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510(k) Data Aggregation
(83 days)
The PerfIC Cath™ is intended for use in adult male patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
The PerfIC Cath™ is a single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in length, with two (2) oval eyelet holes for intra-bladder urine drainage at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. The product will be available in a straight and Coude tip configuration (also termed a Tiemann tip). Additionally, the PerfiC Cath™ will be offered with either aqueous gel lubricant or hydrophilic coating. The distal end of the catheter is connected to a PVC urine collection bag. The product is available in a 14French only.
This document is a 510(k) premarket notification for the Adapta Medical PerfIC Cath™, a urological catheter. It asserts substantial equivalence to a predicate device. The information provided does not include the type of study typically associated with AI/ML device performance (e.g., diagnostic accuracy, sensitivity, specificity, clinical outcome studies). Instead, the performance data focuses on engineering and material characteristics.
Here’s an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Device Attribute | Acceptance Criteria (Predicate PerfIC Cath™) | Reported Device Performance (Modified PerfIC Cath™) |
|---|---|---|
| Intended Use | Intended for bladder drainage in adult male and adult female patients. | Identical |
| Packaging | Pouched kit containing catheter assembly, gauze sponge, gloves, BD wipe, hook. | Pouched kit containing catheter assembly, benzalkonium disinfectant wipe, and plastic hook; thumb holes to facilitate opening by limited dexterity patients. (Substantially Equivalent, some components like gauze and gloves not explicitly mentioned for the new device as being present, but the overall kit concept is similar). |
| Labeling | Adhesive-backed label with preprinted information applied to sterilization pouch; Instructions for Use (IFU) supplied separately. | Identical |
| Protective Cap and Lubricating Tip Assembly | Protective rigid cap with thumb loop over one-piece molded silicone-like lubricant reservoir which retains catheter tip. | Identical |
| Catheter Body | Straight 14 Fr medium soft catheter tube with rounded, sealed proximal tip with two offset inlet holes; nominally 40 cm length. | Straight and Coude (curved tip) 14 Fr, medium soft catheter tube with rounded, sealed proximal (patient contact) tip with two (2) offset inlet holes on opposite sides of the catheter; catheter length nominally 45 cm. (Substantially Equivalent; Coude tip is new and compared to a different predicate (Bever Medical Tiemann Tip K111405)). |
| Protective Outer Sheath | Polypropylene with 4% silicone, 0.004" thick; sufficient length to seal. | Low density polyethylene, 0.002" thick; sufficient length to seal. (Substantially Equivalent, material and thickness differ but function is similar). |
| Urine Collection Bag | 900-ml volume, flat 11 cm x 41 cm, pre-attached. | 1000-ml volume, flat 11 cm x 43 cm, pre-attached. (Substantially Equivalent, slight volume and dimension difference). |
| Sterility | Entire package sterilized via electron beam irradiation to SAL 10-6. | Entire package sterilized via ebeam irradiation to Sterility Assurance Level of 10-6. (Identical) |
| Biocompatibility | Patient contact materials tested according to ISO 10993-1:2009 for Cytotoxicity, Dermal Sensitization, and Irritation (vaginal). | Patient contact materials tested according to ISO 10993-1:2009, including: Cytotoxicity, Dermal Sensitization, and Irritation (vaginal). (Substantially Equivalent) |
| Lubricant | Aqueous lubricant gel | Aqueous lubricant gel or hydrophilic coating-with-water sachet. (Substantially Equivalent, hydrophilic coating is new). |
| Catheter Advancement Force | Force to advance catheter through lubricant reservoir ≤ 1.5 newtons (0.33 pounds). | Force to advance catheter through lubricant reservoir ≤ 1.5 newtons (0.33 pounds). (Identical) |
| Bond Tensile Strength | Sheath to lubricant reservoir & sheath to collection bag inlet bond strength ≥ 2.2 newtons (0.5 pounds). | Identical |
| Overall Catheter Tensile Strength | Separation/Disassembly tensile strength of flexible reservoir component ≥ 15 newtons (3.37 pounds). | Identical |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Design verification and validation testing of the new versions of the intermittent catheter" involving tests for Mechanical Integrity, Advancement Force, and Biocompatibility. However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). The study appears to be an engineering/laboratory-based testing rather than a clinical study with patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The "ground truth" here would relate to the performance of the catheter against engineering specifications, not clinical diagnoses.
4. Adjudication Method for the Test Set:
This information is not provided and is not typically applicable to the type of engineering verification testing described.
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:
No, an MRMC comparative effectiveness study was not done. This device is a urological catheter, not an AI/ML-driven diagnostic or assistive device that would involve human "readers" or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This is a medical device (catheter), not an algorithm or software-only device.
7. The Type of Ground Truth Used:
The "ground truth" or reference standard used here is the established engineering specifications and performance characteristics of the predicate device and relevant international standards (e.g., ISO 10993-1:2009 for biocompatibility). For example, the advancement force acceptance criteria sets the "ground truth" for that specific performance metric.
8. The Sample Size for the Training Set:
This information is not applicable as this is not an AI/ML device that requires a training set. The "training set" would implicitly be relevant prior versions of the device and general engineering knowledge applied to the design.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as point 8. The "ground truth" for the predicate device's performance was established through its initial design verification and validation testing.
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