(105 days)
The TERUMO® SurGuard®3 Safety Needle device is intended for use in the aspiration and iniection of fluids for medical purposes. The TERUMO SurGuard 3 Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The TERUMO SurGuard®3 Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the sheath tooth-cannula and sheath wings-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger or thumb, or by surface activation.
The safety sheath has a finger guide area consisting of a circular dent (for thumb activation) and ramp (for finger activation) which gives the user a concrete confirmation that the user's finger is in the appropriate position in performing the activation. The ramp has steps to provide strong grasp when activating the sheath. There are two stoppers located at the end of the circular dent and ramp which assist in preventing the user's finger from going towards the cannula during activation. Another way of activation is by manually pressing the safety sheath over the needle using a firm surface.
The locking mechanisms are positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use. The needle gauge sizes fall within the 18 to 25 gauge range and the needle lengths are 1" to 2".
The TERUMO SurGuard®3 Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 3, 5, and 10cc/ml.
This 510(k) summary for the Terumo SurGuard®3 Safety Needle focuses on demonstrating substantial equivalence to a predicate device (Terumo SurGuard®2 Safety Needle) rather than providing extensive details about a specific study proving acceptance criteria. In 510(k) submissions, manufacturers often rely on substantial equivalence to existing devices and performance data that supports the safety and effectiveness of the changes made, rather than a full de novo acceptance criteria study for every parameter.
Based on the provided text, a detailed acceptance criteria table with reported performance from a specific study, as well as many of the requested study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details), are not explicitly provided in this 510(k) summary. The document primarily discusses design modifications and general safety and biocompatibility testing.
However, I can extract what is available and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" for the SurGuard®3, nor does it present "reported device performance" in a quantitative, study-specific manner as one might expect for a new performance claim. Instead, it focuses on demonstrating that the modifications to the SurGuard®2 design (specifically the dual locking mechanisms and additional activation methods) do not raise new safety or effectiveness concerns.
The implicit 'acceptance criteria' used for 510(k) often revolve around comparability to the predicate device and meeting relevant standards. The performance aspects discussed are qualitative improvements in safety feature activation.
| Acceptance Criteria (Implied / Deduced) | Reported Device Performance (as described) |
|---|---|
| Safety Feature Activation: | The proposed TERUMO SurGuard®3 Safety Needle is activated by three methods: by pressing the sheath either by finger or by thumb, or by surface activation. This is an improvement from the predicate device (SurGuard®2) which was activated only by surface pressing. |
| Locking Mechanism Effectiveness: | Features two locking mechanisms (sheath tooth-cannula and sheath wings-collar). These are simultaneously activated when manually pressed over the needle. (Implied to be effective based on design improvements and substantial equivalence claim). |
| Biocompatibility: | Device's blood contacting materials were tested in accordance with ISO 10993-1. Results demonstrate that the blood contacting materials are biocompatible. (Specific results not given beyond "biocompatible"). |
| Sterility: | Sterilized using a method validated in accordance with ANSI/AAMI/ISO 11137. Provides a Sterility Assurance Level (SAL) of 10-6. (Specific validation report details not given, but a standard is met). |
| Functional Performance (General Safety Needle, Aspiration/Injection): | Intended for use in the aspiration and injection of fluids for medical purposes. Compatible with standard luer slip and luer lock syringes. (Implied to meet functional performance based on substantial equivalence to the predicate, which performs these functions). No specific performance metrics (e.g., flow rates, leak testing results) are provided. |
| Minimizing Accidental Needlestick: | Manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. The design improvements (dual locking, multiple activation methods) are intended to enhance this. (No specific reduction percentage or study on needlestick rates provided, but implied by design intent). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text for any specific performance testing that would generate these criteria. The document mentions "Manufacturing controls include visual, functional and sterility tests" but does not detail the sample sizes for these.
- Data Provenance: Not explicitly stated as "country of origin" for any specific test data. The device is manufactured by Terumo (Philippines) Corporation. Testing is generally assumed to be conducted in accordance with international standards, but the specific location of testing is not detailed here. It's retrospective in the sense that it's a submission of data to support a regulatory claim, but the nature of the data (e.g., if it involved human subjects or collected historical data) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the summary. For a medical device like a safety needle, "ground truth" often refers to objective physical measurements or established scientific standards rather than expert consensus on a subjective judgment.
4. Adjudication Method for the Test Set
- This information is not provided in the summary, as it's not relevant to the type of device and testing discussed (which focuses on physical and biological properties rather than interpretive expert agreement).
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
- No, an MRMC study was NOT done. This type of study is relevant for diagnostic imaging AI devices, where human readers interpret medical images. The SurGuard®3 Safety Needle is a physical medical device, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for this medical device's performance would primarily involve:
- Objective physical measurements: Demonstrating the locking mechanisms engage, that the sheath covers the needle, the gauge and length specifications, etc.
- Established standards: Compliance with ISO standards for sterilization (ANSI/AAMI/ISO 11137) and biocompatibility (ISO 10993).
- Functional tests: Verification of aspiration/injection capability and compatibility with syringes.
- The summary does not detail specific "ground truth" establishment methods beyond stating compliance with standards and successful testing.
8. The Sample Size for the Training Set
- This is not applicable as the device is not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as point 8.
§ 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).