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Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and in other facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.

The OnSite Waste Sharps Container OWTSH-I is constructed using tinplate steel base with a Nylon and polypropylene restrictive lid system. The OnSite Waste Sharps Container OWTSH-I measures 10 1/2" wide x 4 3/4" deep, and tapers to a dimension of 9" wide x 3 1/8 deep. The height of the container is 8 1/4" in height. The OnSite Waste Sharps Container OWTSH-I is equipped with a locking lid that once closed, prevents anyone from opening it either before or after processing. Labels are on a red background with printed in black text and a bio-hazzard symbol. Labels are adhered to the container at the time of manufacture with the fill line warning printed on the label There is no feature to bend, break, or shear needle, includes blunting of needle in container.

This FDA 510(k) summary for the OnSite Waste Sharps Container (K182235) details the performance testing against established standards. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "There were no clinical testing required to support the medical device," meaning the acceptance criteria and performance are based solely on non-clinical (laboratory) tests.

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

The document does not explicitly state the sample size used for each non-clinical test. However, it indicates that the puncture resistance test was "Performed by an independent materials testing lab," suggesting the use of laboratory samples. The data provenance is non-clinical laboratory testing, likely conducted in the United States or at a facility accredited for these ISO/ASTM standards. The testing is retrospective in the sense that it evaluates the manufactured product's performance against pre-defined standards.

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

Not applicable. For non-clinical performance tests of a physical device like a sharps container, ground truth is established by objective measurements and adherence to specified testing standards (ASTM, ISO). Expert consensus is not typically involved in determining if a physical property (like puncture resistance or leak-proofness) meets a technical specification.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for subjective assessments, especially in clinical or image-based studies. For physical performance tests, the results are typically determined by direct measurement or observation against a predefined pass/fail criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI Vs Without AI Assistance

Not applicable. This device is a physical sharps container and does not involve AI, human readers, or image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device is a physical sharps container and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established objective technical standards and specifications. Specifically:

• Puncture Resistance: Defined by ASTM F2132-01 (2008).
• Leak Resistance: Defined by visual observation against a "no leakage" criterion over 24 hours.
• Impact Resistance: Defined by ISO 23907:2012.
• Stability: Defined by ISO 23907:2012.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device. It does not involve machine learning algorithms that require a "training set." The performance is evaluated based on material science and engineering principles.

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

Not applicable, as no training set is relevant for this type of device.

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