(30 days)
The Medical Data Electronics ESCORT 100/300 Series B Patient Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.
The modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Device is identical to the to the currently marketed device with the exception of the functionality of the Pulse Oximeter (SpO2) Options available. The predicate device, incorporating Nellcor technology, requires user action to invoke special signal processing ('C-Lock') in order to better handle limited patient perfusion. The modified device, incorporating Masimo technology, requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion.
The provided text describes a 510(k) submission for a patient monitor and focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a standalone study for a new device. Therefore, much of the requested information regarding acceptance criteria and study design is not explicitly available in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or performance metrics for the device. Instead, the "acceptance criteria" are implied to be the successful demonstration of substantial equivalence to the predicate device, particularly regarding the functionality of the Pulse Oximeter (SpO2) option.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Modified device (with Masimo technology) is "identical to the currently marketed device" with the exception of SpO2 signal processing. It "requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion." |
| Mitigation of hazards | "Testing of the modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor was conducted by MDE to ensure mitigation of hazards." |
| Compliance with safety standards | "V&V testing and testing of the modified device to safety standards are exactly the same as those conducted on the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a clinical study or a dataset for performance evaluation in the way one might expect for an AI/ML device. The testing described is more aligned with verification and validation (V&V) of a medical device's engineering specifications and safety, rather than a performance evaluation against a specific clinical dataset.
- Sample Size: Not specified.
- Data Provenance: Not specified. The testing was "conducted by MDE" (Medical Data Electronics), suggesting internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The concept of "ground truth" established by experts for a test set is typically relevant for diagnostic or screening devices, often involving interpretation of images or clinical data. The testing mentioned in this document appears to be focused on device functionality and safety, not on clinical diagnostic accuracy requiring expert ground truth.
4. Adjudication Method for the Test Set
Not applicable/Not specified, as there is no mention of a test set requiring expert adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The device described is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The change described is an improvement in signal processing for pulse oximetry, making it less reliant on user intervention.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone patient monitor, but the testing described focuses on the device's performance and safety, particularly the improved pulse oximetry technology. It's not a standalone algorithm in the modern AI/ML sense that would have separate standalone performance metrics distinct from the integrated device. The signal processing improvement in the pulse oximeter is inherent to the device's function.
7. The Type of Ground Truth Used
The document does not detail the type of "ground truth" as it relates to a clinical accuracy study. The "testing" mentioned refers to V&V to ensure "mitigation of hazards" and compliance with "safety standards." In this context, the ground truth would likely be established by engineering specifications, regulatory standards, and objective measurements of the device's functional parameters (e.g., accuracy of SpO2 readings compared to a reference standard, though this level of detail is not provided).
8. The Sample Size for the Training Set
Not applicable/Not specified. The device does not appear to be an AI/ML device that requires a "training set" in the conventional sense. The "Masimo technology" for signal processing would have been developed and validated by Masimo, likely using proprietary datasets, but this information is not part of the 510(k) submission for the ESCORT monitor.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified, as no training set for an AI/ML algorithm is mentioned.
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AUG 19 1399
ATTACHMENT 4
510(k) Summary
Date July 19, 1999
- David M. Trueblood Contact Regulatory Affairs Manager Medical Data Electronics 12720 Wentworth Street Arleta, California 91331 Telephone: 818-768-6411 Telefax: 818-768-4197 e-mail: dave.trueblood(@medicaldataelectronics.com
- ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Device Name
Patient Monitor, Vital Signs Monitor Common May Include Options: Name Cardiac Monitor Carbon Dioxide Analyzer Breathing Frequency Monitor Cardiac Output Computer Invasive Blood Pressure Recorder Temperature RF Physiological Transmitter/Receiver Noninvasive Blood Pressure Defibrillator Pulse Oximetry External Pacer
- The classification names and classifications of the Options available for Classification ESCORT® 100/300 Series B (ESCORT II) Patient Monitors are as follows:
| Option | ClassificationNumber | Class |
|---|---|---|
| Cardiac Monitor | 870.2300 | II |
| Breathing Frequency Monitor | 868.2375 | II |
| Invasive Blood Pressure | 870.1110 | II |
| Temperature | 880.2910 | II |
| Noninvasive Blood Pressure | 870.1130 | II |
| Pulse Oximetry | 870.2700 | II |
| Carbon Dioxide Analyzer | 868.1400 | II |
| Cardiac Output Computer | 870.1435 | II |
| Recorder | 870.2810 | II |
| RF Physiological Transmitter/Receiver | 870.2910 | II |
| Defibrillator | 870.5300 | II |
| External Pacer | 870.3600 | III |
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ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Predicate Device
The modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Device is identical to the to the currently marketed device with the exception of Description the functionality of the Pulse Oximeter (SpO2) Options available. The predicate device, incorporating Nellcor technology, requires user action to invoke special signal processing ('C-Lock') in order to better handle limited patient perfusion. The modified device, incorporating Masimo technology, requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion.
The Medical Data ESCORT® 100/300 Series B Patient Monitor is a Indications For Use portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.
Technological The modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Characteristics has the same technological characteristics as the predicate device with the exception of the type of signal processing utilized for pulse oximeter patient information. The predicate device uses Nellcor 'C-Lock' signal processing in order to better cope with patient motion. The modified device requires no special processing to cope with patient motion or limited patient perfusion.
- Testing of the modified ESCORT® 100/300 Series B (ESCORT II) Patient Testing Monitor was conducted by MDE to ensure mitigation of hazards. V&V testing and testing of the modified device to safety standards are exactly the same as those conducted on the predicate device.
- Conclusions Medical Data Electronics, in accordance with the FFDCA and 21 CFR Part 807 and data included in this premarket notification, concludes that the modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor is safe, effective and substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
AUG 1 9 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David M. Trueblood Requlatory Affairs Manager Medical Data Electronics, Inc. .12720 Wentworth St. Arleta, CA 91331-4329
Re: K992413 Trade Name: ESCORT® 100/300 Series B (ESCORT® II)Patient Monitors Requlatory Class: III Product Code: DRT, DQA and DTE Dated: July 16, 1999 Received: July 20, 1999
Dear Mr. Trueblood:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. David M. Trueblood
response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2
Indications for Use Statement
Page 1 of
510(k) Number (if known): Kaga2413
Device Name: ESCORT 100/300 Series B (ESCORT II)Patient Monitors
Indications for Use:
The Medical Data Electronics ESCORT 100/300 Series B Patient Monitor is a portable r ne modioal Buta Elook of he used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kalk Hill
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 94 2414 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).