(113 days)
The Hospira Sterile Empty Glass Container is intended to be used for admixing compatible medications.
The Sterile Empty Glass Container consists of a Type II glass container in 250 mL, 500 mL and 1000 mL sizes, a 28 mm EPDM rubber stopper, an aluminum overseal that secures the stopper to the glass container, and a unit label with an integrated hangar. The device is sterile and non-pyrogenic.
The provided text describes a traditional 510(k) submission for a Sterile Empty Glass Container. This device is a container for admixing compatible medications and is not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone performance, training set details, ground truth establishment for training data, and expert qualifications for ground truth) are not applicable to this submission.
The acceptance criteria and the study proving the device meets them are focused on the physical and functional aspects of the container, as well as its sterility and material compatibility.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | For admixing compatible medications. | The device's intended use is "admixing compatible medications". The previous indication for "collection of blood" has been removed. |
| Materials of Construction | Must meet applicable material test requirements of ISO 10993. | All materials of construction for the Sterile Empty Glass Container meet the applicable material test requirements of ISO 10993. |
| Functionality | The device must perform as intended. | Performance testing was conducted and found acceptable, ensuring the device performs as intended. |
| Sterility Assurance Level (SAL) | The product SAL must be acceptable for a sterile device. | The product Sterility Assurance Level is 10-6. |
| Non-pyrogenic | The device must be non-pyrogenic. | The device is non-pyrogenic. |
| Manufacture/Washing Procedure | Changes to the washing procedure for the EPDM rubber stopper (moved to vendor, revised procedure) must not negatively impact performance. | A comparison of the wash procedures was provided in Section 11 Device Description, implying the new procedure is acceptable and does not compromise the device. (Specific performance impact of this change is not detailed in the summary, but implied acceptable by overall conclusion). |
Study Details (as inferable for a non-AI/ML device)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated in the provided summary. For a physical device, this would typically involve a certain number of units subjected to various physical, chemical, and biological tests.
- Data Provenance: Not specified, but generally, testing for such medical devices occurs under controlled laboratory conditions, often in the manufacturing country or specialized testing facilities. The tests are prospective, involving new device units.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a hardware medical device (empty glass container) and does not involve AI/ML or expert interpretation of diagnostic output. Ground truth is established through standardized physical, chemical, and biological testing protocols (e.g., meeting ISO 10993 for biocompatibility, sterility testing, pyrogenicity testing, package integrity).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI/ML ground truth establishment involving human interpretation. For this device, "adjudication" would refer to expert review and approval of test results against predefined specifications, a standard Quality Assurance/Regulatory Affairs process rather than an adjudication method for ground truth.
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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
- No. This is a hardware medical device, not an AI-powered device. Therefore, no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware medical device, not an algorithm. Therefore, no "standalone" algorithm performance study was conducted.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Defined Standards and Specifications: The "ground truth" for this device's performance is established by adherence to recognized international standards (e.g., ISO 10993 for biocompatibility) and internal specifications for physical properties, sterility (SAL of 10-6), and non-pyrogenicity. It's objective, measurable data rather than human interpretation or pathology.
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The sample size for the training set
- Not Applicable. This is a hardware medical device, not an AI/ML system requiring a training set.
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How the ground truth for the training set was established
- Not Applicable. This device does not have an AI/ML component; therefore, there is no training set or ground truth associated with one.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).