(109 days)
The 506 Patient monitor interprets and displays real time physiological data of the patient. The 506 is configured to monitor Noninvasive BP (NIBP), SpO2, and Temperature. For each patient vital parameter, the 506 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review. The 506 monitor has utilized existing core technologies from the predicate 507EL monitor for patient monitoring of NIBP, SpO2, and Temperature. Temperature measurement is provided by Kendall's Filac FasTemp module which has been integrated into the 506 monitor. This temperature measurement technology allows predictive or continuous temperature measurement on adult or pediatric patients in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module. This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
The 506 monitor measures and displays real time physiological data of the patient, including a pulse bar plethysmogram and numerical data. The 506 can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP), SpO2, and Temperature. For all these vital parameters, the 506 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
The provided document is a 510(k) summary for the Criticare Systems Inc. Model 506 Patient Monitor. It details the device's functionality, intended use, and its claim of substantial equivalence to a predicate device (507EL Vital Signs Monitoring System, K022435).
However, the document does not contain specific acceptance criteria, comprehensive study details, or performance data in a format that would allow for the construction of the requested table and detailed answers.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. The document states:
- "The 506 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device."
- "Additionally, the 506 complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed."
It lists standards like EN1060-1 NIBP Performance, EN 1060-3 NIBP Performance, AAMI SP-10 NIBP Performance, and EN 865 Oximetry Performance. However, it does not specify the numerical acceptance criteria derived from these standards or the actual performance values achieved by the 506 monitor. Without this data, a table cannot be created.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document states "The patient monitoring technologies present in the 506 monitor have been in clinical use for at least six years in the 507EL monitor and it's predicates." It also mentions "CSI's field experience with these modalities in the predicate devices has been satisfactory."
While this indicates reliance on historical clinical use and field experience of predicate devices, it does not provide details about a specific test set used for the 506 monitor itself, including sample size, data provenance, or whether it was retrospective or prospective.
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)
N/A (Not Applicable) / Missing. Given that the document emphasizes performance equivalence to a predicate device and compliance with standards, and doesn't describe a specific clinical study with a distinct "test set" requiring expert ground truth establishment in the typical sense (e.g., for an AI algorithm interpreting images), this information is not present. The "ground truth" for vital sign monitors is typically derived from established measurement methods and validated reference devices, rather than expert consensus on interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A (Not Applicable) / Missing. Similar to point 3, as no specific clinical test set requiring expert adjudication is described, this information is not provided.
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
N/A (Not Applicable). The 506 Patient Monitor is a vital signs monitor, not an AI-assisted diagnostic imaging device that typically involves human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, implicitly. The device itself is the "standalone" component in the context of its measurements. The document states its performance was "confirmed to be equivalent to the predicate device" and that it "complies with applicable safety and performance standards." This implies testing the device's accuracy in measuring parameters like NIBP, SpO2, and Temperature directly against reference methods or established standards. The measurements it provides are direct outputs, not interpretations requiring human-in-the-loop for determination of the primary output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of a vital signs monitor:
- For NIBP and SpO2: Ground truth would typically be established by comparison to a reference standard device or method (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2) in controlled human or animal studies, or simulation models, as specified by the relevant performance standards (e.g., AAMI SP-10 for NIBP, EN 865 for Oximetry).
- For Temperature: Ground truth would be provided by highly accurate reference thermometers or established methods (e.g., rectal probe for core temperature) specific to the measurement site and method.
The document refers to compliance with standards like EN1060-1, EN 1060-3, AAMI SP-10, and EN 865, which would dictate the appropriate ground truth methods for performance testing.
8. The sample size for the training set
N/A (Not Applicable) / Missing. This device is a traditional physiological monitor, not an AI/ML-based device that typically requires a "training set." The technologies utilized are described as "existing core technologies" and "in clinical use for at least six years," implying established, non-machine learning methods.
9. How the ground truth for the training set was established
N/A (Not Applicable) / Missing. See point 8.
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15 March 2005
AUG 1 2 2005
510K Summary
Model 506 Patient Monitor
Alex Kaplan Contact: Director of QA & RA Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186 USA 262-798-8282 Voice 262-798-8290 FAX
Trade Name: 506 Patient Monitor
Common Name: Vital Signs Monitor
Classification Name: Monitor, Physiological, Patient (74 MWI)
Substantial Equivalence is claimed to : 507EL Vital Signs Monitoring System (K022435).
Device Description:
The 506 monitor measures and displays real time physiological data of the patient, including a pulse bar plethysmogram and numerical data. The 506 can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP), SpO2, and Temperature. For all these vital parameters, the 506 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
Intended Use:
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
Comparison with predicate device:
Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 506 monitor utilizes existing core technologies from the predicate 507EL monitor for patient monitoring of NIBP, SpO2,
@2005 Criticare Systems, Inc All Rights Reserved
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and Temperature. Temperature measurement is provided by Kendall's Filac FasTemp module which has been integrated into the 506 monitor. This temperature measurement technology allows predictive or continuous temperature measurement on adult or pediatric patients in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module. This SpO2 technology has been listed with the capability to be used in an environment where resistance to clinical motion is required. The patient data collected by the 506 monitor is displayed for the user on an alphanumeric display and LEDs equivalent to the predicate device. The 506 monitor utilizes alphanumeric display technology in combination with LED numeric displays. Membrane key panels provide a user interface equivalent to the predicate device. The packaging design of the 506 monitor is molded plastic and allows for it to be either a stationary monitor or to be used during patient translocation within the healthcare facility, as did the predicate 506EL.
Determination of Substantial Equivalence:
The 506 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 506 complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed. The patient monitoring technologies present in the 506 monitor have been in clinical use for at least six years in the 507EL monitor and it's predicates. CSI's field experience with these modalities in the predicate devices has been satisfactory. This combination of equivalence testing, applicable objective standards compliance and field experience substantiates a high level of confidence in the safety and efficacy of the 506 monitor.
Therefore, the 506 monitor is substantially equivalent to the predicate devices.
Compliance to standards and regulations:
The 506 Vital Signs Monitor complies with the following national and international standards:
Safety
UL 60601-1 Medical Electrical Safety EN 60601-1-2 EMC Compliance IEC 60601-2-49 Multiparameter Monitor Safety ISO 10993-5.10-11 Biocompatibility
Performance
IEC 60601-2-30 NIBP Safety EN1060-1 NIBP Performance EN 1060-3 NIBP Performance {including EN 475 Alarm Performance} AAMI SP-10 NIBP Performance EN 865 Oximetry Performance (Equivalent to ASTM F 1415)
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AUG 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Criticare Systems, Inc. c/o Mr. Alex Kaplan Director of QA and RA 20925 Crossroads Circle Waukesha, WI 53186
K051038 Re: Trade Name: 506 Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: August 5, 2005 Received: August 9, 2005
Dear Mr. Kaplan:
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. Alex Kaplan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Freast oc advised that I DTT 3155aanse or our device complies with other requirements of the Act that I DA has made a acterinaulations administered by other Federal agencies. You must of any I cochar statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product tadiation only to begin marketing your device as described in your Section 510(k) I his iciter will anow you to cogm mains of substantial equivalence of your device to a legally premarket notification " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spocific at noliance at (301) 594-4648. 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 micrimational 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,
B.Brimmer 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
510(k) Number (if known): K051038
Device Name: 506 Patient Monitor
Indications for Use:
The 506 Patient monitor interprets and displays real time physiological data of the patient I he 300 I attent inomitor interpred and safigured to monitor Noninvasive BP (NIBP), S.O., and Temperature. For each patient vital parameter, the 506 will be capable of providing limit Temperature. Tor each patient that pat recordings and storing data trends for retrospective alarins and arets, primatig of carpexisting core technologies from the predicate 507EL monitor for patient monitor unfized embining of Niemperature. Temperature measurement is provided 101 patient momtoring of Nibly Op on thich has been integrated into the 506 monitor. This of Rendan's I has Fear enterest and one predictive or continuous temperature measurement temperature measurements in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module.
provided by Nentor of DPOD model.
This system is intended to monitor physiological parameters of patients within any healthcare I mis system is intended to interpret the monitored data made available, will be a environinent. The user, respendere w sistem alarms and patient data analysis will be available to the care provider from the monitor.
Prescription Use (Part 21 CFR 801.109)
AND/OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
B.B. Summer
Division Slan-Om Division of Cardiovascular Devices 510(k) Number Korloßo
§ 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).