CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P

• K Number: K101439
• Device Name: CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
• Manufacturer: CODONICS, INC.
• Date Cleared: 2011-02-07 ( 259 days)
• Product Code: BSZ
• Regulation Number: 868.5160
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K041241 , K050883 , K062388 , K030939

Intended Use

The Codonics Safe Label System (SLS) and SLS Software provides a simple computerbased bar code scanning & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes, and to print labels for prepared drugs and other items in use on patients during surgical procedures.

Codonics Safe Label System (SLS) is generally placed in, however not limited to, the perioperative 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

Device Description

Codonics Safe Labeling System is a simple, integrated system utilizing a bar code scanner to read and confirm drug identity from NDC and other drug ID Barcodes from vials automatically print labels for prepared drugs and other items in use on patients during surgical procedures. The labels are compliant with national regulations focused on improving medication safety in the perioperative environment.

The software components provide functions for scanning vials, creating, indexing, and approved hospital managed promotion of a formulary database, displaying on screen and audibly confirming drug type, printing color The Joint Commission ISO and ASTM compliant labels with 2-D barcodes. The system reads drug vial barcodes and produces waterproof, color labels.

The system can be integrated to function with AIMS system workflow to provide real-time documentation of drug administration when the syringe "2D Barcode" is read.

Codonics Safe Labeling System consists of :

• PC (x86 Pico-ITX based w/on-board RAM) with Ethernet interface .
• . SSD/Flash disk
• Touch screen end-user interface (for configuring and controlling authorized users, . barcode scan and print jobs, selection of label type and manual/automatic label production % dilution factor indication)
• Barcode scanner/decoder .
• Label printing engine .
• Medical grade (EN60601-1) compliant power supply .

Software to support primary functions:

• Linux OS for CPU, I/O (USB, IDE or SATA, AUDIO, Network (Ethernet/WIFI), SSD . Disk access, and Touch Screen LCD display
• Specific Drivers for Touch Screen LCD, Ink Jet label printer, Barcode scanner, . Ethernet/WIFI communications
• NDC or other UDI (Unique Drug Identifier, commonly known in the US as an "NDC") . drug formulary persistent repository (or database) via SSD/USB Flash

In addition to these primary functions, there are other functions that are provided by the software, to include:

• System configuration (network, security, profiles, etc.) .
• Security management to perform accounting and authentication of user data; add . users to the User Database when requested and verify that any authenticating user credentials are correct
• Settings management global component available to all other components in the . application; lookup configuration values given the appropriate configuration key
• User feedback (job and device status, errors, etc.) various events that describe the . current state of the system are generated
• Job function application managers. Each manager is responsible for a specific set of . functionality grouped by a logical theme. For example, the Label Manager handles creating labels based on a set of Label Parameters, the Security Manager handles all issues relating to user management and authentication, and the Print Manager sends commands to and receives responses from the printer hardware

Software Application Description: The software scans user Identification (authentication) and drugs by means of a bar code, and identifies connected devices (printers, computer, and barcode scanner, etc.). The software allows a label to be printed which has a color or colors identifying the type of drug contained in the syringe, the name of the drug or drugs, the units of the drug or drugs, the amount of the drug or drugs, total volume of the syringe, the user ID of the preparer, the time and date of the preparation, and a bar code identifying the contents of the syringe. The software also enables the clinician to document the administration of the drug or drugs by reading the bar code printed on the label and transmitting the drug identification to a third party application (i.e. AIMS system). The system also allows for the labeling of drugs which are combined with other drugs or are diluted. Finally, the software also allows the printing of blank labels, with just the clinician's ID and the data/time.

The major characteristics and functions of the family of devices include:

• Scanning the FDA required drug vial barcode directly from the vial .
• Decoding the manufacturer issued barcode into the required FDA national drug code o (NDC) or Unique Drug Identifier (UDI) number
• Referring the NDC/UDI number to a site managed formulary lookup database .
• Providing audio and ISO-compliant visual "readback" of the drug name .
• Providing a clinical alert if the drug vial is listed as recalled in the site formulary .
• Printing an easy to read, waterproof ISO 26825 compliant color label meeting The . Joint Commission medication management standards and the American Society of Anesthesiologists guidelines for labeling
• Including on same label a printed barcode compliant with national standards for . machine readability allowing integration with an anesthesia information management system (AIMS)
• Providing the basic information by which the printed label barcode can be read to . document medication administration in an AIMS system
• Providing a 2D barcode of information to permit integration with AIMS systems with . potential for alerts if the prepared drug has expired based on preparation time and site specific drug use criteria
• Printing labels with insertion and expiration date and time for IV lines .

AI/ML Overview

The Codonics Safe Labeling System (SLS) is a computer-based bar code scanning and printing system designed for the perioperative environment. It automatically verifies drug identity from NDC (National Drug Code) and other UDI (Unique Drug Identifier) barcodes on drug vials, and then prints compliant labels for prepared drugs and other items used on patients during surgical procedures.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format. Instead, it describes general claims of performance and compliance with relevant standards and regulatory requirements.

Acceptance Criteria (Implied from document)	Reported Device Performance (Implied from document)
Drug Identification Accuracy	Error-free NDC/UDI vial reading.
Labeling Compliance (ASA/ISO standards)	Labeling of prepared drugs to ASA/ISO standards (ISO 26825, ASTM D4774, ASTM D4267, ASTM D6398). Waterproof, color labels with drug name, concentration, expiration, site-specific warnings, dilutions, and class of drug templates. Includes 2D barcodes for AIMS integration.
Warning/Alert Functionality	Provides a clinical alert if the drug vial is listed as recalled in the site formulary. Audible and visual "readback" of drug name.
Integration with AIMS	Provides basic information by which the printed label barcode can be read to document medication administration in an AIMS system. 2D barcode for AIMS integration, potential for alerts if the prepared drug has expired.
System Reliability/Throughput	Documented effective application, throughput, reliability.
Electrical Safety	Passed series of electrical safety tests including FCC Part 15.109, FCC Part 15.107, ETL/UL 60601-1, IEC 60601-1, 60601-1-2 and 61000.
Quality System Compliance	QSR compliance to 21 CFR Part 820.
Hazard Mitigation	Risks related to misreading barcode, database indexing failure, validation failure, incorrect label printing, incorrect barcode presentation were considered and mitigated.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): The document does not specify a distinct numerical sample size for the "test set" in terms of a specific number of drug vials or scenarios tested. It mentions "laboratory (non-clinical environment) and surgical (clinical) tests."
• Data Provenance:
  • Clinical Data: The clinical application of a "prototype Safe Label system at MGH" (Massachusetts General Hospital) is referenced. This suggests a prospective clinical study conducted in the United States.
  • Non-clinical Data: Non-clinical lab tests were conducted utilizing "NDC/UDI codes vials." The provenance of these vials (e.g., specific manufacturers, countries) is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their specific qualifications (e.g., years of experience as a radiologist) used to establish ground truth for the test set. It states that "Medical personnel review the results and inputs processed by the Codonics SLS and offers ample opportunity for competent human intervention." This implies that trained medical professionals, such as physicians, nurses, and technicians (as stated in the "Typical users" section), would effectively act as the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1) for the test set. The reliance on "Medical personnel review" suggests that clinical judgment and established medical protocols would serve as the adjudication or verification process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. It focuses on the standalone performance and compliance of the device rather than comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was conducted. The document states:

• "Both laboratory (non-clinical environment) and surgical (clinical) tests have shown error free NDC/UDI vial reading and labeling of prepared drugs to ASA/ISO standards."
• "The non-clinical lab tests were conducted utilizing NDC/UDI codes vials scanned and compared to the output of the MGH original SafeLabels system."

This indicates that the device's ability to read barcodes, verify drugs, and print labels was tested without explicit mention of human intervention during the performance measurement itself, although human oversight is always implied in a clinical setting. The "Medical personnel review" is primarily for safety and decision-making, not for correcting algorithm errors during the performance study itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance evaluations (both non-clinical and clinical) appears to be:

• Known NDC/UDI codes on vials: For the non-clinical lab tests, the device's output was compared to the "output of the MGH original SafeLabels system," which would have had known correct NDC/UDI codes and associated drug information as its reference. This implies that the ground truth was based on the documented content of the drug vials and correct labeling standards.
• ASA/ISO standards: The device's labeling output was verified against these established standards.
• Hospital formulary: The system's ability to correctly identify drugs against a "site managed formulary lookup database" also relies on the accuracy of this database as ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state a sample size for a "training set." This type of device relies on a pre-programmed formulary database rather than a machine learning model that requires a distinct training set in the conventional sense. The "formulary database" effectively serves as the knowledge base for the device.

9. How the Ground Truth for the Training Set was Established

As there isn't a traditional "training set" in the machine learning sense, the "ground truth" for the device's operational knowledge (the formulary) is established through:

• Hospital-managed formulary database: This database contains drug name, concentration, expiration, site-specific warnings, dilutions, and class of drug templates. This formulary is "approved for use by the hospital pharmacy," implying that it is created and maintained by qualified pharmacy professionals using official drug information sources and hospital policies.
• Standards compliance: The system is designed to comply with numerous recognized consensus standards (ASTM, ISO, Joint Commission, ISMP, ASA), which inherently define the correct appearance and content of labels.

Regulation Number and Section

§ 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).