(114 days)
UltiMed UltiCare Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety shield aids in the prevention of needle stick injuries.
The UltiMed UltiCare Safety Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, plunger rod with gasket, permanently attached hypodermic single lumen needle, needle cap, and protective shield. The UltiMed UltiCare Safety Syringes are non-toxic and nonpyrogenic, and will be available in a variety of combinations of syringe sizes (0.5 to 3.0 ml (cc)), needle sizes (27 to 21 gauge), and needle lengths (5/16" to 1½''). The protective shield is made of clear plastic and is furnished in a retracted position with the needle cap over the needle. When the needle cap is removed, medication can be drawn and injected in the conventional manner. After the injection, the protective shield is engaged by sliding it away from the finger grip to an extended position over the needle and then applying a turning or rotating motion to lock the shield in place.
Here's a breakdown of the acceptance criteria and study information for the UltiMed UltiCare Safety Syringe, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes the UltiMed UltiCare Safety Syringe and states its substantial equivalence to a predicate device. Instead of specific performance metrics with numerical targets, the acceptance criteria are defined by compliance with a set of international ISO standards. The "reported device performance" is the statement of this compliance.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7864 (1993): Sterile Hypodermic Needles for Single Use | Device complies with this standard. |
| ISO 7886-1 (1993): Sterile Hypodermic Syringes for Single Use | Device complies with this standard. |
| ISO 8537 (1991): Sterile single-use syringes, with or without needle, for insulin | Device complies with this standard. |
| ISO 9626 (1991): Stainless Steel Needle Tubing for Manufacture of Medical Devices | Device complies with this standard. |
| ISO 10993-1 (2003): Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing | Device complies with this standard. |
| ISO 10993-4 (2002): Biological Evaluation of Medical Devices: Part 4: Selections of tests for interactions with blood | Device complies with this standard. |
| ISO 10993-5 (1999): Biological Evaluation of Medical Devices: Part 5: Tests for in vitro cytotoxicity | Device complies with this standard. |
| ISO 10993-7 (1995): Biological Evaluation of Medical Devices: Part 7: Ethylene oxide sterilization residuals | Device complies with this standard. |
| ISO 10993-10 (2002): Biological Evaluation of Medical Devices: Part 10: Tests for irritation and delayed-type hypersensitivity | Device complies with this standard. |
| ISO 10993-11 (2006): Biological Evaluation of Medical Devices: Part 11: Tests for systemic toxicity | Device complies with this standard. |
| ISO 11607-1 (2006): Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | Device complies with this standard. |
| Substantial equivalence in intended use, function, and basic composition to predicate device (Sherwood Medical Co. Monoject Safety Syringe 1cc, 3cc and 12 cc size, K922522) | The device is described as "substantially equivalent based on the descriptive data, compliance with standards, simulated clinical use study, and indications for use." |
Study Information
The provided text describes the submission for a 510(k) premarket notification, which focuses on demonstrating "substantial equivalence" rather than a traditional clinical study with a test set and ground truth in the context of diagnostic AI.
Here's the information regarding the "study" (or rather, the evidence presented for substantial equivalence):
-
Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a "test set" in the sense of a dataset for evaluating an AI algorithm.
- It mentions a "simulated clinical use study," but no details regarding its sample size, design, or data provenance (e.g., country of origin, retrospective/prospective) are provided. It's likely this refers to a benchtop or usability study for the physical device.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This concept is not applicable to the information provided. There is no "ground truth" establishment by experts for a test set in the context of an AI or diagnostic device being evaluated. The evaluation is primarily against engineering standards and comparison to a predicate device.
-
Adjudication Method for the Test Set:
- Not applicable, as there is no "test set" in the context of an AI algorithm with expert adjudication.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this is a physical medical device (syringe) and not an AI or diagnostic imaging system that would typically undergo such a study.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
-
The Type of Ground Truth Used:
- The primary "ground truth" here is compliance with established international standards (ISO standards) for mechanical performance, sterility, biocompatibility, and packaging of hypodermic syringes and needles. The other aspect of "ground truth" is that the predicate device (Sherwood Medical Co. Monoject Safety Syringe) is legally marketed and accepted as safe and effective.
-
The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI algorithm requiring a training set.
-
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set.
§ 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).