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 Description

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

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Philips CompuRecord® Peri-Operative Anesthesia Information System Software Release F.0. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Philips CompuRecord Software, Release D.0, K030939) rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of a clinical trial for a novel AI/ML device.

Therefore, many of the requested detailed points regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific AI/ML performance metrics are not explicitly available or applicable in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with numerical performance targets and reported device performance metrics (e.g., sensitivity, specificity, accuracy) as would be expected for a novel AI/ML device study.

Instead, the acceptance criteria are implicit: the new device must meet "defined reliability requirements and performance claims" and demonstrate "substantial equivalence" to the predicate device. The performance is assessed through "system level tests, performance tests, and safety testing from hazard analysis."

Acceptance Criteria (Implicit)	Reported Device Performance
Meets defined reliability requirements.	"The results demonstrate that Philips CompuRecord, Release F.0 meets all defined reliability requirements."
Meets defined performance claims.	"The results demonstrate that Philips CompuRecord, Release F.0 meets all... performance claims."
Substantial equivalence to predicate device (Philips CompuRecord Software, Release D.0, K030939).	"Test results showed substantial equivalence."
Functionality and reliability characteristics established with respect to the predicate device.	"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate."
Pass/Fail criteria for testing based on specifications cleared for the predicate device.	"Pass/Fail criteria were based on the specifications cleared for the predicate device."
All enhancements (Improved PAE Search, Configurable Paired Events, etc.) function as intended.	Implicitly covered by "performance and functionality characteristics."
Non-safety related bug fixes are successfully implemented.	Implicitly covered by "performance and functionality characteristics."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data for algorithmic performance. The testing described refers to system-level verification and validation. Therefore, there is no information on:

Sample size for the test set: Not applicable in this context.
Data provenance: Not applicable. The document refers to "system level tests, performance tests, and safety testing," which would typically involve internal testing and validation of software functionality rather than external clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This is not applicable to the information provided. The testing described is functional and performance testing of software, not an assessment of an AI/ML algorithm's output against expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

This is not applicable. There's no "test set" in the context of clinical cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states that the device is a "Peri-Operative Anesthesia Information System Software" with enhancements and bug fixes. It is not an AI/ML diagnostic or assistive device that would typically undergo an MRMC study to measure improvement in human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While "system level tests" and "performance tests" were done, these are likely functional software tests rather than a standalone performance evaluation of a predictive algorithm against clinical outcomes. The device's primary function is data collection, processing, and recording, not making autonomous decisions or diagnoses.

7. The Type of Ground Truth Used

Given the nature of the device as an information system software, the "ground truth" for its testing would be the expected functional behavior and accuracy of data collection/display as defined by its technical specifications and requirements. This would not be clinical ground truth like pathology, expert consensus, or outcomes data, but rather:

System specifications: The software functions as designed.
Predicate device behavior: The new software performs comparably to the previously cleared predicate.
Hazard analysis: Safety functions are correctly implemented.

8. The Sample Size for the Training Set

This is not applicable. The device described does not appear to be an AI/ML model that requires a training set. It is a software system with programming logic.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set" for this type of device described.

Summary

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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: 978 659 2220 Fax: 978 685 5624 Email: teresa.schmidt@philips.com

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:

1lassification	a disacted00-100	escrintion------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
868.5160.	70 Dar1111	Anesthesia195Machine- 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.
1. The modifications made to CompuRecord include the following enhancements plus non-safety related bug fixes:

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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

Page 9

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)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.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. 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).(2)
Classification. Class II (performance standards).