AGILENT M2636B TELEMON B MONITOR (TELEMON B)

{0}------------------------------------------------ # 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 {1}------------------------------------------------ # 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,<br>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). {2}------------------------------------------------ ## 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/Agilent<br>Technologies | Viridia Information Center Software for<br>M3150A and M3153A, and Viridia Telemetry | M315x,<br>M2600A | K000854 | | Hewlett Packard/Agilent<br>Technologies | HP M2600A Viridia Telemetry System | M2600A | K993516 | | Hewlett Packard/Agilent<br>Technologies | Viridia HP M3000A/M3046A (M3/M4) | M3000A<br>M3046A | K991773 | | Hewlett Packard/Agilent<br>Technologies | HP Models M3000A/M3046A Patient Monitor | M3000A<br>M3046A | K981576 | | Hewlett Packard/Agilent<br>Technologies | Viridia Wave Viewer | M2605A | K974567 | | Hewlett Packard/Agilent<br>Technologies | Detector and Alarm, Arrhythmia | (see M315x ,<br>M30xx,<br>M2600) | K964122 | | Hewlett Packard/Agilent<br>Technologies | HP M1175A, M1176A Component Monitoring<br>System | M1175A,<br>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)]. {3}------------------------------------------------ # 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. న్న {4}------------------------------------------------ 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 {5}------------------------------------------------ # 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 {6}------------------------------------------------ 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