(113 days)
Not Found
No
The summary describes a data management system for collecting and displaying information, with no mention of AI/ML terms, image processing, or performance studies indicative of AI/ML model evaluation.
No.
The device is a data management system for collecting, recording, and displaying anesthesia information; it does not directly treat or diagnose a disease or condition.
No
The device is described as a "data management system" that collects, records, and displays information from other medical devices. It handles existing data rather than generating new diagnostic information itself.
Unknown
The summary describes a data management system that receives data from other medical devices and the hospital network. While it focuses on data handling and display, it doesn't explicitly state that it is only software and includes mentions of system-level qualification testing, environmental testing, and electromagnetic compatibility testing, which could potentially involve hardware components or interactions beyond pure software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is for "electronically collecting, recording, and displaying anesthesia information" and "perioperative information." This focuses on managing data related to a patient's physiological state and medical procedures, not on analyzing samples taken from the body (like blood, urine, tissue) to diagnose or monitor a condition.
- Device Description: The description reinforces this by mentioning receiving, recording, and displaying monitoring information from medical devices and manual entry. It doesn't describe any process of analyzing biological samples.
- Lack of IVD Keywords: There are no mentions of analyzing samples, diagnostic testing, or any other terms typically associated with IVD devices.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a data management system for clinical information, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Perioperative Data Managment System (PDMS) may be used as a data management system for electronically collecting, recording, and displaying anesthesia information.
The Perioperative Data Management System is indicated for electronically collecting, displaying, and recording perioperative information. Federal law restricts this device to sale by or on the order of a physician.
Product codes
73 BSZ
Device Description
The PDMS may be used for receiving, recording and displaying monitoring information from anesthesia systems, other medical devices in the operating room (OR), and through the hospital network and manual entry.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Qualification of the PDMS included a hazard analysis, system level qualification testing, environmental testing, and electromagnetic compatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
| Proprietary Name: | Perioperative Data Managment System | FEB - 6 1998 |
|---|---|---|
| Classification Name: | Gas-Machine, Anesthesia 73BSZ | |
| Device Class: | Class II | |
| Manufacturer: | North American Dräger | |
| 3135 Quarry Road | ||
| Telford, Pennsylvania 18969 | ||
| Establishment Registration Number: | 2517967 |
Devices to which substantial equivalence is claimed: O.R. Data Manager K900937
Device Description:
The PDMS may be used for receiving, recording and displaying monitoring information from anesthesia systems, other medical devices in the operating room (OR), and through the hospital network and manual entry.
Intended Use:
The Perioperative Data Managment System (PDMS) may be used as a data management system for electronically collecting, recording, and displaying anesthesia information
Substantial Equivalence:
The PDMS is substantially equivalent to the OR Data Manager (ORDM).
The PDMS and the ORDM have the same intended use and principal of operation and are substantially equivalent.
Qualification of the PDMS included a hazard analysis, system level qualification testing, environmental testing, and electromagnetic compatibility testing.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine, with a staff and two snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/4 description: The image shows the text 'FEB - 6 1998'. The text is in a simple, bold font. The date is likely a reference to a specific date, February 6, 1998.
Mr. James J. Brennan Director, Requlatory Affairs North American Drager 3135 Quarry Road Telford, PA 18969
Re : K973949 Perioperative Data Management System (PDMS) Regulatory Class: II (two) Product Code: 73 BSZ Dated: December 13, 1997 Received: December 17, 1997
Dear Mr. Brennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: -- -----------General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 1
510(k) Number (if known):
Device Name: Perioperative Data Management System (PDMS)
Indications For Use:
The Perioperative Data Management System is indicated for electronically collecting, displaying, and recording perioperative information. Federal law restricts this device to sale by or on the order of a physician.
197394
(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)
Mr. Puzl-
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K97394 510(k) Number _