DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES

K992323 · Datex-Ohmeda, Inc. · MLD · Nov 1, 1999 · Cardiovascular

Device Facts

• Record ID: K992323
• Device Name: DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
• Applicant: Datex-Ohmeda, Inc.
• Product Code: MLD · Cardiovascular
• Decision Date: Nov 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hcmodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients. Impedance Respiration measurement is indicated for patients ages 3 and up. Cardiocap 5 is indicated for patients with weight from 5 kg (11 lb.) up. The monitor is indicated for usc by qualified medical personnel only.

Device Story

Cardiocap 5 (Models F-MX, F-MXG) is a multiparameter patient monitor for hospital use. Inputs include ECG, impedance respiration, NIBP, temperature, SpO2, invasive blood pressure, airway gases (CO2, O2, N2O, anesthetic agents), airway pressure, volume, flow, and neuromuscular transmission (NMT). Device processes physiological signals to provide real-time monitoring and alarms for hemodynamic, respiratory, and ventilatory status. Operated by qualified medical personnel in clinical settings. Output displayed on monitor for clinician assessment of patient status; facilitates clinical decision-making regarding patient care and intervention. Benefits include continuous patient surveillance and early detection of physiological changes.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on device description and intended use.

Technological Characteristics

Multiparameter monitor for hemodynamic, respiratory, and ventilatory parameters. Includes sensors for ECG, NIBP, SpO2, temperature, invasive pressure, gas analysis (CO2, O2, N2O, anesthetic agents), and NMT. Standalone bedside unit. Software-based signal processing for parameter calculation and alarm generation.

Indications for Use

Indicated for indoor monitoring of hemodynamic, respiratory, ventilatory, and relaxation status in all hospital patients. Impedance respiration indicated for patients age 3+. General monitoring indicated for patients weighing 5 kg (11 lb) and up. For use by qualified medical personnel only.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines that curve and resemble a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 1999

Mr. Joel C. Kent Datex-Ohmeda, Inc. 3 Highwood Drive Tewksbury, MA 01876

K992323 Re: Cardiocap 5 (Models F-MX and F-MXG) and Accessories Regulatory Class: III (three) Product Codes:

| 74 MLD | (ST-Segment with Alarms) |
|--------|-------------------------------------------|
| 74 DPS | (ECG) |
| 73 BZQ | (Breathing Frequency Monitor) |
| 74 DQA | (Sp02) |
| 74 DXN | (NIBP) |
| 80 FLL | (Temperature) |
| 74 DSK | (Invasive Blood Pressure) |
| 73 KOI | (NeuroMuscular Transmission, NMT) |
| 73 CCK | (Analyzer, Gas, CO2, Gaseous-Phase) |
| 73 CBR | (Analyzer, Gas, N2O, Gaseous-Phase) |
| 73 CCL | (Analyzer, Gas, O2, Gaseous-Phase) |
| 73 CBQ | (Analyzer, Gas, Enflurane, Gaseous-Phase) |
| 73 CBS | (Analyzer, Gas, Halothane, Gaseous-Phase) |
| 73 CCI | (Analyzer, Gas, Nitrogen, Gaseous-Phase) |
| 73 BZG | (Diagnostic Spirometer) |

Dated: July 7, 1999 Received: July 12, 1999

Dear Mr. Kent:

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 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). You may, therefore, market the device, subject to the qeneral 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.

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Page 2 - Mr. Joel C. Kent

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 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 Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 requlations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

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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K992323 510(k) Number (if known): _

Device Name: Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories

Indications For Use:

The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hcmodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients.

Impedance Respiration measurement is indicated for patients ages 3 and up.

Cardiocap 5 is indicated for patients with weight from 5 kg (11 lb.) up.

The monitor is indicated for usc by qualified medical personnel only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, Over-The-Counter Use *_*_
and Neurological Devices
510(k) Number K992323 (Optional Format 1-2-96)