(28 days)
The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.
The proposed device, AquaFlate Pre-Filled Sterile Water Syringe 10mL (REF 250-400), is a 10mL syringe prefilled with USP purified water and sterilized via gamma irradiation. The syringe consists of a polypropylene barrel and plunger and latex free rubber for both the plunger gasket and syringe tip cap.
The AquaFlate Pre-Filled Water Syringe 10mL is intended for inflating an indwelling. urethral Foley catheter balloon. In accordance with CDC Guidelines, healthcare facility protocols, and the Foley catheter manufacturer's instructions for use, prior to catheterization, the syringe cap of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded.
The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only.
The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year.
HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.
The provided text describes the 510(k) summary for the AquaFlate Pre-Filled Sterile Water Syringe 10mL. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria for a new and novel AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, specific study design for AI/ML performance, ground truth establishment, expert involvement, and statistical comparisons is not applicable to this type of regulatory submission.
However, I can extract the information relevant to the performance data and equivalence claims made for this product.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of AI/ML performance metrics, the "acceptance criteria" here refer to conformance with established industry standards and regulations for medical devices of this type. The reported device performance is its successful adherence to these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Bench Testing | |
| Small-bore connector testing ISO 80369-7:2016 | Conforms |
| Manual, single-use syringe testing - ISO 7886-1:2017 | Conforms |
| Sterility USP 42 Chapter Sterility Tests | Conforms |
| Biocompatibility Testing | |
| Cytotoxicity ANSI/AAMI/ISO 10993-5:2009 (R) 2014 | Yielded acceptable results |
| Irritation ANSI/AAMI/ISO 10993-10:2013 | Yielded acceptable results |
| Sensitization - ANSI/AAMI/ISO 10993-10:2013 | Yielded acceptable results |
| Sterilization | |
| ANSI/AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013 (Radiation, Part 1) | Validated for gamma irradiation (25kGy min, 40kGy max) to achieve SAL of 10^-6 |
| ANSI/AAMI/ISO 11137-2:2013 (Radiation, Part 2) | Validated |
| ANSI/AAMI/ISO 11137-3:2006 (R) 2010 (Radiation, Part 3) | Validated |
| ANSI/AAMI/ISO 11737-1: 2018 (Microbial Population) | Validated |
| ANSI/AAMI/ISO 11737-2: 2009 (R) 2014 (Sterility Tests) | Validated |
| AAMI TIR 17-2008 (Material Compatibility) | Validated |
| ANSI/AAMI/ISO TIR13004: 2013 (Radiation, Dose Substantiation) | Validated |
| Packaging Validation and Shelf Life | |
| ISTA Procedure 3A (2018) Series (Parcel Delivery) | Underwent testing to support one-year shelf life |
| ASTM D4169-16 (Shipping Containers) | Underwent testing to support one-year shelf life |
| ASTM F1980-16 (Accelerated Aging) | Underwent testing to support one-year shelf life |
| Technological Characteristics Comparison to Predicate Device (AMSure Prefilled Syringe K181814) | Declared "Same" for Intended Use, Technological Characteristics, Materials, Physical Characteristics, Performance Specifications, Quantity, Sterility, Biocompatibility, Principle of Operation, Technical Performance, Utility, Sterility (Method), Environment of Use, Labeling. "Different" for Shelf Life (1 year vs. 3 years). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each of the testing protocols (e.g., how many syringes were tested for sterility, or how many materials were tested for biocompatibility). It broadly states that "performance testing conducted per HR Pharmaceuticals' protocols" and that validation was performed. These are not "test sets" in the AI/ML context, but rather samples used for engineering and quality control validation.
- Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer and third-party labs according to recognized consensus standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a pre-filled sterile water syringe, not an AI/ML diagnostic or therapeutic device. Ground truth, in the AI/ML sense, is not established by human experts for basic device functionality and safety testing like biocompatibility or sterility. Conformance to standards is the "ground truth" here.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not an AI/ML device, there's no diagnostic output requiring adjudication. Test results (e.g., pass/fail for a sterility test) are objective and determined by the methodology of the standard.
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 not an AI/ML device. No human reader studies or comparative effectiveness studies with AI assistance were performed or are relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device. No algorithm-only performance testing was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance, safety, and effectiveness is established by conformance to recognized consensus standards and regulations (e.g., ISO for connectors, USP for sterility, ISO for biocompatibility, ASTM/ISTA for packaging). These standards define acceptable limits and methodologies.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.