(71 days)
The ESCORT Vision Central Station is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.
The modified ESCORT Vision Central Station is a central station monitor comprised of a standard VGA display, a standard personal computer base and an auxiliary base or receiver hub used to mount the network communications hardware. The modified Stickman telemetry transmitter is an RF physiological signal transmitter comprised of an ECG measurement system packaged with a UHF transmitter.
The modified ESCORT Vision Central Station provides centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT II, 100, 300 or 400 Series Bedside Monitors or UHF telemetry receivers. The modified Stickman telemetry transmitter provides ECG signal monitoring and RF signal transmission.
The modified ESCORT Vision Central Station with Stickman Telemetry Transmitters communicates in the new WMTS band, providing protection against interference.
This document describes the ESCORT Vision Central Station with Stickman Telemetry Transmitter. The information provided primarily focuses on substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study specifically proving the device meets those criteria for clinical performance.
Here's a breakdown of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen for AI/ML device evaluations. The focus is on the device's technological characteristics being similar to the predicate and confirmation of testing for safety and accuracy of the ST algorithm.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ST Algorithm Accuracy | "The ST algorithm has been tested for accuracy of the ST segment measurement data." (No specific metrics or quantitative results are provided in this summary.) |
| Safety Standards Compliance | "V&V testing and testing of the modified device to safety standards include the same ones as performed on the predicate devices with tests added to address issues raised as a result of the new hazard analysis." |
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size for any test sets or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the "ST algorithm has been tested for accuracy."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document mentions that "The significance of the ST segment changes must be determined by a physician," but this refers to clinical interpretation, not the establishment of ground truth for a device's performance study.
4. Adjudication method for the test set
This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not explicitly provided. The summary focuses on the device's technical characteristics and substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document indicates that "The ST algorithm has been tested for accuracy." This suggests a standalone evaluation of the algorithm's performance without a human in the loop, but no specific results or study design for this are detailed.
7. The type of ground truth used
The type of ground truth used for the ST algorithm accuracy testing is not specified. It's implied to be related to clinical ST segment changes, but whether this was expert consensus, pathology, or another method is not stated.
8. The sample size for the training set
This information is not provided. The document predates common AI/ML terminology like "training set."
9. How the ground truth for the training set was established
This information is not provided, as the concept of a "training set" and its ground truth establishment in the context of advanced machine learning is not discussed in this 2001 document. The device's modifications are primarily around communication hardware and software for channel/identifier programming, not a major AI algorithm update requiring extensive new training data.
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OCT - 3 2001
ATTACHMENT 4
510(k) Summary
Date July 23, 2001
- Greg Alkire Contact Director, Regulatory Affairs Medical Data Electronics 12723 Wentworth Street Arleta, California 91331 818-768-6411 Ext 2157 Telephone: Or: Robert Bejgrowicz Ext 2821 Telefax: 818-768-7602 Email: galkire@emailmde.com ESCORT® Vision Central Station with Stickman Telemetry Transmitter Device Name Central Station Monitor Common Name Detector and Alarm, Arrhythmia Cardiac Monitor RF Physiological Transmitter/Receiver Classification The classification names and classifications of the ESCORT® Vision Central Station with Stickman Telemetry Transmitter are as follows:
| Device | ClassificationNumber | Class |
|---|---|---|
| Arrhythmia Detector and Alarm | 870.1025 | III |
| Cardiac Monitor | 870.2300 | II |
| RF Physiological Transmitter/Receiver | 870.2910 | II |
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K012336 p. 2/3
| PredicateDevice | ESCORT Vision Central Station, 510(k) K982104, clearance date:November 25, 1998 and the ESCORT Guardian, Model 20601, 510(k)K961138, clearance date: July 14, 1997 |
|---|---|
| DeviceDescription | The modified ESCORT Vision Central Station is a central station monitorcomprised of a standard VGA display, a standard personal computer baseand an auxiliary base or receiver hub used to mount the networkcommunications hardware. The modified Stickman telemetry transmitteris an RF physiological signal transmitter comprised of an ECGmeasurement system packaged with a UHF transmitter. |
| The modified ESCORT Vision Central Station provides centralizeddisplay, storage and recording (or printing) of patient vital sign andwaveform data that are being monitored at ESCORT II, 100, 300 or 400Series Bedside Monitors or UHF telemetry receivers. The modifiedStickman telemetry transmitter provides ECG signal monitoring and RFsignal transmission. | |
| The modified ESCORT Vision Central Station with Stickman TelemetryTransmitters communicates in the new WMTS band, providing protectionagainst interference. | |
| IndicationsFor Use | The ESCORT Vision Central Station is intended to be used toprovide, using a wireless LAN for communication, centralizedsurveillance and documentation of patient vital sign data andarrhythmia/ST monitoring for a variable number of ESCORT II BedsideMonitors and a variable number of UHF telemetry transmitters in thehospital environment. It is intended for use by healthcare practitionerstrained in the use of the equipment only. |
| The ST algorithm has been tested for accuracy of the ST segmentmeasurement data. The significance of the ST segment changes must bedetermined by a physician. | |
| TechnologicalCharacteristics | The modified ESCORT Vision Central Station with Stickman TelemetryTransmitter has the same technological characteristics as the predicatedevice. Additional software is added to facilitate the channel and |
identifier programming capability for Stickman telemetry transmitters
configured for WMTS.
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K012336 p. 3/3
- Testing of the modified ESCORT Vision Central Station with Stickman Testing Telemetry Transmitter is being conducted by MDE to ensure mitigation of hazards. V&V testing and testing of the modified device to safety standards include the same ones as performed on the predicate devices with tests added to address issues raised as a result of the new hazard analysis.
- Medical Data Electronics, in accordance with the FFDCA and 21 CFR Conclusions Part 807 and data included in this premarket notification, concludes that the modified ESCORT Vision Central Station with Stickman Telemetry Transmitter is safe, effective and substantially equivalent to the predicate device.
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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
OCT - 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Greg R. Alkire Director of Regulatory Affairs Medical Data Electronics 12723 Wentworth St. Arleta, CA 91331
Re: K012336
Trade Name: ESCORT Guardian Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: 74 DSI Dated: September 21, 2001 Received: September 24, 2001
Dear Mr. Alkire:
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. Greg R. Alkire
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that 1 DA s issumited of a vederice complies with other requirements of the Act or that FDA had a decemination and your contraster by other Federal agencies. You must comply with CER Box 1907 all rederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); all the Act s requirements, morading, backevring practice requirements as set forth in the quality labeling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will anow you've 500 finding of substantial equivalence of your device to a legally prematicated predicated on "The PDF intention 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 and IT you desire specific acrise for you in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 007.10 for questions on the promotion and advertising of Compliance at (301) 591 1815. Tiber of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation citince, "Wisolulaing of responsibilities under the Act may be obtained from the Division Other general information on your rel rel and Consumer 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,
V. Dealla Tell
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2
Indications for Use Statement
Page of 1
510(k) Number (if known): KO1233 L
Device Name: ESCORT Vision Central Station
Indications for Use:
The ESCORT Vision Central Station is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.
The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012336
Prescription Use \ (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.