SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM

K040202 · Salter Labs · BZD · Mar 4, 2005 · Anesthesiology

Device Facts

• Record ID: K040202
• Device Name: SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
• Applicant: Salter Labs
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Salter Labs High Volume CPAP Cannula System delivers positive airway pressure therapy and is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing adult patients within a homecare and hospital environment.

Device Story

Microprocessor-controlled, compressor-based system; delivers heated, humidified air to patient nares via large-bore cannula (internal bore ≥ 0.130 inches). Replaces traditional CPAP/nasal masks. Compressor assembly generates positive airway pressure (4–12 cmH2O); airflow creates pharyngeal pressurization and mild turbulence to prevent flaccid tissue collapse. Used in home and hospital environments; operated by patients or clinicians. Output provides therapeutic pressure to maintain airway patency; improves patient comfort and compliance compared to mask-based systems.

Clinical Evidence

Extensive laboratory and clinical comparative testing performed. Device demonstrated effectiveness in treating OSA by maintaining pharyngeal airway pressure (4-12 cmH2O) and preventing tissue collapse. Clinical use indicated improved patient comfort and sleep quality compared to existing mask-based systems.

Technological Characteristics

Microprocessor-controlled compressor assembly; heated/humidified air delivery; large-bore cannula (≥ 0.130 inch internal diameter). Standards: EN 60601-1, EN 60601-1-2, UL 2601-1, IEC 529 (IP code), ISO 8185. Standalone system; non-networked.

Indications for Use

Indicated for spontaneously breathing adult patients with obstructive sleep apnea (OSA) in homecare and hospital settings. Not indicated for acute or central OSA.

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

• InnoMed NasalAire™ CPAP Cannula (K number unknown)
• Respironics REMstar CPAP System (K012263)
• Respironics Virtuoso LX Smart CPAP System (K993433)

Submission Summary (Full Text)

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Koyozor

# Salter Labs CPAP High Flow Cannula System

#### 510(k) Summary

| Official Contact | Duane Kazal<br>Director Regulatory Affairs and Quality Assurance<br>Salter Labs, Inc.<br>100 West Sycamore Road<br>Arvin, California 93203 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous ventilator |
| Common or Usual Name | CPAP System |
| Proprietary Name | Salter Labs has not determined a proprietary name<br>at the time of this filing |
| Predicate Device(s) | InnoMed NasalAire™ CPAP Cannula (K number<br>unknown)<br>Respironics REMstar CPAP System (K012263)<br>Respironics Virtuoso LX Smart CPAP System (K993433) |
| Reason for Submission | Initial Introduction into Interstate Commerce |

## Substantial Equivalence

The Salter Labs CPAP High Flow Cannula System is substantially equivalent to other currently available CPAP systems on the market, including the InnoMed NasalAire™ CPAP Cannula and Respironics models noted in this 510(k) Summary for the following reasons:

- . Same intended use.
- . Same operating principle.
- Similar technology. .
- . Similar manufacturing processes.

The primary difference in the Salter CPAP System is the use of a specially-designed large-bore CPAP Cannula, which is used to deliver high volume flow from a compressor to the patient's nares. No CPAP or Nasal Mask is used or intended for use. The resulting high airflow results in a measured pharyngeal pressurization of up to 12 cmH2O and the creation of a mildly-turbulent environment within the pharyngeal airway that prevents flaccid tissue from sticking to other throat tissues.

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Extensive laboratory and clinical testing was done to compare performance of the Salter Labs CPAP System to a predicate device, and was found to be very effective in treating OSA. This device is not intended for use in the treatment of Acute or Central OSA patients.

The Salter Labs CPAP System is composed of three component parts:

- Compressor Assembly: Is a stand-alone molded enclosure that contains a 1) high-output compressor assembly, a heater and a humidifier. The device was designed and tested to meet all requirements of the following consensus safety standards:
- EN 60601-1: "Medical electrical equipment. Part 1: General . Requirements for safety."
- EN 60601-1-2: "Medical electrical equipment: Part 1: General . Requirements for safety - 2. Collateral standard, Electromagnetic compatibility."
- "Standard for Safety for Medical Electrical Equipment, UL 2601-1: . Part 1, General Requirements for Safety."
- IEC 529:1989: "Degrees of Protection provided by enclosures (Code . IP)"
- ISO 8185:1997 "Humidifiers for medical use General requirements." .
- Tubing Assembly: Is an insulated connector tube ranging up to 7 feet 2) that connects the Compressor Assembly to the CPAP Cannula.
- CPAP Cannula: Is a specially-designed cannula with an internal bore 3) diameter of not less than 0.130 inches. The configuration and materials used in this cannula are identical to those of other Salter Labs Oxygen Cannulas. The cannula nares are naturally positioned in close proximity to the patient's nares and the CPAP System supplies 60 lpm to the patient.

The airflow exiting the Salter Labs CPAP Cannula is heated and humidified in order to prevent drying of the patient's nasal and throat tissues. The velocity and volume of air is sufficient to pressurize the pharyngeal airway to pressures from 4 cmH20 up to 12 cmH2O, creating enough pressure to prevent the collapse of flaccid throat tissue. In addition, the air is supplied normally, as it would be in breathing. The result is that as the patient breathes in and out, there is a mild turbulence within the airway that also prevents the closure of flaccid tissues. Together, these actions have been demonstrated to be very effective in laboratory and clinical comparative product testing.

In summary, the device described in this submission is substantially equivalent to the predicate devices noted.

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The Salter Labs device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of the Submissions for Software Contained in Medical Devices," May 1998.

# Intended Use

The Salter Labs High Volume CPAP Cannula System delivers positive airway pressure therapy and is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing adult patients within a homecare and hospital environment.

#### Device Description

The Salter Labs High Volume CPAP Cannula System is a microprocessorcontrolled, compressor-based system that generates positive airway pressures from 4 cmH2O up to 12 cmH2O. The device is intended for use with a Salter Labs connector hose that is used to connect the device to the patient interface: the Salter Labs High Volume CPAP Cannula. The device is designed to provide heated and moist air to the patient through the cannula system, rather than using a nasal or CPAP Mask. Based upon laboratory and clinical use, it has been determined by the patients using this configuration that it offered improved patient comfort and resulted in a restful nights sleep for those studied. It is anticipated that over time, this configuration will improve the degree of patient compliance compared to many of the existing systems on the market due exclusively to its improved comfort.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 - 2005

Mr. Duane Kazal Director, Regulatory Affairs/Quality Assurance Salter Labs, Incorporated 100 West Sycamore Road Arvin, California 93203-2300

Re: K040202

Ko40202
Trade/Device Name: Salter Labs High Volume CPAP Cannula System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 29, 2004 Received: January 4, 2005

Dear Mr. Kazal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your end 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 mendments, or to devices that have been reclassified in accordance with the provisious of Amendinents, or to de rose and Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drug, and Ocenimay, therefore, market the device, subject to the general approval application (11.2 %). The general controls provisions of the Act include controls provisions of the or 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 If your de vice is classified (ose as additional controls. Existing major regulations affecting (1 wry, it may to but to back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear to roundsh further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Kazal

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issuance of a substantial with other requirements mean that FDA nas made a decemmanent watings administered by other Federal agencies. of the Act of any rederal statutes and regarants, including, but not limited to: registration You must comply with an the Fect 3 requirements (art 801); good manufacturing practice and ifsimg (21 CFR Pat 607), lacemig (21 creat (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 82 at t requirements as set form in the quality byovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegni mailering your
This letter will anow you to begin mailering of substantial equivalence of your device to a premarket notification. The I Dr Intellig or shares or sour device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for Jour at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general information on your and Consumer Assistance at its toll-free Division of Bina8-2041 or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincercly yours,

Sulle Michini M.D.

Chiu Lin, Ph.D. Director 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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#### 5.1 Indications for Use

510(k) Number (if known):

Salter Labs High Volume CPAP Cannula System Device Name:

Indications for Use:

The Salter Labs High Volume CPAP Cannula System is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing adult patients within a homecare and hospital environment.

| Prescription Use | <u>XX</u> |
|-----------------------------|-----------|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | ________________ |
|------------------------|------------------|
| (21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| 10:25:21 37:38:20:10:<br>2008 000 0000 1 1 10000 | | |
| ্রিক মিরিকার পারের পারে পারে পারে পারে করে পারে করে পারে করে পারে করে করে করে তার করে করে তার করে করে তার করে করে তার করে করে করে করে করে করে করে করে করে করে করে করে করে করে | Page | |

(Posted November 13, 2003)

Salter Labs 510(k) Submission for the CPAP High Flow Cannula System December 31, 2003

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