(188 days)
The 7271-500 module monitors ECG and Respiration, and the results are displayed on a Kolormon host system.
The ECG and respiration are measured from a 3 lead system providing an ECG waveform and heart rate from one of three selectable ECG vectors as well as a respiration waveform and respiration rate. Respiration is also measured from the active ECG electrode pair. There are two AC coupled sources of power to the front end to power the ECG and respiration circuits. Current is injected into the patient through the ECG electrodes to detect when a lead falls off the patient and through the respiration electrodes to determine the thoracic impedance across the chest to which the respiration cycle correlates. Measurement of the ECG waveform is by potential difference between two of three possible electrodes. The electrode pair is user selected.
The module may be used on either adults or neonates by selecting the adult/neonate option link in the module.
The Kolormon system is a generic patient monitor used in the operating theatre, critical care unit or as a bedside monitor on the ward. Its purpose is to measure and display clinical parameters of a patient via the module and module housing.
The basic system comprises a host monitor and its module housing. Modules, capable of measuring one or more clinical parameters of a patient to which they are connected, may be inserted into the module housing from which the clinical parameters for that module will be monitored. The generic nature of the system comes from the ability to select clinical parameters for monitoring by insertion of the appropriate modules.
The host has a colour screen which displays up to 6 waveforms, numeric values of the clinical parameters monitored (termed derived parameters), trends of clinical parameters, messages (information/cautions and warnings) and labels for keys used to select functions of the modules. There are a set of keys which control the basic functions of the monitor and a strip of six trikeys used to select module functions. Sets of key labels are presented at the bottom of the screen defined by the module whose keys have been selected for display and the previous key selections for that module.
The 7271-500 module monitors ECG and Respiration, and the results are displayed on a Kolormon host system.
The ECG and respiration are measured from a 3 lead system providing an ECG waveform and heart rate from one of three selectable ECG vectors as well as a respiration waveform and respiration rate. Respiration is also measured from the active ECG electrode pair. There are two AC coupled sources of power to the front end to power the ECG and respiration circuits. Current is injected into the patient through the ECG electrodes to detect when a lead falls off the patient and through the respiration electrodes to determine the thoracic impedance across the chest to which the respiration cycle correlates. Measurement of the ECG waveform is by potential difference between two of three possible electrodes. The electrode pair is user selected.
The module may be used on either adults or neonates by selecting the adult/neonate option link in the module.
The Kolormon system is a generic patient monitor used in the operating theatre, critical care unit or as a bedside monitor on the ward. Its purpose is to measure and display clinical parameters of a patient via the module and module housing.
The basic system comprises a host monitor and its module housing. Modules, capable of measuring one or more clinical parameters of a patient to which they are connected, may be inserted into the module housing from which the clinical parameters for that module will be monitored. The generic nature of the system comes from the ability to select clinical parameters for monitoring by insertion of the appropriate modules.
The host has a colour screen which displays up to 6 waveforms, numeric values of the clinical parameters monitored (termed derived parameters), trends of clinical parameters, messages (information/cautions and warnings) and labels for keys used to select functions of the modules. There are a set of keys which control the basic functions of the monitor and a strip of six trikeys used to select module functions. Sets of key labels are presented at the bottom of the screen defined by the module whose keys have been selected for display and the previous key selections for that module.
The provided document is a 510(k) clearance letter from the FDA for the Kontron Kolormon Plus ECG with Respiration Module 7271-500. This document primarily focuses on the regulatory approval process and does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way one might find in a clinical trial report.
However, based on the context of a 510(k) submission, the "acceptance criteria" are interpreted as the requirements for "substantial equivalence" to a predicate device, and the "study" is the information provided in the 510(k) notification itself (which is summarized here by the FDA's decision).
Here's an attempt to answer your questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
Based on this 510(k) clearance, the primary "acceptance criterion" is proving substantial equivalence to a legally marketed predicate device. The document does not provide a table of performance specifications or test results. Instead, it states that the device is "substantially equivalent" for its stated indications for use.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (as stated in document) |
|---|---|
| Substantial Equivalence to a Predicate Device | Determined to be substantially equivalent for the indications for use. |
| Specific Performance Parameters for ECG: | Not listed in this document. The document states it "monitors ECG" and provides "an ECG waveform and heart rate from one of three selectable ECG vectors." |
| Specific Performance Parameters for Respiration: | Not listed in this document. The document states it "monitors Respiration" and provides "a respiration waveform and respiration rate." |
| Safety and Effectiveness (assumed through substantial equivalence) | The FDA found the device to be substantially equivalent, implying it meets basic safety and effectiveness without new clinical data if the predicate device established this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a specified sample size for a test set. 510(k) submissions typically rely on existing engineering tests, performance data, and comparison to a predicate device, rather than new extensive clinical trials, unless new clinical data is explicitly required to demonstrate substantial equivalence. The document does not provide details on data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document does not refer to a test set requiring expert-established ground truth. The FDA's determination of substantial equivalence is based on its review of the submitted 510(k) documentation, including performance data and comparisons to existing devices, reviewed by FDA staff (e.g., Thomas J. Callahan, Ph.D., Director, Division of Cardiovascular, Respiratory, and Neurological Devices).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no external test set requiring expert adjudication is described in this document. The FDA's review process is its own form of "adjudication."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Kontron Kolormon Plus ECG with Respiration Module 7271-500 is a patient monitoring device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm-only device. It's a hardware module that monitors physiological parameters and displays them to a human operator via a host system. Performance assessment would involve the module's accuracy and reliability in measuring ECG and respiration. The document does not detail specific standalone performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device (ECG and respiration monitor), "ground truth" for performance testing (which is not detailed here) would typically come from:
- Calibration standards: For verifying the accuracy of measurements (e.g., known electrical signals for ECG, known respiration simulators).
- Comparison to reference devices: Using another already validated and highly accurate medical device as a reference standard.
The document itself does not specify the ground truth methodology used for any performance testing that would have been part of the 510(k) submission.
8. The sample size for the training set
Not applicable. This document pertains to a 510(k) clearance for a medical device that monitors physiological parameters, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device described here.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1997
Kontron Instruments, Ltd. c/o Mr. Randall C. Mathieson CPC Corporation 200 Cascade Boulevard Milford, Connecticut 06460
Re: K971038 Kontron Kolormon Plus ECG with Respiration Module 7271-500 only Requlatory Class: II (two) Product Code: 74 DPS Dated: August 4, 1997 Received: August 6, 1997
Dear Mr. Mathieson:
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 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 reqistration, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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.
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Page 2 - Mr. Randall C. Mathieson
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K971038
Device Name : KOLORMON plus ECG WITH RESPIRATION MODULE 7271-500
Indications for Use:
The 7271-500 module monitors ECG and Respiration, and the results are displayed on a Kolormon host system.
The ECG and respiration are measured from a 3 lead system providing an ECG waveform and heart rate from one of three selectable ECG vectors as well as a respiration waveform and respiration rate. Respiration is also measured from the active ECG electrode pair. There are two AC coupled sources of power to the front end to power the ECG and respiration circuits. Current is injected into the patient through the ECG electrodes to detect when a lead falls off the patient and through the respiration electrodes to determine the thoracic impedance across the chest to which the respiration cycle correlates. Measurement of the ECG waveform is by potential difference between two of three possible electrodes. The electrode pair is user selected.
The module may be used on either adults or neonates by selecting the adult/neonate option link in the module.
The Kolormon system is a generic patient monitor used in the operating theatre, critical care unit or as a bedside monitor on the ward. Its purpose is to measure and display clinical parameters of a patient via the module and module housing.
The basic system comprises a host monitor and its module housing. Modules, capable of measuring one or more clinical parameters of a patient to which they are connected, may be inserted into the module housing from which the clinical parameters for that module will be monitored. The generic nature of the system comes from the ability to select clinical parameters for monitoring by insertion of the appropriate modules.
The host has a colour screen which displays up to 6 waveforms, numeric values of the clinical parameters monitored (termed derived parameters), trends of clinical parameters, messages (information/cautions and warnings) and labels for keys used to select functions of the modules. There are a set of keys which control the basic functions of the monitor and a strip of six trikeys used to select module functions. Sets of key labels are presented at the bottom of the screen defined by the module whose keys have been selected for display and the previous key selections for that module.
Concurrrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
Nh. Puge
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number <971038
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).