PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03

K093124 · Cardinal Health 207, Inc. · BZD · Mar 10, 2010 · Anesthesiology

Device Facts

• Record ID: K093124
• Device Name: PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03
• Applicant: Cardinal Health 207, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Puresom Nasal Mask is a patient interface for CPAP therapy; delivers positive airway pressure to patient's nose. Device consists of latex-free silicone cushion, polycarbonate frame, and 360-degree rotating 22mm elbow connector. Headgear secures mask to patient. Built-in vent openings in elbow direct air away from face/chest. Used in home or hospital/institutional environments; operated by patient or clinician. Healthcare provider prescribes CPAP therapy; mask facilitates delivery of prescribed pressure. Benefits include treatment of obstructive sleep apnea via maintenance of airway patency. Design modifications from predicate include lower durometer silicone for improved facial seal, three replaceable cushion sizes, and snap-fit elbow connection.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), interconnection compliance (ISO 5356-1, ISO 5367), dead space volume verification, CO2 retention (relative increase ≤20% normal, ≤60% single fault), flow rate vs. pressure performance (±10% tolerance), sound pressure levels, drop testing, and environmental storage testing. All tests passed.

Technological Characteristics

Latex-free silicone cushion; polycarbonate frame/elbow. 22mm rotating connector. 360-degree elbow rotation. Vent openings for CO2 washout. Compliant with ISO 5356-1 and ISO 5367. Biocompatible per ISO 10993-1. Mechanical design; no software or electronics.

Indications for Use

Indicated for adult patients (>30kg) with obstructive sleep apnea requiring continuous positive airway pressure (CPAP) therapy at or above 3cmH2O. For single-patient use in home or clinical settings.

Regulatory Classification

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.

Predicate Devices

• Advantage Series II mask (K031935)
• Advantage Series mask (K012207)
• Mirage Echo (K090490)

Submission Summary (Full Text)

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K093124

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MAR 1 0 2010

### 510 (K) Summary

# 510 (K) Summary as required by 21 CFR 807.92

| 510 (K) Submitter: | CardinalHealth 207<br>Yorba Linda, CA 92887<br>(714) 283 - 2228 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Monther Abushaban<br>(714) 919 - 3660<br>[e-mail] |
| 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 a<br>class II device under the following classification<br>code |

| 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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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 of<br>the Puresom Nasal Mask shall be<br>compliant with ISO10993-1 | All material which may<br>contact the patient or the<br>clinician must be<br>Biocompatible | Pass |
| Interconnections | Interconnections to the patient circuit<br>shall be compliant with ISO 5356-1<br>(EN1281-1) and ISO 5367 | Interconnections to the<br>patient circuit shall be<br>compliant with ISO 5356-<br>1 (EN1281-1) and ISO<br>5367 | Pass |
| Dead Space | Dead space volume: the maximum dead<br>space for the Nasal mask shall be as<br>follows:<br>1-Small ≤180CC<br>2- Regular ≤ 190CC<br>3- large ≤200 CC | The cavities of each<br>model shall not exceed<br>maximum dead space<br>volume of:<br>1- Small ≤ 180 CC<br>2- Regular ≤ 190 CC<br>3- Large ≤ 200 CC | Pass |
| Carbon dioxide retention<br>during operation<br>requirement | Under normal condition, the relative<br>CO2 increase shall not exceed 20% when<br>tested at the min. rated, 5hPa (5cmH2O)<br>and 10hPA (10cmH2O) pressure | The relative CO2 increase<br>shall not exceed 20%<br>when tested at the min.<br>rated, 5hPa (5cmHzO) and<br>10hPA (10cmHzO)<br>pressure | Pass |
| No flow maximum carbon<br>dioxide level requirement | Under single fault condition, the relative<br>CO2 increase shall not exceed 60% after<br>monitor stabilizes | The relative CO2 increase<br>shall not exceed 60% after<br>monitor 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. Flow<br>requirements & Sound<br>pressure level | Characteristics as follow:<br>1- Pressure of 3cmH2O the flow shall be<br>20 LPM±10%; SPL≤42.2 dBA<br>2- Pressure of 5cmH2O the flow shall be<br>26 LPM±10%; SPL≤43.9 dBA<br>3- Pressure of 7cmH2O the flow shall be<br>30.4 LPM±10%; SPL≤45.3 dBA<br>4- Pressure of 10cmH2O the flow shall be<br>36 LPM±10%; SPL≤47.7 dBA<br>5- Pressure of 12cmH2O the flow shall be<br>30.4 LPM±10%; SPL≤45.3 dBA<br>6- Pressure of 16cmH2O the flow shall be<br>44.4 LPM±10%; SPL≤51.1 dBA<br>7- Pressure of 20cmH2O the flow shall be<br>50.1 LPM±10%; SPL≤53.7 dBA | All sample plots shall be<br>within the ±10% tolerance<br>limit of the flow rate. All<br>sound pressure levels<br>shall be ≤ stated max.<br>values. | Pass |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Drop Test | The Puresom Nasal Mask shall be<br>capable of withstanding 6 (six) drops<br>from 6' without damage | All units shall not have<br>any damages. | Pass |
| Shipping Test | The device when enclosed in a bulk<br>shipping box, shall comply with ISTA Pre-<br>shipment test 2A (2004) | Device shall not have any<br>damage | Pass |
| Storage Test | The device shall operate within<br>specification (-20 to 70C, up to 95% non-<br>condensing) | Device shall perform and<br>meet specification within<br>the temperature and<br>humidity range<br>specification | 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 [phone] or [phone] 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