K Number

Device Name

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

Manufacturer

ANALOGIC CORP.

Date Cleared

2005-06-14

(63 days)

Product Code

DSI

Regulation Number

870.1025

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 Description

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. - 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K030931, K041434, K023871, K011152

Reference Devices

K012891, K040113

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard multi-parameter patient monitor that measures physiological signals using established technologies. There is no mention of AI, ML, or any advanced algorithms beyond standard signal processing and analysis (like arrhythmia detection, which is a common feature in patient monitors and typically rule-based). The device description explicitly states that the design of various functions is derived directly from predicate devices, indicating reliance on existing, non-AI/ML technology.

Therapeutic

No.
The device is a patient monitor used for measuring and displaying physiological parameters, which guides clinicians in therapeutic management but does not directly provide therapy.

Diagnostic

Yes

The device is intended to monitor various physiological parameters (ECG, heart rate, NIBP, SpO2, respiration rate, temperature, EtCO2, ICG, Arrhythmia with ST segment detection, CNIBP) and provides information to "guide clinicians in the therapeutic management of their patients." This monitoring and guidance for clinical management fall under the definition of a diagnostic device, as it provides information used for diagnosis, treatment, or prevention of disease.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "compact, lightweight device for measuring, processing, printing, and displaying information derived from nine physiological measurements" and mentions components like an internal thermal printer, batteries, and connections for probes and sensors. This indicates it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, 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.
Device Function: The LIFEGARD II Family monitors physiological parameters directly from the patient's body (ECG, blood pressure, SpO2, respiration, temperature, EtCO2, ICG). It does not analyze samples taken from the body.
Lack of Sample Analysis: The device description details how the measurements are taken (e.g., electrodes for ECG, cuff for NIBP, sensor for SpO2, etc.), and none of these involve the analysis of biological samples.

Therefore, the LIFEGARD II Family falls under the category of patient monitoring devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MHX, DSI, DSJ, DXN, MLC, DQA, DSB, DSA, FLL

Device Description

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.
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.
trained medical personnel

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)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030931, K041434, K023871, K011152

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K012891, K040113

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.

Summary

JUN 1 4 2005

Image /page/0/Picture/1 description: The image shows the text "K05 0919" on the top line and "P. 1/7" on the bottom line. The text is written in a handwritten style. The numbers are clearly visible and the letters are also easily readable.

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:	(978) 326-4186
Facsimile:	(978) 977-6808
E-mail:	Jkwiatkowski@analogic.com

4. Device Name:

Proprietary or Trade Name:	LIFEGARD II Family
Common Name:	Arrhythmia detector and alarm (including ST-segment
measurement and alarm)
Classification Name:	Monitor, Physiological, Patient (with Arrhythmia Detection
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,
870.2770, 870.2900, 880.2910

| Device Panel | CFR
Section | Product
Code | Device
Class | Description |
|--------------------------------------|----------------|-----------------|-----------------|----------------------------------------------------------------------------|
| Cardiovascular
Devices | 870.1025 | MHX | II | Monitor, physiological,
patient(with arrhythmia
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-
pressure, non-invasive |
| | 870.2340 | MLC | II | Monitor, ST segment |
| | 870.2700 | DQA | II | Oximeter |
| | 870.2900 | DSA | II | Cable, transducer and
electrode, patient, (including
connector) |
| General Hospital
and Personal Use | 880.2910 | FLL | II | Thermometer, electronic,
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.

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.

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.

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) .

8. Comparison of Technological Characteristics:

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

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: