(317 days)
Medline Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
Medline Sharps Containers are two-piece conventional, disposable sharps containers. The base container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1g and 2g containers in locking and non-locking variations. The device is intended to be used by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
The provided text describes the acceptance criteria and performance of Medline Sharps Containers, which are medical devices for disposing of contaminated sharps. The document is a 510(k) premarket notification to the FDA. As such, it details physical device compliance rather than software or AI performance. Therefore, many of the requested elements (e.g., sample size for test set, data provenance, ground truth experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device and document.
Here's a breakdown of the requested information based on the provided text, focusing on the device's physical performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Objective | Acceptance Criteria (from BS EN ISO 23907 or ASTM F 2132) | Reported Device Performance |
|---|---|---|
| Container Stability | BS EN ISO 23907 Requirements: "Specimens were placed on a surface with an inclination of 15° in the most adverse position for toppling with no more than 0 failures per container." | Meets ISO 23907 Requirements - Specimens were placed on a surface with an inclination of 15° in the most adverse position for toppling with no more than 0 failures per container. |
| Handle Strength | BS EN ISO 23907 Requirements: The standard implies that the handles should withstand a specified load for a period without failure. (Specific numerical criteria for load/duration not explicitly stated in this summary, but the context implies compliance with the standard's full requirements.) | Meets ISO 23907 Requirements - The sharps containers were filled to 50% of the fill line with de-ionized water and were then suspended by the handles for a period of at least 60 minutes; no failures were observed. |
| Puncture Resistance | ASTM F 2132 Requirements: "Per the acceptance criteria the average force was required to be greater 3.4 lbf (15 N), and no single value from any region was allowed to be below 2.8 lbf." | Meets ASTM F 2132 Requirements - The puncture force was recorded, and the results met the specified criteria (average force > 3.4 lbf (15 N) and no single value below 2.8 lbf). |
| Resistance to Damage (Drop/Impact Test) | BS EN ISO 23907 Requirements: Drop tested at a height of 1m. Acceptance criterion: "no evidence of leakage or damage resulting in a breach of the sharps containment area." Additional testing for OSHS safe lifting limits: "The test allowed only a single failure per test condition" (for five containers used for each test orientation). | Meets ISO 23907 Requirements – Drop tested at height of 1m per test standard. Testing resulted in no evidence of leakage or damage resulting in a breach of the sharps containment area. All Medline products met the acceptance criteria for resistance to damage from a vertical drop. Additional 1m drop testing with 40 lb. or capacity load: The containers passed this test. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Container Stability: Not explicitly stated, but "Specimens" were used. The wording "no more than 0 failures per container" suggests individual containers were tested.
- Handle Strength: Not explicitly stated, but "The sharps containers" were tested.
- Puncture Resistance: Not explicitly stated, but tests were performed on the container secured to an apparatus.
- Resistance to Damage (Drop/Impact Test): "Five containers were used for each test orientation for each tested model."
- Data Provenance: Not specified, but given the submission is to the U.S. FDA, the testing was likely conducted in facilities compliant with relevant standards (e.g., ISO accredited labs), potentially in the U.S. or by a manufacturer supplying the U.S. market. It is retrospective in the sense that the testing was completed before this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a physical device subject to engineering performance testing against established standards, not a diagnostic or AI device requiring expert ground truth in the clinical sense.
4. Adjudication Method for the Test Set
Not applicable. Physical performance tests are judged against objective, measurable criteria defined in the standards (e.g., specific force, leakage, breach of containment).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established engineering and safety standards (BS EN ISO 23907 for "Sharps injury protection – Requirements and test methods – Sharps containers" and ASTM F 2132 for "Standard Test Method for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps"). These standards define objective, measurable criteria for a sharps container's performance regarding stability, handle strength, puncture resistance, and impact resistance.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not an AI model.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).