Search Results

Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The Lifelong Matrix/Lifelong Premium/SAFEWAY syringe with or without needle is a standard piston syringe that consists of a calibrated hollow barrel and a movable plunger. The needle consists of needle tube, needle hub, needle cap. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle or for attaching other devices with a female Luer. The syringe and needles are sterilized by ETO gas. It is a non-pyrogenic and single use device. The main raw materials for syringes are polypropylene and thermoplastic elastomer and for needles raw materials are polypropylene and stainless steel (SS-304).

This document is a 510(k) premarket notification for a medical device (syringes and needles). The key to fulfilling your request is to understand that a 510(k) submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel performance against specific acceptance criteria like an AI/ML device would.

Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set" do not directly apply in the context of this 510(k) submission for a non-AI/ML device like a syringe.

Instead, the submission focuses on comparing the proposed device's characteristics and performance to those of a previously cleared predicate device and demonstrating compliance with relevant industry standards.

Here's how to interpret the document in the context of your request, reframing the information to reflect what is actually present in a 510(k) for this type of device:

For a medical device like the Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily demonstrated through comparison to a legally marketed predicate device and compliance with established international and national standards. This is typical for a 510(k) premarket notification for a Class II device that is not an AI/ML product.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this isn't an AI/ML device with specific accuracy metrics, the "acceptance criteria" are implicitly met by demonstrating similar technological characteristics and compliance with recognized standards as the predicate device. The "reported device performance" is presented as a comparison to the predicate and confirmation of adherence to these standards.

Here's a table summarizing the key comparisons that serve as the basis for "acceptance" in a 510(k) context for this device:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a distinct "test set" sample size in the way an AI/ML study would. Instead, compliance with various ISO and ASTM standards implies specific sample sizes and test methodologies as defined within those standards (e.g., how many syringes are tested for dose accuracy, or how many needles for bond strength). These details are not explicitly itemized in the summary provided, but rather are referenced by the standard itself.
• Data Provenance: The device manufacturer is Lifelong Meditech Private Limited, located in Gurugram, Haryana, India. All testing would have been conducted to demonstrate compliance with international standards (ISO, ASTM, USP) for the purpose of U.S. FDA clearance. The studies referenced are performance testing and biocompatibility testing, which are inherently prospective in nature, conducted on the actual manufactured device Lot(s) to demonstrate their properties.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. For a medical device like a syringe and needle, "ground truth" is not established by human experts in the way it is for image interpretation in AI/ML. Instead, performance is measured against objective physical, chemical, and biological standards (e.g., volume accuracy, material composition, sterility, biocompatibility). These measurements are typically performed by technicians and validated by quality control personnel in certified laboratories.

4. Adjudication Method for the Test Set:

• Not Applicable. As "ground truth" is based on objective measurements against standards rather than subjective human interpretation, there is no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study is relevant for AI/ML devices that assist or replace human readers (e.g., radiologists interpreting images). This device is a syringe, a hardware medical device; its safety and effectiveness are not assessed via human reader performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not Applicable. This is not an AI/ML algorithm. Its "performance" is assessed directly through physical and chemical testing.

7. The Type of Ground Truth Used:

• The "ground truth" for this device is based on objective measurements against established performance standards and material specifications. This includes:

  • Dimensional accuracy (e.g., needle inner diameter, volume calibration)
  • Physical properties (e.g., bond strength, plunger force, needle sharpness)
  • Chemical properties (e.g., EO residuals, material composition)
  • Biological properties (e.g., sterility, absence of pyrogens, biocompatibility)
  • Functionality (e.g., luer lock compatibility)

  These are defined by standards such as ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 series, ISO 11135-1, ASTM D4169-16, ASTM F1929-15, ASTM F1980-16, and USP guidelines.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The "training" for such a device is in its design, manufacturing process, and quality control, not via data-driven model training.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set for an AI/ML algorithm, this question does not apply. The device's design and manufacturing are based on well-established engineering principles and adherence to regulatory and quality standards, the "ground truth" for which are the physical and chemical properties of materials and established mechanical and biological principles.

Ask a specific question about this device