(210 days)
The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing.
The Steripath® Micro Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).
The Steripath® Micro Blood Collection System diverts and sequesters the initial portion of the blood specimen (potentially contaminated blood) in the diversion reservoir. When diversion is complete, a subsequent blood sample flows through a second pathway within the device. The subsequent blood sample is collected into a syringe that is used to inoculate culture bottles. Upon removal of the Initial Specimen Diversion Device®, ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use.
The subject device incorporates multiple syringe oulet accessory configurations that include and three sizes of syringes that are previously cleared as referenced below. The Steripath® Micro Blood Collection System are available:
| Steripath®
Micro Kit
Model
| Number | ISDD® | Inlet Accessory | Outlet Accessory |
|---|---|---|---|
| 4005-EN | P00353 | Luer Extension, 7" | |
| ICU Medical, Inc. | |||
| Model B1754-NS | |||
| K964435 | Syringe, 5ml | ||
| Becton Dickinson | |||
| Model 301027 | |||
| K980987 | |||
| 4010-EN | P00353 | Luer Extension, 7" | |
| ICU Medical, Inc. | |||
| Model B1754-NS | |||
| K964435 | Syringe, 10ml | ||
| Becton Dickinson | |||
| Model 301029 | |||
| K980987 | |||
| 4020-EN | P00353 | Luer Extension, 7" | |
| ICU Medical, Inc. | |||
| Model B1754-NS | |||
| K964435 | Syringe, 20ml | ||
| Becton Dickinson | |||
| Model 301031 | |||
| K980987 |
The provided document is a 510(k) summary for the Steripath® Micro Blood Collection System (K200661). It details the device's indications for use, technology, comparison to a predicate device, and performance testing. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, or contamination rates), sample sizes for test sets, data provenance, information about expert ground truth, adjudication methods, MRMC study details, or standalone performance metrics for the aspects related to the "acceptance criteria and study that proves the device meets the acceptance criteria" as requested in the prompt.
The "Summary of Performance Testing" section lists some requirements and states "PASS" for each, but this is a high-level summary and doesn't provide the detailed numbers, methodologies, or study specifics that would typically characterize a study proving device performance against acceptance criteria. It primarily focuses on comparing the new device to its predicate and ensuring it meets safety and functionality standards.
Therefore, many aspects of your request cannot be fulfilled by the provided document.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions several requirements and functional tests:
- Sequestration
- Minimum Vacuum performance
- Maximum Vacuum performance
- Diversion Volume
- Positive Pressure Maximum
For each of these, the "Verification Test Result" is reported as "PASS". However, the actual acceptance criteria (e.g., minimum percentage of sequestration, specific vacuum pressure ranges, specific diversion volume ranges) are not detailed in this document. The "PASS" result indicates the device met unstated criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the listed performance tests.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The performance tests described (e.g., sequestration, vacuum performance) are technical/engineering tests, not clinical evaluations requiring expert interpretation of ground truth in the context of diagnostic accuracy.
4. Adjudication method for the test set:
- Not applicable/Not provided. These are technical tests, not diagnostic interpretations.
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 blood collection system, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical blood collection system, not an algorithm.
7. The type of ground truth used:
- For the listed performance tests (Sequestration, Vacuum performance, Diversion Volume, Positive Pressure Maximum), the "ground truth" would be established by the physical and functional specifications of the device, measured by engineering testing methods. It is not expert consensus, pathology, or outcomes data in a clinical diagnostic sense. The document states "all design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met."
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document focuses on substantiating equivalency to a predicate device through general functional and safety testing, rather than presenting detailed clinical performance study results against specific, quantitatively defined acceptance criteria for diagnostic accuracy or contamination rates with detailed study methodologies. The "PASS" results for functional requirements confirm the device meets its design specifications but lacks the granular data requested in your prompt.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.