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The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation.

The device is a single-use 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The device has two models, PCAA01 and PCAA03. They are only different in volume; PCAA01 is 10cc, and PCAA03 is 30cc. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and protect cap. The device contacts indirectly with the human body. The duration of contact is less than 24 hours. The product is used in conjunction with the urinary catheter to push the plunger of the syringe to inject the sterilized pre-filled purified water into the balloon of the urinary catheter to inflate the balloon.

Here's a breakdown of the acceptance criteria and study information for the Prefilled Syringe, based on the provided text:

Device: Prefilled Syringe (10cc and 30cc for Foley catheter balloon inflation)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes compliance with recognized standards rather than specific numerical acceptance criteria and reported performance values. The summary states: "All of the tested parameters met the predefined acceptance criteria."

• Cytotoxicity (ISO 10993-5: 2009)
• Sensitization (ISO 10993-10:2010)
• Irritation (ISO 10993-10:2010)
  All tested parameters met predefined acceptance criteria. |
  | Performance Testing | ISO 7886-1: 2017 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use)
  ISO 11040-8: 2016 (Prefilled Syringes Requirements and test methods for finished prefilled syringes)
  ISO 11040-4: 2015 (Prefilled Syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling)
  ISO 11040-6: 2019 (Prefilled Syringes Plastic barrels for injectables and sterilized subassembled syringes ready for filling)
  ISO 80369-1: 2018 (Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements)
  ISO 80369-7: 2016 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications)
  ISO 80369-20: 2015 (Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods)
  USP 40 Purified Water | Performance testing was conducted according to the listed ISO and USP standards. All tested parameters met predefined acceptance criteria. |
  | Material Equivalence | N/A (Comparison to predicate device) | Proposed Device: Polypropylene (barrel, plunger), Pharmaceutical Grade Latex Free Rubber (stopper, protective cap), Purified Water USP (solution).
  Predicate Device: Identical materials.
  The devices have similar technological characteristics and materials. |
  | Sterilization Equivalence | N/A (Comparison to predicate device) | Proposed Device: Sterile (gamma irradiation).
  Predicate Device: Sterile (gamma irradiation).
  Both devices use the same sterilization method. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "test set" in terms of how many syringes were tested for biocompatibility or performance. It only mentions that "Performance testing was conducted on the Prefilled Syringe according to the following standards." The provenance of the data is not specified; however, the manufacturer is based in China, suggesting the testing was likely conducted by or for the manufacturer. No indication of retrospective or prospective study is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a prefilled syringe for foley catheter balloon inflation, not a diagnostic or AI-driven device that requires expert ground truth for interpretation. The "ground truth" here would be the physical properties and functional performance of the device against established engineering and biological standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of medical device testing. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in image analysis or clinical endpoint assessment, which is not relevant to the performance and biocompatibility testing of a prefilled syringe.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study assesses the performance of human readers, often with and without AI assistance, for diagnostic tasks. The Prefilled Syringe is a physical medical device (syringe with purified water) and its performance is evaluated against engineering and biological standards, not by human interpretation or diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical device, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to assess.

7. Type of Ground Truth Used

The ground truth for the Prefilled Syringe is based on:

• Established Industry Standards: Primarily ISO standards (e.g., ISO 7886-1, ISO 11040 series, ISO 80369 series, ISO 10993 series) and USP (United States Pharmacopeia) for purified water. These standards define the acceptable physical, chemical, mechanical, and biological properties and performance requirements for such devices.
• Predicate Device Equivalence: The comparison to the predicate device (K030813) serves as a benchmark, establishing that the proposed device is "as safe and as effective" based on similar technological characteristics and performance.

8. Sample Size for the Training Set

This information is not applicable. As a physical medical device (syringe), it does not involve machine learning or AI, and therefore, there is no "training set."

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.

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