The DYMEDIX Incorporated Reusable Airflow/Snore Scnsor is used with existing recording devices in support of diagnostic recording of nasal, oral airflow and breath sounds (snore). The sensors are used with patients who require a sleep study.

Device Description

During evaluation of sleep disorders and other clinical applications for airflow recording, an airflow sensor is applied to the patient, typically under the nasal passages, to support recording of airflow signals. During the evaluation of sleep disorders and other clinical applications for breath sounds (snore) recording, a snore sensor is applied to the patient to support recording of snore signals. These recorded signals are analyzed by a qualified physician, clinician or licensed medical practitioner in support of diagnosis of sleep and airflow disorders.

The Reusable Airflow/Snore Sensor is a pyroelectricity (pyro) and piezoelectric (piezo) sensor. The temperature difference between patient exhaled air and ambient air generates a small voltage signal, which can be recorded as airflow by diagnostic recording equipment. The vibration from breath sounds (snoring) produce a small voltage signal, which can be recorded as snoring by diagnostic recording equipment. The user's recording device displays the resulting signal for interpretation by a trained physician or clinician.

Polarized Polyvinylidene Fluoride Film (PVDF) is the temperature sensing matcrial. The polarized PVDF material has pyro (temperature) signal generation capability. Polarized PVDF material self generates a small electrical charge in the presence of temperature. The predicate Disposable Airflow/Snore Sensor (K990321) applied the same PVDF Film airflow and breath sound (snore) sensing technology.

The DYMEDIX Airflow/Snore Sensor consists of a temperature sensitive material (PVDF) molded into a reusable housing. The molding material is PVC. This same PVC material is used in the lead wires from the sensor. This same PVC material is used with the predicate DYMEDIX Disposable Airflow/Snore Sensor lead wires, reference K990321.

AI/ML Overview

The DYMEDIX Reusable Airflow/Snore Sensor is intended for diagnostic recording of nasal, oral airflow, and breathing sounds (snore) in patients requiring a sleep study, used in conjunction with existing recording devices.

A table of acceptance criteria and the reported device performance:

The provided document does not explicitly define acceptance criteria as quantitative thresholds for performance metrics. Instead, it relies on demonstrating "equivalent performance" to a predicate device through laboratory data.

Performance Metric/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Airflow Sensing Capability	Equivalent to predicate (DYMEDIX Gemini Sensor K990321)	Demonstrated through laboratory data using polarized PVDF film
Snore Sensing Capability	Equivalent to predicate (DYMEDIX Gemini Sensor K990321)	Demonstrated through laboratory data using polarized PVDF film
Material (temperature sensing)	Polarized Polyvinylidene Fluoride Film (PVDF)	Uses Polarized Polyvinylidene Fluoride Film (PVDF)
Material (housing/lead wires)	PVC material used in predicate (K990321)	Uses PVC material, same as predicate DYMEDIX Disposable Airflow/Snore Sensor lead wires
Biosafety/Biocompatibility	Not explicitly stated, but implied by "standards certifications"	"standards certifications" support safety

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states that "Representative laboratory data are presented to demonstrate equivalent performance." However, it does not specify the sample size used for this testing or the provenance of the data (e.g., number of subjects, country of origin, retrospective or prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The study relies on laboratory data for "equivalent performance" rather than expert clinical assessment as ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document. The study focuses on laboratory data demonstrating equivalence, not human-in-the-loop diagnostic accuracy with adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a sensor, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document describes the device as a "sensor" that generates voltage signals for interpretation by a "trained physician or clinician." It does not mention an algorithm or standalone performance without human interpretation. The study focused on demonstrating the sensor's ability to produce signals equivalent to a predicate device in a laboratory setting.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" implicitly used for this device is the performance of the predicate device, the DYMEDIX Gemini Sensor (Disposable) (K990321), and the Pro-Tech Services Inc. Cannula-Style Thermocouple Airflow Sensor (K913396). The study aimed to show equivalent performance to these legally marketed devices based on "representative laboratory data." There is no mention of expert consensus, pathology, or outcomes data as ground truth for this particular submission.
The sample size for the training set:

This information is not applicable and is not provided. The DYMEDIX Reusable Airflow/Snore Sensor is a physical sensor, not a machine learning model that requires a training set.
How the ground truth for the training set was established:

This information is not applicable and is not provided, as the device is not a machine learning model.

Summary

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Summary of Safety and Effectiveness

Company Name:	DYMEDIX, Inc.3989 Central Ave. NESuite 116Minneapolis, MN 55421
Contact:	Bill Ham, President, COO
Phone:	(763) 789-8280
Fax:	(763) 781-4120
Summary Date:	February 9, 2004
Trade Name:	DYMEDIX Reusable Airflow/Snore Sensor
Common Name:	Airflow Sensor
Classification Name:	Predicate airflow/snore sensors have been found substantially equivalentto 21 CFR 868.2375, Breathing Frequency Monitor, Class II, BZQ.
Predicate Devices:
	510(k) Number:K990321Manufacture:DYMEDIX IncorporatedTrade Name:Gemini Sensor (Disposable)	510(k) Number:	K990321	Manufacture:	DYMEDIX Incorporated	Trade Name:	Gemini Sensor (Disposable)
510(k) Number:	K990321
Manufacture:	DYMEDIX Incorporated
Trade Name:	Gemini Sensor (Disposable)
	510(k) Number:K913396Manufacture:Pro-Tech Services Inc.Trade Name:Cannula-Style Thermocouple Airflow Sensor	510(k) Number:	K913396	Manufacture:	Pro-Tech Services Inc.	Trade Name:	Cannula-Style Thermocouple Airflow Sensor
510(k) Number:	K913396
Manufacture:	Pro-Tech Services Inc.
Trade Name:	Cannula-Style Thermocouple Airflow Sensor

Description of the Reusable Airflow/Snore Sensor 1.0

The Reusable Airflow/Snore Sensor is a pyroelectricity (pyro) and piezoelectric (piezo) sensor. The temperature difference between patient exhaled air and ambient air generates

File: RevA Reuseable Sensor 510(k) FDA Reply 2-9-2004.doc

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a small voltage signal, which can be recorded as airflow by diagnostic recording equipment. The vibration from breath sounds (snoring) produce a small voltage signal, which can be recorded as snoring by diagnostic recording equipment. The user's recording device displays the resulting signal for interpretation by a trained physician or clinician.

2.0 Intended Use of the Reusable Airflow/Snore Sensor

3.0 Technological Characteristics

Polarized Polyvinylidene Fluoride Film (PVDF) is the temperature sensing material. The polarized PVDF material has pyro (temperature) signal generation capability. Polarized PVDF material self generates a small electrical charge in the presence of temperature.

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4.0 Data Summary

Representative laboratory data are presented to demonstrate equivalent performance of the Reusable Airflow/Snore Sensor to the predicate Gemini Sensor.

5.0 Conclusions

The laboratory data and standards certifications support the conclusion of the safety and effectiveness the Reusable Airflow/Snore Sensor.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

Dymedix, Incorporated C/O Mr. Robert Mosenkis CITECH 5200 Butler Pike Plymouth Mecting, Pennsylvania 19462-1298

Re: K040069

Trade/Device Name: Dymedix Reusable Airflow/Snorc Sensor Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: April 27, 2004 Received: April 28, 2004

Dear Mr. Mosenkis:

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 Amendments, or 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 controls provisions of the Act. The general controls provisions of the Act include requirements for 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 8010 tartoon. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Robert Mosenkis

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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). please contact the Office of Compliance at (301) 594-5613. 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 Division of Small Manufacturers, International 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/dsma/dsmamain.html.

Sincerely yours,

Chia-Lin, Ph.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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Indications for Use

510(k) Number (if known):

Device Name: Reusable Airflow/Snore Sensor

Indications for Use:

The DYMEDIX Incorporated Reusable Airflow/Snore Sensor is used with existing recording devices in support of diagnostic recording of nasal, oral airflow and breathing sounds (snore). The sensors are used with patients who require a sleep study.

Prescription Use X (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)

Ave Sch

General Hospital.

Page 1 of 1

510(k) Number

(Posted November 13, 2003)

Regulation Number and Section

§ 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).