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The UltiCare Disposable Syringe is used to draw a quantity of pharmaccutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.

The UltiCare 3 ml Disposable Syringe is a standard piston type hypodermic syringe, with a black colored protective needle cap. This device is a sterile, single-use, disposable piston svringe with permanently affixed hypodermic single lumen needle. This device is a sterile, single use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The UltiCare 3 ml Disposable Syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The UltiCare 3 ml Disposable Syringe is available in a 3.0 cc syringe capacity with a 22 GAUGE x 1½" hypodermic single lumen needle.

This document is a 510(k) summary for a disposable medical device (syringe), not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and compliance with established performance standards for syringes.

Here's the information that is extractable and relevant from the provided document, presented as closely as possible to the requested format:

Acceptance Criteria and Device Performance for UltiCare™ Disposable Syringe (3 ml/cc)

This 510(k) submission primarily relies on demonstrating substantial equivalence to two predicate devices and compliance with recognized international standards for syringes. The "acceptance criteria" are implicitly these standards, and the "reported device performance" is the claim of meeting these standards and being substantially equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use
• Function
• Basic Composition | The UltiCare 3 ml Disposable Syringe is substantially equivalent in intended use, function, and basic composition to the Ulti Med UltiCare 1 ml Disposable Syringe (K994230) and the Becton Dickinson Medsaver Syringe (K941095). The only design change from the 1ml UltiCare syringe is syringe capacity and corresponding dimensional changes, and minimal material component changes. All other aspects are identical. |
  | Material & Sterility | ISO 8537: Sterile, Single-Use Syringes, with or without Needle, for Insulin | UltiCare Disposable Syringes "meet the following standards." (Implies compliance) |
  | Needle Material | ISO 9626: Stainless Steel Needle Tubing for Manufacture of Medical Devices | UltiCare Disposable Syringes "meet the following standards." (Implies compliance) |
  | Intended Use | Draw and administer pharmaceuticals via direct injection or intravenous port/heparin lock/saline lock. | Device is used to draw and administer pharmaceuticals directly to the patient or via an intravenous port, heparin lock, or saline lock. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission is for a conventional medical device (syringe), not an AI/ML device. Performance is demonstrated through substantial equivalence to predicate devices and compliance with ISO standards, rather than through a clinical test set with specific sample sizes and data provenance as would be relevant for an AI/ML algorithm. Testing would have typically involved laboratory-based verification and validation of engineering design and manufacturing against the ISO standards. The document does not detail this testing (which is common for 510(k) summaries of such devices).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. See point 2. Ground truth establishment by experts is not a concept applied to the evaluation of a disposable syringe in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 2.

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 a non-AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a non-AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. For this device, "ground truth" equates to the physical and functional characteristics specified in the ISO standards (e.g., sterility, dimensional accuracy, material properties, fluid delivery pressure/flow) and the functionality of predicate devices. These are not established by expert consensus, pathology, or outcomes data in the way an AI algorithm's performance is evaluated.

8. The sample size for the training set

• Not Applicable. This is a non-AI device; there is no training set.

9. How the ground truth for the training set was established

• Not Applicable. This is a non-AI device; there is no training set or associated ground truth establishment process.

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