(204 days)
The Whitsundays Mask System has two product variants:
• Whitsundays mask
· Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
The Whitsundays Mask System is an accessory to deliver airflow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support (non-life support). It delivers the treatment pressure from the source to the patient's upper airway by providing an air seal between the PAP device and the bottom of the patient's nose.
The Whitsundays mask system has two product variants:
- Whitsundays mask This is the home use variant that is intended for single patient re-use.
- . Whitsundays SLM (Sleep Lab Mask) This is the SLM variant that is intended for multi-patient re-use and must be reprocessed if reused between patients.
The Whitsundays Mask System is made up of 4 main component assemblies: nasal cushion, conduit frame, elbow, and headgear. The nasal cushion and conduit frame are available in various sizes to allow for adequate mask fit in the intended patient population.
The Whitsundays Mask System is a prescription device supplied non- sterile.
The provided text describes the ResMed Whitsundays Mask System and its substantial equivalence to a predicate device, the Scone mask (K180497). The document focuses on non-clinical data and acceptance criteria based on recognized standards.
Here's the breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Design Parameter | Predicate Device Performance (Scone mask) | Reported Device Performance (Whitsundays Mask System) | Acceptance Criteria Comment |
|---|---|---|---|
| Mask Exhaust Flow (Nominal) (ISO 17510:2015 Annex B) | |||
| - Pressure 4 cm H2O | 20 L/min | 20 L/min | Identical |
| - Pressure 9 cm H2O | 31 L/min | 31 L/min | Identical |
| - Pressure 15 cm H2O | 41 L/min | 41 L/min | Identical |
| - Pressure 20 cm H2O | 49 L/min | 49 L/min | Identical |
| - Pressure 25 cm H2O | 55 L/min | 55 L/min | Identical |
| CO2 Re-breathing Performance (ISO 17510:2015 Annex F) | Complies (<20%) | Complies (<20%) | Identical (Acceptance criterion is <20% CO2 re-breathing as per ISO 17510:2015) |
| Physical Dead Space (mL) | |||
| - Frame SML, Cushion S | 109 | 109 | Equivalent (This is a record-only parameter, meaning values are reported rather than needing to meet a specific pass/fail threshold against the predicate, as long as they are comparable) |
| - Frame SML, Cushion SW | 105 | 105 | Equivalent |
| - Frame SML, Cushion M | 113 | 113 | Equivalent |
| - Frame STD, Cushion S | 116 | 116 | Equivalent |
| - Frame STD, Cushion SW | 112 | 112 | Equivalent |
| - Frame STD, Cushion M | 120 | 120 | Equivalent |
| - Frame SML, Cushion L | 119 | 119 | Equivalent |
| - Frame STD, Cushion L | 127 | 127 | Equivalent |
| Resistance to Flow (Pressure drop across mask in cmH2O) (ISO 17510:2015 Annex C) | |||
| - @50 L/min | 0.5 | 0.4 | Resistance to flow values are reported in the instructions for use in accordance with ISO 17510:2015. The subject device has slightly lower resistance, indicating equivalent or improved performance. |
| - @100 L/min | 2.3 | 1.6 | Resistance to flow values are reported in the instructions for use in accordance with ISO 17510:2015. The subject device has significantly lower resistance, indicating equivalent or improved performance. |
| Sound | |||
| - Sound power level | 21 dBA | 24 dBA | Equivalent. While the new device has a slightly higher sound power level (3 dBA increase), this is generally considered a minor difference in acoustic metrics and unlikely to raise new safety or effectiveness concerns, fitting within an "equivalent" assessment for regulatory purposes for this type of device. |
| - Sound pressure level | 14 dBA | 17 dBA | Equivalent. Similar to sound power, a 3 dBA increase in sound pressure is often considered acoustically equivalent or minor in regulatory context for patient comfort if within acceptable ranges, not raising new safety or effectiveness concerns. |
| Biocompatibility | Materials used in predicate | New materials for nasal cushion and conduit frame sleeve | Equivalent. All new materials have been included in previously cleared submissions or underwent biological evaluation as per ISO 10993-1 and ISO 18562-1, meeting the acceptance criteria for biocompatibility. |
| Reprocessing Claims Validation | Single/multi-patient re-use (Scone SLM: 30 cycles) | Single/multi-patient re-use (Whitsundays SLM: 30 cycles) | Identical. Validation performed in accordance with ISO 17664-1 and ISO 17664-2, including cleaning efficacy, disinfection efficacy, residual toxicity, and mechanical integrity testing, ensuring the reprocessing claims are met for the specified use life. |
| Mechanical Integrity | Not explicitly detailed | Met all intended performance requirements | New device completed non-clinical verification and validation testing, including mechanical integrity before and after environmental tests (home cleaning, transportation, storage, operation, free fall, sit test, cleaning, and reprocessing). The acceptance criteria are that the device maintains its mechanical integrity under these conditions. |
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical verification and validation testing" and "bench tests" for performance characteristics. The specific sample sizes for these tests are not provided in the summary.
The data provenance is from bench testing conducted by ResMed Pty Ltd. This is a form of prospective testing, as it involves newly manufactured devices undergoing controlled experiments. The country of origin for the company is Australia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies are primarily engineering and performance tests against recognized standards (e.g., ISO, rather than clinical studies requiring expert ground truth for interpretation like imaging).
4. Adjudication method for the test set
Not applicable. The evaluations are based on quantifiable measurements against established standards (e.g., flow rates, pressure drops, CO2 levels) rather than subjective assessments requiring adjudication.
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
This is not applicable. The device is a medical mask and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical mask, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests is established by international standards such as ISO 17510:2015, ISO 18562, ISO 10993, and ISO 17664. These standards define the acceptable performance limits and methodologies for testing. For some parameters like physical dead space, the "ground truth" is the measured value of the predicate device, against which the new device's measurements are compared for equivalence.
8. The sample size for the training set
This is not applicable. The device is a physical medical mask, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 6, 2023
ResMed Pty Ltd (Registration Number: 3004604967) % Sheila Bruschi Senior Director, Regulatory Affairs Resmed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K223747
Trade/Device Name: Whitsundays Mask System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 14, 2022 Received: June 5, 2023
Dear Sheila Bruschi:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223747
Device Name Whitsundays Mask System
Indications for Use (Describe)
The Whitsundays Mask System has two product variants:
• Whitsundays mask
· Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
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)
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Image /page/3/Picture/0 description: The image shows the ResMed logo. The logo consists of a curved line of dots that transitions from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.
510(k) Summary
[As required by 21 CFR 807.92(c)]
| Date Prepared: | July 6, 2023 |
|---|---|
| Company Name/Owner: | ResMed Pty Ltd1 Elizabeth Macarthur DriveBella Vista, NSW, 2153 Australia |
| Prepared and Submitted by: | Ms. Shu-Ying HuangRegulatory Affairs ManagerTel: +65 65727105Shuying.huang@resmed.com.sg |
| Official Contact: | Ms. Sheila BruschiSenior Director, Regulatory AffairsResMed Corp.9001 Spectrum Center BlvdSan Diego CA 92123 USATel +1 858 922 1803sheila.bruschi@resmed.com |
| Device Trade Name: | Whitsundays Mask System |
| Device Common Name: | Vented Nasal Mask |
| Classification andClassification Name: | 21 CFR 868.5905, 73 BZD (Class II)Accessory to Noncontinuous Ventilator (IPPB) |
| Product Code: | BZD |
| Predicate Device: | Scone mask (K180497) |
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Device Description:
The Whitsundays Mask System is an accessory to deliver airflow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support (non-life support). It delivers the treatment pressure from the source to the patient's upper airway by providing an air seal between the PAP device and the bottom of the patient's nose.
The Whitsundays mask system has two product variants:
- Whitsundays mask This is the home use variant that is intended for single patient re-use.
- . Whitsundays SLM (Sleep Lab Mask) This is the SLM variant that is intended for multi-patient re-use and must be reprocessed if reused between patients.
The Whitsundays Mask System is made up of 4 main component assemblies: nasal cushion, conduit frame, elbow, and headgear. The nasal cushion and conduit frame are available in various sizes to allow for adequate mask fit in the intended patient population.
The Whitsundays Mask System is a prescription device supplied non- sterile.
Indications for Use:
The Whitsundays Mask System has two product variants:
- Whitsundays mask
- . Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed noninvasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
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Image /page/5/Picture/0 description: The image contains the logo for ResMed. The logo features a curved line of dots that transition in color from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.
Comparison Table:
| Design parameter orfeature | Predicate device:Error! Reference source not found.Error! Reference source not found. | Subject device:Error! Reference source not found. | Comments | |
|---|---|---|---|---|
| Indications for Use | The Scone mask is intended to beused by patients weighing morethan 66 lb (30 kg) who have beenprescribed non-invasive positiveairway pressure (PAP) therapy suchas CPAP or bi-level therapy. Themask is intended for single patientre-use in the home and multi-patient re-use in thehospital/institutional environment. | The Whitsundays mask system hastwo product variants:• Whitsundays mask• Whitsundays SLM (Sleep LabMask)Both masks are intended forpatients weighing more than 66 lb(30 kg), who have been prescribednon-invasive CPAP or bi-levelpositive airway pressure (PAP)therapy. The Whitsundays mask isintended for single-patient reuse inthe home environment and theWhitsundays SLM is intended formulti-patient reuse in thehospital/institutional environment.The Sleep Lab Mask (SLM) is theonly variant that is validated andintended for multi-patientreprocessing and must bereprocessed if reused betweenpatients. | Equivalent | |
| Intended Use | The mask is intended to provide aninterface for CPAP or bi-leveldevices. | The mask is intended to provide aninterface for CPAP or bi-leveldevices. | Identical | |
| FDA Product Code | BZD | BZD | Identical | |
| Patient population | Patients weighing more than 66lb(30kg) for whom positive airwaypressure therapy has beenprescribed. | Patients weighing more than 66lb(30kg) for whom positive airwaypressure therapy has beenprescribed. | Identical | |
| Design parameter orfeature | Predicate device:Error! Reference source not found.Error! Reference source not found. | Subject device:Error! Reference source not found. | Comments | |
| Environment of Use | Home or hospital/institutionalenvironment. | Home or hospital/institutionalenvironment. | Identical | |
| Reprocessing claims | Single patient re-use or multi-patient re-use. | Single patient re-use or multi-patient re-use. | Identical | |
| Sterility state as provided | Non-sterile | Non-sterile | Identical | |
| Validated reprocessingmethods | High-Level Thermal disinfection | High-Level Thermal disinfection | Identical | |
| Materials | Materials include silicone, polycarbonate, polybutyleneterephthalate and nylon elastane polyurethane laminate. | Whitsundays mask system has new materials for the nasal cushion andfor the sleeve on the the conduit frame.Device materials include silicone, nylon elastane, polycarbonate, polybutylene terephthalate, polyurethane and nylon elastane polyurethane laminate | Equivalent. All of the materials usedin the subject device have beenincluded in previously clearedsubmissions or have undergonebiological evaluation as per ISO10993-1 and ISO 18562-1. | |
| Cushion type | Cradles patient's nose and sealsunder the nose | Cradles patient's nose and sealsunder the nose | Identical. The cushion is designed toseal in the same way. | |
| Frame type | Tubular conduit | Tubular conduit | Identical. | |
| PAP tubing connectionpoint | 22mm conical connector as per ISO5356-1 over the head connection | 22mm conical connector as per ISO5356-1 over the head connection | Identical. | |
| Exhaust port location | Elbow and cushion | Elbow and cushion | Identical. | |
| Sizes | Cushion available in four sizesFrame available in two sizesHeadgear available in one size | Cushion available three sizesFrame available in two sizesHeadgear available in one size | Equivalent | |
| Mask exhaustflow (Nominal)ISO 17510:2015Annex B | Pressure(cmH2O) | Flow(L/min)'Pillows' curve | Flow(L/min)'Pillows' curve | |
| 4 | 20 | 20 | Identical | |
| 9 | 31 | 31 | ||
| 15 | 41 | 41 | ||
| 20 | 49 | 49 | ||
| 25 | 55 | 55 |
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Image /page/6/Picture/0 description: The image shows the logo for ResMed. The logo features a curved line made of dots that transition in color from blue to red. Below the line of dots, the text "ResMed" is written in a bold, sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for ResMed. The logo consists of the word "ResMed" in a bold, sans-serif font, with the "R" slightly larger than the other letters. Above the wordmark is a curved line made up of a series of dots that transition in color from blue on the left to red on the right. The dots are arranged to create a wave-like pattern.
| Design parameter orfeature | Predicate device:Error! Reference source not found.Error! Reference source not found. | Subject device:Error! Reference source not found. | Comments | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CO2 re-breathingperformance (<20%), ISO17510:2015Annex F | Complies with ISO 17510:2015 CO2requirements (<20%) | Complies with ISO 17510:2015 CO2requirements (<20%) | Identical | ||||||||||
| Physical Dead space(mL) | Frame size | SML | STD | CushionSize | Frame size | SML | STD | Equivalent. This is a record-onlyparameter. | |||||
| CushionSize | S | 109 | 116 | SW | 116 | 124 | |||||||
| SW | 105 | 112 | M | 119 | 127 | ||||||||
| M | 113 | 120 | L | 123 | 130 | ||||||||
| W | 112 | 119 | |||||||||||
| Resistance to flow (Pressuredrop across mask in cmH2O)ISO 17510:2015Annex C | @50 L/min | 0.5 | @100 L/min | 2.3 | @50 L/min | 0.4 | @100 L/min | 1.6 | Resistance to flow values is reportedin the instructions for use inaccordance with ISO 17510:2015. | ||||
| Flow generator setting oncompatible ResMed CPAPand Bi-level flowgenerators. | "Pillows" | "Pillows" | Identical | ||||||||||
| Operating pressure range(cmH2O) | 4 - 25 | 4 - 25 | Identical | ||||||||||
| Sound | Sound power level: 21 dBASound pressure level: 14 dBA | Sound power level: 24 dBASound pressure level: 17 dBA | Equivalent | ||||||||||
| Operating and storagetemperature | Operating temperature: 5°C to 40°CStorage temperature: -20°C to+60°C | Operating temperature: 5°C to 40°CStorage temperature: -20°C to+60°C | Identical | ||||||||||
| Use life | Scone mask: Visual inspection perinstructions for useScone SLM: 30 validatedreprocessing cycles | Whitsundays mask: Visualinspection per instructions for useWhitsundays SLM: 30 validatedreprocessing cycles | Identical |
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Image /page/8/Picture/0 description: The image shows the ResMed logo. The logo features a curved line of dots that transition in color from blue to red. Below the dots, the word "ResMed" is written in a bold, italicized font. The logo is simple and modern, with a focus on the company name and a visual element that suggests movement or flow.
Non-Clinical Data Submitted:
Non-clinical verification and validation testing completed for the new device demonstrated that Whitsundays Mask System met all intended performance requirements. These included:
Applicable performance and safety tests in accordance with ISO 17510:2015 Medical devices – Sleep apnoea breathing therapy - Masks and application accessories:
- CO2 rebreathing
- Mask exhaust flow .
- Resistance to flow
Other bench tests:
- Physical dead space
- . Pressure accuracy and pressure swing performance
- . Mechanical Integrity of the mask system before and after the following environmental tests:
- Home cleaning
- Transportation and Storage
- . Operation environment
- Free fall and sit test
- Cleaning and Reprocessing
Biocompatibility evaluation was conducted in accordance with ISO 18562-1 and ISO 10993-1. This evaluation was conducted on components that had patient exposure classifications of long-term external communicating device (tissue) and /or long-term skin contact.
Validation of reprocessing claims (in accordance with ISO 17664-1 and ISO 17664-2) included a combination of cleaning efficacy, disinfection efficacy, residual toxicity, and mechanical integrity testing.
Whitsundays mask system was designed and tested in accordance with the applicable requirements in relevant FDA consensus standards including:
| Standards | Title |
|---|---|
| ISO 17510:2015 | Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process |
| ISO 18562-2:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter |
| ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs) |
| ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate |
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity |
| ISO 10993-10:2021 | Biological evaluation of medical devices – Part 10: Tests for skin sensitization |
| ISO 10993-17:2002 | Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-18:2021 | Biological evaluation of medical devices – Part 18: Chemical characterization of materials |
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Image /page/9/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line made up of a series of dots that transition in color from blue to purple to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical devicemanufacturer for the processing of medical devices - Part 1: Critical and semi-criticalmedical devices |
|---|---|
| ISO17664-2:2021 | Processing of health care products - Information to be provided by the medical devicemanufacturer for the processing of medical devices - Part 2: Non-critical medicaldevices. |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones andsockets |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by themanufacturer - Part 1: General requirements |
| ISO 20417:2021 | Medical devices — Information to be supplied by the manufacturer |
Substantial Equivalence Conclusion:
The Whitsundays mask system is substantially equivalent to the predicate Scone mask (K180497):
- It has equivalent intended use .
- It has similar technological characteristics
- It has similar performance characteristics ●
- . The differences do not raise any new questions of safety or effectiveness
- It is as safe and as effective as the predicate device
§ 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).