(72 days)
The Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features and safe and effective released SLS Software provides a simple computer-based bar code scanning/RFID & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes and (when configured and available) RFID parenteral vial information and formulary information, and to print labels embedded with RFID tags for prepared drugs and other items in use on patients during surgical procedures. Drug information is human readable on labels, 2D & Linear barcoded on labels, and RFID encoded as part of secondary container medication labels.
Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features is generally placed in, however not limited to, the peri-operative environment to identify syringes prepared for anesthesiology use during surgery. Additional uses include producing labels for IVs and other artifacts used during a surgical procedure. SLS can also be used to print "non-surgical environment" color & text labels as required. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians
Drug preparation and administration in the perioperative environment are integral aspects of pharmacy, patient care clinicians, and anesthesiologist's patient care responsibilities.
Drug selection, preparation, and administration errors occur at the point of care in association with parenteral vial identification, secondary CSP container labeling, and pre-administration selection. Machine readable drug IDs & information in the form of machine-readable barcode and RFID tags serve as additional means to confirm medications (beyond human readable labeling).
Best practices for safe medication preparation and labeling in support of reducing error includes font characteristics & readability, drug class/type color coding, machine readable bar and RFID codes & formulary confirmed information being part of creation & application of secondary container CSP labeling to assist pre-administration selection and dose delivery recording.
Codonics Safe Labeling System (SLS-1) 700i and related 610i, 620i, 630i, SLS-XXX RFID series is a simple, integrated system utilizing a bar code scanner and RFID reader & encoder to confirm drug identity from NDC and other drug ID Barcoded vials and safely & automatically print labels for prepared drugs and other items in use on patients during clinical and surgical procedures. In addition to K101439 series machine readable barcodes, the 700i and related 610i, 620i, 630i, SLS-XXX series configurations when equipped with suitable near field HF, UHF, or HF/UHF RFID modules & software, allows RFID information to be read and formulary information including 3rd party MDD ID content to be written ("encoded") to SLS label RFID tags (Passive) for use by third party applications. The labels are fully compliant with national standards and best practices focused on improving medication safety in the perioperative environment. As a MDD (Master Drug Database) intra-hospital networked device, emission & immunity safety as well as protections in the realm of cyber security is part of the safety and efficacy. The system is small enough to fit on the anesthesia supply cart and integrate seamlessly into the anesthesia workflow allowing use in the OR during patient care. Like the predicate SLS, barcode read NDC/UDI codes indexed to the approved formulary is retained as the "source of truth" for all drugs processed for labeling by SLS RFID series*.
The software components provide functions for scanning/reading vials, indexing against a "source of truth" hospital/healthcare environment managed/commissioned & verified formulary database, displaying on screen and audibly confirming drug type, printing color JCOAHO and ISO and ASTM compliant labels with 2-D barcodes and, when equipped with suitable HF, UHF, or HF/UHF RFID modules & software, RFID tagged information encoding on secondary container CSP labels. The system reads drug vial barcodes and produces waterproof, color labels compliant to FDA/ISMP, ASA, USP, ISO, ASTM, TJC, JCACHO.
*SLS RFID Series products maintain reliance on barcode scanned and formulary verified information to print secondary container labels and encode 2D and RFID tagged information to embedded SLS label RFID tags. The system label output can be integrated to function with 3rd party applications such as an AIMS system workflow to provide real-time documentation of drug administration when the syringe "2D Barcode" or RFID tag is read.
The Codonics Safe Labeling System (SLS) is designed to improve medication safety in perioperative and other clinical environments by verifying drug identity and printing compliant labels. The acceptance criteria and study proving its performance are detailed below, particularly focusing on the advancements in RFID technology.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Drug Identification & Verification | Barcode Reading Accuracy: Error-free NDC/UDI vial reading. | "Error free NDC/UDI vial reading" reported. Input codes and output read content confirmed. |
| RFID Reading Accuracy: Error-free reading of RFID content from vials (when applicable). | "Error free accuracy and precision" verified for input information processing to RFID printed/tagged output. | |
| Formulary Confirmation: Reliable confirmation of drug identity against the site-managed formulary database. | "Reliably confirms vial barcodes with both audible and visual display of the drug name and concentration." "Input codes and output read content was confirmed." | |
| Clinical Alerts: Proper alerts for recalled, not found, or mismatched drugs. | Device provides a clinical alert if the drug vial is listed as recalled, not found, or mis-matched to MDD approved content. | |
| Label Printing & Compliance | Color & Text Compliance: Printing of ISO 26825/ASTM D4774 compliant color and text labels. | Labels are "fully compliant with national standards and best practices focused on improving medication safety." "Medication Label ISO 26825 and ASTM D-4774 consistency tests confirm drug class color & template type, label contents, and characteristics specified in standards submitted." |
| Barcode Readability: Printing of 2D/Linear barcodes compliant with national standards for 3rd party machine readability. | "Included on same label a printed barcode compliant with national standards for machine readability by 3rd party applications." "Printed label resolution (including barcode clarity) has been documented in pre-release testing." | |
| RFID Encoding Accuracy: Accurate encoding of RFID tags with drug and formulary information. | "Error free accuracy and precision" verified for input information processing to RFID printed/tagged output. "Tag contents are verified with the 3rd party reader and configurations are released accordingly." | |
| Waterproof Labels: Production of waterproof labels. | Device "produces waterproof, ASA compliant color secondary container labels per ISO and ASTM standards." | |
| Readability/Resolution: End-user acceptance of touch screen readability, color, responsiveness, and printed label resolution. | ||
| User acceptance for screen readability, color, responsiveness, and printed label resolution (including barcode clarity) has been documented in pre-release testing. | Workflow Efficiency: Provides efficiency in typical workflows when compared to manual labeling. | "The read-to-label time (open syringe, needle and vial, draw drug into syringe and apply completed label) provides efficiency in typical workflows when compared to using standard labeling with handwritten time, date, concentration and initials." |
| Electrical Safety & EMC | Electrical Safety Compliance: Meets IEC 60601-1 standards for patient contact and anesthesia environment. | "Passed electrical safety and emission tests with issued certification." "Designed to meet patient contact and anesthesia environment electrical safety (IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, IEC 60601-1-2:2014+A1:2020 and 61000: Medical electrical equipment safety standards)." |
| EMC Compatibility: Compliant with relevant EMC standards (e.g., CISPR 11, FCC Class A, IEC 60601-1-2). | "Passed electrical safety and emission tests with issued certification." "TUV certified compliant to listed standards herein including Additional Information Reasonably Deemed Necessary to access safe and effective use." | |
| RF Exposure: Complies with FCC RF Part 2.1091 and RSS-102 Issue 5 Exposure. | "Radio frequency and exposure criteria for EMC compatibility, CISPR 11 limits of radio disturbance, safe use and FCC RF Part 2.1091 and RSS-102 Issue 5 Exposure." | |
| System Reliability | Reliability/Throughput: Effective application, throughput, reliability, and expected results. | "Laboratory and preliminary tests have documented effective application, throughput, reliability, and expected results consistent with the SLS-1 K101439 predicate devices." |
| Error Prevention (RFID): Prevention of writing to already written tags and discrimination of presented vs non-presented tags. | "Discrimination of presented versus non-presented tags is managed and writing to already written tags prevented via unique identification." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The non-clinical lab tests verifying NDC/UDI coded vials and RFID performance were conducted with a "Preliminary Verification Test SLS Configurations Safe Label System Confirmation of Functionality reporting greater than 10,000 RFID labels of 25 drugs in the various drug class colors and RFID payload."
- Data Provenance: The document states that both laboratory (non-clinical environment) and surgical (clinical) tests were performed. There is no specific mention of the country of origin for the data, but the regulatory compliance refers to US (FCC, ANSI, ASTM, Joint Commission, ASA) and international (ISO, IEC, TUV, CISPR) standards, suggesting a general applicability or data collected within these regulatory frameworks. The description implies prospective testing as part of product development and verification before market release.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish ground truth for the test set.
- Qualifications of experts: While not explicitly stated for the test set ground truth, the "Typical users of this system are trained professionals, including but not limited to physicians, nurses, pharmacists, and technicians" who ultimately control and review the device's output. The system's output is based on "site managed formulary lookup database" which is managed by "DOP pharmacy, anesthesiology, Dir Medical Staff, etc." These clinicians and department heads would collectively define the "source of truth" for the formulary.
4. Adjudication Method for the Test Set
- The document does not explicitly describe an adjudication method for the test set in the conventional sense (e.g., 2+1, 3+1 for image interpretation).
- The system uses a "source of truth" which is the "site managed formulary lookup database." The device's performance is verified against this established database for drug identification, concentration, and associated labeling information. "Input codes and output read content was confirmed," indicating a direct comparison against expected outputs derived from this ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not explicitly mentioned or described in the provided text. The device is described as a "scanning/RFID & printing system" and not an AI-assisted diagnostic tool that humans interpret. Its function is to automate and verify drug labeling, not to assist human readers in making diagnostic decisions where an "effect size of how much human readers improve with AI vs without AI assistance" would be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The device's core function is an automated process of scanning, verifying against a formulary, and printing/encoding. The non-clinical lab tests verifying "error free NDC/UDI vial reading and labeling of prepared drugs to ASA/ISO standards" and "error free accuracy and precision" for RFID processing are effectively standalone performance evaluations of the algorithm and hardware.
- The document states, "No automated decision processes tied to patient care are involved with SLS operation. ... Medical personnel review the results and inputs processed by the Codonics SLS and offers ample opportunity for competent human intervention in the case of a malfunction or other failure." This confirms that while the device performs its functions autonomously, it operates within a workflow that includes human oversight.
7. Type of Ground Truth Used
- The primary ground truth used is the site-managed formulary lookup database. This database contains verified drug names, concentrations, expiration data, and site-specific rules.
- For barcode and RFID performance, the ground truth is the known, correctly coded/tagged information on the original drug vials and the intended output for the generated labels. This is based on established national and international standards (NDC, UDI, ASA, ISO, ASTM, TJC).
8. Sample Size for the Training Set
- The document does not specify a sample size for a training set. This is generally a concept applicable to machine learning algorithms. The SLS system appears to operate based on established rules, databases, and barcode/RFID standards rather than learning from a training dataset in the typical AI/ML sense. It is a deterministic system that performs verification and printing based on pre-defined information.
9. How Ground Truth for the Training Set Was Established
- As the system does not appear to use a training set for machine learning, the concept of establishing ground truth for a training set is not applicable in this context. The core "knowledge" for the device, the drug formulary, is established and managed by "DOP pharmacy, anesthesiology, Dir Medical Staff, etc.," and is a human-curated and verified database that the system utilizes.
§ 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).