(109 days)
No
The device description and performance studies focus on the physical components and mechanical performance of a respiratory mask, with no mention of AI/ML capabilities or data processing.
Yes
The device is used for noninvasive positive airway pressure (PAP) therapy, which is a medical treatment.
No
Explanation: The Scone Mask is intended for noninvasive positive airway pressure (PAP) therapy and delivers air pressure to the patient; it does not gather or interpret data to diagnose a condition.
No
The device description explicitly states it is an "externally placed vented respiratory mask" and details its physical components (headgear, frame, cushion, elbow), indicating it is a hardware device. The performance studies also focus on physical and functional testing of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Scone Mask Function: The Scone Mask is an external respiratory mask used to deliver positive airway pressure directly to the patient's airway. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use clearly states it's for delivering PAP therapy, not for diagnostic testing.
- Device Description: The description details the physical components and how it connects to a PAP source, with no mention of analyzing biological samples.
The Scone Mask is a medical device, specifically a respiratory mask used for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Scone Mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive 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.
Product codes
BZD
Device Description
The Scone Mask is an externally placed vented respiratory mask. Positive air pressure (PAP) source is directed to the patient's airway non-invasively, via the nose. The mask connects to the positive pressure flow source through conventional air tubing via an industry standard conical connector. The mask is held in place with adjustable head straps.
The Scone Mask comprises 4 subassemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The cushion and frame are available in various sizes to fit a wide patient population.
The Scone Mask 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
Nose (patient's airway via the nose)
Indicated Patient Age Range
patients weighing more than 66 lb (30 kg)
Intended User / Care Setting
Home and 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 the Scone device 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
- Total mask flow
- Flow resistance
Other bench tests:
- Physical dead space
- Functional tests
- Mechanical integrity performance following relevant environmental exposure
- Home cleaning
- Transportation
- Operation environment
- Relevant abuse use case tests
Biocompatibility evaluation was conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 10993-17 and ISO 10993-18 on components that were manufactured using new materials with patient exposure classifications of permanent external communicating device (tissue) and /or permanent skin contact.
Validation of reprocessing claims included a combination of cleaning efficacy, disinfection efficacy, residual toxicity and mechanical integrity testing.
Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit N20 (K171212).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
June 15, 2018
ResMed Ltd Ms. Kim Kuan Lee Senior Regulatory Affairs Manager 1 Elizabeth Macarthur Drive Bella Vista, 2153 Au
Re: K180497
Trade/Device Name: Scone Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 16, 2018 Received: May 18, 2018
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
for 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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Scone Mask
Indications for Use (Describe)
The Scone Mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive 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.
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
[As required by 21 CFFR 807.92(c)]
| Date Prepared | February 23, 2018 |
|---|---|
| Company Name / | |
| Owner | ResMed Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW, 2153 Australia | |
| Prepared & submitted | |
| by | Mr. Kim Kuan LEE |
| Senior Regulatory Affairs Manager | |
| Tel: +61 2 8884 1000 | |
| Fax: + 61 2 8884 2004 | |
| kim.lee@resmed.com.au | |
| Official Contact | Ms Cecilia Silva |
| Associate Manager, Regulatory Affairs | |
| ResMed Corp. | |
| 9001 Spectrum Center Blvd | |
| San Diego CA 92123 USA | |
| Tel: +1 858 836 6256 | |
| Fax: +1 858 836 5519 | |
| Cecilia.Silva@resmed.com | |
| Device Trade Name | Scone Mask |
| Device Common Name | Vented Nasal Mask |
| Classification & | |
| Classification Name | 21 CFR 868.5905, 73 BZD (Class II) |
| Accessory to Noncontinuous Ventilator (IPPB) | |
| Legally Marketed | |
| Predicate Device | AirFit N20 (K171212) |
| Device Description | The Scone Mask is an externally placed vented respiratory mask. |
| Positive air pressure (PAP) source is directed to the patient's airway | |
| non-invasively, via the nose. The mask connects to the positive | |
| pressure flow source through conventional air tubing via an industry | |
| standard conical connector. The mask is held in place with adjustable | |
| head straps. |
The Scone Mask comprises 4 subassemblies: headgear, frame,
cushion and elbow. The exhaust ports are incorporated into the elbow
and cushion assemblies. The cushion and frame are available in
various sizes to fit a wide patient population.
The Scone Mask is a prescription device supplied non-sterile. |
| Intended 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. |
| Submission reason | New Device |
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Similarities and differences with the predicate AirFit N20 device
Delivering treatment pressure generated from a positive airway pressure (PAP) device to the patient's airway is the technological principle of both the subject Scone Mask and the previously cleared predicate AirFitN20 (K171212) device.
The subject and predicate device have an identical intended use and the following similarities:
- . A silicone elastomer cushion to achieve an air seal at the patient's nose.
- The cushion is held in place via the mask frame
- . The frame is strapped to the patient's head and sits along the sides of the face, held in place via head straps.
- An elbow assembly connects to the PAP device tubing.
- Exhaust ports flush out CO2.
- . The mask can be disassembled for cleaning and reprocessing in accordance with the labelling.
- . Polymeric materials are used for the construction of the pneumatic and structural components. Foam padded fabric materials are used for the construction of the head strap.
- A port compliant to ISO 5356-1 is used to connect to the PAP delivery hose.
- . Multiple cushion and frame sizes are available to allow for adequate mask fit over the intended patient population.
- . Similar performance i.e. both masks have similar operating pressure range and pressure flow characteristics and operate on the same "Pillows" ResMed flow generator settings.
- . Same operating environments i.e. re-use in the home and hospital / institution environments
The main differences between the subject Scone Mask and the previously cleared predicate device AirFit N20 (K171212) are:
- . The PAP device tubing is connected to the Scone device at the top of the patient's head, whereas the predicate device is connected near the nose.
- The new device is labelled for a smaller operating pressure . range compared to the predicate AirFit N20 device.
These differences do not affect the substantial equivalence claim to the predicate device because non-clinical testing demonstrated that the new device has equivalent performance to and is as safe as the predicate device.
-
Non-clinical data Non-clinical verification and validation testing completed for the new device demonstrated that the Scone device 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
-
Total mask flow ●
-
. Flow resistance
5
Other bench tests:
- Physical dead space
- Functional tests .
- Mechanical integrity performance following relevant . environmental exposure
- o Home cleaning
- O Transportation
- Operation environment O
- Relevant abuse use case tests O
Biocompatibility evaluation was conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 10993-17 and ISO 10993-18 on components that were manufactured using new materials with patient exposure classifications of permanent external communicating device (tissue) and /or permanent skin contact.
Validation of reprocessing claims included a combination of cleaning efficacy, disinfection efficacy, residual toxicity and mechanical integrity testing.
Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit N20 (K171212).
The Scone Mask is substantially equivalent to the predicate AirFit
Substantial Equivalence Conclusion
-
it has the same intended use -
N20 device (K171212): -
it has similar technological characteristics
-
it has similar performance characteristics
-
the differences do not raise any new questions of safety or effectiveness
-
it is at least as safe and as effective as the predicate device -