COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM

K083413 · Philips Medical Systems · BSZ · Dec 18, 2008 · Anesthesiology

Device Facts

• Record ID: K083413
• Device Name: COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
• Applicant: Philips Medical Systems
• Product Code: BSZ · Anesthesiology
• Decision Date: Dec 18, 2008
• 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 Anesthesia Information System Software is a computer-based system which collects, processes, and records data directly from medical monitors which themselves are attached to the 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 version of the administration of anesthesia to a patient, perform a pre-operative assessment, and document (chart) nursing care in the PACU.

Device Story

CompuRecord is a peri-operative anesthesia information system software. It collects, processes, and records physiological data directly from medical monitors attached to patients in the operating room. The system facilitates the generation of paper and electronic anesthesia records, pre-operative assessments, and PACU nursing documentation. Enhancements in Release F.0 include improved search configurations, case browser search, document export, vitals warnings, advanced reporting, dynamic worklists, and surgical outcome scoring. The system is operated by clinicians in the peri-operative environment to support clinical documentation and decision-making.

Clinical Evidence

No clinical data. Performance was established through bench testing, including system-level tests, performance tests, and hazard analysis. Pass/Fail criteria were based on specifications cleared for the predicate device.

Technological Characteristics

Software-based peri-operative anesthesia information system. Functions as a data collection and documentation platform. Connectivity involves integration with medical monitors in the operating room. Software release F.0.

Indications for Use

Indicated for use in the peri-operative environment for patients undergoing anesthesia. Used by anesthetists to generate anesthesia administration records, perform pre-operative assessments, and document nursing care in the PACU.

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 CompuRecord Software, Release D.0 (K030939)

Submission Summary (Full Text)

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K0y34/13

## DEC 1 8 2008

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 CFR §807.92.

The submitter of this premarket notification is:

Teresa Schmidt Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099

Tel: [phone] Fax: [phone] Email: [e-mail]

This summary was prepared on 17 November 2008.

### The name of this device is the CompuRecord® Peri-Operative Anesthesia Information System Software Release F.O

Classification names are as follows:

| 1<br>lassification | a disacted<br>00-100 | <br>escrintion<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 868.5160. | 70 Dar<br>1111 | Anesthesia<br>195<br>Machine<br>- All - March - Market - Production - Production - Province - Province - Province - Province - Province - Province - Province - Province - Province - Province - Province - Pr |

- The new device is substantially equivalent to the previously cleared Philips 1. CompuRecord Software, Release D.0 marketed pursuant to K030939.
- 2. The modifications made to CompuRecord include the following enhancements plus non-safety related bug fixes:

Improved PAE Search Configurable Paired Events Improved Case Browser Search Document Export from Case Browser Enhanced Vitals Warning Advanced Reporting Service Dynamic Anesthesia Worklist Surgical Outcome Score

- The new device has the same Indications for Use and Intended Use as the legally న. marketed predicate devices.
- The new device has the same technological characteristics as the legally marketed 6. predicate devices.

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- Verification, validation, and testing activities establish the performance, 7. functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that Philips CompuRecord, Release F.0 meets all defined reliability requirements and performance claims.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 8 2008

Ms. Teresa Schmidt Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road, MS 0480 Andover, Massachusetts 01810-1099

Re: K083413

Trade/Device Name: Philips CompuRecord® Peri-Operative Anesthesia Information System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: November 17, 2008 Received: November 18, 2008

Dear Ms. Schmidt:

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), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Ms. Schmidt

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Suste Y. Michael Omd

Chiu Lin, Ph.D. 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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K08 3413
p. i of 1

3.1 ODE Indications Statement

#### Indications for Use

510(k) Number (if known):

Device Name: Philips CompuRecord® Peri-Operative Anesthesia Information System

Indications for Use:

The Philips CompuRecord Peri-Operative Anesthesia Information System Software is a computer-based system which collects, processes, and records data directly from medical monitors which themselves are attached to the 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 version of the administration of anesthesia to a patient, perform a pre-operative assessment, and document (chart) nursing care in the PACU.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Suite y. Mchais, M.D.

of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k083413 Confidential

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