(224 days)
The sharpsCAN™ Model I Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access.
The SharpsCAN™ is a disposable sharps container that is intended for the safe disposal of used medical sharps. This sharpsCAN™ is marketed as one model.
- sharpsCAN™ Model 1 pint,
The sharpsCAN™ container is stable, closable, puncture resistant, impact resistant, and leak-proof on both the sides and bottom. The sharpsCAN™ uses a vertical opening for the disposal of sharps and is intended to be used in an upright position during use with the required wall mount unit accessory.
The provided text describes the acceptance criteria and the study that proves the device (sharpsCAN™) meets those criteria. The device is a sharps container, and the study involves performance testing against recognized standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Standard / Requirement | Reported Device Performance |
|---|---|---|
| Puncture Resistance Testing | ASTM F2132-01 | Met and exceeded performance testing according to design specifications. |
| Leak-Proof Testing | 29 CFR 1910.1030 | Met and exceeded performance testing according to design specifications. |
| Toppling Resistance | CSA Z316.6-07 | Met and exceeded performance testing according to design specifications. |
| Impact Resistance and Spillage Testing | Not explicitly stated (likely internal) | Met and exceeded performance testing according to design specifications. |
| Stability Testing | Not explicitly stated (likely internal) | Yes (Table 5-1 indicates "Stability Testing" was performed and passed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each performance test. It broadly states "Four types of performance tests were performed."
- Data Provenance: The data is generated from internal performance testing conducted by Medical Engineering Development Solutions, Inc. (MEDS). The country of origin is implicitly the United States, as MEDS is based in Colorado, and the submission is to the U.S. FDA. The study is a prospective performance test designed to evaluate the physical characteristics of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable to this type of device and study. The "ground truth" for a sharps container's performance is established by objective engineering standards and regulations (e.g., ASTM F2132-01 for puncture resistance, 29 CFR 1910.1030 for leak-proof). There are no human experts "interpreting" results in the way a medical image might be interpreted. The device's performance is measured against quantifiable physical criteria.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human interpretation or consensus is required to establish a gold standard, such as in clinical trials involving diagnostic accuracy or image interpretation. For physical performance testing of a sharps container, the results are objectively measured against predefined standards, and no human adjudication process is mentioned or necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar fields. The sharpsCAN™ is a physical medical device (a sharps container), and its evaluation focuses on its physical performance characteristics, not on human interpretation or diagnostic accuracy assisted by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical product, not an AI algorithm. Its performance is intrinsic to its design and material properties, tested through physical simulations and measurements, not through an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the sharpsCAN™ study is based on established engineering standards and regulatory requirements. These include:
- ASTM F2132-01 (for Puncture Resistance)
- 29 CFR 1910.1030 (for Leak-Proof Testing)
- CSA Z316.6-07 (for Toppling Resistance)
- The FDA guidance document "Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers," issued in October 1993, also served as a basis for evaluation.
These standards define the objective and measurable criteria that the device must meet to be considered safe and effective.
8. The Sample Size for the Training Set
This question is not applicable. The sharpsCAN™ is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development. The "training" for this device would refer to its design and manufacturing process, optimized through engineering principles.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device. The design and manufacturing process would be informed by established engineering principles, material science, and regulatory requirements, rather than a data-driven training set with an established ground truth.
§ 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).