(112 days)
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.
The OMI Retractable Safety Syringe works like this: STEP 1 After cap removal, fluid draw-up and aspiration is unchanged from conventional syringes. STEP 2 As the plunger rod is depressed and the plunger stopper makes contact with the needle hub, the elastic membrane conforms to the conical shape of the needle hub. The plunger stopper membrane stretches until the plunger rod is fully depressed and maximum fluid is expelled from the svringe. STEP 3 At the point of full plunger rod depression, the application of the injection force overcomes the strength of the web joining the inner and outer portions of the needle hub. As this web fractures and the outer portion of the needle hub moves forward, the plunger stopper membrane is simultaneously pierced by the conical end of the hub, releasing the inner portion of the hub carrying the needle to be retracted into the hollow stem of the plunger rod by the coiled spring. The activation force is controlled. The extra pressure required at the end of the injection stroke to retract the needle is minimal. The entire procedure designed for singlehanded use, with no change to common habits. STEP 4 The fracturing of the needle hub and the piercing of the plunger stopper allow the needle to be forced into the plunger rod by the coiled spring. The speed of this retraction and the minimal dead space avoids blood or fluid spatter. Retraction is accompanied by an audible "click" and the highly visible separation of the needle hub. The syringe is EO sterilized, non-pyrogenic, and latex free.
The provided text describes a 510(k) premarket notification for the OMI Ret retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device, the SEZ Safety Syringe (K031163), rather than presenting a detailed study with specific acceptance criteria and performance metrics in the format of AI device evaluation.
However, I can extract the relevant information and present it in a manner that aligns with your request where possible, while noting limitations due to the nature of the legal filing.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion (Type of Test/Characteristic) | Acceptance Criteria (Predicate Device K031163) | Reported Device Performance (OMI Retractable Safety Syringe) |
|---|---|---|
| Intended Use | Safety hypodermic syringe for intramuscular and subcutaneous injection, aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, latex free. | Identical: "This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free." |
| Principle of Operation (Safety Feature) | Activation in two steps: Disassemble needle assembly, then retract into barrel and confine by pushing plunger. | Activation in a single step: "After injecting the medicine, the plunger is pushed in just a bit harder causing the retraction mechanism to pull the needle permanently inside the barrel." (This is presented as an improvement/difference but still meeting the safety intent.) |
| Volume (ml/cc) | 3 and 5 ml | 1, 3, 5 and 10 ml sizes (Broader range, but implies individual sizes meet performance) |
| Nozzle Type | Female conical lock fitting with rotatable internally threaded neck. | Needle and hub are integral to the syringe, not separable. (Structural difference, but functionally equivalent for intended use). |
| Barrel Marking | Conforms to ISO7886-1:1993(E) | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conforms to ISO 10993-1 | Identical |
| Materials | Plastic parts: polypropylene; Gasket: thermoplastic rubber; Packing film: Medipeel film; Packing paper: Ethypel paper. | Identical |
| Sterility | Sterilized by ethylene oxide gas (SAL = 10⁻⁶) | Identical |
| Clinical Acceptability | (Implicitly acceptable as a legally marketed device) | "The results of the investigation showed that the OMI Ret retractable Safety Syringe is clinically acceptable." |
Study Proving Device Meets Acceptance Criteria:
The document refers to a "clinical investigation" and "test for the comparison between OMI Ret retractable Safety Syringe and the legally marketed predicate device." This study was performed "in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA'."
2. Sample Size for the Test Set and Data Provenance
- The document does not explicitly state the sample size used for the clinical investigation or comparison test.
- The data provenance (country of origin, retrospective/prospective) is not specified. However, the study was conducted to meet FDA regulations for a US-marketed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- The document does not provide details on the number of experts, their qualifications, or how ground truth was established for the clinical investigation. For a physical device like a syringe, "ground truth" would likely refer to objective measurements of performance (e.g., retraction force, completeness of retraction, prevention of needlesticks in simulated or actual use).
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (like AI in radiology) where human readers make a judgment. The OMI Ret retractable Safety Syringe is a physical medical device.
6. Standalone Performance Study
- Yes, a standalone study (referred to as a "clinical investigation" and "test for the comparison") was performed to demonstrate that the OMI Ret retractable Safety Syringe itself ("algorithm only" in AI terms) met the necessary safety and performance criteria, including comparison to the predicate device. The goal was to show "clinical acceptability."
7. Type of Ground Truth Used
- Based on the context of a safety syringe, the "ground truth" would likely involve objective measurements related to:
- Mechanical performance: Retraction force, completeness of needle retraction, prevention of re-exposure.
- Usability/Human factors: Ease of use, activation force, audible/visible confirmation of retraction, potential for needlestick incidents in simulated use.
- Biocompatibility: In vitro and in vivo testing demonstrating material safety.
- Sterility assurance.
- The document states that the findings were based on "biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the previous device."
8. Sample Size for the Training Set
- This is not applicable as the OMI Ret retractable Safety Syringe is a physical device, not an AI/software device that would require machine learning training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (no training set for a physical device).
§ 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).