(262 days)
The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
The Intermittent Catheter (final name to be determined) is a hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinent Catheter is inserted into the urethra to drain urine from the bladder. The Intermittent Catheter is available in 7 in. and 16 in. lengths. The 7 in. catheter is available in sizes 8, 10, 12, 14 Fr and the 16 in. catheter is available in sizes 8, 10, 12, 14, 16 Fr. The Intermittent Catheter is provided sterile, using e-beam Irradiation sterilization. The device is made from Thermo-plastic Elastomer (TPE), and is phthalate free, PVC free. This directly hydrated catheter is packaged in a peel-able 4 sided pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid in one compartment. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid There is a gripper on the 16 inch catheter to aid with the insertion process, if desired.
Based on the provided text, the device in question is an Intermittent Catheter, and the submission is a 510(k) Pre-market Notification seeking substantial equivalence to a predicate device. The document does not describe an AI/ML-based medical device. Therefore, many of the requested elements pertaining to AI/ML device testing (e.g., training set, test set, ground truth establishment for AI, MRMC studies, standalone algorithm performance, number of experts for AI ground truth, adjudication methods) are not applicable to this submission.
The document primarily focuses on demonstrating substantial equivalence through non-clinical testing of physical performance, biocompatibility, sterilization, and packaging integrity, comparing the new device to its predicate.
Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present for this type of device submission.
Acceptance Criteria and Device Performance for an Intermittent Catheter
1. A table of acceptance criteria and the reported device performance
The document states: "The physical performance properties of the Intermittent Catheter met all applicable requirements of BS EN ISO 20696:2018, Sterile urethral catheters for single use." and "Biocompatibility testing met the requirements of the following standards..." and "Sterilization met all requirements of the following FDA-recognized standards:".
Since this is a substantial equivalence submission for a traditional medical device (not AI/ML), the "acceptance criteria" are compliance with established performance and safety standards, and the "reported device performance" is that it "met all applicable requirements" or "met all requirements." Specific numerical accept/fail criteria or performance metrics are not explicitly tabulated in the summary provided.
| Acceptance Criteria Category | Applicable Standard(s) / Requirement | Reported Device Performance |
|---|---|---|
| Physical Performance | BS EN ISO 20696:2018 (Sterile urethral catheters for single use) | Met all applicable requirements |
| Biocompatibility | ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2021, ISO 10993-17:2002, ISO 10993-18:2020 | Met the requirements of the listed standards. Biological endpoints addressed: cytotoxicity, intracutaneous irritation, vaginal irritation, sensitization, acute systemic toxicity, and subacute systemic toxicity. |
| Sterilization | ISO 11137-1:2006, ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2018, ANSI/AAMI/ISO 11737-2:2019 | Met all requirements of the listed FDA-recognized standards. |
| Packaging Integrity | Not explicitly listed, but implied by "Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life." | Tested and verified maintenance of sterile barrier through shelf life. |
| Transportation Testing | Not explicitly listed, but implied by "Transportation testing was conducted in order to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment." | Tested and verified no impact to device safety or efficacy due to transportation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly provided. The text mentions "Testing was conducted to support size designation..." but does not give the number of catheters or samples tested for each criteria (e.g., "size designation," "lubricity," "security of fit," "flow rate," "kink stability," "tensile force").
- Data Provenance: Not specified. Standard medical device testing for regulatory clearance is generally conducted under controlled laboratory conditions, not typically involving patient data in the same way as AI/ML or clinical trials. It's safe to assume the testing facilities are in the country of the applicant (USA) or a compliant jurisdiction, but this is not stated. The data would be prospective in the sense that the tests were conducted specifically for this submission.
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. This is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image/data interpretation. Testing involves physical and biological assays against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not an AI/ML diagnostic study involving human interpretation and adjudication. Testing involves objective measurements and adherence to specified performance limits within standards.
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, and no MRMC study was conducted or required. The "effectiveness" is demonstrated by meeting performance standards and equivalence to the predicate device.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the AI/ML sense. The "ground truth" for this device's testing is adherence to the specified requirements in the referenced international and FDA-recognized standards (e.g., BS EN ISO 20696:2018 for physical properties, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization). For example, "ground truth" for lubricity would be a quantitative measurement meeting a predefined specification within the standard.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical medical device, not an AI/ML model.
§ 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.