(119 days)
Not Found
No
The device description focuses on converting physical pressure changes into electrical signals using passive electronic components. There is no mention of AI or ML algorithms for data processing or interpretation.
No
The device is an accessory for polysomnography equipment used to detect and record respiratory airflow signals and snoring during sleep disorder studies. It converts physical signals into electrical ones for measurement, but it does not treat or alleviate a medical condition; it is solely for diagnostic purposes.
Yes
The device is described as detecting and recording respiratory airflow signals and snoring during sleep disorder studies, and converting pressure/flow changes into electrical signals for measurement by polysomnography equipment. This process of identifying and measuring physiological parameters to understand a patient's condition falls under the definition of a diagnostic device.
No
The device description explicitly details hardware components like a piezo-electric ceramic element, electronic circuitry, and a plastic cylinder chamber, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Salter Labs BiNAPS Airflow Pressure Transducer directly measures physiological signals (airflow and pressure changes) from a patient's breathing and snoring in vivo (within the living body) via a nasal cannula. It converts these physical signals into electrical signals for recording by polysomnography equipment.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient.
Therefore, because the device interacts directly with the patient's body to acquire physiological data rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nares and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pro-Tech Pressure Transducer 510(k) #K982293
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
Director Regulatory Affairs and Quality Assurance
Salter Labs
100 W. Sycamore Road
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
1
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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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