(215 days)
The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The sterile insulin syringe for single use with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with the calibration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock consists of a Piston, Plunger, and Barrel. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in various lengths, diameters, tip types, needle tip configurations, nozzle types, barrel marking specs, volumes, sizes, and needle lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Insulin Syringe for Single use, with needle consists of a Needle Cap, Needle, Piston, Plunger, Barrel, and End Cap. It is EO Sterilized and intended for Prescription use by patients. It is for single use and operates by pulling and pushing the plunger along inside the barrel to take in and expel fluids. It comes in 0.3ml, 0.5ml, and 1ml volumes with fixed needles of 8mm and 13mm lengths. Materials include Isoprene Rubber, PP, PE, and SUS304.
The Sterile Hypodermic needle for Single use consists of a Protective cap, Needle, Adhesives, and Needle hub. It is EO Sterilized and intended for Prescription use by Medical professionals and trained care givers. It is for single use and for Manual Use Only. It comes in various sizes and needle lengths. Materials include PP, Epoxy resin, and SUS304.
This document is a 510(k) summary for hypodermic syringes, insulin syringes, and hypodermic needles. It describes the devices, their indications for use, and a comparison to a predicate device (K190002). The document primarily focuses on demonstrating substantial equivalence to the predicate device through comparisons of technological characteristics and compliance with recognized performance standards. It certifies that the devices meet various ISO standards and biological evaluation requirements.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a "table of acceptance criteria and reported device performance" as you might expect for a diagnostic AI device with metrics like sensitivity, specificity, or AUC. Instead, for these medical devices (syringes and needles), acceptance criteria are met through compliance with established international standards for design, performance, and biocompatibility. The reported device performance is stated as "Complied with" these standards.
Here's how we can infer the acceptance criteria and reported performance from the text:
| Device Component/Characteristic | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Hypodermic Syringe | ISO 7886-1 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | Complied with ISO 7886-1 |
| ISO 7864 (Sterile hypodermic needles for single use) | Complied with ISO 7864 | |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Complied with ISO 9626 | |
| ISO 10993-4 (Biological Evaluation - Interactions with Blood) | Complied with ISO 10993-4 (Hemolytical effect) | |
| ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity) | |
| ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization) | Complied with ISO 10993-10 (Irritation, Sensitization) | |
| ISO 10993-11 (Biological Evaluation - Systemic Toxicity) | Complied with ISO 10993-11 (Acute Systemic Toxicity) | |
| USP 788 (Particulate Matter in Injections) | Complied with USP 788 | |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complied with ISO 10993-7 | |
| ISO 11135 (Sterilization of health-care products – Ethylene oxide) | Complied with ISO 11135 | |
| ISO 11607-2 (Packaging for terminally sterilized medical devices) | Complied with ISO 11607-2 | |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Endotoxin Limit | 20 EU per device | |
| Pyrogenicity | Complied with European Pharmacopoeia 9.0 (2.6.8) | |
| Insulin Syringe | ISO 8537 (Sterile single-use syringes, with or without needle, for insulin) | Complied with ISO 8537 |
| ISO 10993-4 (Biological Evaluation - Interactions with Blood) | Complied with ISO 10993-4 (Hemolytical effect) | |
| ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity) | |
| ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization) | Complied with ISO 10993-10 (Irritation, Sensitization) | |
| ISO 10993-11 (Biological Evaluation - Systemic Toxicity) (Acute, Sub-acute, Sub-chronic) | Complied with ISO 10993-11 (Acute Systemic Toxicity, Sub-acute Systemic Toxicity, Sub-chronic Systemic Toxicity) | |
| USP 788 (Particulate Matter in Injections) | Complied with USP 788 | |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complied with ISO 10993-7 | |
| ISO 11135 (Sterilization of health-care products – Ethylene oxide) | Complied with ISO 11135 | |
| ISO 11607-2 (Packaging for terminally sterilized medical devices) | Complied with ISO 11607-2 | |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Endotoxin Limit | 20 EU per device | |
| Pyrogenicity | Complied with European Pharmacopoeia 9.0 (2.6.8) | |
| Hypodermic Needle | ISO 7864 (Sterile hypodermic needles for single use) | Complied with ISO 7864 |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Complied with ISO 9626 | |
| ISO 10993-4 (Biological Evaluation - Interactions with Blood) | Complied with ISO 10993-4 (Hemolytical effect) | |
| ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity) | |
| ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization) | Complied with ISO 10993-10 (Irritation, Sensitization) | |
| ISO 10993-11 (Biological Evaluation - Systemic Toxicity) | Complied with ISO 10993-11 (Acute Systemic Toxicity) | |
| USP 788 (Particulate Matter in Injections) | Complied with USP 788 | |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complied with ISO 10993-7 | |
| ISO 11135 (Sterilization of health-care products – Ethylene oxide) | Complied with ISO 11135 | |
| ISO 11607-2 (Packaging for terminally sterilized medical devices) | Complied with ISO 11607-2 | |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Endotoxin Limit | 20 EU per device | |
| Pyrogenicity | Complied with European Pharmacopoeia 9.0 (2.6.8) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for test sets in the traditional sense of a clinical trial or algorithm evaluation. The testing referenced refers to compliance with ISO standards, which typically involve specific sampling plans and test methods for manufacturing quality control and performance validation.
- Test Set Sample Size: Not explicitly stated as individual numbers for device testing. Compliance with ISO standards implies that appropriate sample sizes were used according to those standards for each specific test (e.g., performance, biocompatibility).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are "performance testing" and "biocompatibility studies" conducted to demonstrate compliance with international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic medical devices or AI algorithms. For syringes and needles, the "ground truth" is defined by the technical specifications and performance requirements outlined in the ISO standards themselves, verified through physical and chemical testing.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (e.g., 2+1) are used to resolve disagreements among multiple human readers in the context of diagnostic evaluations, typically for AI or imaging studies. For the direct performance testing of syringes and needles against standards, there isn't a "ground truth" established by human readers that requires adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This submission is for physical medical devices (syringes and needles), not a diagnostic AI system, so such a study would not be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable. This refers to the performance of a software algorithm or AI model without human intervention. The devices being reviewed are physical medical instruments (syringes and needles), not software or AI.
7. Type of Ground Truth Used:
The "ground truth" in this context is adherence to the technical specifications and safety/performance parameters defined by internationally recognized standards (e.g., ISO 7886-1 for syringes, ISO 7864/9626 for needles, ISO 8537 for insulin syringes, and ISO 10993 series for biocompatibility). This is established through objective technical measurements and laboratory test results that demonstrate the device meets these pre-defined (standardized) criteria. It is not expert consensus, pathology, or outcomes data in the sense of diagnostic device validation.
8. Sample Size for the Training Set:
This information is not applicable. A "training set" is used for machine learning or AI model development. These devices are physical medical products, not AI systems, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).