DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

K981378 · Datex-Engstrom, Inc. · DRT · Nov 3, 1998 · Cardiovascular

Device Facts

• Record ID: K981378
• Device Name: DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
• Applicant: Datex-Engstrom, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Datex-Engstrom Light Monitor, F-LM1, F-LMP1 is for stationary and mobile monitoring of patient's ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case. The monitor is intended for use by qualified medical personnel only. The Light Monitor is intended for patients with weight of 5kg (11lb.) or more. Respiration monitoring is intended for patients ages 3 and up.

Device Story

Datex-Engstrom Light Monitor (F-LM1, F-LMP1) provides multi-parameter physiological monitoring; inputs include ECG, SpO2, body temperature, invasive/non-invasive blood pressure, respiration, and CO2. Device intended for stationary or mobile use in hospitals and ambulances; requires protective case for outdoor operation. Operated by qualified medical personnel. Output displayed on monitor for real-time clinical assessment; assists clinicians in patient status evaluation and decision-making. Benefits include continuous monitoring of vital signs to detect physiological changes in patients weighing 5kg or more.

Clinical Evidence

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

Technological Characteristics

Multi-parameter patient monitor for ECG, SpO2, temperature, blood pressure, respiration, and CO2. Form factor supports stationary and mobile use. Connectivity and specific material standards not detailed in provided text.

Indications for Use

Indicated for patients weighing ≥5kg requiring monitoring of ECG, SpO2, body temperature, invasive/non-invasive blood pressure, CO2, and respiration. Respiration monitoring indicated for patients aged ≥3 years. For use by qualified medical personnel in hospitals and ambulances.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

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

Re: K981378 Datex-Engstrom Light Monitor F-LM1, F-LMP1 Requlatory Class: II (two) Product Code: 74 DRT Dated: August 6, 1998 Received: August 7, 1998

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 general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation (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, r other Federal laws or regulations.

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Page 2 - Mr. Joel C. Kent

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 requlation (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. Callehan

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

## Indications For Use:

The Datex-Engstrom Light Monitor, F-LM1, F-LMP1 is for stationary and mobile monitoring of patient's ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case.

The monitor is intended for use by qualified medical personnel only. The Light Monitor is intended for patients with weight of 5kg (11lb.) or more. Respiration monitoring is intended for patients ages 3 and up.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| | Lmk Madow | 11-2-98 |
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| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

| (Division Sign-Off) | Over-The-Counter Use |
|-------------------------------------------------------------------|--------------------------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | (Optional Format 1-2-96) |

| 510(k) Number | |
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