(159 days)
The Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.
The Puresom Nasal (CPAP) Mask is intended to be used with positive airway pressure devices such as CPAP. It provides a seal such that positive pressure from positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with a mild detergent, such as Ivory® dishwashing liquid or unscented baby shampoo in water. The design consists of latex-free silicone cushion designed to fit over the patients' nose. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion shall be connected to a polycarbonate frame that supports the cushion and provides a connection for a 90º elbow. The elbow shall be capable of rotating freely through 360º. The silicone cushion is designed in such a way that it can be easily removed by the patient, from the polycarbonate frame for cleaning or replacement purposes. The elbow connects to a conventional air delivery hose between the mask and the positive airway pressure source via a 22mm polycarbonate fitting on the elbow. The 22 mm connector is designed in such a way that it can rotate freely through 360º. The built in vent openings are molded into the front side of the elbow and a snap-on shroud is assembled to the elbow to direct the air away from the patient's face and chest. The vent openings may be visually inspected for obstruction prior to use.
Here's a breakdown of the acceptance criteria and study information for the Puresom Nasal Mask based on the provided text:
Acceptance Criteria and Device Performance
| Attribute | Requirement | Reported Device Performance | Result |
|---|---|---|---|
| Biocompatibility | All materials used in the construction of the Puresom Nasal Mask shall be compliant with ISO10993-1 | All material which may contact the patient or the clinician must be Biocompatible | Pass |
| Interconnections | Interconnections to the patient circuit shall be compliant with ISO 5356-1 (EN1281-1) and ISO 5367 | Interconnections to the patient circuit shall be compliant with ISO 5356-1 (EN1281-1) and ISO 5367 | Pass |
| Dead Space | The maximum dead space for the Nasal mask shall be as follows: 1-Small ≤180CC 2- Regular ≤ 190CC 3- large ≤200 CC | The cavities of each model shall not exceed maximum dead space volume of: 1- Small ≤ 180 CC 2- Regular ≤ 190 CC 3- Large ≤ 200 CC | Pass |
| Carbon dioxide retention during operation | Under normal condition, the relative CO2 increase shall not exceed 20% when tested at the min. rated, 5hPa (5cmH2O) and 10hPa (10cmH2O) pressure | The relative CO2 increase shall not exceed 20% when tested at the min. rated, 5hPa (5cmHzO) and 10hPa (10cmHzO) pressure | Pass |
| No flow maximum carbon dioxide level | Under single fault condition, the relative CO2 increase shall not exceed 60% after monitor stabilizes | The relative CO2 increase shall not exceed 60% after monitor stabilizes | Pass |
| CPAP pressure vs. Flow requirements & Sound pressure level | Characteristics as follow: 1- Pressure of 3cmH2O the flow shall be 20 LPM±10%; SPL≤42.2 dBA 2- Pressure of 5cmH2O the flow shall be 26 LPM±10%; SPL≤43.9 dBA 3- Pressure of 7cmH2O the flow shall be 30.4 LPM±10%; SPL≤45.3 dBA 4- Pressure of 10cmH2O the flow shall be 36 LPM±10%; SPL≤47.7 dBA 5- Pressure of 12cmH2O the flow shall be 30.4 LPM±10%; SPL≤45.3 dBA 6- Pressure of 16cmH2O the flow shall be 44.4 LPM±10%; SPL≤51.1 dBA 7- Pressure of 20cmH2O the flow shall be 50.1 LPM±10%; SPL≤53.7 dBA | All sample plots shall be within the ±10% tolerance limit of the flow rate. All sound pressure levels shall be ≤ stated max. values. | Pass |
| Drop Test | The Puresom Nasal Mask shall be capable of withstanding 6 (six) drops from 6' without damage | All units shall not have any damages. | Pass |
| Shipping Test | The device when enclosed in a bulk shipping box, shall comply with ISTA Pre-shipment test 2A (2004) | Device shall not have any damage | Pass |
| Storage Test | The device shall operate within specification (-20 to 70C, up to 95% non-condensing) | Device shall perform and meet specification within the temperature and humidity range specification | Pass |
Study Information
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the test sets used in each non-clinical test (e.g., how many masks were dropped for the drop test, or how many units were subjected to the shipping test). It generally refers to "All material," "The cavities of each model," "All sample plots," and "All units."
- The provenance of the data (country of origin, retrospective or prospective) is not specified. However, given it's a 510(k) submission to the FDA, the testing would be conducted in controlled environments by the manufacturer or authorized testing facilities. It's not a clinical study involving patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the non-clinical engineering and performance tests described. Ground truth established by human experts (e.g., radiologists) is typically relevant for AI/imaging device studies. The tests here relate to physical and functional properties of the mask.
-
Adjudication method for the test set:
- Not applicable. The tests involve objective measurements against predefined requirements (e.g., volume, CO2 percentage, flow rates, dBA levels, physical damage).
-
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:
- No. This is a non-clinical 510(k) submission for a physical medical device (nasal mask) and does not involve AI or imaging analysis with human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device; there is no algorithm or AI component involved.
-
The type of ground truth used:
- The "ground truth" for these tests are the established industry standards, regulatory requirements, and engineering specifications (e.g., ISO standards, specific volume limits, CO2 percentages, sound levels, physical damage criteria). The device's performance is compared directly against these objective criteria.
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The circular graphic appears to contain an abstract design. The text "CareFusion" is in a bold, sans-serif font.
MAR 1 0 2010
510 (K) Summary
510 (K) Summary as required by 21 CFR 807.92
| 510 (K) Submitter: | CardinalHealth 207Yorba Linda, CA 92887(714) 283 - 2228 |
|---|---|
| Contact Person: | Monther Abushaban(714) 919 - 3660Monther.Abushaban@CardinalHealth.com |
| Establishment Registration Number: | 2050001 |
| Date Prepared: | March 3, 2010 |
| Name of the Device: | Puresom Nasal Mask |
| Common/ usual name: | Mask for use with ventilator |
| Classification: | The Puresom Nasal Mask System is classified as aclass II device under the following classificationcode |
| Product code | CFR Section | Panel |
|---|---|---|
| 73 BZD | 21 CFR 868.5905 | Anesthesiology |
Reason for the submission: This Special 510 (K) Premarket Notification is a submission for changes to a current device for use with obstructive sleep apnea. The design change is to the latex-free silicone cushion durometer. Also the PureSom mask has replaceable cushions (3 sizes of cushions with a single frame) with adjustable forehead pads.
The Puresom Nasal (CPAP) Mask system is for use with continuous positive Intended Use: airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.
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Image /page/1/Picture/0 description: The image contains the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The circular graphic appears to contain a stylized image of hands. The text "CareFusion" is written in a bold, sans-serif font.
Device Description: The Puresom Nasal (CPAP) Mask is intended to be used with positive
airway pressure devices such as CPAP. It provides a seal such that positive pressure from positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with a mild detergent, such as Ivory® dishwashing liquid or unscented baby shampoo in water.
The design consists of latex-free silicone cushion designed to fit over the patients' nose. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion shall be connected to a polycarbonate frame that supports the cushion and provides a connection for a 90º elbow. The elbow shall be capable of rotating freely through 360º. The silicone cushion is designed in such a way that it can be easily removed by the patient, from the polycarbonate frame for cleaning or replacement purposes.
The elbow connects to a conventional air delivery hose between the mask and the positive airway pressure source via a 22mm polycarbonate fitting on the elbow. The 22 mm connector is designed in such a way that it can rotate freely through 360º.
The built in vent openings are molded into the front side of the elbow and a snap-on shroud is assembled to the elbow to direct the air away from the patient's face and chest. The vent openings may be visually inspected for obstruction prior to use.
Predicate Device Information: The predicate devices are Advantage Series II mask (K031935), Advantage Series mask (K012207) and Mirage Echo (K090490).
Summary of Technological Characteristics
of Device Compared to the Predicate Device: The Puresom Nasal (CPAP) is the same device as the Advantage Nasal Mask which was cleared for market under 510(k) (Advantage Nasal Mask No.K012207).
Modifications to the Nasal Mask that are associated with this submittal are as follows:
- Use of a lower durometer silicone durometer that is more pliable and will tend to . conforms better to the patients face.
- Use of 3 replaceable cushion sizes allows the physician to select the proper cushion . sizes that accommodate the patient.
- The Elbow Connection Method was changed from a clip to snap fit .
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Image /page/2/Picture/0 description: The image shows the word "CareFusion" in a bold, sans-serif font. To the left of the word is a circular logo with a design inside. The logo appears to have a layered or maze-like pattern within the circle.
The modified Nasal Puresom mask has the following similarities to those which previously received 510(k) concurrence:
- have the same indicated use, ●
- use the same nasal mask operating principle, .
- incorporate the same basic nasal design with the exception of modifications described . in this submittal.
- are manufactured and packaged utilizing the same basic processes. .
Summary of Nonclinical Testing For The Device and Conclusions:
| Attribute | Requirement | Parameter | Result |
|---|---|---|---|
| Biocompatibility | All materials used in the construction ofthe Puresom Nasal Mask shall becompliant with ISO10993-1 | All material which maycontact the patient or theclinician must beBiocompatible | Pass |
| Interconnections | Interconnections to the patient circuitshall be compliant with ISO 5356-1(EN1281-1) and ISO 5367 | Interconnections to thepatient circuit shall becompliant with ISO 5356-1 (EN1281-1) and ISO5367 | Pass |
| Dead Space | Dead space volume: the maximum deadspace for the Nasal mask shall be asfollows:1-Small ≤180CC2- Regular ≤ 190CC3- large ≤200 CC | The cavities of eachmodel shall not exceedmaximum dead spacevolume of:1- Small ≤ 180 CC2- Regular ≤ 190 CC3- Large ≤ 200 CC | Pass |
| Carbon dioxide retentionduring operationrequirement | Under normal condition, the relativeCO2 increase shall not exceed 20% whentested at the min. rated, 5hPa (5cmH2O)and 10hPA (10cmH2O) pressure | The relative CO2 increaseshall not exceed 20%when tested at the min.rated, 5hPa (5cmHzO) and10hPA (10cmHzO)pressure | Pass |
| No flow maximum carbondioxide level requirement | Under single fault condition, the relativeCO2 increase shall not exceed 60% aftermonitor stabilizes | The relative CO2 increaseshall not exceed 60% aftermonitor stabilizes | Pass |
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Image /page/3/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular graphic to the left of the company name. The graphic appears to be an abstract design. The text "CareFusion" is written in a bold, sans-serif font.
| CPAP pressure vs. Flowrequirements & Soundpressure level | Characteristics as follow:1- Pressure of 3cmH2O the flow shall be20 LPM±10%; SPL≤42.2 dBA2- Pressure of 5cmH2O the flow shall be26 LPM±10%; SPL≤43.9 dBA3- Pressure of 7cmH2O the flow shall be30.4 LPM±10%; SPL≤45.3 dBA4- Pressure of 10cmH2O the flow shall be36 LPM±10%; SPL≤47.7 dBA5- Pressure of 12cmH2O the flow shall be30.4 LPM±10%; SPL≤45.3 dBA6- Pressure of 16cmH2O the flow shall be44.4 LPM±10%; SPL≤51.1 dBA7- Pressure of 20cmH2O the flow shall be50.1 LPM±10%; SPL≤53.7 dBA | All sample plots shall bewithin the ±10% tolerancelimit of the flow rate. Allsound pressure levelsshall be ≤ stated max.values. | Pass |
|---|---|---|---|
| Drop Test | The Puresom Nasal Mask shall becapable of withstanding 6 (six) dropsfrom 6' without damage | All units shall not haveany damages. | Pass |
| Shipping Test | The device when enclosed in a bulkshipping box, shall comply with ISTA Pre-shipment test 2A (2004) | Device shall not have anydamage | Pass |
| Storage Test | The device shall operate withinspecification (-20 to 70C, up to 95% non-condensing) | Device shall perform andmeet specification withinthe temperature andhumidity rangespecification | Pass |
In conclusion verification testing performed verified that the Pursom Nasal meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR ) 0 2010
Mr. Monther Abushaban Regulatory Affairs Manager Cardinal Health 207, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887
Re: K093124
Trade/Device Name: Puresom Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: November 19, 2009 Received: February 16, 2010
Dear Mr. Abushaban:
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.
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.
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Page 2- Mr. Abushaban
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
h for
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CardinalHealth
510 (K) Number (if Known): Device Name: Puresom Nasal Mask
Indications for Use
Device Name: Puresom Nasal Mask
Indications for Use:
The Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.
Prescription Use x (Part 21CFR 801 subpart D) AND/ OR
Over the Counter Use: (Part 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Arhultho
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Special 510K Notification: Puresom Nasal Mask
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).