(71 days)
The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.
The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to prevent accidental needle sticks and automatically activate during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A non-removable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged.
The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.
The provided text is related to a 510(k) premarket notification for a medical device called the "Pro-Lock CT Safety Infusion Set." This document describes the device, its intended use, and a comparison to a predicate device, along with a list of performance tests conducted.
However, the document does not describe a study that uses a test set, ground truth established by experts, or any of the metrics (like sensitivity, specificity, or AUC) typically associated with AI/ML device performance. It also does not mention an AI algorithm, human readers, or any multi-reader multi-case (MRMC) comparative effectiveness study.
The document focuses on the mechanical and material performance of a physical medical device (an infusion set) against established international standards for medical devices and biocompatibility. The acceptance criteria are the successful completion of these specified tests according to the outlined standards.
Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device's performance because the provided text is about a physical medical device and its traditional regulatory submission.
Here's what I can extract from the provided text regarding the performance evaluation of the physical device:
The document describes the performance testing of the Pro-Lock™ CT Safety Infusion Set to demonstrate its substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria alongside reported numeric device performance results. Instead, it lists the tests performed and the standards adhered to, implying that meeting these standards constitutes the acceptance criteria. The narrative states that the results of these tests "effectively demonstrate the proposed device... is equivalent to the predicate device."
| Test Performed | Test Method / Standard (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Priming Volume | Per Internal Test Method | Priming Volume: 0.20cc (This is a device characteristic, not directly a "performance" in terms of pass/fail, but it indicates adherence to design specs.) |
| Gravity Flow | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Needle Insertion/Extraction Force | ISO 10555-6: 2015 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted | Implicitly met the standard during evaluation for substantial equivalence. |
| Air Leakage | ISO 8536-8: 2004 - Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus | Implicitly met the standard during evaluation for substantial equivalence. |
| Liquid Leakage | ISO 10555-1: 2013, Annex C - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Luer Lock Fittings | ISO 594-2: 1998 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment | Implicitly met the standard during evaluation for substantial equivalence. |
| Occlusion with Clamp | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Extension Tensile and % Elongation | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Power Injection Simulation | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Maximum Infusion Rate: 11.8 cPs is 5 ml/sec for 20 gauge (This is a stated performance spec, implicitly met to demonstrate equivalence). |
| Port Septum/Needle Evaluation for Coring | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Break Pull Test/Static Load Pull Test | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Needle to Extension Joint | ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters Part 1: General Requirements | Implicitly met the standard during evaluation for substantial equivalence. |
| Corrosion Resistance | ISO 11070: 2014 - Sterile single-use intravascular introducers, dilators and guidewires | Implicitly met the standard during evaluation for substantial equivalence. |
| Shelf Life (3 years) | ISO 11607-1: 2009+A1:2014; ASTM F1980-16; ISO 10555-1: 2013; ASTM F-1929-15; ASTM F-1140 | Implicitly met the standards for shelf-life validation. |
| Shipping Test | ISO 11607-1: 2009+A1:2014; ISTA-2A-2011; ASTM F-1929-15; ASTM F-1140 | Implicitly met the standards for shipping integrity. |
| Simulated Use Study: Sharps Injury Prevention | FDA's Guidance: Medical Devices with Sharps Injury Prevention Features | Implicitly met the guidance for sharps injury prevention, as it's a "Safety Infusion Set" designed to prevent accidental needle sticks. |
| Living Hinge Fatigue | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Force at Break | Per Internal Test Method | Implicitly met the internal method during evaluation for substantial equivalence. |
| Evaluation of Magnetic Field Interactions, Heating, and Artifacts | ASTM F2052-15; ASTM F2119-07; F2182-11a; F2213-06; ASTM F 2503-13 | The device was evaluated against these standards for MRI compatibility, implying it met the criteria for safe use or appropriate labeling in an MRI environment. |
| Biocompatibility | ISO 10993-1: Externally communicating device, indirect blood path exposure, prolonged duration (greater than 24 hours and less than 30 days), with specific endpoints: Sensitization/Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Cytotoxicity (ISO 10993-5), Pyrogenicity (ISO 10993-11), Hemocompatibility (ISO 10993-4), Material Characterization (ISO 10993-18). | Implicitly met all specified biocompatibility endpoints according to ISO 10993 standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for individual tests. The testing seems to be laboratory-based verification and validation.
- Data Provenance: Not applicable in the context of clinical data provenance. The data comes from "non-clinical testing performed" at Medcomp®.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the type of device and testing described. Performance is based on meeting engineering and biocompatibility standards, not expert clinical assessment of diagnostic output.
4. Adjudication method for the test set:
- Not applicable. Performance is measured against physical standards, not through expert adjudication.
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 is a physical medical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used:
- The "ground truth" here is adherence to national and international engineering and biocompatibility standards (e.g., ISO, ASTM, FDA Guidance). These standards define acceptable physical properties and safety profiles for the device.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML algorithm requiring a training set and its associated ground truth establishment.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).