(112 days)
No
The device description focuses on the physical sensing technology (pyroelectricity and piezoelectricity) and the analysis is performed by a trained physician or clinician, not by the device itself. There is no mention of AI, ML, or related concepts.
No
The device is described as supporting diagnostic recording of nasal/oral airflow and breath sounds for analysis by a physician, not for treating any condition.
No
The device is a sensor used to record physiological signals (airflow and breath sounds) which are then analyzed by a medical professional in support of diagnosis. The device itself does not make a diagnosis.
No
The device description explicitly details physical components like sensors (pyroelectricity and piezoelectric), temperature-sensitive material (PVDF), and a reusable housing made of PVC, indicating it is a hardware device with sensing capabilities.
Based on the provided information, the DYMEDIX Incorporated Reusable Airflow/Snore Sensor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description clearly states that the sensor is applied to the patient (under the nasal passages) to record airflow and breath sounds. It does not analyze blood, urine, tissue, or any other sample taken from the patient.
- The device measures physical signals. It measures temperature differences in exhaled air and vibrations from breath sounds. These are physical phenomena, not biological or chemical markers analyzed in a sample.
- The analysis is performed by a clinician. The recorded signals are analyzed by a qualified physician, clinician, or licensed medical practitioner. While IVDs also require interpretation, the primary diagnostic work in an IVD is performed on the sample itself using reagents or other analytical methods.
The device is a sensor that captures physiological signals in vivo (on the living body) for subsequent interpretation by a healthcare professional. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal passages
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician, clinician or licensed medical practitioner
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)
Representative laboratory data are presented to demonstrate equivalent performance of the Reusable Airflow/Snore Sensor to the predicate Gemini Sensor.
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.
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.
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
Summary of Safety and Effectiveness
| Company Name: | DYMEDIX, Inc.
3989 Central Ave. NE
Suite 116
Minneapolis, 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 equivalent
to 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
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
File: RevA Reuseable Sensor 510(k) FDA Reply 2-9-2004.doc
.
1
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.
2.0 Intended Use of the Reusable Airflow/Snore Sensor
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.
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.
2
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
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.
4
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
5
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)