PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE

K030939 · Philips Medical Systems · BSZ · Jul 15, 2003 · Anesthesiology

Device Facts

• Record ID: K030939
• Device Name: PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
• Applicant: Philips Medical Systems
• Product Code: BSZ · Anesthesiology
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Philips CompuRecord® Peri-Operative Anesthesiology Information System Software is a computer-based system which collects, processes, and records data directly from anesthesiological monitors which themselves are attached to patients in the operating room environment. CompuRecord is generally indicated in the peri-operative environment when the anesthetist decides to generate a paper and electronic record of the administration of anesthesia to a patient, perform a pre-operative assessment, and documentation of {chart} nursing care in the PACU.

Device Story

System collects, processes, and records physiological data directly from anesthesiological monitors attached to patients in operating rooms; PACU nursing care documentation. Used by anesthetists to generate paper and electronic anesthesia records and perform pre-operative assessments. Modification updates operating system, enables network connectivity, and web access. Output facilitates clinical documentation and record-keeping for anesthesia administration.

Clinical Evidence

Bench testing only. Verification activities included system-level tests, integration tests, and safety testing derived from risk analysis. Pass/Fail criteria based on predicate device specifications.

Technological Characteristics

Computer-based information system; software-based architecture; network and web-enabled. Operates by interfacing with anesthesiological monitors to collect and process patient data.

Indications for Use

Indicated for patients in the peri-operative environment requiring anesthesia administration, pre-operative assessment, and PACU nursing care documentation. Used by anesthetists to generate paper and electronic records.

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

• Philips device (K854213)

Submission Summary (Full Text)

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## KO30939

510 (k) Summary 8.0

## JUL 15 2003

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is:

Judith K. Phillips Philips Medical Systems Cardiac & Monitoring Systems 1082 Bower Hill Road Pittsburgh, PA 15243 Tel. [phone] Fax. [phone] e-mail: [e-mail]

This summary was prepared on March 21, 2003

- 2. The name of this device is the Philips CompuRecord® Peri-Operative Anesthesia Information System. Classification names are as follows:

| Regulation No. | Classification Name |
|----------------|---------------------------------|
| None | Computers and software, medical |
| 868.5160 | Gas-Machine, Anesthesia |
| 868.1890 | Calculator, Drug Dose |

- 3. The new device is substantially equivalent to the previously cleared Philips device marketed pursuant to K854213.
- 4. The modification is primarily a software based change that updates the operating system and allows network use and web access.

5. The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment The Philips CompuRecord is intended as a computer-based system which collects, processes, and records data directly from anesthesiological monitors which themselves are attached to patients in the operating room environment. It is indicated in the peri-operative environment when the anesthetist decides to generate a paper and electronic record of the administration of anesthesia to a patient, perform a pre-operative assessment, and documentation [chart] nursing care in the PACU.

- 6. The new device has the same technological characteristics as the legally marketed predicate devices.
- 7. Verification testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, inteqration tests, and safety testing from risk analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 2003

Ms. Judith Phillips Philips Medical Systems Cardiac & Monitoring Systems 1082 Bower Hill Road Pittsburgh, PA 15243

Re: K030939

Trade/Device Name: Philips CompuRecord Peri-operative Information System Software Regulation Number: 21 CFR 868.5160 Regulation Name: Accessory to gas machine for anesthesia or analgesia Regulatory Class: II Product Code: BSZ Dated: June 19, 2003 Received: June 20, 2003

Dear Ms. Phillips:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA) { ft 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Judith Phillips

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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) 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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Susan Runoe

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known):

Philips CompuRecord® software Device Name:

Indications for Use: The Philips CompuRecord® Peri-Operative Anesthesiology Information System Software is a computer-based system which collects, processes, and records data directly from anesthesiological monitors which themselves are attached to patients in the operating room environment.

CompuRecord is generally indicated in the peri-operative environment when the anesthetist decides to generate a paper and electronic record of the administration of anesthesia to a patient, perform a pre-operative assessment, and documentation of {chart} nursing care in the PACU.

sta. Zettlemann

General Hospital

510(k) Number:

(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)
OR
Over-The-Counter Use

(Optional Format 1-2-96)