(36 days)
DepotOne is a sterile single use hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans.
DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.
The DepotOne needles comprise of a length of Hypodermic grade stainless steel tube connected to a female connector (hub) that is designed to mate with a male connector of a piston syringe or an intravascular administration set. The other end of the tube is sharpened with a lancet tip in accordance with ISO7864: 1993. The sharpened section of tube is of a reduced diameter. The fluid is injected or removed through a side aperture adjacent to the sharpened tip.
The acceptance criteria and study proving the DepotOne™ device meets these criteria are detailed in the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated through adherence to various ISO and EN standards. While specific numerical targets for "acceptance criteria" are not always explicitly stated in the document for each test (e.g., "passed"), compliance with these standards is the acceptance criterion.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Material Composition | |
| Cannulae: Stainless Steel | Stainless Steel |
| Hub (6% Locking Luer): Polypropylene (Predicate) | Polycarbonate (DepotOne™) - Note: Difference in material stated not to impact sterilization and chosen for superior bond strength. |
| Needle Lubricant: Silicone | Silicone |
| Adhesive: Epoxy | Epoxy |
| Sterilisation Method: ETO | ETO |
| Needle Shield: Polypropylene | Polypropylene |
| Physical and Functional Performance (per relevant ISO standards) | |
| ISO 7864:1993 Sterile Hypodermic Needles for Single Use compliance | DepotOne™ conforms to the requirements. |
| - Needle/Hub Bond Test | Passed to EN ISO 7864:1993. |
| - Patency of Lumen Test | Passed to EN ISO 7864:1993. |
| - Extractables Test | Passed to EN ISO 7864:1993. |
| - Acidity and Alkalinity Test | Passed to EN ISO 7864:1993. |
| EN ISO 9626:1995 Stainless Steel Tubing for Medical Devices | |
| - Bend Test (for tubing) | Passed to EN ISO 9626:1995. Note: For 1.2mm (18G) XTW and 0.8mm (21G) XTW, passed requirements for nearest available data (1.1mm 19G XTW and 0.7mm 22G XTW) as no specific max deflection data in standard. |
| - Breakage Test (for tubing) | Passed to EN ISO 9626:1995. |
| Additional Performance Tests | |
| Fluid Flow Tests | Passed. |
| Breakage Tests for completed needles | Passed. |
| Bend Tests for complete needles (including swaged tip) | Passed. |
| Penetration force tests | Passed. |
| Sterilization & Biocompatibility | |
| EN550 (ETO sterilization validation) | Needles EO sterilized by a validated method in accordance with EN550. |
| EN556 (sterility certification) | Sterilization certified to comply with EN556 and validated by an independent laboratory to a Sterility Assurance Level (SAL) of 10-6. |
| Pyrogenicity (LAL test, European Pharmacopoeia) | Tested for freedom of Pyrogens by LAL (limulus amebocyte lysate) test conducted by an independent laboratory in accordance with European Pharmacopoeia. Performed on samples from every production batch/lot. |
| Residual Gas Contents (EN ISO10993-7) | Tested in accordance with EN ISO10993-7. Limiting viewe 20mg ethylene oxide/24hrs. |
| Luer Connector Compatibility | |
| ISO 594-2 (6% Luer connector) | Proximal end securely attached to a 6% Luer connector, in accordance with ISO 594-2. (Note: Predicate device K-Pack II did not completely meet this requirement, but DepotOne™ does.) |
| ISO 6009 (color coding of connector) | Connector is color coded in accordance with ISO 6009. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample sizes for each test mentioned (e.g., how many needles were subjected to bend, breakage, or bond tests). It only states that "DepotOne™M needles have passed the following tests" or "DepotOne™ needles have been subjected to and passed the following tests."
The data provenance is from prospective testing conducted by Imprint Pharmaceuticals Ltd. and independent laboratories on the DepotOne™ device itself. The country of origin for the testing facilities is not explicitly stated, but Imprint Pharmaceuticals is based in Surrey, UK.
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 hypodermic needles is established by compliance with international engineering and sterilization standards (e.g., ISO, EN, Pharmacopoeia) and validated laboratory testing, not by expert consensus on clinical interpretation or outcomes in the same way as, for example, an imaging diagnostic device. The expertise lies in engineering, materials science, microbiology, and quality assurance.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., reading images), which is not the case for the physical and biological testing of a hypodermic needle. The "adjudication" is inherent in whether the device objectively passes or fails the specified criteria of the international standards.
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 applicable, as the device is a hypodermic needle and not an AI-enabled diagnostic or interpretive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable, as the device is a hypodermic needle and does not involve AI algorithms.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on International Standards and validated laboratory test results. This includes:
- Engineering specifications for materials, dimensions, and physical properties (e.g., bend, breakage, bond strength, fluid flow, penetration force).
- Biological safety and sterility standards (e.g., SAL of 10-6, pyrogenicity, residual gas content).
These standards and test methods serve as the objective "truth" against which the device's performance is measured.
8. The Sample Size for the Training Set
This information is not applicable, as the device is a physical hypodermic needle and does not involve an AI algorithm or a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is 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).