Search Results

The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

The Hemoflow F3 and F4 dialyzers are low-flux, single-use, ethylene oxide (EO) sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The membrane surface areas of the F3 and the F4 dialyzers are 0.3 m2 and 0.7 m2, respectively.

The Hemoflow F3 and F4 dialyzers are low-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain a semi-permeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The provided text is related to a 510(k) premarket notification for Hemoflow F3 and F4 Dialyzers, not a study describing acceptance criteria and device performance in the context of AI or software. Therefore, much of the requested information (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or present in this document.

However, I can extract the relevant performance data and highlight the acceptance criteria as stated for the dialyzers themselves and the summary of compliance.

Here's an attempt to structure the available information, noting where information is not present as per your request related to an "AI device":

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

For medical devices like dialyzers, performance is typically demonstrated through various tests meeting established standards. While specific numerical acceptance criteria (e.e.g. "urea clearance must be >X") are not explicitly listed in easily interpretable tables for each test, the text states the ultimate acceptance: "All testing met predetermined acceptance criteria." and "Results of the proposed devices' design verification tests met the requirements and demonstrated that, like the predicate device, the Hemoflow F3 and F4 dialyzers are safe and effective for their intended use."

The key performance characteristic highlighted and its reported value are:

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 mentions "A retrospective data analysis performed on the Hemoflow F3 and F4 dialyzers included 10 pediatric ESRD patients on HD treated for 12 consecutive weeks." This appears to be a clinical "test set" for the clinical effectiveness aspect (adequate clearance), not for the engineering performance tests.

• Sample Size (Clinical): 10 pediatric ESRD patients
• Data Provenance (Clinical): Retrospective. Country of origin not specified.

For the engineering performance tests listed in Table 2, the sample size of dialyzers tested is not explicitly stated.

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 document describes a medical device (dialyzers), not an AI device that relies on expert human interpretation for ground truth.

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

Not applicable. This document describes a medical device, not a diagnostic or AI system requiring adjudication of expert interpretations.

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 document is for a medical device (dialyzers), not an AI-assisted diagnostic tool.

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

Not applicable. This document is for a medical device (dialyzers), not an AI algorithm.

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

For the clinical study mentioned: "adequate clearance" with a mean spKt/V of 1.78 (F3) and 2.18 (F4) served as the "ground truth" or outcome measure for the clinical effectiveness aspect. This is outcomes data (clinical efficacy in terms of clearance).
For the engineering performance tests, the "ground truth" is typically established by physical measurements and adherence to established engineering standards (e.g., ISO 8637:2010) and regulatory guidance.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI device.

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

Not applicable. There is no mention of a training set as this is not an AI device.

Ask a specific question about this device

Hemodialysis with a PUREFLUXTM-L hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only.

This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The PUREFLUXTM-L hemodialyzer is a medical device used as an artificial kidney system for the treatment of patients with renal failure. During treatment. blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The PUREFLUXTM-L hemodialyzer is composed of polyethersulfone fiber and is available in various sizes, which are differentiated by membrane surface area.

The provided document is a 510(k) summary for the Nipro PUREFLUX™-L Hemodialyzer. It details the device's description, intended use, and a comparison to predicate devices, but it does not contain the information requested in points 1-9 regarding specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study that would typically be associated with AI or diagnostic imaging devices.

The document discusses non-clinical studies for "analyte clearance (urea, creatinine, phosphate, Vitamin B12), ultrafiltration coefficient and pressure drop" to establish substantial equivalence to predicate devices (K062079 Baxter Xenium Hemodialyzer, K926005 Fresenius Hemoflow, K043244 Fresenius Optiflux). However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size or ground truth establishment for a training set.

This type of information is generally not relevant for 510(k) submissions of hemodialyzers, which rely on demonstrating substantial equivalence in physical and performance characteristics (like clearance rates and ultrafiltration) to already approved predicate devices, rather than the types of clinical performance evaluations and AI model validation studies relevant to the provided questions.

Ask a specific question about this device

The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.

The Gambro Polyflux family Capillary Dialyzers/Filters, labeled for single and multiple use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States. These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Polyamide. Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

This device is a hemodialyzer, not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for this type of medical device which relies on physical and clinical performance rather than a data-driven model.

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

Not applicable. Ground truth for a hemodialyzer's performance is established through in-vitro and clinical testing (e.g., clearance rates, ultrafiltration rates, safety), not expert consensus on interpretations of data.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, this is not an AI/ML device that requires human readers for interpretation.

6. Standalone Performance Study

Yes, the device underwent "in vitro testing... to compare the performance of the proposed device configurations to the predicate configurations." This represents a standalone study of the device's technical specifications and performance characteristics.

7. Type of Ground Truth Used

The ground truth for the device's performance is established through:

• In-vitro testing: Measuring direct physical and chemical performance characteristics of the dialyzer (e.g., membrane permeability, solute clearance).
• Clinical studies: Observing the device's effectiveness and safety in real-world patient use. The comparison is against the performance of legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device that uses a training set.

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

Not applicable.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The IDEMSA Hemophan Hollow Fiber Dialyzers are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statement is essentially the same as the indication statement of the predicate devices.

The IDEMSA Hemophan Dialyzer has been designed for use in hemodialysis and associated forms of treatment for chronic or acute kidney failure.

The IDEMSA Hemophan Dialyzers are a family of hollow fiber dialyzers that provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Hemophan which is substantially equivalent to the Hemophan membranes utilized in the Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers (cleared for marketing in the United States under 510(k) # K982337). The Hemophan membranes utilized in both IDEMSA Hemophan dialyzers and Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers are manufactured by Membrana GmbH (formerly Akzo (Enka AG)) of Germany. Hemophan® is a modified cellulose membrane that was developed by ENKA to improve the blood compatibility of the regenerated cellulose membrane Cuprophan®. Cuprophan® membranes utilized in both Cobe CentrySystem 160E dialyzers and Baxter CF25 are also manufactured by the former Akzo (Enka AG). The Terumo Clirans T175 series dialyzers also use a cellulose membrane.

Blood enters a blood inlet port where it is distributed to the Hemophan membrane. The fibers used in the proposed device are substantially equivalent in design to the previously cleared Haidylena and Cobe CentrySystem dialyzers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The wall thickness of the Hemophan and Cuprophan fibers in the Haidylena, Cobe CentrySystem 160E, Baxter CF25, and the proposed device is 8 microns. The inner diameter of Hemophan and Cuprophan in the Haidylena, Baxter CF25 dialyzer and the proposed device is 200 microns.

Blood is pumped via a roller purno from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers where water waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.

This 510(k) summary describes a conventional dialyzer, a device that performs a physical function (filtration) rather than an AI/ML-driven diagnostic or therapeutic function. Therefore, many of the requested fields related to AI/ML device performance, such as sensitivity, specificity, MRMC studies, and ground truth establishment for a training set, are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IDEMSA Hemophan Dialyzers are based on demonstrating substantial equivalence to predicate devices (Haidylena Cuprophan and Hemophan Hollow Fiber, Cobe CentrySystem 160E, Baxter CF25, and Terumo Clirans T175 dialyzers) in terms of construction, design, intended use, and function. Specific performance parameters were evaluated in vitro.

Note on Technological Equivalence: The document emphasizes that the Hemophan membrane in the proposed device is the same as in the Haidylena predicate, and manufactured by the same entity. Other predicates use Cuprophan or other cellulose membranes, which are described as being functionally similar or having slightly different properties (e.g., Hemophan developed to improve blood compatibility of Cuprophan).

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 explicitly state a "test set" sample size in the context of typical AI/ML validation. The in-vitro performance testing was conducted on samples of the proposed device. The number of units tested for each in-vitro parameter (ultrafiltration coefficient, pressure drop, clearance rates) is not specified.

Data provenance is not explicitly stated beyond "In vitro testing was performed on the proposed device." This suggests the testing was conducted prospectively on newly manufactured devices. The manufacturer is based in Segovia, Spain.

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 for this type of device. "Ground truth" in this context refers to established engineering and physiological performance standards rather than expert consensus on medical images or patient outcomes. The substantial equivalence argument relies on comparing the device's measured physical and performance characteristics against those of legally marketed predicate devices, which are already accepted as safe and effective.

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

Not applicable. The performance metrics are objectively measured physical properties and clearance rates against established benchmarks or predicate device specifications, not subjective assessments requiring adjudication.

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 diagnostic or assistive device. It is a conventional medical device whose function does not involve human "readers" or "AI assistance."

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

Not applicable. This is not an algorithm-only device. It is a physical medical device. The "performance" described is the device's physical function.

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

The "ground truth" for this device's performance is based on established engineering specifications, material properties, and the known performance characteristics of legally marketed predicate devices. For clearance parameters, these are objective measurements (e.g., amount of urea removed per unit time) against expected or benchmark values for effective dialysis.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable.

Ask a specific question about this device

Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The A-15 Hemodialyzer is a conventional hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. Each A-15 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box. It is sterilized by gamma radiation and intended, and labeled, for single use only.

The provided text is a 510(k) summary for the Althin Medical AB A-15 Hemodialyzer, which is a medical device. This document does not describe a study involving performance metrics like accuracy, sensitivity, or specificity, which are typically associated with AI/ML model evaluations. Instead, it describes a
The acceptance criteria are that the device perform equivalently to the predicate device. The study performed that demonstrates that the A-15 Hemodialyzer meets this criteria is functional testing. The functional testing was based on the specifications of the predicate device, the Altra Nova 140 Hemodialyzer (K945625). The results of the functional testing showed "significant equivalence." Additionally, biocompatibility testing was performed in accordance with ISO 10993, and the device passed all indicated tests.

Here's a breakdown of the requested information based on the provided text. Please note that many of the categories you requested are typically relevant for AI/ML device evaluations and are not applicable to the traditional medical device submission described here.

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified in the document. The testing involved "functional testing" and "biocompatibility testing," but the number of units tested is not provided.
• Data provenance: Not explicitly stated. The company, Althin Medical AB, is based in Sweden. The testing would have been conducted to support the 510(k) submission to the FDA in the USA.

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)

• Number of experts: Not applicable. The "ground truth" for this type of device is based on established engineering specifications and industry standards for functional and biocompatibility performance, not expert medical opinion on individual cases.

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

• Adjudication method: Not applicable. This does not involve interpretation of data by multiple experts.

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

• MRMC study: No. This is a traditional hemodialyzer, not an AI/ML device, so such a study is not relevant or described.

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

• Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of ground truth: The ground truth for this device's performance is based on established engineering specifications for hemodialyzers (e.g., ultrafiltration coefficient, clearance) and the requirements of biocompatibility standards (ISO 10993). Performance is compared against the specifications of a legally marketed predicate device.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not a machine learning device and therefore does not have a "training set" in the context of AI/ML.

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

• Ground truth for training set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The A-18 Hemodialyzer is a conventional hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.

Each A-18 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box.

It is sterilized by gamma radiation and intended, and labeled, for single use only.

The Althin Medical AB A-18 Hemodialyzer is a conventional hemodialyzer used to treat patients with acute or chronic renal failure. The device was deemed substantially equivalent to the Althin Medical Inc Altra Nova 170 Hemodialyzer (K945621).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the functional testing. It only mentions "functional testing has been conducted to evaluate the functional performance of the A-18 Hemodialyzer."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.

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 document refers to "specifications cleared for the predicate device" as the basis for testing, implying a comparison against established performance standards rather than expert-defined ground truth for specific cases.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The submission focuses on demonstrating substantial equivalence to a predicate device through functional and biocompatibility testing.

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

This question is not applicable as the device is a hemodialyzer, a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI algorithms is not relevant. The "functional testing" described evaluates the device's physical performance.

7. The Type of Ground Truth Used

The ground truth for the functional testing appears to be based on the specifications and performance characteristics of the legally marketed predicate device (Altra Nova 170 Hemodialyzer), along with established industry standards for biocompatibility (ISO10993). This is a comparative "ground truth" rather than an expert consensus, pathology, or outcomes-based ground truth typical for diagnostic AI.

8. The Sample Size for the Training Set

This question is not applicable as the A-18 Hemodialyzer is a physical medical device and does not involve a training set in the context of machine learning or AI.

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

This question is not applicable for the same reason as point 8.

Ask a specific question about this device

The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer.

The provided text describes a 510(k) submission for the Asahi AM-R Series Dialyzers. It focuses on a modification to the device (update of dialyzer casings) and assesses its substantial equivalence to a predicate device.

Crucially, this document is a 510(k) summary and approval letter, not a study report detailing acceptance criteria and performance data in the manner typically associated with clinical or standalone performance studies for AI/software devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because it is not a study report designed to evaluate such metrics.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:
   • Cannot be provided. This document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy) like you would find for a diagnostic or AI device. The "performance" assessment is qualitative, stating "Revisions to the casing dimensions... are demonstrated to have an insignificant impact on the performance of the dialyzers."

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

   • Cannot be provided. The document does not describe a "test set" in the context of typical AI/software device evaluation. It refers to a modification of a physical medical device (dialyzer casing) and likely involved engineering tests or bench testing, not a data-driven test set.

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):

   • Cannot be provided. Ground truth, in the context of AI, refers to independently verified labels for data. This document describes a physical device modification, not an AI model requiring annotated data. The assessment of "insignificant impact on performance" would have been made by engineers and regulatory reviewers based on design specifications and potentially bench testing, not expert-labeled test sets.

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

   • Cannot be provided. Not applicable to this type of device modification submission.

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:

   • Cannot be provided. Not applicable. This is not an AI/software device.

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

   • Cannot be provided. Not applicable. This is not an AI/software device.

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

   • Cannot be provided. Not applicable.

8. The sample size for the training set:

   • Cannot be provided. Not applicable. This is not an AI/software device.

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

   • Cannot be provided. Not applicable.

Summary based on the document:

This 510(k) submission is for a physical medical device (dialyzer), specifically a modification to its casing. The core of the submission is to demonstrate that this physical change does not alter the safety or effectiveness of the device compared to its legally marketed predicate.

The "study" referenced is the comparison to the predicate device and the demonstration that the casing revisions have an "insignificant impact on the performance of the dialyzers." This implies a technical assessment (likely engineering and/or bench testing) rather than a clinical trial or AI model validation study.

The acceptance criterion, implicitly, is that the modified device's performance characteristics related to its intended use (hemodialysis) remain substantially equivalent to the predicate device, thereby ensuring no new issues of safety or effectiveness are raised. The document states this outcome was achieved.

Ask a specific question about this device