(49 days)
No
The device description explicitly states that the sensors contain "no active electronics or software," and the function is based on a passive piezo material generating a voltage signal. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
Explanation: The device is explicitly stated to be used "in support of diagnostic recording" and for "sleep study diagnosis," indicating its role in diagnosis rather than treatment.
No
Explanation: The device is described as a sensor that generates a small voltage in response to physical motion (stretch, compression, vibration). This voltage signal is then recorded by existing sleep study recording devices. The professionals (physicians, clinicians) interpret these recorded signals in support of sleep study diagnosis. The device itself is a data acquisition component, not a diagnostic device that performs analysis or makes a diagnosis.
No
The device description explicitly states that the sensors "contain no active electronics or software." The device is a hardware sensor that generates a voltage signal.
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 provide information for diagnosis, monitoring, or screening.
- Device Function: The DYMEDIX sensors described here are external sensors that are applied to the patient's body (chest, abdomen, limbs). They measure physical parameters (respiratory effort and limb movement) directly from the patient's body.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It generates a voltage signal based on physical changes in the body.
- Support for Diagnosis: While the data collected by these sensors is used in support of diagnostic recording for sleep studies, the sensors themselves are not performing the diagnostic test on a biological sample. The diagnosis is made by professionals interpreting the recorded signals from the sleep study equipment.
Therefore, the DYMEDIX Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor fall under the category of medical devices used for physiological monitoring, but they do not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.
Product codes
BZQ
Device Description
The Respiratory Effort Belt Sensor and Limb Movement Sensor are reusable devices. The sensors use a self-generating, piezo material technology. The piezo material generates a small voltage in response to stretch, compression and vibration due to motion. The sensors contain no active electronics or software. The Respiratory Effort Belt Sensor attaches to the patient with a Velcro belt and a cloth strap. The Limb Movement Sensor is applied to the patient with a Velcro belt. The Respiratory Effort Belt Sensor is applied to the upper chest and/or abdomen. Respiration effort results in stretch of the sensor with chest and/or abdomen circumference change indicative of respiration effort. The sensor transfers this change to a small voltage signal which can be recorded. The Limb Movement Sensor is applied to the arm, hand, leg or foot of the patient. The sensor translates limb movement into a small voltage signal which can be recorded. The sensors connect to the user's sleep study recording equipment. The sleep study recording equipment amplifies and conditions the sensor signal to the user's preferences. The sleep study recording device provides electrical isolation for the applied sensors. The sensors consist of a piezo material, polarized Polyvinylidene Fluoride Film (PVDF) sensor assembly. The sensor assembly has lead wires attached. The lead wires comply with 21 CFR Part 898 Performance Standards for Sensor Lead Wires and Patient Cables. The sensor lead wires interface to the user's existing sleep recording device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper chest and/or abdomen (for Respiratory Effort Belt Sensor); arm, hand, leg or foot (for Limb Movement Sensor)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis.
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
Laboratory data are presented to establish the performance of the Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor in comparison to predicate sensors. Patient contact material biocompatibility is provided. A Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898 is provided.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the text "K040605" written in a handwritten style. The text is oriented diagonally, running from the bottom left to the upper right corner of the image. The characters are bold and slightly distorted, giving them a casual, informal appearance.
Summary of Safety and Effectiveness
APR 2 6 2004
| 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: | April 12, 2004 | |
| Trade Name: | Reusable Respiratory Effort Belt Sensor
Reusable Limb Movement Sensor | |
| Common Name: | Respiration Effort Sensor, Limb Movement Sensor | |
| Classification Name: | Predicate devices have been found substantially equivalent to
21 CFR 868.2375, Breathing Frequency Monitor, Class II, BZQ. | |
| Predicate Device(s): | | |
| | 510(k) Number: | K001030 |
| | Manufacture: | DYMEDIX Inc. |
| | Trade Name: | Respiratory Effort Belt Sensor, Periodic Limb Movement
Sensor |
| | 510(k) Number: | K923402 |
| | Manufacture: | Pro-Tech, Inc. |
| | Trade Name: | Crystal Trace Piezo Respiratory Effort Sensor |
| | 510(k) Number: | K940014 |
| | Manufacture: | Pro-Tech, Inc. |
| | Trade Name: | PLM Sensor, Model PLM1 (Periodic Limb Movement) |
1.0 Description of Sensors
The Respiratory Effort Belt Sensor and Limb Movement Sensor are reusable devices. The sensors use a self-generating, piezo material technology. The piezo material generates a small voltage in response to stretch, compression and vibration due to motion. The sensors contain no active electronics or software.
1
The Respiratory Effort Belt Sensor attaches to the patient with a Velcro belt and a cloth strap. The Limb Movement Sensor is applied to the patient with a Velcro belt.
The Respiratory Effort Belt Sensor is applied to the upper chest and/or abdomen. Respiration effort results in stretch of the sensor with chest and/or abdomen circumference change indicative of respiration effort. The sensor transfers this change to a small voltage signal which can be recorded.
The Limb Movement Sensor is applied to the arm, hand, leg or foot of the patient. The sensor translates limb movement into a small voltage signal which can be recorded.
The sensors connect to the user's sleep study recording equipment. The sleep study recording equipment amplifies and conditions the sensor signal to the user's preferences. The sleep study recording device provides electrical isolation for the applied sensors.
2.0 Intended Use of Sensors
The sensors arc applied to the patient prior to a sleep study evaluation. The Respiratory Effort Belt Sensor provides a signal that is recorded as respiration effort, chest/abdomen movement. The Limb Movement Sensor provides a signal that is recorded as arm, hand, leg, foot movement. Professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis. The sensors are contraindicated for use as apnea monitoring sensors.
The sensors indication for use is:
The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.
2
3.0 Technological Characteristics
The sensors consist of a piezo material, polarized Polyvinylidene Fluoride Film (PVDF) sensor assembly. The sensor assembly has lead wires attached. The lead wires comply with 21 CFR Part 898 Performance Standards for Sensor Lead Wires and Patient Cables. The sensor lead wires interface to the user's existing sleep recording device.
4.0 Data Summary
Laboratory data are presented to establish the performance of the Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor in comparison to predicate sensors. Patient contact material biocompatibility is provided.
A Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898 is provided.
5.0 Conclusions
The laboratory data, skin contact material information and certification presented support the conclusion of the safety and effectiveness the Respiratory Effort Belt Sensor and Limb Movement Sensor.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Dymedix, Inc. C/O Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger LN. Stoughton, WI 53589
Re: K040605
Trade/Device Name: Dymedix Reusable Respiratory Effort Belt Sensor, Model 601 Regulation Number: 868.2375 Regulation Name: Respiratory Belt Sensor and Limb Movement Sensor Regulatory Class: II Product Code: BZQ Dated: March 02, 2004 Received: March 08, 2004
Dear Mr. Syring:
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 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Syring
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 531-542 of the Acti: 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 vours.
Chiu 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): K040605
Device Name: Reusable Respiratory Effort Belt Sensor and a Reusable Limb Movement Sensor Indications for Use:
The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.
Prescription Use X Over-The-Counter Usc AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cotuh
v. General Hospital.
510(k) Number:
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