LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P

K050919 · Analogic Corp. · DSI · Jun 14, 2005 · Cardiovascular

Device Facts

• Record ID: K050919
• Device Name: LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
• Applicant: Analogic Corp.
• Product Code: DSI · Cardiovascular
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434. The purpose and function of the LIFEGARD II Family is to monitor: ECG; Heart rate; Non-invasive blood pressure (NIBP); Functional arterial oxygen saturation (SpO2); Respiration rate; Temperature and; End-tidal carbon dioxide (EtCO2); Impedance Cardiography (ICG); Arrhythmia with ST segment detection; Continuous non-invasive blood pressure (CNIBP). The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below: Height: 4 ft - 7 ft - 6 in (122 - 229 cm); Weight: 67 350 lbs (30 159 Kg). The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

Device Story

LIFEGARD II Family is a compact, lightweight multi-parameter patient monitor for hospital/clinical use. It acquires physiological signals including ECG (3/5 lead), respiration, SpO2 (via light transmissivity), temperature (thermistor), NIBP (oscillometric), CNIBP (radial artery pressure sensor), EtCO2 (side-stream), and ICG (thoracic bioimpedance). Device processes inputs to display waveforms and numeric values on an LCD screen, with optional internal thermal or external USB printing. Arrhythmia/ST segment software performs beat detection, lead selection, classification, and ventricular tachyarrhythmia detection. Operated by trained medical personnel to guide therapeutic management via real-time hemodynamic monitoring. Powered by internal lead-acid batteries or mains. Benefits include continuous, non-invasive, accurate, and frequent patient data collection during stationary care or transport.

Clinical Evidence

Bench testing only. Verification testing conducted per IEC 60601-1, 60601-1-2, 60601-2-27, 60601-2-30, 60601-2-49, ANSI/AAMI EC 13, ANSI/AAMI EC 57, ANSI/AAMI SP10, EN 864, and EN 865. Performance of SpO2 module verified via Nellcor data. Mechanical shock, vibration, altitude, and enclosure robustness testing performed.

Technological Characteristics

Multi-parameter monitor; internal lead-acid battery or mains power; LCD display; thermal printer; USB connectivity. Measurement principles: ECG (3/5 lead), oscillometric NIBP, thermistor temperature, side-stream EtCO2, thoracic electrical bioimpedance (ICG), radial artery pressure sensor (CNIBP), and dual-wavelength pulse oximetry. Software includes arrhythmia/ST segment analysis. Complies with IEC 60601-1, 60601-1-2, 60601-2-27, 60601-2-30, 60601-2-49, ANSI/AAMI EC 13, EC 57, SP10, EN 864, and EN 865.

Indications for Use

Indicated for adult and pediatric patients in hospital/clinical settings for monitoring ECG, heart rate, NIBP, SpO2, respiration, temperature, EtCO2, ICG, arrhythmia/ST segment, and CNIBP. ICG restricted to adults 122-229cm and 30-159kg. CNIBP intended for continuous monitoring of systolic, diastolic, mean BP, and pulse rate by trained personnel.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• C3 Patient Monitors (K030931, K041434)
• M3046A (M2/M3/M4) Compact Portable Patient Monitor (K023871)
• Continuous non-invasive blood pressure Multi-parameter patient monitoring system (K011152)
• Pulse Oximeter, Sensors and Cables (K012891)
• Physiological Signal Amplifier (K040113)
• Vasotrac APM205A

Submission Summary (Full Text)

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JUN 1 4 2005

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### 510(k) Summary For Analogic Corporation

## LIFEGARD II Family

#### Date this Summary was Prepared: 1.

April 8, 2005

:

#### 2. Submitter's Name and Address:

| Submitter's Name: | Analogic Corporation |
|-----------------------|----------------------|
| Address: | 8 Centennial Drive |
| City, State, and Zip: | Peabody, MA 01960 |
| Registration Number: | 1219601 |

#### 3. Contact Person:

| Name: | Janet R. Kwiatkowski |
|------------|---------------------------|
| Title: | Regulatory Affairs |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |

#### 4. Device Name:

| Proprietary or Trade Name: | LIFEGARD II Family |
|------------------------------|-----------------------------------------------------------------------------------|
| Common Name: | Arrhythmia detector and alarm (including ST-segment<br>measurement and alarm) |
| Classification Name: | Monitor, Physiological, Patient (with Arrhythmia Detection<br>or Alarms) |
| Classification Panel: | Cardiovascular Devices |
| Product Codes: | MHX, DSI, DSJ, DXN, MLC, DQA, DSB, DSA, FLL |
| Code of Federal Regulations: | 870.1025, 870.1100, 870.1130, 870.2340, 870.2700,<br>870.2770, 870.2900, 880.2910 |

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| Device Panel | CFR<br>Section | Product<br>Code | Device<br>Class | Description |
|--------------------------------------|----------------|-----------------|-----------------|----------------------------------------------------------------------------|
| Cardiovascular<br>Devices | 870.1025 | MHX | II | Monitor, physiological,<br>patient(with arrhythmia<br>detection or alarms) |
| | 870.1025 | DSI | II | Detector and alarm, arrhythmia |
| | 870.2770 | DSB | II | Plethysmograph, impedance |
| | 870.1100 | DSJ | II | Alarm, blood-pressure |
| | 870.1130 | DXN | II | System, measurement, blood-<br>pressure, non-invasive |
| | 870.2340 | MLC | II | Monitor, ST segment |
| | 870.2700 | DQA | II | Oximeter |
| | 870.2900 | DSA | II | Cable, transducer and<br>electrode, patient, (including<br>connector) |
| General Hospital<br>and Personal Use | 880.2910 | FLL | II | Thermometer, electronic,<br>clinical |

### Regulatory Classification of LIFEGARD II Family

#### న. Predicate Devices:

The legally marketed devices to which equivalence is being claimed are:

The C3 Patient Monitors cleared under Premarket Notification K030931 and K041434.

- . The Impedance Cardiography (ICG) parameter incorporated in the LIFEGARD II Family is identical in all aspects to the parent C3 Family.
- . The electrocardiograph (ECG) parameter incorporated in the LIFEGARD II Family is identical to the parent C3 Family.
- The end-tidal carbon dioxide (EtCO2) method of measurement is identical to the . parent C3 Family.
- The temperature probes are pre-amendment devices. The method of temperature . measurement is identical to the parent C3 Family.
- . The non-invasive blood pressure (NIBP) measurement method is identical to parent C3 Family.

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The M3046A (M2/M3/M4) Compact Portable Patient Monitor device cleared under K023871. This predicate device was chosen specifically for the arrhythmia with ST segment indication.

The continuous non-invasive blood pressure Multi-parameter patient monitoring system cleared under K011152. The LIFEGARD II contains the identical technology of the predicate device.

The Pulse Oximeter, Sensors and Cables with accessories and Physiological Signal Amplifier cleared under K012891and K040113, respectively. The technology as cleared in K012891 and K040113 is identical to the technology incorporated in the LIFEGARD II Family of devices.

#### 6. Description of LIFEGARD II Family

The LIFEGARD II Family is a compact, lightweight device for measuring, processing, printing, and displaying information derived from nine physiological measurements:

- . Electrocardiogram (ECG). A three lead or five lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optional printer. The design of the ECG function is derived directly from the predicate devices, the parent C3 Family of patient monitors.
- . Respiration. Waveform and numeric respiration rate value from ECG. Airway respiration rate from EtCO2 if available. The design of the respiration parameter is derived directly from the predicate devices, the parent C3 Family of patient monitors.
- Arrhythmia with ST segment analysis software performs five distinct operations: beat . detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement. The design of arrhythmia with ST segment function provides VF and ST segment deviation functionality similar to the predicate device, M3046A (M2/M3/M4) Compact Portable Patient Monitor
- . Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System and Sandman SD20 Amplifier patient monitor and system.
- . The temperature is measured using thermistor probes for continuous temperature measurements. These are pre-amendment devices.
- . Blood pressure is measured non-invasively (NIBP) by the oscillometric method. This is the same as in the predicate devices, parent C3 Family of patient monitors.

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- Continuous non-invasive blood pressure (CNIBP) is a non-invasive blood pressure . monitor which uses a pressure sensor placed on the wrist over the radial artery. This is the same technology as in the predicate device, Vasotrac APM205A.
- . End-tidal CO2 (EtCO2) This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system. This is the same as in the predicate devices, parent C3 Family of patient monitors.
- Impedance Cardiograph (ICG). This mode uses Thoracic Electrical Bioimpedance (TEB). . This is identical in all aspects to the predicate device, the C3 ICG.
- An internal thermal printer records waveforms, hemodynamic parameters and tabular . trends on a 50-mm wide strip chart.
- . External USB printing identical to the parent C3 Family.

The LIFEGARD II Family is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. A fully charged battery will power the monitor for three hours.

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#### 7. Intended Use:

The device is for use on individual adult and pediatric patients in hospital areas and hospitaltype facilities, such as clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434.

The purpose and function of the LIFEGARD II Family is to monitor:

- . ECG
- . Heart rate
- . Non-invasive blood pressure (NIBP)
- Functional arterial oxygen saturation (SpO2) .
- Respiration rate
- . Temperature and
- . End-tidal carbon dioxide (EtCO2)
- Impedance Cardiography (ICG) .
- . Arrhythmia with ST segment detection
- Continuous non-invasive blood pressure (CNIBP) .

The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below:

- . Height: 4 ft - 7 ft - 6 in (122 - 229 cm)
- Weight: 67 350 lbs (30 159 Kg) .

The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

#### 8. Comparison of Technological Characteristics:

The technological characteristics of the LIFEGARD II Family are the same as the legally marketed predicate devices.

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#### Non-clinical Tests to Be Used In Determination of Substantial Equivalence: 9.

Prior to marketing the LIFEGARD II Family, verification testing activities will be conducted to establish the compliance, performance and reliability characteristics of the LIFEGARD II Family. This is to include the following non-clinical tests:

IEC 60601-1 (including Amendments 1 & 2), Medical Electrical Equipment - General Requirements for Safety

IEC 60601-1-2: 2001 Medical electrical equipment - Electromagnetic compatibility emission limits meet Group 1 Class B

IEC 60601-2-27 Medical electrical equipment - Particular requirements for the safety of electrocardiographic monitoring equipment

IEC 60601-2-30 Medical electrical equipment - Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

IEC 60601-2-49 Medical electrical equipment - Particular requirements for the safety of multifunction patient monitoring equipment

ANSI/AAMI EC 13 Cardiac monitors, heart rate meters, and alarms

ANSI/AAMI EC 57 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

ANSI/AAMI SP10 Manual, Electronic, or Automated Sphygmomanometers

EN 864 Capnometers for use with humans

EN 865 Pulse Oximeters

Mechanical shock and vibration tests will be performed in accordance with IEC 60068 series of standards to ensure transport does not damage the device

Shipping container transportation tests will be performed in accordance with IEC 60068-2-27 to ensure packaging of equipment is not adversely affected during shipping

Altitude tests will be performed to ensure that operation at higher altitudes does not adversely affect electrical safety or performance

Tests will be performed to verify enclosure material robustness and resistance to cleaning materials commonly used in hospitals

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2050219 p.717

#### 10. Conclusions from Non-clinical Testing:

The test schedule of the LIFEGARD II Family combined with the AAMI EC 57 tests already performed including the current test data from Nellcor showing equivalent performance of the SpO2 module incorporated into the LIFEGARD II Family demonstrates that the performance of the LIFEGARD II Family patient monitors is substantially equivalent to the parent C3 Family of patient monitors and the non-Analogic predicate devices cited in Section 5 of this summary. The device will present no new concerns regarding safety and effectiveness.

APPENDIX D

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Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2005

Ms. Janet R. Kwiatkowski Regulatory Affairs Specialist Analogic Corporation 8 Centennial Drive Peabody, MA 01960

Re: K050919

Trade Name: LIFEGARD II Family Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: DSI Dated: April 8, 2005 Received: April 12, 2005

Dear Ms. Kwiatkowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nevers for over for a seeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorobate) to regars and ment date of the Medical Device Amendments, or to conninered proc to 1125 20, 2017, 11:28 provisions of the Federal Food, Drug, de nees may been receases of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, are every, mains 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 If your device 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 -- Ms. Janet R. Kwiatkowski

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be actived a determination that your device complies with other requirements of the Act that I Dri has Intact and regulations administered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set of it in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quality by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control proved in arketing your device as described in your Section 510(k) I mis letter will and my of substantial equivalence of your device of your device to a legally premated predicated 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 If you desire specific aarroliance at [phone]. Also, please note the regulation entitled, connact the Office of Complains and (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and oddess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B/Simmons for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: LIFEGARD II Family

### Indications for Use Statement

The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434.

The purpose and function of the LIFEGARD II Family is to monitor:

- ECG .
- . Heart rate
- Non-invasive blood pressure (NIBP) .
- Functional arterial oxygen saturation (SpO2) .
- . Respiration rate
- Temperature and .
- End-tidal carbon dioxide (EtCO2) .
- Impedance Cardiography (ICG) .
- Arrhythmia with ST segment detection .
- Continuous non-invasive blood pressure (CNIBP) .

X

The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below:

- Height: 4 ft 7 ft 6 in (122 229 cm) .
- Weight: 67 350 lbs (30 159 Kg) .

The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

Prescription Use

(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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