(119 days)
The Salter Labs BiNAPS Airflow Pressure Transducer is an accessory intended for use with polysomnography equipment during 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.
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 provided text is a 510(k) summary for the Salter Labs Bi-NAPS Airflow Pressure Transducer and does not contain acceptance criteria or a study proving its performance in the typical sense of a clinical or analytical validation study.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Pro-Tech Pressure Transducer Airflow Sensor K982293). This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed device, rather than proving its performance against a specific set of clinical acceptance criteria.
Therefore, many of the requested items cannot be answered directly from the provided text because they are not relevant to a substantial equivalence submission of this type.
Here's an attempt to extract relevant information and explain why other items are not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as a formal table of acceptance criteria with corresponding performance results. The core of the submission is predicated on the device having "Equivalent performance in all operating ranges" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Same intended use | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Same operating principle | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Same technology | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Similar manufacturing processes | Meets this criterion, as stated in the "Substantial Equivalence" section. |
| Equivalent performance in all operating ranges | "Demonstrates equivalent performance" to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission relies on demonstrating equivalence rather than presenting a performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As there's no mention of a clinical or analytical performance study with a test set requiring ground truth, no experts for this purpose are mentioned.
4. Adjudication Method for the Test Set
This information is not provided. No test set requiring adjudication is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is not provided. This type of study is not mentioned as it's not typically required for a substantial equivalence claim for this type of device. There is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This information is not provided. The device is a physical transducer, not an algorithm. Performance is assessed through its functional equivalence to a predicate.
7. Type of Ground Truth Used
This information is not provided. No specific "ground truth" for a performance study is mentioned. The ground for equivalence is the predicate device's established performance and characteristics.
8. Sample Size for the Training Set
This information is not provided. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Not applicable as there is no training set for an AI/ML model.
Summary of what the document primarily communicates:
The Salter Labs Bi-NAPS Airflow Pressure Transducer sought 510(k) clearance by demonstrating substantial equivalence to the Pro-Tech Pressure Transducer Airflow Sensor (K982293). The basis for this equivalence is:
- Same intended use (detecting respiratory airflow and snoring during sleep disorder studies).
- Same operating principle (piezo-electric ceramic element converting pressure changes to electrical signals).
- Same technology.
- Similar manufacturing processes.
- Equivalent performance in all operating ranges.
The FDA reviewed this claim and determined it to be substantially equivalent, allowing the device to be marketed. The documentation does not describe a clinical performance study with defined acceptance criteria and a test set; instead, it relies on the similarities and equivalent performance to an already legally marketed device.
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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 KazalDirector Regulatory Affairs and Quality AssuranceSalter Labs100 W. Sycamore RoadArvin, 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 (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
§ 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).