UNIVERSAL XACTTRACE

K043132 · Medcare Flaga · MNR · Dec 21, 2004 · Anesthesiology

Device Facts

• Record ID: K043132
• Device Name: UNIVERSAL XACTTRACE
• Applicant: Medcare Flaga
• Product Code: MNR · Anesthesiology
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

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.

Device Story

Universal XactTrace is a battery-powered, reusable respiratory effort sensor using Respiratory Inductive Plethysmography (RIP) technology. It consists of abdomen and thorax sensor belts with an integrated amplifier in the buckle. The device measures respiratory effort signals, processes them, and outputs electrical signals to a physiological recorder via bipolar touch-proof connectors. It is used in hospitals, sleep centers, and clinics by healthcare professionals to assist in diagnosing sleep disorders. The device is worn over clothing; the buckle acts as an on/off switch. Output signals are viewed by clinicians on connected recording equipment to assess respiratory patterns, aiding in clinical decision-making for sleep disorder diagnosis. It is not an apnea monitor.

Clinical Evidence

Bench testing only. Verification included hardware and firmware testing against design requirements, risk analysis, and compliance with IEC 60601-1 and IEC 60601-1-2 standards. Comparative bench testing demonstrated that signals detected by the Universal XactTrace were reliable and comparable to those obtained from the predicate devices (Crystal Trace Piezo and Summit IP).

Technological Characteristics

Respiratory Inductive Plethysmography (RIP) sensor. Materials: elastic/velcro belts. Power: 3.0V/1000mAh CR2477 Lithium button cell (non-replaceable). Connectivity: Bipolar touch-proof safety connectors to physiological recorders. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC). Form factor: Belt with integrated buckle-mounted amplifier (<60g). Signal output: 0.05 to 5.0Hz frequency range, ±5.6 mV max amplitude. Firmware-based signal processing.

Indications for Use

Indicated for patients undergoing diagnostic evaluation for sleep disorders or sleep-related respiratory disorders in clinical or institutional settings. Not for use as an apnea monitor.

Regulatory Classification

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.

Predicate Devices

• Crystal Trace Piezo Respiratory Effort Sensor (K923402)
• Summit IP (K040194)

Submission Summary (Full Text)

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K043132

**Medicare**

### DEC 21 2004

### 510(k) Summary

#### Submitter

Medcare Flaga Sidumuli 24 108 Reykjavik Iceland Europe

Tel: [phone] Fax: [phone]

Registration Number: 9611753

#### Contact person

Kolbrún Eydís Ottósdóttir Email: [e-mail], [e-mail]

#### 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

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#### 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 [phone] = www.medcare.com

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Table 1 Comparative Table

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

Medcare Flaga ▪ Sidumuli 24 ▪ 108 Reykjavik ▪ iceland ▪ phone [phone] ▪ www.medcare.

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Medcare Flaga ■ Sidumuli 24 ▪ 108 Reykjavik ▪ Iceland ▪ phone [phone] ▪ fax [phone] ▪ www.medgare.

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#### 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.

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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#### Indication for Use

510(k) Number (if known):

Device Name: Universal XactTrace

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.

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

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