Search Results

The BiFlex Evo is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The Bi-Flex Evo Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes,10/12 and 12/14 FR, and two lengths, 35 and 45 cm.

This document is a 510(k) summary for a medical device called "Bi-Flex Evo," a ureteral access sheath. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Analysis of the provided text reveals that this document focuses on a physical medical device (a urological catheter/sheath) and its mechanical performance, biocompatibility, and sterilization, rather than an AI-powered diagnostic or imaging device.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML-based medical device (such as sample size for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The document discusses "bench testing" to demonstrate mechanical strength and "biocompatibility" testing, which are standard for physical medical devices.

Here's the relevant information that can be extracted from the document, along with explanations for why other requested information is not present:

1. A table of acceptance criteria and the reported device performance

The document states: "All bench testing results confirmed that the products described in this submission met the necessary specification." However, it does not explicitly list the quantitative acceptance criteria for these tests (e.g., specific tensile strength values, burst pressures, etc.) nor the exact numerically reported performance results. It only provides a qualitative statement of meeting specifications.

Table of Acceptance Criteria and Reported Device Performance (as inferred):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This pertains to a physical device, not an AI model. "Test set" in this context would refer to the number of physical units tested. The document does not specify the number of devices used for bench testing, biocompatibility, or sterilization validation. Data provenance (country, retrospective/prospective) is not relevant for this type of device testing as it's not based on patient data.

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. Ground truth in the context of AI/ML refers to labels for data. For a physical device, performance is evaluated against engineering specifications and international standards, not expert consensus on data interpretation.

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

• Not Applicable. This refers to methods for establishing ground truth for data labeling, which is not relevant for a physical medical device's performance testing.

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. MRMC studies are used to evaluate diagnostic imaging systems, often in conjunction with AI. This is a physical device (ureteral access sheath), not an imaging system or AI diagnostic tool.

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

• Not Applicable. This refers to AI algorithm performance. This device is a physical instrument.

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

• The "ground truth" for a physical device like this is its adherence to engineering specifications, material properties, and performance standards (e.g., mechanical strength, biocompatibility, sterility) as defined by established industry and regulatory guidelines (e.g., ISO, FDA guidance documents). There is no "expert consensus" on imaging or clinical outcomes data for its function.

8. The sample size for the training set

• Not Applicable. This refers to AI model training data.

9. How the ground truth for the training set was established

• Not Applicable. This refers to AI model training data ground truth.

Summary of Device Performance/Compliance (as per 510(k) Summary):

The manufacturer conducted bench testing to demonstrate that the Bi-Flex Evo Ureteral Access Sheath:

• Provides adequate mechanical strength for its intended use.
• Meets necessary specifications for performance.
• Is biocompatible in accordance with ISO 10993.
• Has validated sterilization processes in accordance with recognized industry standards.
• The material change in the dilator (LDPE to Polyurethane) provides increased flexibility for safer introduction and does not affect the intended use or fundamental scientific technology.
• The addition of printed marks aids in visualization of penetration depth for safer insertion.

The conclusion is that the Bi-Flex Evo is substantially equivalent to its predicate device (Bi-Flex Ureteral Access Sheath K140441) and is safe and effective for its intended use.

Ask a specific question about this device

The Roca.IJ Soft Stents are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic techniques.

The stents are not intended as a permanent indwelling devices, it is recommended that:

• The indwelling time not exceed 6 days when the device is used with the removal string;

• The indwelling time not exceed 365 days when the device is used without the removal string.

The RocaJJ Soft Stents system is a set consisting of a tubular double pigtail stent made up of flexible radiopaque polyurethane, with a polypropylene-monofilament suture loop in order to facilitate the extraction of the ureteral stent.

The devices may include a pusher with a radiopaque tip, and a guidewire. Otherwise, these sets may include only a pusher.

The RocaJJ Soft Stents are from 4.8 to 8.0 Fr in diameter and from 24 to 30 cm in specified length.

This document is a 510(k) Summary for the RocaJJ Soft Stents. It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices based on various bench tests.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for each bench test. The data provenance is described as "bench testing conducted by Promepla SAM," indicating in-house testing. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as these are bench tests, not clinical studies involving patients.

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):

This information is not applicable to this submission. The "ground truth" for the acceptance criteria listed is based on engineering specifications and recognized industry standards (e.g., ISO 10993 for biocompatibility), not expert interpretation of medical data. Therefore, there were no medical experts establishing ground truth for these bench tests.

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

This information is not applicable. Adjudication methods are typically relevant for clinical studies where there's a need to resolve discrepancies in expert interpretation of medical images or patient outcomes. For bench testing, individual tests are performed to specified criteria, and the results either pass or fail.

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:

This information is not applicable. The RocaJJ Soft Stents are a medical device (ureteral stent), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This information is not applicable. This is not an AI algorithm; it's a physical medical device.

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

The "ground truth" for the performance of the RocaJJ Soft Stents is based on:

• Engineering specifications and design requirements: These define what the stent is supposed to do (e.g., withstand certain forces, drain effectively).
• Recognized industry standards: Such as ISO 10993 for biocompatibility.
• Comparison to predicate devices: Demonstration of similar performance characteristics to legally marketed devices.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.

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

This information is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device

The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

The ENDOFLOW® II System includes the electro medical device and a full range of disposables dedicated to perform endoscopic procedures for Endo-urology, Hysteroscopy and Laparoscopy surgerv. The ENDOFLOW® II System is a complete fluid management system permitting, all-in-one, the control of the Irrigation, the temperature of the fluid and the suction. The ENDOFLOW® II permits a continuous and non-pulsating liquid flow to inflate and clean the surgical field and to improve the surgeon's visibility. With the ENDOFLOW® II system, the indicated pressure on the machine is identical to the pressure in the cavity. The ENDOFLOW® II heats and maintains the fluid bag at 38°C during the entire procedure. The user can disable this function. The ENDOFLOW® II, in its double chamber version, MEN02PUS, offers an aspiration system that can be activated with the touch screen and/or a footswitch.

The provided text is a 510(k) summary for the device ENDOFLOW II – Irrigation, Warming and Suction System. It outlines the device's intended use and compares its technological characteristics and functions to predicate devices to establish substantial equivalence.

However, the document does not contain specific details about acceptance criteria, reported device performance figures, sample sizes, data provenance, expert qualifications, ground truth establishment methods, or the results of any multi-reader multi-case (MRMC) or standalone comparative effectiveness studies.

The "H. Performance Data" section merely states: "Performance testing have been executed to validate the performance and safety of the devices. Verification and validation activities were conducted to establish the performance and safety characteristics of the ENDOFLOW® II. The results of these activities demonstrate that the ENDOFLOW® II is safe and effective when used in accordance with its intended use and labeling." This is a general statement and does not provide the requested detailed information about the study or its outcomes.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, and data provenance based on the provided text. The document confirms that performance testing was performed and that the device was found safe and effective, but it doesn't offer the detailed evidence of that testing.

Ask a specific question about this device

The Bi-Flex Ureteral Access Sheath is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The Bi-Flex Ureteral Access Sheath is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopaque and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR, and two lengths, 35 and 45 cm.

The provided document is a 510(k) summary for the Bi-Flex Ureteral Access Sheath. It describes the device, its intended use, and its technological characteristics compared to a predicate device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria.

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, detailed study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies for new, non-substantially equivalent devices or AI/software as a medical device (SaMD) clearances.

This 510(k) submission primarily relies on physical and functional testing to support the claim of substantial equivalence.

Here's what can be extracted based on the provided text, while also noting what is not present:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics with defined thresholds. The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating that the device is as safe and effective as the predicate device by meeting similar design and material specifications and passing standard physical and functional tests.
• Reported Device Performance:
  • "Results of physical and functional testing support a determination of substantial equivalents for the Bi-Flex Ureteral Access Sheath when compared to the predicate device." This is a high-level statement that general performance was found to be acceptable relative to the predicate. No specific numerical performance values are given.
  • The document lists various technological characteristics of the proposed device, which can be interpreted as design specifications that the device met to be considered substantially equivalent to the predicate. These are listed in "Table 1: Proposed Device" column. The implicit "acceptance criterion" for each of these is that it matches or is comparable to the predicate device's characteristic.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not specified. The document mentions "physical and functional testing" but does not detail the specific tests, sample sizes, or where these tests were conducted.

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/Not specified. This is not an AI/SaMD device where expert-established ground truth is typically required for a test set.

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

• Not applicable/Not specified.

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. This is not an AI/SaMD device for which an MRMC study would be conducted.

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

• No. This is a hardware medical device, not an algorithm.

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

• Not applicable in the usual sense for clinical performance. The "ground truth" for this device's performance would be engineering specifications and standards for material properties, mechanical integrity, and biocompatibility, as confirmed through physical and functional testing.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable. This device does not involve a training set.

Summary of Study:

The study involved physical and functional testing of the Bi-Flex Ureteral Access Sheath. The details of these tests, including specific methodologies and quantitative results, are not provided in this 510(k) summary. The purpose of this testing was to demonstrate that the new device is substantially equivalent to the predicate device (ROCAMED RocaUS Platinum, K120160) by comparing their intended use, technology, principles of operation, and materials. The FDA's clearance of K140441 indicates that based on the submitted data, the agency agreed with the claim of substantial equivalence.

Ask a specific question about this device

The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.

The provided documentation is a 510(k) summary for the ROCAMED RocaUS Platinum, a ureteral access sheath. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the same way a new AI/ML-driven diagnostic device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not present in this document because it is not a clinical study report for a diagnostic or treatment outcome device. The "performance data" referred to in this document relates to physical and functional testing, not clinical performance measures like accuracy or sensitivity.

Here's an attempt to fill in the table and address the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a medical device (ureteral access sheath) demonstrating substantial equivalence, the "acceptance criteria" are primarily met through comparison to predicate devices across technological characteristics and intended use, supported by physical and functional testing. There are no explicit performance metrics like sensitivity, specificity, or accuracy derived from a clinical study with a test set that would have numerical acceptance criteria.

• 2 lumens
• Dilator Material: LDPE+BaSO4
• Sheath Material: Pebax-SST-PTFE
• Fr Size: 10/12, 12/14
• Length: 35 cm
• Guidewire compatibility: 0.032", 0.035" |
  | Safety | Implied by substantial equivalence to legally marketed predicate devices and successful physical/functional testing. Changes in dilator material (LDPE instead of PTFE) stated to "ease insertion into the patient and reduce trauma." |
  | Performance (Functional) | Results of physical and functional testing support substantial equivalence. (Specific reported performance values for these tests are not detailed in this summary). |
  | Materials | Materials chosen are considered substantially equivalent or improved (e.g., LDPE for dilator) compared to predicate devices, based on physical and functional testing. |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. This document refers to physical and functional testing, not a clinical test set of patient data. The specifics of samples used for these engineering tests (e.g., number of devices tested for tensile strength or burst pressure) are not provided in this summary.
• Data Provenance: Not applicable for clinical test data. The physical and functional testing would have been conducted by Promepla SAM.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., pathology, expert consensus on images) is not relevant for this type of medical device submission, which relies on physical and mechanical properties and comparison to predicates.

4. Adjudication method 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. This device is not an AI-assisted diagnostic tool and therefore did not undergo an MRMC study related to AI assistance.

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

Not applicable. This device is not an algorithm.

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

Not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance would be against engineering specifications and predicate device characteristics, verified through physical and functional testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm.

Ask a specific question about this device