(331 days)
This device is intended for administration of drug solution, or blood sampling into/from a Reservoir implanted in the body.
The Nipro Huber Infusion Set is a standard non-coring Huber type needle and administration set. The device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The basic structure of the device consists of a cannula, fixing rotating wings, a clamp, tube and luer connector. This device is also available with Y- tube and a injection plug. The needle is bent at a 90° angle and is available in gauges 19, 20 and 22 and in lengths of ¾ " - 1 ½".
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: NIPRO Huber Infusion Set
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Flow rate | 19G: 41-52 ml/min | |
| 20G: 24-38 ml/min | ||
| 22G: 10-15 ml/min | ||
| 24G: 4-6 ml/min | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) | |
| 2. Air leakage – pressure endurance | Must show no signs of air leakage of 50 [kPa] for 15 seconds. | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) |
| 3. Set Leakage – Endurance test | With y-site: 1.8MPa | |
| Without y-site: 3.7MPa | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) | |
| 4. Wrapping paper leakage | Must not leak under the condition of 1.1[kPa] for 10 seconds. | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) |
| 5. Cannula/Hub adhesive strength measurement | 19G: ≥ 69 N | |
| 20G: ≥ 54 N | ||
| 22G: ≥ 34 N | ||
| 24G: ≥ 22 N | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) | |
| 6. Popping needle tip inspection | No sound of puncture popping noise. | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) |
| 7. Tensile Adhesive strength (Hub / tube, Y connector / tube, Connecting tube / connector) | Must withstand a static tensile force of 15[N] for 15 seconds. | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) |
| 8. Test for particulate matter | Contamination Index I = Na - Nb 90 | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) |
| 9. Injection Site (rubber button) | Must show no signs of air leakage of 50 [kPa] for 15 seconds. | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) |
| 10. Transportation Testing | Withstand distribution environment | "successfully met the requirements for these standards." (Implies meeting or exceeding listed criteria.) |
| Biocompatibility Tests (ISO 10993 Parts 4, 5, 10, 11) | Per requirements of ISO 10993 for prolonged duration, indirect blood path contacting device. | "Biocompatibility tests were performed according to ISO 10993 Parts 4, 5, 10 and 11 as a prolonged duration, indirect blood path contacting device." (Implies successful conformance.) |
Note: The document explicitly states: "NIPRO Huber Infusion Set successfully met the requirements for these standards. In addition, it met or exceeded the acceptance criteria for the following performa[nce tests]." This indicates that the device's performance aligned with all specified acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for each of the performance tests.
Regarding data provenance:
- Country of Origin: Not explicitly stated for the testing data. However, the submitter is Nipro Medical Corporation (Miami, FL, USA), and some standards referenced are international (ISO) and some Japanese (JIS, JP).
- Retrospective or Prospective: Not specified. Standard performance testing of a medical device prior to market release is typically prospective, but the document does not explicitly state this.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the tests described are objective, quantitative performance measurements of a physical medical device, not clinical evaluations requiring expert interpretation (e.g., image analysis, diagnosis). The "ground truth" for these tests are the physical standards and measurement protocols themselves.
4. Adjudication Method for the Test Set
This section is not applicable. As mentioned above, the tests are objective performance measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) interpreting cases (e.g., medical images) with and without AI assistance to measure the AI's impact on human performance. The NIPRO Huber Infusion Set is a physical medical device (an infusion set), not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to its evaluation.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the "performance testing" detailed in the document can be considered a standalone evaluation of the device's physical and functional characteristics. The tests listed (flow rate, leakage, adhesive strength, etc.) evaluate the device itself, independent of human interaction beyond operating the testing equipment. Since this is not an AI algorithm, the "algorithm only" aspect doesn't directly apply, but the principle of evaluating the device's intrinsic performance is met.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on established national and international standards and specifications for medical devices, specifically infusion sets and catheters. These include:
- ISO standards (ISO 8536-4, ISO 10555-3, ISO 7864, ISO 594-1, ISO 11135-1, ISO 10993 parts 4, 5, 10, 11)
- USP (United States Pharmacopeia) standards (USP 31 , USP 31 )
- JIS (Japanese Industrial Standards) (JIS T3221:2005)
- JP (Japanese Pharmacopoeia) (JP15)
- ASTM (American Society for Testing and Materials) (ASTM D4169-05)
- IAEA (International Atomic Energy Agency) (IAEA-TECDOC-539)
The acceptance criteria listed (e.g., specific flow rates, pressure tolerances, tensile strength values) are derived from these standards, representing the "ground truth" for what constitutes acceptable performance for this class of device.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its performance testing as there would be for an AI model.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.