(30 days)
Not Found
No
The document describes a data collection and processing system for anesthesia records, with enhancements focused on search, reporting, and workflow. There is no mention of AI or ML technologies.
No.
The device is a computer-based system for collecting, processing, and recording data from medical monitors for documentation purposes, not for providing direct therapy.
No
The device collects, processes, and records data from medical monitors and documents anesthesia administration, pre-operative assessments, and nursing care. It does not state that it analyzes this data to diagnose a medical condition.
Yes
The device description explicitly states "The name of this device is the CompuRecord® Peri-Operative Anesthesia Information System Software Release F.O" and the entire submission focuses on software modifications and testing, without mentioning any associated hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system collects, processes, and records data directly from medical monitors attached to patients. It's used for documenting anesthesia administration, pre-operative assessments, and nursing care. This is focused on patient monitoring and record-keeping, not on analyzing samples taken from the body (like blood, urine, tissue, etc.) to diagnose or monitor a condition.
- Device Description: The description focuses on software enhancements for data management, searching, reporting, and workflow. There's no mention of analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
The Philips CompuRecord Peri-Operative Anesthesia Information System Software is a clinical information system designed to manage patient data collected during surgery. It's a medical device, but not an IVD.
N/A
Intended Use / 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.
Product codes
BSZ
Device Description
The CompuRecord® Peri-Operative Anesthesia Information System Software Release F.0 is a computer-based system. Modifications to the previous version include: Improved PAE Search, Configurable Paired Events, Improved Case Browser Search, Document Export from Case Browser, Enhanced Vitals Warning, Advanced Reporting Service, Dynamic Anesthesia Worklist, and Surgical Outcome Score.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthetist/operating room environment, PACU
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation, and testing activities establish the performance, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
| 1
lassification | a disacted
00-100 |
| escrintion |
|---|
| -------------------- |
| 868.5160. |
| 1111 |
| 195 |
| Machine |
-
All - March - Market - Production - Production - Province - Province - Province - Province - Province - Province - Province - Province - Province - Province - Province - Pr |
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The new device is substantially equivalent to the previously cleared Philips 1. CompuRecord Software, Release D.0 marketed pursuant to K030939.
-
- 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.
1
- 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.
2
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.
3
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
4
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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