(112 days)
No
The document describes a data collection and recording system with software updates for operating system, network, and web access. There is no mention of AI or ML capabilities, image processing, or training/test sets typically associated with AI/ML development.
No.
The CompuRecord system is described as collecting, processing, and recording data from monitors, primarily for documentation and information management in an anesthesiology setting, rather than directly treating a condition or altering body function.
No
The system collects and records data from monitors but does not interpret or diagnose conditions, nor does it aid in detecting/analyzing disease. Its purpose is documentation and data management during anesthesia administration.
Yes
The device description explicitly states it is a "computer-based system" and the modification is "primarily a software based change". While it interacts with hardware (anesthesiological monitors), the device itself, as described, is the software system.
Based on the provided information, the Philips CompuRecord® Peri-Operative Anesthesiology Information System Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
- CompuRecord's Function: The description clearly states that CompuRecord collects, processes, and records data directly from anesthesiological monitors which themselves are attached to patients. This means it's dealing with real-time physiological data from a patient in vivo (within the living body), not analyzing samples in vitro (outside the body).
- Intended Use: The intended use is to generate a record of anesthesia administration, perform pre-operative assessments, and document nursing care. These are all related to patient management and documentation during surgery and recovery, not diagnostic testing of samples.
Therefore, CompuRecord falls under the category of a medical device used for patient monitoring and data management, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
BSZ
Device Description
The modification is primarily a software based change that updates the operating system and allows network use and web access.
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, hospital environment, 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
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.
Summary of Performance Studies
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.
Key Metrics
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
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 |
-
- The new device is substantially equivalent to the previously cleared Philips device marketed pursuant to K854213.
-
- 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.
1
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.
2
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
3
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)