(77 days)
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No
The document describes standard signal processing and data gathering for vital signs monitoring, with no mention of AI or ML technologies. The performance studies focus on standard validation and verification, not AI/ML specific metrics or training/test sets.
No
The device is described as a vital signs monitor, which gathers and displays physiological parameters. It does not perform any therapeutic intervention or treatment.
Yes
Explanation: The device is described as a "vital signs monitor" that performs "complex data gathering and signal processing tasks" 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." These functions are inherently diagnostic as they provide information about a patient's medical condition.
No
The device description explicitly states that the device "contains the hardware and software needed to perform complex data gathering and signal processing tasks," indicating it is a hardware-software combination device, not software-only.
Based on the provided information, the Escort M8 Vital Signs Patient Monitor Model 3810 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to monitor vital signs (heart rate, ECG, blood pressure, temperature, respiration, SpO2, capnometry) of patients. This involves measuring physiological parameters directly from the patient's body.
- Device Description: The device description confirms it's a patient monitor that gathers and processes data from the patient to display vital signs.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The Escort M8 does not perform this function. It measures parameters on the patient.
Therefore, the Escort M8 Vital Signs Patient Monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DRT, DXN, DSK, FLL, BZQ, DQA, CCK, MHX, DRG, DSF, DXJ
MHX, CCK, DSK, DRT, DQA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Hospital settings / general hospital use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Invasive Pressure Monitoring
Measurement range: -10 to 300 mmHg
Measurement accuracy: +/- 2 mmHg or +/- 2%
Heart Rate Range: 30 to 240 bpm.
Heart Rate Accuracy: +/- 4 bpm
Sensitivity: 5 uV/V/mmHg
Capnometer
Accuracy 0 to 20 min: 0 to 38 mmHg: +/- 4 mmHg; 39 to 99 mmHg: +/- 12%
Accuracy 20 min and up: 0 to 38 mmHg: +/- 2 mmHg; 39 to 99 mmHg: +/- 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
Flow Rate: 50ml per min.
Respiration Rate: 0 to 150 bpm
Respiration Accuracy: 0 to 70 bpm : +/- 1 bpm; 71 to 120 bpm +/- 2 bpm; 121 to150 bpm +/- 3 bpm
Arrhythmia Detector and Alarm
Heart Rate Range: 15 to 300 bpm.
Heart range accuracy: +/- 2 bpm or +/- 1%, whichever is greater
Pacer rejection: Rejects all pulses of amplitude +/- 2mV to +/- 700mV and duration 0.1 to 2 ms with no tail
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.
Arrhythmia analysis: Asystole, Couplets, Bigeminy, Trigminy, Ventricular Tachycardia, Ventricular Fibrillation, Ventricular Rhythm, Ventricular runs, Multi-focal PVC's, and R-on-T.
Oximeter
Saturation Range: 1% to 100%
Saturation Accuracy: 70 to 100% +/- 2 digits -no motion; 70 to 100% +/- 3 digits -motion; 0 to 69% unspecified
Saturation Resolution: 1%
Pulse rate range: 25 to 240 Bpm
Pulse rate accuracy: 25 to 240 +/- 3 digits -no motion; 25 to 240 +/- 5 digits -motion
Pulse rate resolution: 1 BPM
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.
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
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.
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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).
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§ 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.
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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.: | (407) 275-3220 Ext: 166 |
| Fax No.: | (407) 206-9568 |
| 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.
1
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 (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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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
6
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