 50L/min:0.17 ± 0.1cmH2O Pressure drop through mask @ 100L/min:0.73 ± 0.1cmH2O | With diffuser:Pressure drop through mask @ 50L/min:0.14 ± 0.1cmH2O Pressure drop through mask @ 100L/min:0.65 ± 0.1cmH2O Without diffuser: Pressure drop through mask @ 100L/min:0.15 ± 0.1cmH2O Pressure drop through mask @ 100L/min:0.62 ± 0.1cmH2O | F&P Eson™ 2 Nasal Mask has a higher pressure drop and is in conformance with ISO 17510-2. |
| Dead Space | Small: 69 ccMedium: 86 ccLarge: 98 cc | Small: 61 ccMedium: 67 ccLarge: 79 cc | F&P Eson™ 2 Nasal Mask has more dead space and is in conformance with ISO 17510-2 |
| Pressure Range | 4 to 30 cmH2O | 4 to 25cmH2O | F&P Eson 2 has a higher allowable pressure rating |
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7
| Feature | F&P Eson™ 2 Nasal Mask | Predicate Device:Eson™ Nasal Mask (K121597) | Comment |
|---|---|---|---|
| Sound | With diffuser:Sound power level: 21.3 dBA with uncertainty 2.5 dBA.Sound pressure level: 13.3 dBA with uncertainty 2.5 dBA.Without diffuser:Sound power level: 31.4 dBA with uncertainty 2.5 dBA.Sound pressure level: 23.4 dBA with uncertainty 2.5 dBA. | With diffuser:Sound power level: 30 dBA with uncertainty 2.5 dBA.Sound pressure level: 22 dBA with uncertainty 2.5 dBA.Without diffuser:Sound power level: 32 dBA with uncertainty 2.5 dBA.Sound pressure level: 24 dBA with uncertainty 2.5 dBA. | F&P Eson™ 2 Nasal Mask is quieter than the predicate. |
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| Feature | F&P Eson™ 2Nasal Mask | Predicate Device:Eson™ NasalMask (K121597) | Comment |
|---|---|---|---|
| Materials ofConstruction | Swivel:polycarbonate,ink pad print. Elbow:polycarbonate. Diffuser assembly:polycarbonate,polyethylenephthalate withpigment. Frame assembly:polycarbonate,ink pad print,blue colorant. Seal assembly:polycarbonate,silicone, inkpad print. Headgear:nylon/spandex,polyurethanefoam, nylon,grey and bluecolorant. Headgearclips: acetal. | Swivel:polycarbonate,grey colourant. Elbow:polycarbonate. Diffuser assembly:polycarbonate,polyester fibre. Frame:Polycarbonate. Seal assembly:polycarbonate,silicone. Headgear:nylon/spandex,polyurethanefoam. Headgearclips: acetal. Headgearbuckle: nylon,grey colorant. | F&P Eson™ 2 Nasal Maskand Eson™ Nasal Mask areconstructed from similarmaterials.Differences in materials fromthe predicate underwentcytotoxicity, sensitizationand extractables andleachables testing todemonstrate that the deviceis biocompatible as per ISO10993. |
Non-Clinical Tests
Testing of the F&P Eson™ 2 Nasal Mask was compared to the predicate K121597 Eson Nasal Mask for performance and biocompatibility. These tests demonstrate substantial equivalence of the F&P Eson™ 2 Nasal Mask to the predicate device.
The F&P Eson™ 2 Nasal Mask has been tested to the following standards:
- . ISO 17510-2:2007 Sleep Apnoea Breathing Therapy - Part 2: Masks and Applications Accessories
- . ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
Specific tests used to show conformance to these standards include:
- . Transportation and storage testing to provide evidence that the mask will perform as intended once it arrives to the prescribed user. Results were that the product had no
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visible deformations, sufficiently removed CO2 through the exhaust vents, had no visible lint on the seal, had no offensive odour, that the packaging was still intact.
- . Automatic High-Level Disinfection to provide evidence that the mask can effectively be disinfected in a certified washer disinfector. The mask was able to achieve the minimum 6 log reduction.
- Thermal Disinfection to provide evidence that the mask can effectively be disinfected through thermal disinfection cycles of 75°C for 30min, 80°C for 10min and 90°C for 1min. The mask was able to be thermally disinfected through the predetermined cycles.
- . Sound Emissions to provide evidence that the sound pressure level is less than 25 dBA. Mask was able to achieve a sound pressure level of less than 25dBA with the diffuser system.
- . Carbon Dioxide Flushing to determine if the mask is able to meet the minimum carbon dioxide flush rate. Under the worst case scenario, the mask was able to sufficiently flush carbon dioxide at a suitable rate.
- Shelf Life Assessment to show that the materials used in the mask have the ability to . retain their structural integrity during storage. It was determined that the mask's materials have well known properties, are very stable and present a very remote risk of degradation within a shelf life of 10 years.
Clinical Tests
Not applicable - no clinical testing was performed with respect to the Eson™ 2 nasal mask.
Conclusion
The comparison of features, performance, and intended use demonstrate that the F&P Eson™ 2 Nasal Mask is substantially equivalent to the predicate K121597 Eson Nasal 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).