(191 days)
No
The summary describes a record-keeping and drug management system with adverse drug event screening, but it does not mention or imply the use of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a comprehensive record-keeping system for anesthesia, intended for documenting, tracking, and managing information related to anesthesia procedures and drug administration, not for directly treating or diagnosing patients.
No
This device is an information management system for anesthesia, primarily focused on record-keeping, drug management, and adverse drug event screening. It does not perform diagnostic functions but rather assists clinicians in documenting and managing patient data during the anesthesia process.
No
The device description explicitly mentions the use of "DocuSys' optional digital-Drug Management System" which includes scanning a barcode affixed to a "Syringe Label Cradle" or using "DocuJect" to record drug delivery. These components suggest the inclusion of hardware elements beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for record keeping and management of anesthesia procedures, including patient data, drug administration, and adverse drug event screening. This is focused on clinical workflow and information management, not on analyzing biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as a software application program that runs on a computer system and connects to patient monitors. This aligns with an information system, not a device designed to perform in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
The system's function is to support the clinical process of anesthesia administration and documentation, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs.
The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSys' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record, performing ADE checks, and submitting medication utilization information for billing purposes.
The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature.
Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.
Product codes
BSZ
Device Description
The DocuSys System is substantially equivalent to the Philips CompuRecord Peri-Operative Anesthesiology Information System. (K030939) and the SAFERsleep System (K050883) marketed by Safer Sleep, LLC.
All three systems are software application programs that run on Windows-based computer systems. The Phillips, Safer Sleep and DocuSys systems are intended for use by anesthesiologists for the tracking and record keeping of anesthesia procedures including the administration of drugs. All three systems can connect electronically to patient monitors that are used during the anesthesia procedure to provide a detailed record of the anesthesia process for record retention and billing purposes.
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
anesthesiologists, pre-op, intra-op, and PACU areas
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
Testing was performed at two levels to ensure that the Anesthesia Information and digital-Drug Management System would perform as intended: Non-clinical bench testing to test each function and clinical testing to verify performance of the software. The Anesthesia Information and digital-Drug Management System meets applicable standards for performance and EMC compliance.
Non-clinical Testing: Testing was performed to evaluate the functional modules.
Clinical Testing: Clinical testing was performed by DocuSvs and third party clinicians. All values were taken in a normal operating environment. The testing shows that the data was accurately received and recorded.
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
FEB 2 2 2007
510(k) Summarv
DocuSys Inc. Anesthesia Information and digital-Drug Management System The following information is in accordance with 21 CFR 807.92
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
DocuSys, Inc. 820 S. University Blvd. Suite 3-H Mobile Al.36609 Tel: 251-461-9903 Fax: 251-461-9960 Contact Person: Gordon J. Peters, Director Regulatory Compliance Cell (770)842-1489
Date Prepared: May15, 2006
Name of Device
Anesthesia Information and digital-Drug Management System, DocuSys, Inc.
Device Classification/Classification Panel
21 C.F.R. 868.5160 Class II Anesthesiology Panel
Predicate Devices
INTENDED USE
The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs.
The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSvs' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed
1
to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record. performing ADE checks, and submitting medication utilization information for billing purposes.
The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature.
Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.
DESCRIPTION OF THE DEVICE/SUBSTANTIAL EQUIVALENCE
The DocuSys System is substantially equivalent to the Philips CompuRecord Peri-Operative Anesthesiology Information System. (K030939) and the SAFERsleep System (K050883) marketed by Safer Sleep, LLC.
All three systems are software application programs that run on Windows-based computer systems. The Phillips, Safer Sleep and DocuSys systems are intended for use by anesthesiologists for the tracking and record keeping of anesthesia procedures including the administration of drugs. All three systems can connect electronically to patient monitors that are used during the anesthesia procedure to provide a detailed record of the anesthesia process for record retention and billing purposes.
PERFORMANCE DATA
The Anesthesia Information and digital-Drug Management System uses currently available technology found in legally marketed devices. Testing was performed at two levels to ensure that the Anesthesia Information and digital-Drug Management System would perform as intended: Non-clinical bench testing to test each function and clinical testing to verify performance of the software. The Anesthesia Information and digital-Drug Management System meets applicable standards for performance and EMC compliance.
Non-clinical Testing
Testing was performed to evaluate the functional modules.
Clinical Testing
Clinical testing was performed by DocuSvs and third party clinicians. All values were taken in a normal operating environment. The testing shows that the data was accurately received and recorded.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2007
Mr. Gordon J. Peters Director Regulatory Compliance DocuSys, Incorporated 820 S. University Boulevard, Suite 3-H Mobile, Alabama 36609
Re: K062388
Trade/Device Name: The Anesthesia Information and Digital-Drug Management System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: February 9, 2007 Received: February 16, 2007
Dear Mr. Peters:
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 - Mr. Peters
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 Incall that I DA mas made a autes and regulations administered by other Federal agencies. of the Act of ally I oderal statues and spirements, including, but not limited to: registration 1 ou mast conting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF R Fart 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of events of 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) This telef will anow you to organ mading of substantial equivalence of your device to a premailted 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), n you desire specific at has not of Compliance at (240) 276-0120. 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 may obtain 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,
Qrs
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
Indications for Use Form
510(k) Number (if known) ____ K062388
Device Name: The Anesthesia Information and digital- Drug Management System Indications for Use:
The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs.
The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSys' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record, performing ADE checks, and submitting medication utilization information for billing purposes.
The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature.
Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.
Prescription Use X Use OR
Over-The-Counter
(Per 21 C.F.R. 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
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Write May for Husband
Concurrence of CDRH, Office of Device Evalu
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