(268 days)
This device is intended to inject into or aspirate from, the body.
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. 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 luer lock or luer slip piston syringes. The devices are intended to be used by doctors, medical- related practitioners and self-injection by patients as directed by doctors or medical-related practitioners. The needle hub or connector of the needle is designed to reduce medication waste. Low dead space needles are operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intravascular, and intradermal.
This document is a 510(k) summary for a medical device called "STERiJECT Low Dead Space" and "STERiJECT The INViSIBLE Needle". It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single table of "acceptance criteria" against which "reported device performance" is explicitly measured in a quantitative manner as one might find for a diagnostic software. Instead, it demonstrates conformance to recognized industry standards, which serve as the implicit acceptance criteria for various aspects of the device. The "reported device performance" is the statement of "conformance" or "meets the requirements".
| Aspect Tested | Acceptance Criteria (FDA Recognized Standard) | Reported Device Performance |
|---|---|---|
| Needle Tubing | ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods) | Conforms |
| Sterile Hypodermic Needles (General) | ISO 7864:2016 (Sterile hypodermic needles for single-use – Requirements and test methods) | Conforms |
| Small-Bore Connectors (Luer Compatibility) | ISO 80369-7:2021 (Small-bore connectors for liquid and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications) | Meets requirements (with specific mention of needle hub length creating dead space not being a new question of safety) |
| Low Dead Space Capability | Bench testing | Bench testing demonstrating capability was conducted. |
| Cytotoxicity (Biocompatibility) | ISO 10993-5:2009 (Biological evaluation of medical devices – Part 11: Tests for in vitro cytotoxicity) | Conforms |
| Irritation and Skin Sensitization (Biocompatibility) | ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization) | Conforms |
| Systemic Toxicity (Biocompatibility) | ISO 10993-11:2017 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity) | Conforms |
| Hemolytic Properties (Biocompatibility) | ASTM F756-17 (Standard Practice for Assessment of Hemolytic Properties of Materials) | Conforms |
| Pyrogen Test (Biocompatibility) | USP Chapter Pyrogen Test | Conforms |
| Particulate Matter | USP (Particulate Matter in Ophthalmic Solutions) | Met USP acceptance criteria |
| Sterilization Validation (Methodology) | ISO 11137-1:2006/AMD 1:2013 (Sterilization of health care products-Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) | Conforms |
| Sterilization Validation (Dose Establishment) | ISO 11137-2:2013 (Sterilization of health care products-Radiation - Part 2: Establishing the sterilization dose) | Conforms |
| Packaging Validation (Materials & Systems) | ISO 11607-1:2019 (Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems) | Conforms |
| Packaging Validation (Leak Detection) | ASTM F3039-15 (Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration) | Conforms |
| Packaging Validation (Shipping Performance) | ASTM D4169-22 (Standard Practice for Performance Testing of Shipping Containers and Systems) | Conforms |
| Accelerated Aging (Shelf-Life Validation) | ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) | Conforms (for a shelf-life of 5 years) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., number of needles tested for tensile strength, number of samples for cytotoxicity). It broadly states that "non-clinical testing data" was used. The data provenance is implied to be from the manufacturer's own testing as part of their device development and validation process in Japan, given the applicant's location. The studies are prospective in the sense that they are performed specifically to validate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device submission. The "ground truth" for the performance of a hypodermic needle is established by its adherence to internationally recognized consensus standards, physical measurements, and biological safety tests, not by expert consensus on interpretations of images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. This device is a physical medical instrument, not a diagnostic or AI-driven system requiring adjudication of results from multiple readers.
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 not an AI-driven or diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Conformance to recognized consensus standards (e.g., ISO, ASTM, USP) for physical properties, materials, sterility, packaging, and biocompatibility.
- Bench testing results for specific performance characteristics like low dead space capability.
- Biocompatibility testing to assess the biological response to the device materials.
- Sterilization and shelf-life validation based on established protocols.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).