(253 days)
The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction or urethral obstruction or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.
The Applied Medical Technology, Inc. (AMT) Low-Profile Suprapubic Catheter & Drainage Set (LPSPC) consists of two primary assemblies. The LPSPC is identical in materials and manufacturing processes to the Low-Profile Balloon Feeding Device cleared in K161413 for a different indication.
The Suprapubic Catheter is used to provide urinary diversion and drainage through the lower abdomen, placed and maintained in a percutaneously prepared cystostomy opening. The Drainage Set is intended to allow a connection between the suprapubic catheter device and a urinary collection bag system. The device is designed for bladder drainage by way of a secured (initial placement) or formed (replacement) cystostomy tract and may be used for irrigation. Patients may include: any user with urethral trauma, those who require long-term catheterization and urethral catheterization is intolerable, or those with a spinal cord injury and an inability to self-catheterize who may find the suprapubic method simpler to manage.
The LPSPC is a urinary drainage device made principally of silicone elastomer. The device consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlocking irrigation port, and safety plug. The catheter is inserted through the stoma and into the urinary bladder and is secured by the internal retention balloon. The device is offered in various sizes to accommodate different stoma diameters and lengths. On the shaft near the end is located a balloon which, when properly inflated, acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device.
The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set.
The Drainage Set is identical in material and manufacturing process to certain configurations of the Irrigation Set included with the AMT Bowel Management Device previously cleared in K180026. The right-angle connector of the Drainage Set is compatible with the interlock on the LPSPC and is used to direct fluids drained from the bladder, through the catheter, and into a separate urinary collection bag.
The AMT Low-Profile Suprapubic Catheter & Drainage Set may optionally be marketed with a Foley Insertion Tray accessory. If included, the accessory would be a legally marketed Foley Insertion Tray, such as:
- AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664)
- Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt)
- Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, 510(k) exempt)
The device is sold as sterile and can be initially placed in an outpatient-setting by a health care professional. The device may be replaced in an outpatient-setting or home setting by a health care professional or care giver.
The provided text describes a 510(k) premarket notification for the "AMT Low-Profile Suprapubic Catheter & Drainage Set." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics in the format requested.
Therefore, much of the requested information cannot be extracted directly from this document. The document primarily describes the types of testing performed and concludes that the device met acceptance criteria, but generally does not specify these criteria or report quantitative performance results against them.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states that the device "met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate/reference devices." However, specific numerical acceptance criteria and precise performance data are not detailed in this summary. The performance is generally stated as meeting standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met acceptance criteria for permanent contact (>30 days) with mucosal membrane and breached/compromised surfaces, based on ISO 10993 standards. |
| Sterilization | Achieved a Sterility Assurance Level (SAL) of 10-6. Complies with ISO 11135 and ISO 10993-7. |
| Shelf Life | Packaging complies with ASTM F1980-21, ISO 11607-1 & 2, and ISTA 3A 2018. |
| Bench Testing (General) | Met or exceeded all predetermined specifications for performance principles. |
| Bench Testing (Specific Examples - criteria not detailed, assumed to be 'met') | Balloon Assembly Bond Peel/Tear Strength, Balloon Burst, Fill Valve Blow Out, Fill Valve Pullout, Flow Rate, Leak Test, Tubing Tensile Strength, Minimum Overmold Bond Strength, Stoma Pullout, Tubing Cyclic and Tensile Test, Main Strap Tensile Strength, Side Strap Tensile Strength. |
| MR Compatibility | Complies with ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), ASTM F2119-07 (Reapproved 2013) (MR image artifacts), ASTM F2182-19e2 (radio frequency induced heating). |
| Enteral Feeding Systems Design & Testing | Complies with ISO 20695 First edition 2020-03. |
| Enteral Feeding Devices with Retention Balloon | Complies with ASTM F2528-06 (Reapproved 2023). |
| Small-bore Connectors | Complies with ISO 80369-1 Second edition 2018-11. |
| Clinical Performance (based on literature review) | Determined to function clinically as intended and benefits outweigh risks in the target user population. Risks (hematuria, wound infection, UTI, leakage, poor fit, discomfort, bladder spasms) are similar to those seen with this device type. |
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:
- Bench Testing: Not specified. The document lists the types of tests but not numbers of samples.
- Clinical Performance (Literature Review): Clinical experience was reported on 34 adults and 188 pediatric patients across 22 published articles.
- Data Provenance: The clinical data is from a systematic literature review (retrospective). The countries of origin are not specified, only that the literature from "independent organizations" was reviewed.
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 was a systematic literature review, not a study where experts established ground truth for newly collected patient data. The "ground truth" for the clinical performance was derived from the findings reported in the published literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The clinical evidence was gathered through a systematic literature review. The "reporting of this systematic review was guided by the standards of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement, as well as the Cochrane Handbook for Systematic Reviews of Interventions. Assessment of the included literature was completed using the critical appraisal tools published by the Joanna Brigges Institute." This describes the methodology for reviewing existing literature, not an adjudication process for a new test set.
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 device is a suprapubic catheter, not an AI-assisted diagnostic or therapeutic device. The submission does not mention any AI components or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical performance aspects, the "ground truth" was derived from "clinical experience... reported on 34 adults and 188 pediatric patients" across published literature, guidelines from organizations like the Pediatric Urologists of Canada and the Canadian Urological Association, operative textbooks, and information from the International Continence Society (ICS). This can be broadly categorized as published clinical outcomes data and expert-derived guidelines/clinical experience.
8. The sample size for the training set
Not applicable. This is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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.