(236 days)
To administer parenteral fluids / medication into the patient's intravascular system.
The sterile I.V. Administration Set is indicated for use to administrater parenteral fluids medication into the paticits vascular system.
The product is Single Use Sterile Infusion Set for Medical Use. The infusion set consists of the components as illustrated in figure given below.
The provided text is a Premarket Notification [510(k)] Summary for an "I.V. Administration Set" by Angiplast Pvt. Ltd. This document primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not present in the provided text. The document refers to compliance with ISO standards and comparisons to predicate devices as the basis for equivalence.
Here's an attempt to answer the questions based only on the provided information, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets or a detailed report of the device's performance against such criteria. Instead, it states:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 8536-4 | "Our brand comply with the requirements of ISO 8536-4 in all critical requirements." |
| Substantial Equivalence to Predicate Devices | "From the comparison it is observed that our product is found to be substantially equivalent to Two similar American Products." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text does not describe a "test set" and thus, no sample size or data provenance (country of origin, retrospective/prospective) for such a set. The "comparison" mentioned refers to technical characteristics against predicate devices, not a clinical or performance test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. There is no mention of "experts" establishing "ground truth" for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the document. As no "test set" is described, there is no mention of an adjudication method.
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
This information is not provided in the document. The device is an "I.V. Administration Set," a medical hardware device, not an AI or software device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
This information is not provided in the document beyond the implication that adherence to ISO 8536-4 and comparison to predicate devices serves as the "truth" for establishing substantial equivalence. This is based on technical characteristics and regulatory compliance rather than expert consensus, pathology, or outcomes data from a specific study.
8. The Sample Size for the Training Set
This information is not provided in the document. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. As no "training set" is mentioned, no ground truth establishment method for it is described.
Summary of the Study (as described in the document):
The document describes a Premarket Notification [510(k)] Summary intending to demonstrate substantial equivalence of the Angiplast I.V. Administration Set to two legally marketed predicate devices:
- PRIMARY I.V. SET, Convertible Pin, 100 Inch with Backcheck Valve and 2 CLAVE® ports Piggyback MICRODRIP® with OPTION-LOK® (Trade Name: LifeShield®) manufactured by Abbott Laboratories.
- Continu-Flo® Solution Set (Trade Name: Interlink® System) manufactured by Baxter Healthcare Corporation.
The "study" or justification for equivalence presented relies on:
- Comparison of Technical Characteristics: The document states, "Summary of comparative technical characteristics... From the comparison it is observed that our product is found to be substantially equivalent to Two similar American Products." However, the actual comparative table of detailed characteristics is not provided in a readable format in the extracted text (it appears as scanned text with significant OCR errors).
- Compliance with International Standards: The document explicitly states, "The two American brands as well as our brand comply with the requirements of ISO 8536-4 in all critical requirements." ISO 8536-4 is the standard for "Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed." This compliance suggests that the device meets established safety and performance benchmarks for IV administration sets.
The FDA's response (K012189 dated March 5, 2002) confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device... [and] have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This FDA determination is the "proof" that the device meets the implied acceptance criteria for market entry under the 510(k) pathway, which is substantial equivalence 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.