(204 days)
Not Found
No
The document describes a physical mask system for delivering positive airway pressure and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to deliver airflow and positive air pressure for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support.
No
This device is described as an "accessory to deliver airflow and positive air pressure generated by positive airway pressure (PAP) devices" for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support. It only delivers treatment and does not perform any diagnostic function.
No
The device description clearly outlines physical components (nasal cushion, conduit frame, elbow, headgear) and discusses physical performance testing (CO2 rebreathing, resistance to flow, mechanical integrity, biocompatibility, reprocessing validation). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver airflow and positive air pressure for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as an accessory to deliver pressure from a PAP device to the patient's airway. It provides an air seal. This is a mechanical function related to therapy delivery.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). There is no mention of this device interacting with or analyzing any biological samples.
- Performance Studies: The performance studies focus on aspects like CO2 rebreathing, mask exhaust flow, resistance to flow, pressure accuracy, mechanical integrity, and reprocessing validation. These are all related to the physical and functional performance of a respiratory therapy device, not diagnostic accuracy.
In summary, the Whitsundays Mask System is a medical device used for delivering therapy, not for diagnosing a condition or analyzing biological samples.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's upper airway, bottom of the patient's nose
Indicated Patient Age Range
patients weighing more than 66 lb (30 kg),
Intended User / Care Setting
Home or hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Scone mask (K180497)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
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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
1
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
2
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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510(k) Summary
[As required by 21 CFR 807.92(c)]
| Date Prepared: | July 6, 2023 |
|---|---|
| Company Name/Owner: | ResMed Pty Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW, 2153 Australia | |
| Prepared and Submitted by: | Ms. Shu-Ying Huang |
| Regulatory Affairs Manager | |
| Tel: +65 65727105 | |
| Shuying.huang@resmed.com.sg | |
| Official Contact: | Ms. Sheila Bruschi |
| Senior Director, Regulatory Affairs | |
| ResMed Corp. | |
| 9001 Spectrum Center Blvd | |
| San Diego CA 92123 USA | |
| Tel +1 858 922 1803 | |
| sheila.bruschi@resmed.com | |
| Device Trade Name: | Whitsundays Mask System |
| Device Common Name: | Vented Nasal Mask |
| Classification and | |
| Classification 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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Image /page/4/Picture/0 description: The image shows the logo for ResMed. The logo consists of 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.
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 or
feature | 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 be
used by patients weighing more
than 66 lb (30 kg) who have been
prescribed non-invasive positive
airway pressure (PAP) therapy such
as CPAP or bi-level therapy. The
mask is intended for single patient
re-use in the home and multi-
patient re-use in the
hospital/institutional environment. | 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. | Equivalent | |
| Intended Use | The mask is intended to provide an
interface for CPAP or bi-level
devices. | The mask is intended to provide an
interface for CPAP or bi-level
devices. | Identical | |
| FDA Product Code | BZD | BZD | Identical | |
| Patient population | Patients weighing more than 66lb
(30kg) for whom positive airway
pressure therapy has been
prescribed. | Patients weighing more than 66lb
(30kg) for whom positive airway
pressure therapy has been
prescribed. | Identical | |
| Design parameter or
feature | 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/institutional
environment. | Home or hospital/institutional
environment. | 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 reprocessing
methods | High-Level Thermal disinfection | High-Level Thermal disinfection | Identical | |
| Materials | Materials include silicone, polycarbonate, polybutylene
terephthalate and nylon elastane polyurethane laminate. | Whitsundays mask system has new materials for the nasal cushion and
for 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 used
in the subject device have been
included in previously cleared
submissions or have undergone
biological evaluation as per ISO
10993-1 and ISO 18562-1. | |
| Cushion type | Cradles patient's nose and seals
under the nose | Cradles patient's nose and seals
under the nose | Identical. The cushion is designed to
seal in the same way. | |
| Frame type | Tubular conduit | Tubular conduit | Identical. | |
| PAP tubing connection
point | 22mm conical connector as per ISO
5356-1 over the head connection | 22mm conical connector as per ISO
5356-1 over the head connection | Identical. | |
| Exhaust port location | Elbow and cushion | Elbow and cushion | Identical. | |
| Sizes | Cushion available in four sizes
Frame available in two sizes
Headgear available in one size | Cushion available three sizes
Frame available in two sizes
Headgear available in one size | Equivalent | |
| Mask exhaust
flow (Nominal)
ISO 17510:2015
Annex B | Pressure
(cm
H2O) | 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 or
feature | Predicate device:
Error! Reference source not found.
Error! Reference source not found. | Subject device:
Error! Reference source not found. | Comments | | | | | | | | | | |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------|-----------------|------------|------------|-----|-----|-------------------------------------------------|--|-----|------------------------------------------------------------------------------------------------------------|
| CO2 re-breathing
performance (