UNIVERSAL XACTTRACE by MEDCARE FLAGA

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Universal XactTrace Ventilatory Effort Recorder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and compliance with regulatory standards, rather than defining specific numerical performance acceptance criteria (e.g., sensitivity, specificity) for a clinical outcome.

Acceptance Criteria Category	Reported Device Performance
Safety Standards Compliance	Conforms to IEC60601-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment, General Requirements for safety).
EMC Compatibility	Conforms to IEC60601-1-2:2001 (Electromagnetic Compatibility - requirements and tests).
Cable and Lead Compliance	Conforms to CDRH Guidance Document on the "Performance Standard for Lead Wires and Patient Cables" March 9, 1998.
Signal Detection Reliability/Usability	Signals detected with Universal XactTrace were compared to signals detected with predicate devices (Crystal Trace Piezo Respiratory Effort Sensor and Summit IP), demonstrating "reliability and usability of the abdominal and thoracic respiratory effort signals measured."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document mentions "the signals detected with the Universal XactTrace were compared to signals detected with the predicate devices." This implies a comparison study, but the number of subjects or recordings used for this comparison is not provided.
Data Provenance: Not explicitly stated. The context suggests that the testing was performed internally ("internal testing and verification") and externally by SEMKO. It does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The study described is a comparison of instrument signals, not a clinical study requiring expert ground truth for disease diagnosis. The ground truth for signal comparison would be the signals produced by the predicate devices themselves.

4. Adjudication Method for the Test Set:

Not applicable. As described, the study is a technical comparison of signals rather than a diagnostic performance study requiring adjudication of clinical outcomes by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document describes a comparison of device signals to those of predicate devices, not an assessment of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed in the sense that the device's signal output was directly compared to the predicate devices. The "algorithm" in this context refers to the device's internal processing of respiratory effort signals. The performance discussed is about the output signal's characteristics, not an AI-driven diagnostic interpretation.

7. Type of Ground Truth Used:

The ground truth used for performance assessment was the signals generated by the predicate devices (Crystal Trace Piezo Respiratory Effort Sensor and Summit IP). The study aimed to show that the Universal XactTrace produced comparable respiratory effort signals.

8. Sample Size for the Training Set:

Not applicable. This device is a sensor and signal processor, not an AI/machine learning algorithm that requires a training set in the conventional sense for diagnostic classification. The embedded software implies some signal processing logic, but this is likely rule-based or engineered, not a trained model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8. The device's functionality is based on Respiratory Inductive Plethysmography (RIP) technique and standard signal processing, not on a machine learning model trained with a ground truth dataset.

Summary

{0}------------------------------------------------

K043132

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 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

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 RespiratoryEffort 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 within-build amplifier.
Equipment to beconnected to	Physiological recorder.	Physiological recorder.	Physiological recorder.
Materials in contactwith patient's skin	Velcro loop and elastic.	None. The sensor belts and bands should beworn over light clothing.	None. The sensor belts should be wornover light clothing.
Dimension ofamplifying module	No amplifying module.	Patient Input Box:Height 21mmWidth 41mmLength 59mm	Buckle of sensor belt:Height 13mmWidth 42mmLength 55mmTotal weight <60g.
Weight	Not specified.	Patient Input Box including battery but notsensor belt: 39g.
Various Band/ Sensorbelt sizes	Yes.	Yes.	Yes.
Belt cable connectors -recorder end	Bipolar touch proof safety connectors.	Among others: Bipolar touch proof safetyconnectors.	Bipolar touch proof safety connectors.
Power Source	No power source.	Replaceable battery: one N size (IEC-LR1)alkaline battery.	Non replaceable internal battery:3.0V/1000mAh Type CR2477 LithiumButton Cell.
On/Off Control	N.A.	Connection/Disconnection of sensor belt toPatient Input Box.	Connection/Disconnection of SensorBelt Buckle.
Battery consumption	N.A.	Approximately 800 hours operating time perbattery.	2000 hours nominal operating time.
Indicators	No.	3 (red, amber, green) LEDs.Status of battery.Operation mode.	2 (yellow, green) LEDs.Status of battery.
Embedded Software	No.	Yes.	Yes.
Signal processing	No.	Yes.	Yes.
Patient safety	Not specified.	Conforms to IEC60601-1:1988+A1:1991+A2:1995.	Conforms to IEC60601-1:1988+A1:1991+A2:1995.
	Crystal Trace Piezo RespiratoryEffort Sensor (K923402)	Summit IP (K040194)	Universal XactTrace
Method of Connectionto Patient	Sensor belts + Velcro bands are appliedaround thorax and abdomen.	Sensor belts + bands are applied around thoraxand abdomen.	Sensor belts are applied around thoraxand abdomen.
Single use	No part single use.	No part single use.	No part single use.
Signals measured	Abdominal and thoracic respiratoryeffort.	Abdominal and thoracic respiratory effort.	Abdominal and thoracic respiratoryeffort.
Signals output	Abdomen and thoracic respiratoryeffort.	Abdomen and thoracic respiratory effort.Sum.	Abdomen and thoracic respiratoryeffort.
Typical signal outputsize	Not specified.	$1mVpp$	$1.5mVpp$
Maximum signalamplitude	Not specified.	$±5.0 mV$	$±5.6 mV$
Frequency rangeoutput signal	Not specified.	0.05 to 5.0Hz.	0.05 to 5.0Hz.
Sensor Technology	Piezo material technology.	Respiratory Inductive Plethysmography (RIP)technique.	Respiratory Inductive Plethysmography(RIP) technique.
EMC compatibility	Not specified.	IEC60601-1-2:2001	IEC60601-1-2:2001.

Medcare Flaga ▪ Sidumuli 24 ▪ 108 Reykjavik ▪ iceland ▪ phone +354 510 2010 ▪ www.medcare.

Page 3 of

{3}------------------------------------------------

Medcare Flaga ■ Sidumuli 24 ▪ 108 Reykjavik ▪ Iceland ▪ phone +354 510 2010 ▪ fax +354 510 2010 ▪ www.medgare.

Page 4 of 5

{4}------------------------------------------------

Performance Testing

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.

Conclusion

Based on the extensive testing, performance data and comparison to the predicate devices. it is the conclusion of Medcare Flaga that the Universal XactTrace is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person with outstretched arms. The symbol is black, and the background is white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2004

Mr. Kolbrún Eydís Ottósdóttir Regulatory Affairs Medcare Flaga Sidumuli 24 108 Reykjavik Iceland EUROPE

Re: K043132

Trade/Device Name: Universal XactTrace Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: November 1, 2004 Received: November 12, 2004

Dear Mr. Ottósdóttir:

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.

{6}------------------------------------------------

Page 2 - Mr. Ottósdóttir

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 (OS) 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 (240) 276-0120. 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,

Chin-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

{7}------------------------------------------------

Indication for Use

510(k) Number (if known):

Device Name: Universal XactTrace

Indications For Use:

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.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart.C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

fr. E. ferill

ision Si esthesiology, General Hospital, sion of AN Infection Control. Dental Devices

Page 1 of 1

510(k) Number __

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).