(232 days)
Disposable TPE Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The applicant device is single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of thermoplastic elastomer (TPE) and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel.
The proposed device is provided sterilized.
The provided document is a 510(k) summary for a Disposable TPE Infusion Set. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study report with performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods for establishing ground truth, which are typically found in studies relevant to AI/ML software.
The document states: "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device." This indicates that physical and functional tests were performed on the device to ensure it met pre-defined engineering and safety standards, rather than a clinical study evaluating an algorithm's performance.
Therefore, many of the requested details about acceptance criteria and study particulars for a software/AI device cannot be extracted from this document.
Here's a breakdown of what can be inferred or what is explicitly missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of specific thresholds for performance metrics (e.g., accuracy, sensitivity, specificity) for a software device. For this hardware device, acceptance criteria would typically relate to physical properties, flow rates, sterility, material biocompatibility, and mechanical integrity. The document only generally states the device "met all design specifications."
- Reported Device Performance: No specific performance metrics (like accuracy, sensitivity, etc.) are reported in the document. The general statement is that it "met all design specifications" and was "substantially equivalent to the predicate device."
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. This document pertains to a physical medical device (infusion set), not a software algorithm. Testing would involve a certain number of manufactured units, but the count is not provided.
- Data Provenance: Not applicable in the context of clinical "data provenance" for algorithm training/testing. The testing performed would be laboratory-based validation of the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For a physical infusion set, ground truth is established through engineering specifications, validated test methods (e.g., flow rate testing, material testing, sterility testing), and adherence to standards, not expert clinical consensus on images or diagnoses.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not applicable for a physical device. Test results are typically compared against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This is a physical medical device, not an AI/ML diagnostic tool requiring human reader comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This refers to an algorithm's performance, which is not relevant here.
7. The Type of Ground Truth Used
- Type of Ground Truth: For this device, ground truth would be established by validated engineering specifications, international standards (e.g., for sterility, biocompatibility, flow rate), and material properties testing. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI would be.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no software algorithm or "training set" mentioned or implied for this physical device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
In summary, the provided 510(k) summary for the Disposable TPE Infusion Set is for a conventional physical medical device. It does not contain the type of information related to AI/ML software performance, acceptance criteria, study design (like sample sizes, expert involvement, and ground truth establishment) that your questions are designed to elicit. The "study" referenced is general laboratory testing to confirm the device meets its design specifications and is substantially equivalent to a predicate device.
§ 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.