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The EZ-Protect™ Hydrophilic Closed System Intermittent Catheter is intended to drain urine from the bladder.

The EZ-Protect Hydrophilic Closed System Intermittent Catheters and EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits are sterile, closed system, single use, disposable, hydrophilic coated PVC catheter with either a straight or coude tip, self-contained along with a water sachet pouch to activate the hydrophilic coating and a collection bag. The EZ-Protect Hydrophilic Closed System Intermittent Catheters and EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits are used to drain urine from the bladder. The EZ-Protect Hydrophilic Closed System Intermittent Catheters are 16 inches in length and in sizes from 8 Fr. to 18 Fr. The EZ-Protect Hydrophilic Closed System Intermittent Catheters are designed with the collection bag and introducer tip allowing the user to insert the catheter without having to touch the catheter.

The EZ-Protect Hydrophilic Closed System Intermittent Catheter Kit consists of components used to drain urine from the bladder. The EZ-Protect Hydrophilic Closed System Intermittent Catheter Kit contains the sterile EZ-Protect Hydrophilic Closed System Intermittent Catheter (subject of this submission) along with the following Class I, exempt devices: gauze pad, Benzalkonium Chloride (BZK) swab/wipe, gloves, underpad and privacy disposal. The kit components are purchased, off the shelf by the kit packager Hangzhou Jimushi Medical CO., LTD. (Uricare). These components are similar to those provided in predicate device Rusch Hydrophilic Intermittent catheters (K183461) and reference device MTG Instant Cath (K080878).

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2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

The RÜSCH SoftSimplastic balloon catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity in ml and shaft size in French gauge (Fr.), Charrière (Ch.) or millimeters (mm) are indicated on the funnel of each individual catheter. They have a radiopaque contrast stripe along the shaft and are supplied sterile.

The following tip types are available: Couvelaire and Coudé/Mercier. Sizes range from 14 to 24 Ch./Fr. The catheters have a length of approximately 42 cm.

The RÜSCH SoftSimplastic balloon catheters are made of PVC uncoated. These catheters are only for short term usage. Maximum duration of use: Up to 30 days.

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The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for individuals (men, women, pediatrics) who are unable to promote natural urine flow or have a significant volume of residual urine following a natural bladder-voiding episode.

The catheter is inserted into the urethra to reach the bladder, allowing urine to drain and ensuring bladder emptying.

Ready to use Nelaton Catheter is a sterile, single use catheter, intended to be inserted through the urethra to the bladder for intermittent urine drainage. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of adult and pediatric patients (including males and females).

The catheter is made of polyurethane, and is not made with PVC. It is prelubricated with a hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel at the proximal end can be connected to a urine collection container. There is a gripper on the catheters for adult males (length of 40cm), which serves as protection from the user's touch and aids the user during insertion.

The catheter is sealed in a foil pouch with the hydration liquid (distilled water) in one compartment, so the coated catheter is lubricated by direct contact with the hydration liquid and can be ready to use. Ready to use Nelaton Catheter is sterilized by E-beam irradiation, and the shelf life is 3 years.

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This 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.

Note: 8 inch Sleeved IC 3 Pocket consists of a subset of the original population:

8 inch Sleeved IC 3 Pocket
This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

Sleeved IC 3 (not finalized) catheters are E-beam sterilized hydrophilic-coated, single-use catheters. The subject device has two drainage eyelets that are used to manage urinary incontinence.

The device is inserted into the urethra to drain urine from the bladder.

The device is available in 16 inch and 8-inch lengths. The device is available in various Fr sizes ranging from Fr 08 through Fr 16. The catheter is made from Thermo-plastic Elastomer (TPE), (not made with phthalates, not made with PVC). The catheter sleeve is manufactured from Low Density Polyethylene (LDPE). The catheter sleeve allows for the user to grip the catheter anywhere along the length during insertion.

The device is packaged in a foil which was designed to be easy to open and to facilitate access to the catheter. The device is contained in a primary package that consists of both the catheter assembly and the hydration fluid. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid. The device is available with and without the integrated urine collection bag. The device is available in straight and pocket packaging configurations.

The subject device covers several configurations:
• Sleeved IC 3 straight (SWT) is an intermediate catheter in a straight configuration
• Sleeved IC 3 Plus is the same catheter with an attached urine bag
• Sleeved IC 3 Pocket has the catheter coiled up for a smaller footprint
• Sleeved IC 3 Plus Pocket is the same coiled catheter with an attached urine bag

The devices are surface devices with mucosal membrane contact with prolonged contact duration (> 24 hours to 30 days) due to cumulative use. The devices are intended to be used in both professional healthcare facilities and the home environment.

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LoFric Origo is indicated for short- and long-term bladder management with intermittent urinary catheterization.

The subject device: LoFric® Origo™ is a range of sterile, single-use, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheters, designed to accommodate the individual anatomy of male users, are available in various lengths and French sizes, and come in three tip designs: Nelaton (straight tip), Flexible (straight ball-shaped tip), and Tiemann (Coudé tip). Each catheter is individually packaged together with an adjustable insertion grip, or an extendable protective sleeve attached to the catheter along with a sterile water sachet (packet). The adjustable insertion grip or the extendable protective sleeve are provided to minimize touching the catheter shaft directly during insertion and retraction. The water sachet is provided for wetting of the hydrophilic surface and is to be broken immediately before use in order to soak the tubing.

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The Cure Twist® is a pre-lubricated intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Twist® Female Catheter is a ready-to-use intermittent catheter pre-lubricated with a water based gel and includes polished eyelets for smooth insertion and easy drainage. The catheters are manufactured in CH8 to CH16 sizes. They are single use devices made from polyvinyl chloride (PVC) and sterilized by ethylene oxide.

The Cure Medical Catheter Insertion Kits components are used to aid catheter insertion. The Cure Twist® Female Catheter plus insertion kit include the Cure Twist® Female Catheter, ambidextrous gloves (PVC or nitrile), a benzalkonium chloride (BZK) wipe, an under pad and a urine collection bag with a universal connector.

The Cure Twist catheters are expected to be used in professional healthcare facilities, homes, work, public bathrooms, as well as out and about.

The provided document is an FDA 510(k) clearance letter for the Cure Twist Female Catheter. It outlines the device, its indications for use, and a comparison to a predicate device, along with a summary of performance data. However, it does not contain the specifics of a study or acceptance criteria in the format requested, particularly for AI/machine learning device evaluation.

The document indicates that the device is a urological catheter, not an AI/ML device. Therefore, a study proving an AI device meets acceptance criteria, including specifics like sample sizes for test and training sets, expert consensus, MRMC studies, or ground truth establishment, would not be found in this type of clearance letter. The performance data points listed (sterilization, biocompatibility, packaging integrity, etc.) are standard for a physical medical device, not an AI algorithm.

Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the physical and mechanical properties of a catheter, validated through standard engineering and biological testing, not AI model performance.

Explanation of why the requested information cannot be provided from this document:

• Device Type: The Cure Twist Female Catheter is a physical medical device (urological catheter), not an artificial intelligence/machine learning (AI/ML) device.
• Performance Data Scope: The "Performance Data" section lists tests relevant to physical medical devices (e.g., sterilization, biocompatibility, packaging integrity, flow rate, tensile strength). These are not metrics or studies typically associated with evaluating AI/ML algorithms.
• Absence of AI/ML Specifics: There is no mention of deep learning models, algorithms, human readers, ground truth consensus for image or data interpretation, or any other elements that would be present in a study proving an AI device's performance.

If this were an AI device, the 510(k) summary would typically include details about:

• Clinical Performance Study: Often a standalone study or a multi-reader, multi-case (MRMC) study.
• Performance Metrics: Sensitivity, specificity, AUC, F1-score, accuracy, etc.
• Test Set Description: Number of cases, demographics, data provenance, and how ground truth was established.
• Training Set Description: Size and how ground truth was established.
• Human Reader Performance: If AI assistance improves human reader performance (MRMC).

Since the provided document pertains to a traditional physical medical device, those types of studies and acceptance criteria are not applicable or detailed within this clearance letter.

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Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is for male patients only (adults and pediatric above the age of 1 years).

The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.

The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.

The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

The provided FDA 510(k) clearance letter and supporting Traditional 510(k) summary pertain to a urological catheter (Luja Coudé) and its substantial equivalence to a predicate device. This document focuses on the mechanical and material properties of the catheter, not on an AI/software as a medical device (SaMD) or diagnostic imaging device.

Therefore, many of the requested details, such as MRMC comparative effectiveness studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, and complex adjudication methods, are not applicable to this type of medical device submission. These elements are typically required for AI/ML-based diagnostic devices where performance is measured in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) and reader improvement.

The provided information focuses on bench testing (non-clinical performance) to demonstrate the device's physical and biological properties meet established standards and are equivalent to the predicate.

Here's an analysis of the provided text in relation to your questions, highlighting what is available and what is not:

Analysis of Acceptance Criteria and Study Proof for Luja Coudé Catheter

Based on the provided FDA 510(k) clearance letter and Traditional 510(k) summary, the Luja Coudé catheter demonstrates its performance through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies or AI/ML performance evaluations involving human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Biocompatibility and bench performance testing were conducted to verify the proposed subject devices with modified hydrophilic coating met the pre-determined acceptance criteria per specified requirements." It also states, "The subject devices met the pre-determined acceptance criteria after simulated shipping distribution and aging cycle per specified performance requirements."

However, the specific numerical acceptance criteria or the exact reported performance values are not detailed in this public summary. Instead, the summary lists the tests conducted and confirms that the device met the criteria.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical test (e.g., number of catheters tested for friction, kink, etc.). It only states that "Testing was performed on final, finished, and sterilized devices." This is typical for bench testing where the number of units tested is governed by standard protocols (e.g., ISO, ASTM, internal methods) to achieve statistical confidence for manufacturing and design verification, but individual numbers are not usually disclosed in 510(k) summaries unless a specific, novel statistical method for performance testing is employed.
• Data Provenance: The studies are "non-clinical" (bench testing). Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in the context of human subject data. The device is manufactured by Coloplast A/S in Humlebæk, Denmark, and the tests would have been performed in a controlled laboratory environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not Applicable. For this type of device (a physical urological catheter), "ground truth" is established through physical measurements, chemical analysis, and standardized biological assessments in a lab setting, not by human experts interpreting clinical data (like radiologists interpreting images). The "experts" involved would be engineers, material scientists, and microbiologists conducting the tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among human readers/experts in diagnostic studies, typically for AI/ML device validation. This is not relevant for the bench testing of a physical catheter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study is relevant for AI/ML-driven diagnostic devices where the AI assists human readers. This device is a physical medical instrument, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. This question applies to AI algorithms. The Luja Coudé is a physical catheter designed for direct patient use via insertion, not an algorithm.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is based on:
  • Standardized Bench Test Measurements: Objective physical properties (e.g., friction coefficients, kink resistance, dimensions, pH, osmolality) measured against international and proprietary Coloplast standards (ISO 20696, Coloplast TMs).
  • Biocompatibility Testing: Laboratory assays and in-vivo animal models (for systemic toxicity, irritation, sensitization) that demonstrate the material's safety in a biological environment, conforming to ISO 10993 standards.
  • Sterility Assurance Level (SAL): Defined by microbial inactivation standards (SAL 10⁻⁶).

8. The Sample Size for the Training Set

• Not Applicable. The concept of a "training set" is for AI/ML models. This device does not use an AI/ML model. The design and manufacturing process for the catheter would involve extensive development and testing, but not in the sense of an "AI training set."

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no AI training set, there is no ground truth to establish for it. The development of the catheter relies on established engineering principles, material science, and manufacturing quality control.

Summary: The provided document is a 510(k) summary for a physical medical device (catheter) that relies on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence and safety/effectiveness. It does not involve AI/ML technology or human reader studies. Therefore, many of the questions related to AI/ML device validation are not applicable.

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Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.

The subject device is intended used for drainage of the urinary system, sterile and for single use. Duration of use ≤ 24 hours. The subject device is supplied in four forms: Uncoated type, Normal type, Water sachet type, Ready-to-use type. The Disposable Intermittent Catheter is made from the TPU, and the hydrophilic coating (optional). The surface hydrophilic coating is made from polyvinyl pyrrolidone. The free contact sleeve is optional.

The provided FDA 510(k) clearance letter and summary describe a Disposable Intermittent Catheter (TPU Catheter). This document focuses on the substantial equivalence of the new device to a predicate device based on non-clinical performance testing.

It is crucial to understand that this document does not describe a study involving algorithms, human readers, or image analysis. Therefore, many of the requested categories related to AI performance, expert review, and ground truth for such studies are not applicable. The information provided pertains to the physical and material characteristics, sterility, and biocompatibility of a medical device (a catheter).

Here's an analysis of the acceptance criteria and supporting studies as presented in the document, with explanations for the unapplicable sections:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on compliance with various international standards for medical devices, particularly those for urethral catheters, sterilization, packaging, and biocompatibility. The "reported device performance" is the statement that the device met these criteria.

Study Details (Non-AI/Software Device)

Since this is a physical medical device (catheter) and not an AI/software device, most of the requested fields related to AI study design are not applicable.

1. Sample sized used for the test set and the data provenance:

   • Sample Size for Test Set: Not explicitly stated in terms of a "test set" as understood in AI/software evaluation. Each test (e.g., kinking, seal strength, biocompatibility, sterility) would have its own sample size of catheters or materials, but these specific numbers are not provided in the summary.
   • Data Provenance: Not applicable in the context of an AI/software device. The tests are performed on the manufactured catheters themselves.

2. 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. Ground truth, in the context of human expert review for AI, is not relevant here. The "ground truth" for these performance tests is established by adhering to the methodologies and pass/fail criteria defined in the referenced international standards. The evaluation is conducted by qualified laboratory technicians and scientists in accordance with these standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. This concept is for resolving discrepancies in expert opinion for ground truth establishment in studies involving diagnostic/interpretive tasks. This device undergoes standardized physical and biological testing, not interpretive adjudication.

4. 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 an intermittent urinary catheter, not an AI-assisted diagnostic tool. No MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Standardized Test Results / Compliance with ISO/ASTM Standards. For example, "ground truth" for sterility is the absence of microbial growth as determined by ISO 11737-2 methods. For biocompatibility, it's the lack of adverse biological responses per ISO 10993 series. These are objective measurements against defined criteria, not expert consensus on an interpretation.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/software device with a "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. This is not an AI/software device with a "training set."

Summary of the Device and Study from the Document:

The Disposable Intermittent Catheter (TPU Catheter) underwent non-clinical performance testing to demonstrate its safety and effectiveness and substantial equivalence to a legally marketed predicate device (K200134). The studies involved a series of tests to ensure the device complies with relevant international standards for physical characteristics (e.g., kinking resistance, friction), sterilization (radiation processing, sterility assurance, bioburden), packaging integrity, shelf life, and biocompatibility. All tests met their predetermined acceptance criteria, leading to the conclusion that the device is as safe and effective as the predicate. The changes in material (TPU instead of PVC) and sterilization method (radiation instead of ethylene oxide, though both achieve SAL 10-6) were supported by specific testing, especially biocompatibility.

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The Silicone Urethral Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine, or for routine post-operative drainage and bladder irrigation. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old).

The Silicone Urethral Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of shaft, drainage funnel, inflation funnel, irrigation funnel (if present), balloon and valve. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid.

The device is made of silicone and available in different types (e.g., male, female, Tiemann, 2-way, 3-way etc.) and sizes for adult and pediatric use.

The device is for single use and provided with sterile. The indwelling time is no more than 30 days.

This document is a 510(k) clearance letter for a Silicone Urethral Catheter, a physical medical device. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in submissions for AI/ML-enabled medical devices.

Therefore, the provided document does not contain the information requested for an AI/ML-enabled medical device. It thoroughly details the non-clinical performance testing for a traditional, physical medical device, but there is no mention of an algorithm, AI, machine learning, or any form of data-driven performance metrics, ground truth establishment, or human-in-the-loop studies.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a Silicone Urethral Catheter, which is a physical product for urine drainage. The 510(k) summary focuses on its material, dimensions, performance (e.g., flow rate, balloon integrity), biocompatibility, sterilization, and shelf-life. There's no indication of any software, algorithm, or AI component.
• Non-Clinical Testing Only: The "Summary of Non-Clinical Performance Testing" explicitly states the types of bench tests conducted (e.g., Balloon Size and Shaft Size, Flow Rate, Balloon Integrity, etc.) and biocompatibility tests.
• No Clinical/Animal Testing: Section 9, "Clinical Testing and animal testing," explicitly states: "Clinical and animal testing were not performed for Silicone Urethral Catheter as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Silicone Urethral Catheter, did not require clinical and animal studies to support substantial equivalence." This further confirms the absence of any studies involving human data or interpretations by experts for diagnostic purposes that would be relevant to AI/ML.

To answer your specific questions based on the absence of this information in the provided document:

1. Table of acceptance criteria and the reported device performance: Applicable to physical performance characteristics (e.g., flow rate, balloon volume), but not "AI performance" criteria like sensitivity, specificity, AUC.

   • Acceptance Criteria Examples (from document):
     • Meets all requirements of biocompatibility (tested per ISO 10993-1)
     • Meets pre-determined testing and acceptance criteria for bench tests (ASTM F623-19, ISO 20696:2018, FDA guidance 'Conventional Foley Catheters')
     • Sterilized in accordance with ISO 11135:2014
     • Maintains product and package integrity and device sterility throughout shelf-life.
   • Reported Device Performance: The document states that the testing "demonstrated that the Silicone Urethral Catheter meets all the pre-determined testing and acceptance criteria" and that "All evaluation acceptance criteria were met" for biocompatibility. Specific quantitative results are not provided in this summary but would be in the full submission.

2. Sample size used for the test set and the data provenance: Not applicable to an AI test set. This would refer to the number of units tested for physical properties (e.g., how many catheters were tested for flow rate). The document doesn't specify these sample sizes, nor does it mention data provenance as it's not a data-driven device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" as understood in AI/ML (e.g., expert labels for images) was established, as there's no diagnostic or analytical function.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No AI component, no human readers involved in a diagnostic workflow related to the device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to diagnostic ground truth. The "ground truth" for this device would be its physical specifications and performance against established standards (e.g., a catheter's flow rate must meet X ml/min, balloon must hold Y volume without rupture).

8. The sample size for the training set: Not applicable. No AI model to train.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) clearance letter for the Silicone Urethral Catheter pertains to a conventional medical device and does not contain any information related to AI/ML device performance, acceptance criteria, or study methodologies.

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The Cure Catheter Insertion Kit is an intermittent urinary catheter kit indicated for the purpose of bladder drainage for males and females. The urinary catheter kit comes in a variety of configurations and sizes packaged sterile for single-use.

The Cure Catheter Insertion Kits (K1, K2, K2-90, K3), Cure Hydrophilic Catheter Kit (HMxxUK), Cure Pocket Catheter Kit (MxxUK), Cure Catheter Closed System Kit (CSxx)) contain sterile products used during intermittent urinary catheterization. Two types of kit are provided, one where a urinary catheter is included and one without a catheter. The components allow users to select one or more of the products to help prevent contamination of the environment and the user and to maintain a no-touch technique during the insertion of the catheter. Catheters are inserted through the urethra and indicated for the purpose of bladder drainage.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Cure Catheter Insertion Kit" and related products. It outlines the regulatory classification, intended use, and a comparison to a predicate device.

However, it does not contain information about specific acceptance criteria or a study that objectively proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or screening device.

The "Performance Data" section lists various validation tests for general device characteristics, such as:

• Sterilization validation: Conforms to AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008/AMD:2019.
• Biocompatibility testing: Conforms to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1".
• Sterile packaging: Conforms to ISO 11607-1:2019 and ISO 11607-2:2019.
• Real-time aged shelf-life testing: Conforms to ISO 11607-1:2006 with justification to version 2019.
• Packaging integrity testing: Conforms to ASTM F2096-11 (2019).
• Urinary catheter testing: Conforms to ISO 20696:2018.

These are standard engineering and safety tests for medical devices, ensuring they are safe, sterile, and perform their basic mechanical function. They are not clinical performance studies to assess diagnostic accuracy or the direct clinical efficacy of a software-driven device.

Therefore, the specific information requested in the prompt, such as acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity), study design details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), is not available in this 510(k) clearance letter.

This document is for a urological catheter and accessories, which are physical medical devices, not an AI or software-based diagnostic tool. The performance data listed refers to the manufacturing, material, and sterility aspects, which are crucial for this type of device, but do not involve the types of criteria and studies you've asked about for AI/diagnostic devices.

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