(39 days)
No
The description focuses on basic signal processing of respiratory effort using the RIP technique and does not mention any AI/ML components or algorithms.
No
The device is described as "intended for diagnostics purposes only" and is used to measure respiratory effort to assist in the diagnosis of sleep disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Universal XactTrace is intended for diagnostics purposes only..." and "Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders."
No
The device description explicitly states it is a "small battery powered reusable respiratory effort sensor" and is composed of a "sensor belt and a belt cable," indicating it includes physical hardware components beyond just software.
Based on the provided information, the Universal XactTrace is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Universal XactTrace Function: The Universal XactTrace measures respiratory effort by being worn externally on the patient's abdomen and thorax. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is to measure respiratory effort to assist in the diagnosis of sleep disorders. This is a physiological measurement taken directly from the patient, not an analysis of a sample.
Therefore, the Universal XactTrace falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
Product codes
MNR
Device Description
The Universal XactTrace is a small battery powered reusable respiratory effort sensor. It incorporates electronics to measure and process a respiratory effort signal to provide an electrical signal suitable for connection to the inputs of a physiological recorder.
The Universal XactTrace is composed of a sensor belt and a belt cable. The sensor belt has two types: abdomen belt that is applied around the patient's abdomen and thorax belt that is applied around the patient's thorax. The sensor belts are intended to be worn over clothing. The belt cable is used to connect the belt sensor to a physiological recorder.
The Universal XactTrace is powered by a non replaceable battery that is built in the buckle of the sensor belt and switches on/off when the buckle is connected/unconnected.
The Universal XactTrace is based on Respiratory Inductive Plethysmograph (RIP) technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, thorax
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, institutions, sleep centers, sleep clinics, or other test environments.
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)
The Universal XactTrace has been tested and verified in various phases, internal testing and verification as well as external testing.
The design was verified throughout the design process. Hardware and firmware test specification were tested to ensure compliance to all design requirements.
Risk analysis was performed, appropriate measures were implemented and their effectiveness verified.
External test house, SEMKO, was used to confirm compliance to the following standards:
- IEC60601-1:1998 +A1:1991 and A2:1995 Medical Electrical Equipment, General . Requirements for safety to ensure that there are no detrimental effects on patients. operators or the surrounding environment.
- IEC60601-1-2:.2001 Medical Electrical Equipment Part 1, General Requirements for . safety 2. Collateral Standard: Electromagnetic compatibility - requirements and tests. These includes both emission tests to ensure that no intolerable electromagnetic disturbances are introduced to the environment and immunity tests to ensure safe and effective operation in the presence of electromagnetic interference.
Cables and leads confirm to CDRH Guidance Document on the "Performance Standard for Lead Wires and Patient Cables" March 9 1998.
Furthermore the signals detected with the Universal XactTrace were compared to signals detected with the predicate devices "Crystal Trace Piezo Respiratory Effort Sensor" and "Summit IP". The result demonstrates the reliability and usability of the abdominal and thoracic respiratory effort signals measured with the Universal XactTrace.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Medicare
DEC 21 2004
510(k) Summary
Submitter
Medcare Flaga Sidumuli 24 108 Reykjavik Iceland Europe
Tel: 011 354 510 2000 Fax: 011 354 510 2010
Registration Number: 9611753
Contact person
Kolbrún Eydís Ottósdóttir Email: kolbrun@medcare.com, regulatory@medcare.com
Preparation Date
November 1st, 2004
Device
Trade Name: Classification Name: Regulation Number: Product Code: Device Class: Classification Panel:
Universal XactTrace Ventilatory Effort Recorder 868.2375 MNR Class II Anesthesiology
Predicate Devices
Crystal Trace Piezo Respiratory Effort Sensor from Pro -Tech Product Code: BZQ 510(k) Number: K923402
Summit IP from Compumedics USA Product Code: MNR 510(k) Number: K040194
1
Device Description
The Universal XactTrace is a small battery powered reusable respiratory effort sensor. It incorporates electronics to measure and process a respiratory effort signal to provide an electrical signal suitable for connection to the inputs of a physiological recorder.
The Universal XactTrace is composed of a sensor belt and a belt cable. The sensor belt has two types: abdomen belt that is applied around the patient's abdomen and thorax belt that is applied around the patient's thorax. The sensor belts are intended to be worn over clothing. The belt cable is used to connect the belt sensor to a physiological recorder.
The Universal XactTrace is powered by a non replaceable battery that is built in the buckle of the sensor belt and switches on/off when the buckle is connected/unconnected.
The Universal XactTrace is based on Respiratory Inductive Plethysmograph (RIP) technique.
Intended Use
Universal XactTrace is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.
Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.
Technological Characteristics
The comparison table is provided as a summary of the technological characteristics relative to the predicate devices. The summary demonstrates that the Universal XactTrace has no significant differences from the predicate devices that would adversely affect product safety and effectiveness.
Medcare Flaga = Sidurnuli 24 = 108 Reykjavik = Iceland = phone +354 510 2010 = www.medcare.com
2
Table 1 Comparative Table
| | Crystal Trace Piezo Respiratory
Effort Sensor (K923402) | Summit IP (K040194) | Universal XactTrace |
|---------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Modules | Abdomen and Thorax sensor belts. | Abdomen and Thorax sensor belts.
Amplifying box a separate module. | Abdomen and Thorax sensor belts with
in-build amplifier. |
| Equipment to be
connected to | Physiological recorder. | Physiological recorder. | Physiological recorder. |
| Materials in contact
with patient's skin | Velcro loop and elastic. | None. The sensor belts and bands should be
worn over light clothing. | None. The sensor belts should be worn
over light clothing. |
| Dimension of
amplifying module | No amplifying module. | Patient Input Box:
Height 21mm
Width 41mm
Length 59mm | Buckle of sensor belt:
Height 13mm
Width 42mm
Length 55mm
Total weight