(92 days)
The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.
The UTC 3 mL Cartridge (UTC Cartridge) is a is a sterile, single-use cartridge intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The UTC Cartridge is for use in hospitals and outpatient care environments.
The UTC 3 mL Medication Cartridge consists of 3 primary components: a 3mL cartridge that looks like a small syringe, 22G x 0.5 in. needle, and protective cap.
The distal end of the device has a male luer lock used to attach the needle and withdraw medication from a vial. Once filled, the plunger is removed, needle is discarded, and protective cap is place on the luer until the cartridge is inserted into the CADD-MS 3 Infusion Pump and secured into place with the infusion pump's lid. The protective cap can then be discarded and the male luer can then be attached to the female luer of an infusion set.
The provided FDA 510(k) summary for the UTC 3mL Medication Cartridge (K230718) does not describe an AI/ML-driven medical device, nor does it detail acceptance criteria related to algorithmic performance metrics (e.g., accuracy, sensitivity, specificity) for such a device. Instead, it concerns a physical medical device (a medication cartridge) and its substantial equivalence to a predicate device based on material, design, and performance testing for sterility, biocompatibility, and physical properties.
Therefore, many of the requested points regarding AI/ML device testing (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.
However, I can extract the performance data and acceptance criteria relevant to this specific device, as described in the 510(k) summary, and present them in a structured way that aligns with your request's format, even if the "performance" is mechanical/biological rather than algorithmic.
Here's the information based on the provided document, interpreting "acceptance criteria" and "device performance" in the context of a physical medical device clearance:
Device: UTC 3mL Medication Cartridge (K230718)
Type of Device: Infusion Pump Syringe (Accessory to an Infusion Pump)
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily demonstrated through conformance to recognized international standards and specific performance tests. The summary states that the tests "demonstrated to be in conformance with" or "met the USP acceptance criteria," indicating successful performance against these standards.
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit from Compliance) | Reported Device Performance |
|---|---|---|---|
| Performance Testing | ISO 7886-1:2017 | Conformance to "Syringes for manual use" | Demonstrated conformance. |
| ISO 7886-2:2020-04 | Conformance to "Syringes for use with power-driven syringe pumps" | Demonstrated conformance. | |
| ISO 594-1:1986 | Conformance to "Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements" | Demonstrated conformance. | |
| ISO 594-2:1998 | Conformance to "Conical fitting" | Demonstrated conformance. | |
| Biocompatibility | ISO 10993-1 series | Meets established biological safety parameters for "externally communicating, prolonged exposure device that indirectly contacts the blood path." | All required tests completed successfully (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Subacute Toxicity, Hemocompatibility). |
| Particulate Matter | USP | Meets "Particulate Matter in Injection" acceptance criteria. | Met USP acceptance criteria. |
| Sterilization | ISO 113135:2014 | Validation via Overkill Approach (e.g., Half-Cycle method) and pyrogen test (Bacterial Endotoxin testing). | Sterilized with Ethylene Oxide as per standard, validation successful. |
| Packaging/Shelf-Life | ASTM D4169-16 | Packaging integrity after conditioning and simulated transportation deemed acceptable for product protection and sterility maintenance. | All packaging properties "deemed acceptable." |
| Sterile Barrier Packaging | ASTM 1929 | Conformance to Dye Penetration Test. | Performed, accepted. |
| ASTM F1886/F1886M-16 | Conformance to Visual Inspection Test. | Performed, accepted. | |
| ASTM F2069-11 | Conformance to Bubble Leak Test. | Performed, accepted. | |
| Shelf-Life | ASTM F1980-16 | Validation of 1-year shelf-life via accelerated aging. | 1-year shelf-life validated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each of the performance and biocompatibility tests. It only lists the standards followed. For medical device testing, sample sizes are typically defined by the specific test method within the referenced standards (e.g., ISO, ASTM, USP).
The data provenance is implied to be from laboratory testing conducted as part of the device development and regulatory submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the sense of clinical study data. These are bench/lab tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable here as the "ground truth" for this physical device is established by objective engineering and biological test standards (e.g., whether a Luer taper fits correctly, whether a material is cytotoxic, whether packaging maintains sterility) rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical data review, especially in imaging studies, where expert disagreement needs resolution. For physical device performance tests, the outcome is typically an objective pass/fail against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The UTC 3mL Medication Cartridge is a physical component, not an AI/ML algorithm used for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective engineering and biological test standards and measurements. This includes:
- Physical dimensions and tolerances (e.g., Luer taper).
- Material properties (e.g., polypropylene).
- Biological responses (e.g., cytotoxicity, irritation, hemocompatibility through ISO 10993 series).
- Sterility assurance (e.g., Bacterial Endotoxin testing, ethylene oxide validation).
- Particulate assessment (USP ).
- Packaging integrity and shelf-life stability.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).