BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER

K051313 · Salter Labs · MNR · Sep 15, 2005 · Anesthesiology

Device Facts

• Record ID: K051313
• Device Name: BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
• Applicant: Salter Labs
• Product Code: MNR · Anesthesiology
• Decision Date: Sep 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The Salter Labs BiNAPS Airflow Pressure Transducer is an accessory intended for use with sleep disorder studies for the purpose of detecting and recording respiratory airflow signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula.

Device Story

Device is a two-channel passive airflow pressure transducer; used during sleep diagnostic sessions. Input: respiratory pressure waves and airflow captured via nasal cannula. Operation: air pressure/flow impinges on a piezo-electric ceramic element within a plastic cylinder; element flexes to generate proportional voltage; signal attenuated/filtered by passive electronic circuitry. Output: electrical signals transmitted to polysomnography equipment. Used in clinical sleep labs; operated by sleep technicians/clinicians. Output allows visualization of breathing patterns and snoring on polysomnography recorders; assists clinicians in diagnosing sleep disorders. Device requires no external power source.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and comparison of design, materials, and operating principles to the predicate device.

Technological Characteristics

Passive device; no power source required. Components: nasal cannula, luer lock fitting, plastic cylinder chamber, piezo-electric ceramic element, passive electronic filtering/attenuation circuitry. Form factor: transducer housing for connection to polysomnography equipment.

Indications for Use

Indicated for use in sleep disorder studies to detect respiratory airflow and snoring in sleeping patients via nasal cannula.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• Pro-Tech Pressure Transducer (K982293)

Submission Summary (Full Text)

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p. 42 of 96

# SEP 1 5 2005

#### 7.0 510(k) Summary

### Salter Labs Bi-NAPS Airflow Pressure Transducer

## 510(k) Summary

# K_US 13/3 13/3 (Not yet received)

| Official Contact | Duane Kazal<br>Director Regulatory Affairs and Quality Assurance<br>Salter Labs<br>100 W. Sycamore Road<br>Arvin, California 93203 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.2375 Breathing Frequency Monitor |
| Product Code | MNR |
| Common or Usual Name | Airflow Pressure Transducer |
| Proprietary Name | BI-NAPS Nasal Airflow and Snore Transducer |
| Predicate Device | Pro-Tech Pressure Transducer 510(k) #K982293 |
| Reason for Submission | Initial Introduction into Interstate Commerce |

### Substantial Equivalence

The Salter Labs Airflow Pressure Transducer is substantially equivalent to the Pro-Tech Pressure Transducer Airflow Sensor for the following reasons:

- Same intended use. ●
- Same operating principle. .
- Same technology. .
- Similar manufacturing processes. .
- Equivalent performance in all operating ranges. .

### Description of the Device

The Salter Labs Airflow Pressure Transducer is a two output channel device used to acquire respiratory low pressure waves and low air flow that are sensed through a Nasal Cannula typically worn by a subject during a sleep diagnostic session. It is used to convert changes in air pressure and flow, occurring during sleep, into electrical signals that can be measured by polysomnography equipment. The Nasal Cannula directs the airflow and pressure waves generated by breathing and snoring from the nares and mouth of a patient through a luer lock fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a piezo-electric ceramic element. The piezo element, when flexed by the impinging air pressure changes, generates a proportional electric voltage. This voltage is attenuated and filtered by

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subsequent passive electronic circuitry composing the sensor. The Salter Labs Airflow Pressure Transducer does not require a power source.

The Salter Labs Airflow Pressure Transducer uses equivalent components and design of existing marketed devices such as Pro-Tech Pressure Transducer Airflow Sensor (K982293). The Salter Labs Airflow Pressure Transducer is designed with equivalent circuitry and parts to that of the predicate device, demonstrates equivalent performance, and is substantially equivalent to it.

### Intended Use

The Salter Labs Airflow Pressure Transducer is a reusable device intended for use during sleep disorder studies to detect respiratory airflow and snoring for recording onto a polysomnography recorder via nasal pressure changes.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle or bird-like figure with three stylized lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

SEP 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Duane Kazal Director, RA/QA Salter Labs 100 West Sycamore Road Arvin, California 93203

Re: K051313

Trade/Device Name: Salter Labs BiNAPS Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: September 8, 2005 Received: September 12, 2005

Dear Mr. Kazal:

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 more othing to 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 approvisions of the Act. The general controls provisions of the Act include controls provided 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 Ccntrols) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ), it hay of Each of Federal Regulations, Title 21, Parts 800 to 898. In your device an may publish further announcements concerning your device in the Eederal Register.

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#### Page 2 - Mr. Kazal

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 Incall that I DX mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal business requirements, including, but not limited to: registration I ou intist confire wart 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF Rev or 7), modity systems (QS) regulation (21 CFR Part 820); and if requirents as set fortir in the quality systems (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 and w Jourse of Substantial equivalence of your device to a premarket notified.com - 12 device results in a classification for your 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 at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 generational 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,

Clare

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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p. 10 of 96

510(k) Number (if known): Unknown

Device Name:

Salter Labs BiNAPS

Indications for Use:

The Salter Labs BiNAPS Airflow Pressure Transducer is an accessory intended for use with The Salter Laos DINAL O Filmon a research disorder studies for the purpose of detecting and polysonling signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula.

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)

Page のI

(Posted November 13, 2003)

Clair Sylvion

(Division Sign (Division Sign Of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Ancalifornial Devic 510(k) Number