MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I

{0}------------------------------------------------ # 11.0 510(k) Summary of Safety and Effectiveness # DEC 0 3 2001 This Special 510(k) submission notifies the FDA of our intention to introduce the M3560A I this beend o r the CMS and module for the CMS and V24/V26 family of patient monitors. #### 11.1 Manufacturer/Submitter Denise Haley Quality and Regulatory Affairs Engineer Philips Medizinsysteme Böblingen GmbH Point of Care Diagnostics Division Hewlett-Packard Str. 2 71034 Böblingen Germany Telephone: 978-659-2701 978-685-5624 Fax: e-mail: denise haley@hsgmed.com #### 11.2 Establishment Registration Number 9610816 #### 11.2 Manufacturing Site Addresses: Philips Medizinsysteme Böblingen GmbH Hewlett-Packard Str. 2 71034 Böblingen Germany #### AND Diametrics Medical, Incorporated 2658 Patton Road Saint Paul, MN 55113-1136 USA #### Sterilization Site 11.3 Does not apply. #### 11.4 Date November 1, 2001 Philips Medical Systems {1}------------------------------------------------ ### 11.6 Device Name, Trade Name Proprietary Name: Component Monitoring System and V24/V26 Patient Monitor, M3560A Blood Analysis Portal System Plug-In Module Common Name: Patient Monitor Systems, Blood Analyzer Plug-In Module #### 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 | |----------------|---------|--------------------------------------------------------------------------|------| | 870.1025 | MHX | Monitor, Physiological, Patient (with<br>arrhythmia detection or alarms) | 3 | | 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 | | 862.1170 | CGZ | Electrode, Ion-Specific, Chloride | 2 | | 862.1120 | CHL | Electrode Measurement, Blood Gases | 2 | | 862.1145 | JFP | Electrode, Ion-Specific, Calcium | 2 | | 862.1665 | JGS | Electrode, Ion-Specific, Sodium | 2 | | 862.1600 | CEM | Electrode, Ion-Specific, Potassium | 2 | | 864.6400 | GKG | Hematocrit | 2 | | 862.1770 | CDS | Electrode, Ion-Specific, Urea Nitrogen | 2 | #### 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. These components of the CMS and V24/V26 Monitor Systems are unchanged from the previous submission and remain compliant. These components were previously cleared for commercial use in Premarket Notifications 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 CMS and V24/V26 family of patient monitors with the M3560A Blood Analysis Portal System Module is substantially equivalent to the previously cleared devices listed below: | Manufacturer | Device | Model | 510(k) | |--------------------------|----------------------------------------|---------------------------------------------------|---------| | Agilent Technologies | Agilent Component Monitoring System | M1175A,<br>M1176A,<br>M1177A | K002758 | | Agilent Technologies | Agilent Component Monitoring System | M1175A,<br>M1176A,<br>M1177A,<br>M1205A | K001722 | | Agilent Technologies | Agilent Component Monitoring System | M1175A,<br>M1176A,<br>M1177A,<br>M3000A<br>M3046A | K001333 | | Agilent Technologies | HP Viridia Component Monitoring System | M1175A,<br>M1176A,<br>M1177A | K992674 | | Hewlett-Packard | M1032A VueLink Plug-In Module | M1032A | K923682 | | Diametrics Medical, Inc. | IRMA Blood Analysis System | Series 2000 | K981270 | | Hewlett-Packard | HP Component Monitoring System | M1175A,<br>M1176A,<br>M1177A | K882609 | | i-STAT | i-STAT 200 Portable Clinical Analyzer | i-STAT 200 | K940918 | #### 11.9 Modification Description The modification in this submission is the addition of an alternate blood analysis module to the current plug-in i-STAT module as a component to the CMS and V24/V26 family of patient monitors. The proposed M3560A Blood Analysis Portal System is substantially equivalent to the Diametrics IRMA Blood Analysis System but provides a plug-in interface instead of an RS232 interface connection. Only Diametrics analysis cartridges (IRMA cartridges) are used with this module. The new M3560A Blood Analysis Portal System is also smaller than the current Diametrics IRMA Blood Analysis System and does not operate via battery power. #### 11.10 Intended Use The Component Monitoring System and V24/V26 family of patient monitors is intended for the monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by healthcare professionals whenever there is a need for monitoring the physiologic parameters of adult, neonatal, and pediatric patients. {3}------------------------------------------------ # 11.12 Fundamental Technology The fundamental scientific technology employed in the operation of this device has not es and the states and the success of the red 2/2/2001). K001722 (cleared The fundamental scientric technivolegy on.groy on not 2002/2001), K001722 (cleared changed from the predicate devices [K002758 (cleared 2/2/2001), K001722 (cleared changed from the predicate devices [K002750 (cleared 5/1/1998), and K940918 (cleared 5/10/1994)]. # 11.13 Design Controls Verification, validation, and testing activities will be successfully conducted and completed Verification, validation, and establish the safety, performance, and reliability characteristics prior to commercialization to establish the safety, performance, tests prior to commercialization to establish the barely, perten . Testing involves system level tests, of the M3560A Blood Analysis Forcal System : " compense to the many of the market testing. integration tests, safety tests from hazard and for the prodicate devices to integration tests, salety lests from hazard unarysis, and of the predicate devices to demonstrate substantial equivalence. ાપર {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a human figure or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 0 3 2001 Philips Medizinsysteme Böblingen GmbH c/o Ms. Denise Haley Philips Medical Systems, Inc. 3000 Minuteman Road Andover, MA 01810 Re: K013624 Trade Name: Component Monitoring System and V24/V26 Patient Monitor Family with M3560A Blood Analysis Portal System Plug-in Module Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor Regulatory Class: Class III (three) Product Code: MHX Dated: November 1, 2001 Received: November 5, 2001 Dear Ms. Haley: We have reviewed your Section 510(k) premarket notification of intent to market the device n & nave roviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreate) is the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, in cannon with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, are every mains 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 11 your device to such additional controls. Existing major regulations affecting your device can may or subject to outsil Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ #### Page 2 - Ms. Denise Haley Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Drive issual.to sever device complies with other requirements of the Act that I Dr Has Interes and regulations administered by other Federal agencies. You must of any I coural statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Fart 6077, mooning (21 CFR Part 820); and if applicable, the electronic forth in the quind of the 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) I mis letter will and w you'll ough finding of substantial equivalence of your device to a legally prematics notication. Thesults 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 11 Parceles. Additionally, for questions on the promotion and advertising of Compinance at (301) 294-661 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general mistmances, International 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. Van Tiem James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # 3.1 ODE Indications for Use Statement # Indications for Use Statement **510(k) Number:** K013624 (if known) Device Name: Component Monitoring System and V24/V26 Patient Monitor family with Device Namer Composis Portal System Plug-In Module ### Indications for Usc: The Component Monitoring System and V24/V26 family of patient monitors is intended for The Component Monitoring Oystem and of multiple physiological parameters. The devices the monitoring, recording, and alaming of maniped by healthcare professionals whenever there is a are indicated for use in licannelers of adult, neonatal, and pediatric patients. PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use Division of Cardiovascular & Respiratory Devices 510(k) Number K013424 OR November 1, 2001