(21 days)
TeleMon is indicated for use in the monitoring, recording, and alarming of multiple physiologic parameters in adult and pediatric patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
TeleMon is a prescription devices for use in healthcare facilities by trained healthcare professionals. TeleMon is not intended for home use.
The Agilent M2636B TeleMon B Monitor is an upgraded version of the current M2636A TeleMon, which is an extension device for the M2600A Telemetry System. The modification in this submission is the addition of audible alarms, the display of pulse and PVC rate numerics, a software upgradeable NBP module with improved measurement time, and the addition WaveViewer functionality to the M2636A TeleMon B Monitor, a multi-parameter monitor as an extension to the M2600A Telemetry System. The new device will be known as the M2636B TeleMon B Monitor.
The provided text is a 510(k) summary for the Agilent M2636B TeleMon B Monitor. It describes an upgrade to an existing device and primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria or a specific study proving the device meets those criteria in the way one might find for a novel device with specific performance metrics.
However, based on the available information, here's an attempt to extract and infer the closest information to your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantitative acceptance criteria and corresponding reported device performance values in the typical sense of a clinical or performance study.
Instead, the acceptance criteria are implicitly tied to the performance specifications of the predicate devices. The document states:
"Pass/fail criteria are based on the specifications cleared for the predicate devices to demonstrate substantial equivalence."
This implies that the M2636B TeleMon B Monitor is expected to perform at least as well as, or within the accepted specifications of, the legally marketed predicate devices, particularly the M2636A TeleMon Monitor.
The "reported device performance" is not explicitly quantified but is implicitly stated to be in compliance with the predicate device's performance through the substantial equivalence argument. The modifications (audible alarms, display of pulse and PVC rate numerics, improved NBP module, WaveViewer functionality) are presented as additions/improvements, not as changes to core performance that would necessitate new, specific performance studies beyond ensuring they integrate safely and effectively within the existing framework.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a clinical study with a sample size. The testing activities mentioned are primarily related to design controls, system-level tests, integration tests, safety tests, interference testing, and hardware testing. These are typically engineering verification and validation activities, not clinical trials with patient data.
Therefore, there is no information on:
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical "test set" requiring expert-established ground truth is described in the provided text. The submission focuses on substantial equivalence based on engineering and performance specifications relative to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical "test set" requiring adjudication for ground truth is described.
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. This device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would involve human readers or an MRMC study to assess diagnostic improvement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm for medical image analysis or a similar application where standalone algorithm performance would be assessed in isolation. It is a monitoring device that presents physiological data to healthcare professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as there is no mention of a study involving ground truth in the context of clinical performance data. The "ground truth" for this device's performance would be its accurate measurement and display of physiological parameters as defined by its technical specifications and comparison to established medical standards (e.g., accuracy of ECG, NBP measurements) which are implicitly covered by its predicate devices.
8. The sample size for the training set
Not applicable. The document does not describe any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. As no training set is described, there is no information on how its ground truth would be established.
Summary of Study (as described in the 510(k) context):
The "study" described in this 510(k) is primarily focused on design controls, verification, validation, and testing activities to ensure the new M2636B TeleMon B Monitor meets the safety, performance, and reliability characteristics established for its predicate devices.
The key statement regarding this "study" is:
"Verification, validation, and testing activities will be successfully conducted prior to commercialization to establish the safety, performance, and reliability characteristics of the M2636B TeleMon B Monitor. Testing involves system level tests, integration tests, safety tests from hazard analysis, interference testing, and hardware testing. Pass/fail criteria are based on the specifications cleared for the predicate devices to demonstrate substantial equivalence."
This indicates an engineering and regulatory compliance approach to demonstrating equivalence, rather than a clinical trial with specific patient-based performance metrics against a clinical ground truth. The acceptance is based on meeting the established specifications of the M2636A TeleMon Monitor (K001436) and other predicate devices in terms of functionality and safety.
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11.0 510(k) Summary of Safety and Effectiveness
This Special 510(k) submission notifies the FDA of our intention to introduce the M2636B TeleMon B Monitor--an upgraded version of the current M2636A TeleMon, which is an extension device for the M2600A Telemetry System.
11.1 Manufacturer/Submitter
Denise Haley Quality and Regulatory Affairs Engineer
Agilent Technologies, Incorporated Patient Monitoring Division Healthcare Solutions Group 3000 Minuteman Road MS 0490 Andover, MA 01810-1099
Telephone: 978-659-2701 Fax: 978-685-5624 e-mail: denise haley(@hsgmed.com
11.2 Establishment Registration Number 1218950
11.3 Manufacturing Site Address
Agilent Technologies, Incorporated Patient Monitoring Division Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099
11.4 Sterilization Site
Does not apply.
11.5 Date
June 8, 2001
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11.6 Device Name, Trade Name
Proprietary Name: Agilent M2636B TeleMon B Monitor (TeleMon B)
Common Name: Multi-Parameter Portable Patient Monitor
[This device uses the M2601A Agilent (Viridia) Transmitter, a component of the Agilent M2600A Telemetry System.]
Component Classifications:
Device classification information is presented in the following table. The FDA has placed all devices with arrhythmia and alarm capability in Class III. The
| Classification | Procode | Description | Tier |
|---|---|---|---|
| 870.2300 | DRT | Monitor, Cardiac | 2 |
| 870.1025 | DSI | Detector and Alarm, Arrhythmia | 3 |
| 870.2340 | DPS | Electrocardiograph | 2 |
| 870.1110 | DSK | Computer, Blood Pressure | 2 |
| 870.1120 | DXQ | Cuff, Blood Pressure | 2 |
| 870.1130 | DXN | System, Measurement, Blood-Pressure,Non-Invasive | 2 |
| Table 1: Panel 74, Cardiovascular | ||||||
|---|---|---|---|---|---|---|
| ------------------------------------ | -- | -- | -- | -- | -- | -- |
11.7 Performance Standards
Mandatory Standards:
21 CFR Part 898 establishes a performance standard for electrode lead wires and patient cables, and for arrhythmia detectors and alarms for the procodes and device classifications contained in the system and codified at 870.1025. This component of the Agilent M2636B TeleMon is unchanged from the previous submission for the M2600A Telemetry System and Viridia/Agilent Information System, and remains compliant. These components were previously cleared for commercial use in Premarket Notification K000854 (cleared April 3, 2000), K993516 (cleared November 8, 1999), K980429 (cleared September 9,1998), and K991773 (cleared June 7, 1999).
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11.8 Substantial Equivalence
The Agilent M2636B TeleMon B Monitor is substantially equivalent to the previously cleared devices listed below:
| Manufacturer | Device | Model | 510(k) |
|---|---|---|---|
| Agilent Technologies, Inc. | M2636A TeleMon Monitor | M2636A | K001436 |
| Hewlett Packard/AgilentTechnologies | Viridia Information Center Software forM3150A and M3153A, and Viridia Telemetry | M315x,M2600A | K000854 |
| Hewlett Packard/AgilentTechnologies | HP M2600A Viridia Telemetry System | M2600A | K993516 |
| Hewlett Packard/AgilentTechnologies | Viridia HP M3000A/M3046A (M3/M4) | M3000AM3046A | K991773 |
| Hewlett Packard/AgilentTechnologies | HP Models M3000A/M3046A Patient Monitor | M3000AM3046A | K981576 |
| Hewlett Packard/AgilentTechnologies | Viridia Wave Viewer | M2605A | K974567 |
| Hewlett Packard/AgilentTechnologies | Detector and Alarm, Arrhythmia | (see M315x ,M30xx,M2600) | K964122 |
| Hewlett Packard/AgilentTechnologies | HP M1175A, M1176A Component MonitoringSystem | M1175A,M1176A | K941811 |
11.9 Modification Description
The modification in this submission is the addition of audible alarms, the display of pulse and PVC rate numerics, a software upgradeable NBP module with improved measurement time, and the addition WaveViewer functionality to the M2636A TeleMon B Monitor, a multi-parameter monitor as an extension to the M2600A Telemetry System. The new device will be known as the M2636B TeleMon B Monitor
11.10 Intended Use
TeleMon is indicated for use in the monitoring, recording, and alarming of multiple physiologic parameters in adult and pediatric patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
TeleMon is a prescription devices for use in healthcare facilities by trained healthcare professionals. TeleMon is not intended for home use.
11.12 Fundamental Technology
The fundamental scientific technology employed in the operation of this device has not changed from the predicate devices [K001436 (cleared June 7, 2000), K000854 (cleared April 3, 2000), K993516 (cleared November 8, 1999), K980429 (cleared September 9,1998), and K991773 (cleared June 7, 1999)].
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K011824 p. 4/4
11.13 Design Controls
Verification, validation, and testing activities will be successfully conducted prior to commercialization to establish the safety, performance, and reliability characteristics of the M2636B TeleMon B Monitor. Testing involves system level tests, integration tests, safety tests from hazard analysis, interference testing, and hardware testing. Pass/fail criteria are based on the specifications cleared for the predicate devices to demonstrate substantial equivalence.
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Image /page/4/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2001
Ms. Denise Haley Quality and Regulatory Approvals Engineer Healthcare Solutions Group Patient Monitoring Division MS 0490 Agilent Technologies, Inc. 3000 Minuteman Road Andover, MA 01810-1099
Re: K011824
Trade Name: Agilent M2636B TeleMon B Monitor Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 DSI Dated: June 8, 2001 Received: June 11, 2001
Dear Ms. Haley:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally b really is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commission stated in the chelosate) to legally markets of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control Cosment Act (21cc). Tourine), alercesson on the Act include requirements for annual provisions of the rec. "The general omanufacturing 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 regulations (1 comarket Approval), it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good 099. I I subblainany equirements, as set forth in the Quality System Regulation (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 mspotions, the Food and result in regulatory action. In addition, FDA may publish
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Page 2 - Ms. Denise Haley
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.
This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri inding of backantar vqur 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 II you desire specific advice for your do need and the Office of Compliance a additionally 607.10 for m Thio diagnosions on the promotion and advertising of your device, (301) 594-4045. Additionally, for quest at (301) 594-4639. Also, please note the regulation entitled, "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
information on your responsibilities under the Act 1004 Mac (607) and its Information on your responsibilities and its receins. In 1201) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
J. Reese Dilland III
James L. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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3.1 ODE Indications for Use Statement
Indications for Use Statement
510(k) Number: K011824
(if known)
Device Name: Agilent M2636B TeleMon B Monitor
Indications for Use:
TeleMon is indicated for use in the monitoring, recording, and alarming of multiple physiologic receivour is indicated for as a sents patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use (Per 21 CFR 801.109)
Agilent Technologies
June 8, 2001
§ 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.