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.

Device Description

AI/ML Overview

The provided text describes the Salter Labs CPAP High Flow Cannula System, but it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving device performance.

Specifically, the text mentions "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." and "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." However, it does not provide specific acceptance criteria, study methodologies, sample sizes, ground truth details, or statistical results from these tests.

Therefore, I can only fill in the parts for which information is available and will note where data is missing.

Acceptance Criteria and Device Performance Study for Salter Labs CPAP High Flow Cannula System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specific Targets/Metrics)	Reported Device Performance
Not specified in the provided text.	"very effective in treating OSA" "offered improved patient comfort" "resulted in a restful nights sleep for those studied"
Pharyngeal pressurization	Up to 12 cmH2O (achieved by the device)
Airflow to patient	60 lpm (achieved by the device)
Heated and humidified airflow	Achieved (to prevent drying of nasal and throat tissues)
Prevention of flaccid tissue collapse	Demonstrated through pressurization and mild turbulence

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The text mentions "those studied" implying a clinical study, but no number is provided.
Data Provenance: The text refers to "laboratory and clinical testing" but does not specify the country of origin or whether the data was retrospective or prospective. Given the 510(k) submission is to the FDA, it is likely the clinical testing was conducted in the US, but this is not explicitly stated. It implies prospective clinical data due to comparing performance to a predicate and patient feedback after use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, the provided text does not describe an MRMC comparative effectiveness study. The comparison mentioned is between the Salter Labs CPAP System and a predicate device in terms of overall performance and patient comfort, not specifically how human readers improve with AI assistance. The device itself is a piece of medical hardware, not an AI-driven diagnostic or assistive tool in the typical sense that would involve human readers interpreting outputs.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The text describes the performance of the device (Compressor Assembly, Tubing Assembly, CPAP Cannula), which operates autonomously to deliver therapy. In this context, the device's performance for delivering positive airway pressure and humidified air would be considered "standalone" as it doesn't involve a human operator in its core function of delivering therapy. However, this is not an "algorithm only" study as might be conducted for an AI diagnostic tool.

7. The type of ground truth used

The ground truth for effectiveness ("very effective in treating OSA") and patient experience ("improved patient comfort," "restful nights sleep") appears to be based on:
- Clinical Efficacy/Outcomes: Implied by "very effective in treating OSA," likely measured through physiological parameters or symptom resolution.
- Patient Reported Outcomes (PROs): Implied by feedback on "improved patient comfort" and "restful nights sleep."
- Physiological Measurements: Specifically, "measured pharyngeal pressurization of up to 12 cmH2O" is a direct measurement of the device's physical effect rather than an expert consensus per se.

8. The sample size for the training set

Not applicable/Not specified. The device is a hardware system, not an AI model that requires a training set in the conventional sense. The "training" in this context refers to engineering and design iterations, not algorithmic learning.

9. How the ground truth for the training set was established

Not applicable/Not specified as there is no mention of a "training set" for an AI model. The device's design and performance were likely optimized through engineering tests and possibly pilot human trials, but these are not described as a "training set" with ground truth in the context of machine learning.

Summary

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Koyozor

Salter Labs CPAP High Flow Cannula System

510(k) Summary

Official Contact	Duane KazalDirector Regulatory Affairs and Quality AssuranceSalter Labs, Inc.100 West Sycamore RoadArvin, 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 nameat the time of this filing
Predicate Device(s)	InnoMed NasalAire™ CPAP Cannula (K numberunknown)Respironics REMstar CPAP System (K012263)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 (240) 276-0120. 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 (301) 443-6597 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	XX
(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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্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

Regulation Number and Section

§ 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).