(174 days)
JT series Disposable 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-JT series disposable infusion set is plastic, 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 Polyvinyl chloride and used to connect various components; 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; Male conical fitting is used for connecting with vein needle for medical solution transfusion. The proposed device is provided sterilized.
Here's a breakdown of the acceptance criteria and study information for the Disposable Infusion Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list specific acceptance criteria with numerical targets for the device's performance. Instead, it states that the device "comply[s] with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission" (which are not included in the provided text).
The reported device performance is indirect and qualitative:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with voluntary standards | Device complies with voluntary standards as detailed in Sections 9, 11, and 17 of the premarket submission (details not provided here). |
| Safety | Considered "as safe" as the predicate device(s). |
| Effectiveness | Considered "as effective" as the predicate device(s). |
| Performance | Performance is "substantially equivalent" to the predicate device(s). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Testing on unit level (Module verification)", "Integration testing (System verification)", "Final acceptance testing (Validation)", "Performance testing (Verification)", and "Safety testing (Verification)" were performed, but no sample sizes are given for these tests.
- Data Provenance: Not specified. However, the manufacturer is Shanghai Jinta Medical Co., Ltd. in China, so it's likely the testing occurred in China. The study type is non-clinical testing, which implies lab-based testing rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. This was a non-clinical study, so there was no "ground truth" established by medical experts for a test set of patient data. The ground truth would be based on engineering specifications and compliance with standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method:
- Adjudication Method: Not applicable, as this was a non-clinical study without human interpretation of clinical cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Disposable infusion set, did not require clinical studies to support substantial equivalence."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study: Yes, this essentially describes the non-clinical performance and safety testing conducted. The device (Disposable Infusion Set) itself is a physical medical device, not an algorithm. The testing described ("Risk Analysis," "Requirements Reviews," "Design Reviews," "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," "Safety testing") demonstrates its standalone performance against design specifications and voluntary standards. There is no "human-in-the-loop" aspect to the function of this specific device to be evaluated.
7. Type of Ground Truth Used (for the test set):
- Ground Truth Type: For this non-clinical submission, the "ground truth" for the test set would be derived from engineering specifications, design requirements, and voluntary standards. Performance was measured against these predefined technical benchmarks and safety requirements for medical devices of this type.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This document describes the submission for a physical medical device (infusion set), not an AI/ML algorithm. Therefore, there is no "training set" in the machine learning sense. The device is designed and manufactured based on established engineering principles and materials.
9. How Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device. The device's design and manufacturing are based on established engineering and material science principles, guided by regulatory standards for medical devices.
§ 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.