ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810

K062144 · Invivo Corporation · MHX · Oct 12, 2006 · Cardiovascular

Device Facts

• Record ID: K062144
• Device Name: ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
• Applicant: Invivo Corporation
• Product Code: MHX · Cardiovascular
• Decision Date: Oct 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Escort M8 Vital Signs Patient Monitor Model 3810 is intended for use as a vital signs monitor for adult and pediatric patients in a hospital setting.

Device Story

Escort M8 Model 3810 is a multiparameter patient monitor for hospital use. It collects physiological signals via sensors for ECG, non-invasive/invasive blood pressure, temperature, respiration, SpO2, and capnometry. The device processes these signals to calculate heart rate, respiration rate, and detect arrhythmias. Data is displayed on an 8.4-inch color TFT LCD. Clinicians use the monitor to observe real-time patient status and alarms. The device aids in clinical decision-making by providing continuous monitoring and automated arrhythmia analysis (e.g., asystole, ventricular fibrillation, PVCs). It benefits patients by enabling timely intervention through continuous vital sign tracking and alarm notification.

Clinical Evidence

No clinical data. Evidence consists of bench testing and validation using patient simulators under simulated use conditions. Performance requirements for accuracy and precision were verified against standards including IEC 60601-2-34 (invasive pressure), ISO 21647 (capnometry), and AAMI/ANSI EC 57 (arrhythmia detection). Electrical safety, EMC, and biocompatibility were confirmed via UL 60601-1, IEC 60601-1-2, and ISO 10993-1.

Technological Characteristics

Multiparameter monitor with 8.4-inch color TFT LCD (640x480). Parameters: ECG, NIBP, IBP, Temp, Resp, SpO2, EtCO2. Connectivity: 902-928 MHz spread spectrum wireless transmitter/receiver. Standards: UL 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 21647, AAMI/ANSI EC 57. Arrhythmia detection algorithm compliant with AAMI/ANSI EC 57.

Indications for Use

Indicated for adult and pediatric patients in hospital settings for monitoring vital signs, including heart rate, ECG, non-invasive/invasive blood pressure, temperature, respiration, SpO2, and capnometry (eTCO2/FiCO2), with arrhythmia detection.

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

• Zoe Medical Nightingale Monitoring System (K001775)
• Escort II + 400 Series (Escort Prism) (K014294)
• Polaris 2004 Capnograph (K040011)
• Masimo SET Radical Pulse Oximeter (K992340)
• Datascope Passport 2 with View 12 ECG Analysis Module (K020550)

Submission Summary (Full Text)

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# 510K SUMMARY OF SAFETY AND EFFECTIVENESS FOR ESCORT M8 VITAL SIGNS PATIENT MONITOR MODEL 3810

## 1. Submitter Information:

Invivo Corporation 12601 Research Parkway Orlando, Fl 32826

0C7 1 2 2006

| Contact Person: | Rusty Kelly |
|-----------------|-------------------------|
| Title: | Quality Control Manager |
| Telephone No.: | [phone] Ext: 166 |
| Fax No.: | [phone] |
| Date Prepared: | July 5, 2006 |

## 2. Device Name:

Classification Name: Monitor, cardiac (incl. Cardiotachometer and rate alarm)

Propietary Name: Escort M8 Vital Signs Patient Monitor Model 3810

| Device | Product Code | CFR Reference | Class |
|-----------------------------|--------------|---------------|-------|
| ECG | DRT | 870.2300 | II |
| non invasive blood pressure | DXN | 870.1130 | II |
| invasive blood pressure | DSK | 870.1110 | II |
| temperature | FLL | 880.2910 | II |
| respiration | BZQ | 868.2375 | II |
| SPO2 (Oximeter) | DQA | 870.2700 | II |
| ETCO2 (Capnometer) | CCK | 868.1400 | II |
| arrhythmia detection | MHX | 870.1025 | II |
| transmitter and receiver | DRG | 870.2910 | II |
| recorder | DSF | 870.2810 | II |
| display | DXJ | 870.2450 | II |

Product Codes:

# 3. Device Description:

The Escort M8 Vital Signs Patient Monitor Model 3810 is a multiparameter patient monitor intended to monitor adult and pediatric patient vital signs for general hospital use. The Escort M8 contains the hardware and software needed to perform complex data gathering and signal processing tasks that allow it to produce accurate and reliable measurements of physiological parameters such as heart rate, ECG, non invasive blood pressure, temperature, respiration, SPO2, and capnometry (eTCO2 and FiCO2), provides arrhythmia detection and displays this information on an LCD display.

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# 4. Substantial Equivalence:

The Escort M8 Vital Signs Patient Monitor is substantially equivalent to the following devices:

| Zoe Medical Nightingale Monitoring System | 510(k) K001775 |
|-------------------------------------------------------|----------------|
| Escort II + 400 Series (Escort Prism) | 510(k) K014294 |
| Polaris 2004 Capnograph | 510(k) K040011 |
| Masimo SET Radical Pulse Oximeter | 510(k) K992340 |
| Datascope Passport 2 with View 12 ECG Analysis Module | 510(k) K020550 |

# 5. Indications for Use

The Escort M8 Vital Signs Patient Monitor is intended for use as a vital signs monitor for adult and pediatric patients in hospital settings.

# 6. Comparison to Predicate Devices

The Escort M8 Vital Signs Patient Monitor is a modification of the Zoe Medical Nightingale Monitoring System. This modification adds a capnometer, invasive blood pressure monitor, arrhythmia detector and alarm, strip chart recorder, replaces the existing oximeter, adds lead selectivity to ECG and increases the size of the display.

# 7. Technological Characteristics

A comparison of the technological characteristics of the Escort M8 Vital Signs Patient Monitor and the predicate devices has been performed. The results of this comparison demonstrate that the Escort M8 Vital Signs Patient Monitor is equivalent to the marketed predicate devices in technological characteristics.

## 8. Environmental and non-clinical testing

Applicable environmental and non-clinical testing was performed per UL60601 and IEC 60601-1-2 as well as other applicable standards and procedures. The Escort M8 Vital Signs Patient Monitor passed all tests.

## 9. Performance data

The performance data included in this submission to compare equivalency of the Escort M8 Vital Signs Patient Monitor with its predicate devices met the performance requirements for accuracy and precision and indicates substantial equivalence to the predicate devices. Equivalent performance in meeting user requirements was also determined.

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## 10. Summary of performance Testing

Validation and Verification Testing confirmed that this device operates as designed and intended. The specifications for this device were verified in bench testing under simulated use conditions. Compliance to performance standards was confirmed by bench testing.

This device was validated using patient simulators under simulated use conditions. The functional requirements and user needs of the Escort M8 Vital Signs Patient Monitor were verified to have been met.

#### General

| Parameter | Requirement | Pass/Fail |
|-------------------|-------------------------------------|-----------|
| Electrical Safety | UL 60601-1:2003, IEC 60601-1-1:2000 | Pass |
| EMC | IEC 60601-1-2 | Pass |
| Biocompatibility | ISO 10993-1 | Pass |
| Shock | IEC 60068-2-27 | Pass |
| Vibration | IEC 60068-2-64 | Pass |

## Invasive Pressure Monitoring

| Parameter | Requirement | Pass/Fail |
|----------------------|----------------------|-----------|
| Measurement range | -10 to 300 mmHg | Pass |
| Measurement accuracy | ± 2 mmHg or ± 2% | Pass |
| Heart Rate Range | 30 to 240 bpm. | Pass |
| Heart Rate Accuracy | ± 4 bpm | Pass |
| Sensitivity | 5 uV/V/mmHg | Pass |
| Standard | IEC 60601-2-34: 2000 | Pass |

#### Capnometer

| Parameter | Requirement | Pass/Fail |
|------------------------|-----------------------------------------------|-----------|
| Accuracy 0 to 20 min | 0 to 38 mmHg: $\pm$ 4 mmHg | Pass |
| | 39 to 99 mmHg: $\pm$ 12% | |
| Accuracy 20 min and up | 0 to 38 mmHg: $\pm$ 2 mmHg | Pass |
| | 39 to 99 mmHg: $\pm$ 5% of reading +0.08% for | |
| | every 1mmHg above 38 mmHg | |
| Measurement Range | 0 to 99 mmHg ; 0 to 13.0 Vol%; 0 to 13.0 kPa | Pass |
| Flow Rate | 50ml per min. | Pass |
| Respiration Rate | 0 to 150 bpm | Pass |
| Respiration Accuracy | 0 to 70 bpm : $\pm$ 1 bpm | Pass |
| | 71 to 120 bpm $\pm$ 2 bpm | |
| | 121 to150 bpm $\pm$ 3 bpm | |
| Standard | ISO 21647:2004 | Pass |

#### Transmitter and Receiver

| Parameter | Requirement | Pass/Fail |
|---------------|----------------------------------------|-----------|
| Frequency | Spread spectrum 902 to 928 MHz | Pass |
| Transmission | Bidirectional with seamless auto-retry | Pass |
| FCC Licensing | 47 CFR Part 15 | Pass |

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## Multiple Lead Selection on Cardiac Monitor

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The testing of AAMI/ANSI EC 13 will be completed prior to product release, testing still ongoing.

## Arrhythmia Detector and Alarm

| Parameter | Requirement | Pass/Fail |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Heart Rate Range | 15 to 300 bpm. | Pass |
| Heart range accuracy | $\pm$ 2 bpm or $\pm$ 1%, whichever is greater | Pass |
| Pacer rejection | Rejects all pulses of amplitude $\pm$ 2mV to $\pm$ 700mV and duration 0.1 to 2 ms with no tail | Pass |
| Tall T-Wave rejection | Without Arrhythmia Option: Rejects all T-Waves less than or equal to 120% of 1mV QRS. With Arrhythmia Option: Rejects T-Waves less than or equal to 60% of 1mv QRS. | Pass |
| Arrhythmia analysis | Asystole, Couplets, Bigeminy, Trigminy, Ventricular Tachycardia, Ventricular Fibrillation, Ventricular Rhythm, Ventricular runs, Multi-focal PVC's, and R-on-T. | Pass |
| Standard | AAMI/ANSI EC 57: 1998 | Pass |

#### Oximeter

| Parameter | Requirement | Pass/Fail |
|-----------------------|----------------------------------|-----------|
| Saturation Range | 1% to 100% | Pass |
| Saturation Accuracy | 70 to 100% ± 2 digits -no motion | Pass |
| | 70 to 100% ± 3 digits -motion | Pass |
| | 0 to 69% unspecified | Pass |
| Saturation Resolution | 1% | Pass |
| Pulse rate range | 25 to 240 Bpm | Pass |
| Pulse rate accuracy | 25 to 240 ± 3 digits -no motion | Pass |
| | 25 to 240 ± 5 digits -motion | Pass |
| Pulse rate resolution | 1 BPM | Pass |

### Display

| Parameter | Requirement | Pass/Fail |
|------------------|-----------------------------|-----------|
| Type | Color Active Matrix TFT LCD | Pass |
| Size | 8.4 in./21.3 cm diagonal | Pass |
| Resolution | 640 x 480 pixels | Pass |
| Number of Traces | 4 channels | Pass |

# 11. Quality System

This device is being designed and manufactured in a quality system that has been certified to EN 13485:2003 requirements, and conforms with the Medical Device Directive requirements found in the European Council Directive 93/42/EEC.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2006

Invivo Corporation c/o Mr. Rusty Kelly Quality Control Manager 12601 Research Parkway Orlando, FL 32826

Re: K062144

Trade Name: Escort M8 Vital signs Patient Monitor, Model 3810 Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (With Arrhythmia Detection or Alarm) Regulatory Class: Class II (two) Product Code: MHX, CCK, DSK, DRT, DQA Dated: July 26, 2006 Received: July 27, 2006

Dear Mr. Kelly:

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. Rusty Kelly

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advisou that i bromination that your device complies with other requirements of the Act that I DA has made a acterimant administered by other Federal agencies. You must or any I cueral statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 807); moother (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product raction of to begin marketing your device as described in your Section 510(k) I mis letter will and in your e FDA finding of substantial equivalence of your device to a legally prematication of the 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 rryou desire 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Ramimmar 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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## INDICATIONS FOR USE

510K Number: K062144

Device Name: Escort M8 Vital Signs Patient Monitor Model 3810

Indications for Use: The Escort M8 Vital Signs Patient Monitor Model 3810 is intended for use as a vital signs monitor for adult and pediatric patients in a hospital setting.

Prescription Use J (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)

Condurrence of CDRH, Office of Device Evaluation (ODE)

*Blummemman*
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K212144

Confidential