(112 days)
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.
The Philips CompuRecord® Peri-Operative Anesthesia Information System 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. The modification is primarily a software based change that updates the operating system and allows network use and web access.
The Philips CompuRecord® Peri-Operative Anesthesia Information System is a software modification that updates the operating system and allows network use and web access. This device was cleared through the 510(k) pathway, indicating that it was found to be substantially equivalent to a previously cleared predicate device (K854213). For devices cleared via substantial equivalence, the primary assessment is whether the new device is as safe and effective as the predicate, rather than establishing new, specific performance metrics through detailed clinical studies in the same way a novel device might.
Here's an analysis of the provided information concerning the acceptance criteria and study, structured to address your specific points:
Since this is a software modification to an existing device, the "acceptance criteria" and "device performance" are focused on maintaining the safety and effectiveness established for the predicate device, especially regarding the new software's functionality.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Outcome | Reported Device Performance |
|---|---|---|
| System Functionality | Maintain specifications cleared for predicate devices. | "Pass/Fail criteria were based on the specifications cleared for the predicate devices." "Test results showed substantial equivalence." |
| Reliability | Establish reliability characteristics. | "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device." |
| Safety | Address safety from risk analysis. | "Safety testing from risk analysis" was performed. |
| Software Integrity | Function correctly with updated operating system, network, and web access. | "Modification is primarily a software based change that updates the operating system and allows network use and web access." Implied successful operation. |
| Intended Use | Continue to meet the intended use of the predicate device. | "The new device has the same intended use as the legally marketed predicate devices." Also, "collects, processes, and records data directly from anesthesiological monitors," "generate a paper and electronic record," "perform a pre-operative assessment," and "documentation [chart] nursing care in the PACU." |
| Technological Characteristics | Maintain same technological characteristics as predicate. | "The new device has the same technological characteristics as the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in terms of patient data or clinical cases. The testing described is "system level tests, integration tests, and safety testing from risk analysis." This suggests a focus on software validation and verification, rather than clinical performance evaluation on a patient dataset. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of the testing (system, integration, safety), it's unlikely that "ground truth" in a clinical diagnostic sense (like expert consensus on medical images) was established for an external test set. The "ground truth" for software validation would be adherence to functional requirements and specifications.
4. Adjudication Method for the Test Set
This information is not provided. As explained above, the testing described does not suggest a need for a clinical adjudication method like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted or described in the provided summary. The submission focuses on substantial equivalence through verification testing, not comparative clinical effectiveness with human readers.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
The device itself is a "computer-based system which collects, processes, and records data" to assist an anesthetist. Its functionality is inherently integrated with human use (the anesthetist decides to generate records, performs assessments). The verification testing would have assessed the software's ability to perform these functions accurately and reliably, which could be considered its "standalone" performance within its intended use context. However, there isn't a separate study reported that isolates the algorithm's performance from human interaction in a way typical of diagnostic AI.
7. Type of Ground Truth Used
The "ground truth" for this device's validation appears to be the pre-defined specifications and requirements for the predicate device, as well as the software's ability to correctly implement the updated operating system, network, and web access functionality. This is a technical (engineering/software) ground truth rather than a clinical ground truth (e.g., pathology, outcomes data, expert consensus on a diagnosis).
8. Sample Size for the Training Set
This information is not applicable/not provided. The Philips CompuRecord is described as an information system for collecting, processing, and recording data, implying a rule-based or deterministic system rather than a machine learning (AI) system that requires a "training set" in the context of deep learning or similar algorithms. The term "training set" typically refers to data used to train a predictive model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided because, as noted above, the device does not appear to be an AI/machine learning system that would have a "training set" with associated ground truth established in the usual sense. Its validation focuses on functional correctness and adherence to specifications.
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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.
- The submitter of this premarket notification is:
Judith K. Phillips Philips Medical Systems Cardiac & Monitoring Systems 1082 Bower Hill Road Pittsburgh, PA 15243 Tel. 412-279-3263 Fax. 412-279-7163 e-mail: judy.phillips@philips.com
This summary was prepared on March 21, 2003
-
- 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 |
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- The new device is substantially equivalent to the previously cleared Philips device marketed pursuant to K854213.
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- The modification is primarily a software based change that updates the operating system and allows network use and web access.
- 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.
-
- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- 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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its head and wings. Below the eagle are three wavy lines.
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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)
§ 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).