(60 days)
Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.
The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.
The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.
The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.
The document describes a medical device, the AF531 Oro-Nasal SE Face Mask, and its substantial equivalence to predicate devices, rather than a study on an AI/ML powered device. Therefore, it does not contain the information required to answer your query regarding acceptance criteria and performance studies for an AI/ML device.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample sizes used for a test set (in the context of AI/ML).
- Data provenance (country of origin, retrospective/prospective) for AI/ML data.
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication method for AI/ML ground truth.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
- Sample size for a training set in an AI/ML context.
- How ground truth for a training set was established for an AI/ML model.
The document is a 510(k) summary for a physical medical device (a face mask for ventilation) and focuses on demonstrating substantial equivalence based on intended use, design, materials, and performance specifications relevant to a physical component. The "Non-Clinical Data Submitted" section lists engineering and biological performance tests (e.g., total mask leak, pressure drop, sound testing, biocompatibility), not AI/ML model performance metrics.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
December 30, 2024
Respironics, Inc. Gary LeMere Principal Regulatory Affairs Specialist 1001 Murry Ridge Ln Murrysville, Pennsylvania 15668
Re: K243394
Trade/Device Name: AF531 Oro-Nasal SE Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: October 31, 2024 Received: October 31, 2024
Dear Gary Lemere:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
AF531 Oro-Nasal SE Face Mask
Indications for Use (Describe)
Medium and Large Size:
The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size:
The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kq) who are appropriate candidates for noninvasive ventilation.
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 – K243394
| Date Prepared | December 27, 2024 |
|---|---|
| Company Name/ Owner | Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668(724) 733-0200 |
| Official Contact | Gary LeMerePrincipal Regulatory Affairs Specialist |
| Proprietary Name(s) | AF531 Oro-Nasal SE Face Mask |
| Common/Usual Name | Oro-Nasal Face Mask |
| Classification | Class II |
| Product Code | CBK - ventilator, continuous, facility use |
| Regulation Name | Continuous ventilator |
| Regulation Number | 21 CFR 868.5895 |
| Review Panel | Anesthesiology |
| Primary Predicate Device510(k)Product Code | AF541 SE Full Face MaskK150638CBK |
| Secondary Predicate Device510(k)Product Code | AF531 SE Full Face MaskK101129CBK |
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Device Description
The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.
The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.
The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.
Indications for Use
AF531 Oro-Nasal SE Face Mask
Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.
| DesignParameter orFeature | Subject Device:AF531 Oro-Nasal SE FaceMask | Primary Predicate:AF541 SE Full Face MaskK150638(September 18, 2015) | Secondary Predicate:AF531 SE Full Face MaskK101129(September 16, 2010) | Comments |
|---|---|---|---|---|
| Intended Use | Intended Use | |||
| ClassificationProduct Code | CBK | CBK | CBK | Identical |
| RegulationNumber | 21 CFR§ 868.5895 | 21 CFR§ 868.5895 | 21 CFR§ 868.5895 | Identical |
| Classification | II | II | II | Identical |
| Indications forUse | Medium and Large:The AF531 Oro-Nasal SEFace Mask is intended toprovide a patient interfacefor application ofnoninvasive ventilation. Themask is to be used as anaccessory to ventilatorswhich have adequate alarmsand safety systems forventilation failure, and which | The AF541 SE Full FaceMask is intended to providea patient interface forapplication of noninvasiveventilation. The mask is tobe used as an accessory toventilators which haveadequate alarms and safetysystems for ventilationfailure, and which are | The AF531 SE Full FaceMask is intended toprovide a patient interfacefor application ofnoninvasive ventilation.The mask is to be used asan accessory to ventilatorswhich have adequatealarms and safety systemsfor ventilation failure, and | Equivalent |
| DesignParameter orFeature | Subject Device:AF531 Oro-Nasal SE FaceMask with click-style elbow | Primary Predicate:AF541 SE Full Face MaskK150638(September 18, 2015) | Secondary Predicate:AF531 SE Full Face MaskK101129(September 16, 2010) | Comments |
| are intended to administerCPAP or positive pressureventilation for treatment ofrespiratory failure,respiratory insufficiency orobstructive sleep apnea.The mask is for single use inthe hospital/institutionalenvironment only. The maskis to be used on patients(>30 kg) who areappropriate candidates fornoninvasive ventilation.Small:The AF531 Oro-Nasal SEFace Mask is intended toprovide a patient interfacefor application ofnoninvasive ventilation. Themask is to be used as anaccessory to ventilatorswhich have adequate alarmsand safety systems forventilation failure, and whichare intended to administerCPAP or positive pressureventilation for treatment ofrespiratory failure,respiratory insufficiency orobstructive sleep apnea.The mask is for single use inthe hospital/institutionalenvironment only. The maskis to be used on patients 7years or older (>20 kg) whoare appropriate candidatesfor noninvasive ventilation. | intended to administerCPAP or positive pressureventilation for treatment ofrespiratory failure,respiratory insufficiency orobstructive sleep apnea.The mask is for single usein the hospital/ institutionalenvironment only. Themask is to be used onpatients (>40lbs/20kg) whoare appropriate candidatesfor noninvasiveventilation. | which are intended toadminister CPAP orpositive pressureventilation for treatment ofrespiratory failure,respiratory insufficiency, orobstructive sleep apnea.The mask is for single usein the hospital/institutionalenvironment only. Themask is to be used onpatients 7 years or older(>40lbs/20kg) who areappropriate candidates fornoninvasiveventilation | ||
| PatientPopulation | Small Size: Patients >7years (>20kg)Medium/Large Size: >30kg | All sizes: Patients>40lbs/20kg | Small Size: Patients >7years (>40lbs/20kg) | Equivalent |
| FunctionalIndication | Interface for application ofnoninvasive ventilation | Interface for application ofnoninvasive ventilation | Interface for application ofnoninvasive ventilation | Identical |
| Environmentof Use | Hospital/Institutional Environment | Hospital/Institutional Environment | Hospital/Institutional Environment | Identical |
| ReprocessingClaims | Single use | Single use | Single use | Identical |
| AnatomicalSites | Nose and mouth | Nose and mouth | Nose and mouth | Identical |
| DesignParameter orFeature | Subject Device:AF531 Oro-Nasal SE FaceMask with click-style elbow | Primary PredicateAF541 SE Full Face MaskK150638(September 18, 2015) | Secondary Predicate:AF531 SE Full Face MaskK101129(September 16, 2010) | Comments |
| Sterile State asProvided | Non-Sterile | Non-Sterile | Non-Sterile | Identical |
| Useful Life | ≤ 7 days | Not Defined | Not Defined | Equivalent |
| Device Design | Polycarbonate faceplateSilicone cushionClick-Style ElbowsSE option withoutentrainment valveElbow retention hub toretain click-style elbowHeadgearAccessory Port Cap | Nylon FaceplateSilicone cushionClick-Style ElbowsSE option withoutentrainment valveNo elbow retention hubintegral to AF541design; elbows attachvia faceplateHeadgearAccessory Port Cap | PolycarbonatefaceplateSilicone cushionPress-fit ElbowsSE option withoutentrainment valveElbow retention hub toretain press-fit elbowHeadgearPick-off Port Cap | Equivalent |
| Faceplate/Cushion Type | Covers nose and mouth | Covers nose and mouth | Covers nose and mouth | Identical |
| ExhalationDevice Design | Separate exhalation devicerequired | Separate exhalation devicerequired | Separate exhalation devicerequired | Identical |
| Headgear Type | CapStrap or four-pointheadgear | CapStrap or four-pointheadgear | CapStrap or four-pointheadgear | Identical |
| Patient CircuitConnection | 22mm click-style elbow with22mm connector | 22mm click-style elbow with22mm connector | 22mm press-fitelbow with 22mmconnector | Equivalent |
| Mask Sizes | Small, Medium, and Large | Small, Medium, Large, andExtra-Large | Small | Equivalent |
| Materials -Elbows | SE Click-Style Elbow:Polypropylene (Blue)Accessory Port Cap:Silicone | SE Click-Style Elbow:Polypropylene (Blue)Accessory Port Cap:Silicone | SE Press-Fit Elbow:Polycarbonate (Blue)Pick-off Port Cap:Silicone | Identical toPrimarypredicate |
| Materials -Mask andHeadgearComponent | Mask Materials:Faceplate:Polycarbonate/polysiloxaneCushion: PolysiloxaneClick-Style Elbow Hub:PolycarbonateSplit Washer: PolycarbonateForehead Arm:Polycarbonate/ polysiloxaneSupport Retaining Clip:PolycarbonateForehead Bracket:Polycarbonate/polysiloxaneDisposable Foam ForeheadSpacer: Polyurethane foam | Mask Materials:Faceplate: NylonOver the nose / under thenose Cushion: SiliconeOver the Nose / under thenose Hub: NylonHeadgear Materials:4 Point Crown HeadgearMaterials:Forehead Pad Bracket:NylonForehead Adjuster BallPost:NylonForehead Adjuster Button:NylonDisposable Foam ForeheadSpacer:Polyurethane | Mask Materials:Faceplate: Polycarbonate/polysiloxaneCushion: PolysiloxanePress-Fit Elbow Hub:PolycarbonateSplit Washer:PolycarbonateForehead Arm:Polycarbonate/polysiloxaneSupport Retaining Clip:PolycarbonateForehead Bracket:Polycarbonate/polysiloxaneDisposable FoamForehead Spacer:Polyurethane foam | Equivalent |
| DesignParameter or | Subject Device:AF531 Oro-Nasal SE Face | Primary PredicateAF541 SE Full Face Mask | Secondary Predicate:AF531 SE Full Face Mask | Comments |
| Feature | Mask with click-style elbow | K150638(September 18, 2015) | K101129(September 16, 2010) | |
| Headgear Clip:Polypropylene,Tension Clip:PolyoxymethyleneVelcro Hook: NylonHeadgear Material: NylonPolyester Polyurethane,Nylon | ||||
| CapStrap Materials:CapStrap Halo: NylonCapStrap Soft Goods:Nylon, Polyester/Polyurethane,Polyester/Lycra Knit ElasticCapStrap Clip:Acetal copolymer | CapStrap Headgear:Cap: Nylon Fabric, Foam,Pad Bracket: NylonAdhesive: LoctiteHeadgear Clip:PolypropyleneVelcro Hook: Nylon | CapStrap Materials:CapStrap Halo: NylonCapStrap Soft Goods:Nylon,Polyester/ Polyurethane,Polyester/Lycra KnitElasticCapStrap Clip:Acetal copolymer | ||
| Headgear Materials:Headgear Clip:Acetal copolymerHeadgear Material: Nylon,Lycra, Polyester/polyurethane,Polyoxymethylene | Headgear Material: NylonPolyester Polyurethane | Headgear Materials:Headgear Clip:Acetal copolymer.Headgear Material: Nylon,Lycra Polyester/polyurethane,Polyoxymethylene | ||
| Performance Specifications | ||||
| PressureRange | 4 to 40cmH2O | 4 to 40cmH2O | 4 to 40cmH2O | Identical |
| Total MaskLeak | Specification:≤15 SLPM@4.0cmH2O≤25 SLPM@40.0cmH2O | SE Specification, all sizes:≤15 SLPM@4.0cmH2O≤25 SLPM@40.0cmH2O | Specification:≤15 SLPM@4.0cmH2O≤25 SLPM@40.0cmH2O | Identical |
| Pressure Drop | Specifications:≤ 1.0cmH2O@50SLPM≤ 4.0cmH2O@100SLPM | Specifications:≤ 1.0cmH2O@50SLPM≤ 4.0cmH2O@100SLPM | Specifications:≤ 1.0cmH2O@50SLPM≤ 4.0cmH2O@100SLPM | Identical |
| Sound Powerand PressureLevel | Test results at 10cmH2O:Power Level:18.2dBA@1mPressureLevel:10.9dBA@1m | Test results:Power Level:16.5dBAPressure Level:9.4dBA | Not provided in originalsubmission | Equivalent |
| DeadspaceVolume (mL) | Specification:S: <350mLM: <525mLL: <650mL | Specification:S: <700mLM: <700mLL: <700mL | Specification:S: <350mL | Equivalent |
| NIVO NebulizerCompatibility | Compatible with NIVONebulizer | Compatible with NIVONebulizer | Compatible with theAerogen SE elbow andNIVO Nebulizer | Equivalent |
Comparison Table 1: AF531 Oro-Nasal SE Face Mask
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Discussion of Similarities and Differences
The subject device AF531 Oro-Nasal SE Face Mask has the following similarities and differences in comparison to the predicate devices:
Similarities:
- Intended use ●
- Product Code ●
- Operating Principle .
- Similar Design ●
- Similar Materials
- Compatible with NIVO Nebulizer ●
Differences:
- The subject device has the click fit elbow design that was not present on the secondary ● predicate device
- Minor design / material changes to hub to accommodate the click style elbow ●
Discussion on Differences:
The difference between the subject device and the secondary predicate is the incorporation of the click-style elbow with hub that replaces the press fit elbow. This characteristic does not differ from the primary predicate. The change to incorporate the click style elbow does not represent a technologically different characteristic.
Non-Clinical Data Submitted
Non-clinical verification testing completed for the new device demonstrated that the AF531 Oro-Nasal SE Face Mask with click-style elbow met all intended performance requirements. These include:
- Total Mask Leak ●
- Pressure Drop Closed to Atmosphere ●
- Sound Testing and Pressure Level ●
- . Physical Dead Space
AF531 Oro-Nasal SE Face Mask with the click-style elbow was designed and tested in accordance with the applicable relevant consensus standards including:
| ISO 17510:2015 | Medical devices – Sleep apnoea breathing therapy – Masks and applicationaccessories |
|---|---|
| ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation and testingwithin a risk management process |
| ISO 10993-3:2014 | Biological evaluation of medical devices – Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity |
| ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices – Part 10: Tests for skinsensitization |
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| ISO 10993-12:2012 | Biological evaluation of medical devices – Part 12: Sample preparation andreference materials |
|---|---|
| ISO 10993-17:2002 | Biological evaluation of medical devices – Part 17: Establishment ofallowable limits for leachable substances |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemicalcharacterization of medical device materials within a risk managementprocess |
| ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 1: Evaluation and testing within a risk managementprocess |
| ISO 18562-2:2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 2: Tests for emissions of particulate matter |
| ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications – Part 3: Tests for emissions of volatile organic compounds(VOCs) |
| ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 4: Tests for leachables in condensate |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied bythe manufacturer – Part 1: General requirements |
| ISO 14971-1:2019 | Medical devices – Application of risk management to medical devices |
| ISO 5356-1:2004 | Anaesthetic and respiratory equipment - Conical connectors Part 1: Conesand sockets |
Substantial Equivalence Conclusion
The subject device, AF531 Oro-Nasal SE Face Mask with click-style elbow, is substantially equivalent to the predicate devices, AF541 SE Full Face Mask (K150638) and AF531 SE Full Face Mask (K101129).
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).