PERIOPERATIVE DATA MANAGEMENT SYSTEM

K973949 · Draeger Medical, Inc. · BSZ · Feb 6, 1998 · Anesthesiology

Device Facts

• Record ID: K973949
• Device Name: PERIOPERATIVE DATA MANAGEMENT SYSTEM
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Perioperative Data Managment System (PDMS) may be used as a data management system for electronically collecting, recording, and displaying anesthesia information

Device Story

PDMS functions as a data management system for the operating room (OR). It receives, records, and displays monitoring information from anesthesia systems, other medical devices, and manual entry, including data via hospital networks. Operated by clinicians in the OR, the system centralizes perioperative data to assist in clinical documentation and information management. It does not perform active patient monitoring but serves as a repository and display interface for data generated by other devices, facilitating clinical decision-making through organized information presentation.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including hazard analysis, system-level qualification, environmental testing, and electromagnetic compatibility testing.

Technological Characteristics

Data management system for OR environment. Interfaces with anesthesia systems, medical devices, and hospital networks. Connectivity via network integration. Software-based data collection and display. No specific materials or energy sources defined beyond standard electronic computing hardware.

Indications for Use

Indicated for electronically collecting, displaying, and recording perioperative information. Prescription use only.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Predicate Devices

• O.R. Data Manager (K900937)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

| Proprietary Name: | Perioperative Data Managment System | FEB - 6 1998 |
|------------------------------------|--------------------------------------------------------------------------|--------------|
| Classification Name: | Gas-Machine, Anesthesia 73BSZ | |
| Device Class: | Class II | |
| Manufacturer: | North American Dräger<br>3135 Quarry Road<br>Telford, Pennsylvania 18969 | |
| Establishment Registration Number: | 2517967 | |

Devices to which substantial equivalence is claimed: O.R. Data Manager K900937

## Device Description:

The PDMS may be used for receiving, recording and displaying monitoring information from anesthesia systems, other medical devices in the operating room (OR), and through the hospital network and manual entry.

## Intended Use:

The Perioperative Data Managment System (PDMS) may be used as a data management system for electronically collecting, recording, and displaying anesthesia information

## Substantial Equivalence:

The PDMS is substantially equivalent to the OR Data Manager (ORDM).

The PDMS and the ORDM have the same intended use and principal of operation and are substantially equivalent.

Qualification of the PDMS included a hazard analysis, system level qualification testing, environmental testing, and electromagnetic compatibility testing.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine, with a staff and two snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/4 description: The image shows the text 'FEB - 6 1998'. The text is in a simple, bold font. The date is likely a reference to a specific date, February 6, 1998.

Mr. James J. Brennan Director, Requlatory Affairs North American Drager 3135 Quarry Road Telford, PA 18969

Re : K973949 Perioperative Data Management System (PDMS) Regulatory Class: II (two) Product Code: 73 BSZ Dated: December 13, 1997 Received: December 17, 1997

Dear Mr. Brennan:

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 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, 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 (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 Failure to comply with the GMP regulation may result in assumptions. regulatory 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 regulations.

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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/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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Attachment 1

510(k) Number (if known):

Device Name: Perioperative Data Management System (PDMS)

Indications For Use:

The Perioperative Data Management System is indicated for electronically collecting, displaying, and recording perioperative information. Federal law restricts this device to sale by or on the order of a physician.

197394

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Mr. Puzl-

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K97394 510(k) Number _