(191 days)
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.
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.
The provided 510(k) summary for the DocuSys Anesthesia Information and digital-Drug Management System (K062388) focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone performance study.
Here's a breakdown of the information that can be extracted and what is not present based on your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Modules | Not explicitly stated (implied: "perform as intended") | "Testing was performed to evaluate the functional modules." (Outcome not quantified) |
| Data Accuracy (Clinical) | Not explicitly stated (implied: "accurately received and recorded") | "The testing shows that the data was accurately received and recorded." (No quantitative metrics) |
| EMC Compliance | Applicable standards (not specified which ones) | "The Anesthesia Information and digital-Drug Management System meets applicable standards for performance and EMC compliance." |
| Overall Performance | Not explicitly stated (implied: "perform as intended") | "The Anesthesia Information and digital-Drug Management System meets applicable standards for performance..." |
Missing Information: The document does not provide specific, quantifiable acceptance criteria (e.g., "95% accuracy in drug administration recording," "less than 1% data loss"). The performance statements are high-level and confirm that testing was done and the device performed as intended, but they lack empirical data.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document only states "Clinical testing was performed by DocuSys and third party clinicians."
- Data Provenance: Not specified. It only mentions the testing was done "in a normal operating environment." There is no mention of country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified beyond "DocuSys and third party clinicians."
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe any study involving human readers comparing performance with and without AI assistance. This device is an information system, not an AI diagnostic tool, so such a study would not be directly applicable in the typical sense.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in part.
- Non-clinical bench testing: "Testing was performed to evaluate the functional modules." This implies a form of standalone testing for individual functionalities.
- Clinical Testing: While involving clinicians for data entry and interaction, the core function of "accurately received and recorded" data speaks to the system's standalone performance in data handling. However, it's not a study of an algorithm's diagnostic performance but rather system functionality.
7. Type of Ground Truth Used
- Ground Truth Type: For the "accurately received and recorded" data, the ground truth would implicitly be the actual physiological data from monitoring devices and the intended drug information/events recorded by clinicians. It's a functional ground truth, not a diagnostic one (like pathology or outcomes data).
8. Sample Size for the Training Set
- Sample Size (Training Set): Not mentioned. This type of device (anesthesia information and drug management system) likely undergoes standard software development and testing cycles rather than a distinct "training set" in the machine learning sense. The "Non-clinical bench testing" and "Clinical testing" serve as verification and validation steps for the developed software.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment (Training Set): Not mentioned. Given the nature of the device, "ground truth" for development would be defined by functional specifications and clinical requirements for accurate data capture, display, and drug management rules.
Summary of what the document does convey regarding testing:
- Two levels of testing:
- Non-clinical bench testing: To evaluate individual functional modules.
- Clinical testing: To verify software performance in a "normal operating environment."
- Focus of clinical testing: To show that data was "accurately received and recorded."
- Compliance: The system meets applicable standards for performance and EMC compliance.
Overall Context:
This 510(k) pertains to a medical information system that manages data related to anesthesia and drug administration, including features like adverse drug event screening and narcotics tracking. The review focuses on its functionality and substantial equivalence to existing predicate devices (PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM and SAFERsleep System), which are also information systems. The testing described is typical for software functionality and data integrity for such systems, rather than the rigorous statistical performance metrics often associated with AI/ML diagnostic devices.
§ 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).