F&P SIMPLUS FULL FACE MASK

K130328 · Fisher & Paykel Healthcare Limited · BZD · Jun 5, 2013 · Anesthesiology

Device Facts

• Record ID: K130328
• Device Name: F&P SIMPLUS FULL FACE MASK
• Applicant: Fisher & Paykel Healthcare Limited
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Device Story

Non-invasive patient interface; delivers pressurized gases (CPAP/Bi-Level) to patient nose and mouth. Silicone seal covers nose/mouth; held by adjustable headgear straps. Connects to breathing tube via swivel adaptor; includes exhaust holes for CO2 flushing. Optional oxygen pressure port for therapy/monitoring. Used in home or clinical settings by adult patients. Device facilitates respiratory therapy; improves patient compliance through mask design.

Clinical Evidence

Bench testing only. Performance compared to predicate HC431; biocompatibility compared to predicate Eson. Testing conducted per ISO 17510-2:2007 (mask performance) and ISO 10993-1:2009 (biological evaluation).

Technological Characteristics

Silicone seal; adjustable headgear; swivel adaptor; non-rebreathing valve. Standards: ISO 17510-2:2007 (mask performance), ISO 10993-1:2009 (biocompatibility). Mechanical interface; no electronics or software.

Indications for Use

Indicated for adult patients diagnosed by a physician as requiring CPAP or Bi-Level ventilator treatment. Suitable for single-patient home use or multi-patient clinical use with proper disinfection.

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

• Flexifit™ Series HC431 Full Face Mask (K040506)
• Eson Nasal Mask (K121597)

Submission Summary (Full Text)

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# Section 5 - 510(k) Summary

JUN 0 5 2013

| CARDER COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COL<br><br>A-444400<br>AND ALL<br>And And And And Andred American |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>.<br>LEBERES<br>Advisorial<br>*****<br>.<br><br> |

15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: [phone] Facsimile: [phone] Website: www.fphcare.com

| Date Prepared | 7 February 2013 |
|---------------------|------------------------------------------------------------------------------------------------|
| Contact Person | Sue Cho |
| Contact Details | Address: 15 Maurice Paykel Place, East Tamaki |
| | PO Box 14 348, Panmure |
| | Auckland, New Zealand |
| | Telephone: [phone] |
| | Fax: [phone] |
| Trade Name | F&P Simplus™ Full Face Mask |
| Common Name | Full Face Mask |
| Classification Name | Non continuous ventilator IPPB<br>(21 CFR § 868.5905, product code BZD) |
| Predicate Devices | K040506 Flexifit™ Series HC431 Full Face Mask, Fisher &<br>Paykel Healthcare - for performance |
| | K121597 Eson Nasal Mask, Fisher & Paykel Healthcare - for<br>material biocompatibility |

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#### Device Description 5.1

The F&P Simplus™ Full Face Mask is a non-invasive patient interface. The mask includes a silicone seal which covers the nose and mouth of a patient and is held in place by adjustable headgear straps. The mask connects to a single breathing tube via a swivel adaptor to receive pressurized gases. The gases delivered to the patient may be humidified and/or oxygen enriched. The exhaust holes on the mask housing allow exhaled air to be flushed out while the system is in operation.

An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.

#### 5.2 Intended Use

The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

#### 5.3 Technological Characteristics Comparison

The F&P Simplus™ Full Face Mask has the following similarities to the previously cleared Fisher & Paykel Healthcare Flexifit™ Series HC431 Full Face Mask:

- Similar intended use. -
- -Both masks deliver CPAP gases through the nose and mouth.

The key differences between the two masks are that the F&P Simplus™ Full Face Mask:

- -Has a permanently attached ball elbow rather than a detachable swivel elbow.
- Is smaller in size with under lip design as opposed to the under chin design. -
- -Has a modified non-rebreathing valve design.
- Has a modified headgear clip design. -
- -Has a modified design and location of exhaust holes.

#### 5.4 Non-Clinical Tests

Testing of the F&P Simplus™ Full Face Mask was compared to the predicate K040506 Flexifit™ Series HC431 Full Face Mask for performance and K121597 Eson Nasal Mask for biocompatibility. These tests demonstrate substantial equivalence of the F&P Simplus™ Full Face Mask to the two aforementioned predicate masks. Copies of test reports are included in Appendix A.

The F&P Simplus™ Full Face Mask has been tested to the following standards:

- . ISO 17510-2:2007 Sleep Apnea Breathing Therapy - Part 2: Masks and Applications Accessories
- ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing Within a Risk Management Process

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#### Conclusion ર.5

The comparison of features, performance, and intended use demonstrate that the F&P Simplus™ Full Face Mask is substantially equivalent to the predicate K040506 Flexifit Series HC431 Full Face Mask for performance and K121597 Eson Nasal Mask for biocompatibility.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 5, 2013

Fisher & Paykel Healthcare, Limited Ms. Sue Cho 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland, New Zealand 2013

Re: K130328

Trade/Device Name: F&P Simplus™ Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 6. 2013 Received: March 7, 2013

Dear Ms. Cho:

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. Iisting 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.

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Page 2 - Ms. Cho

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Kwame Ulmer, M.S. Acting Division 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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## Section 4 - Indications for Use Statement

K130328

510(k) Number:

Device Name:

F&P Simplus™ Full Face Mask

Indications for Use:

The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

1=HIF+S

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of Anesthesloiogy, General Hospital Division of Ancolnosters

510(k) Number

Anva