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This device is a disposable system designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected, and is indicated for use to relieve elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus).

CSF (TM) is a disposable system designed for the drainage of cebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected. The radiopaque silicone ventricular catheter has been specially designed to drain the cerebropinal fluid from the ventricles through a series of perforations, and it can be inserted into the ventricular cavity with a 30 cm stainless steel stylet included in the system. The CSF (TM) includes a 400 or 600 ml collection bag (respectively CSF400™ and CSF600™) with a bottom drainage port, a small reservoir of 50 ml for liquid just drained, a 270 mm height scale for system 600 and 200 mm for model 400 which is used for positioning the collection unit, a drip chamber which enables visualization of the CSF flow as the fluid enters the bag and permits an approximate measurement of the drainage flow rate, a one-way valve to prevent reflux of the fluid, a 3 way stopcock and a 20 cc syringe to prime the system before its connection to the catheter. The system is designed to facilitate ventricular drainage, fluid injection, CSF sampling and intracranial pressure monitoring. The CSF (TM) system is presented individually packed and sterile.

This submission describes the CSF400™ and CSF600™ Central Nervous System Fluid Drainage Sets, which are disposable systems designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag. The purpose of this document is to determine whether the device meets acceptance criteria based on the provided information.

1. Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance acceptance criteria with numerical targets. Therefore, the "acceptance criteria" are implied to be that the device exhibits "Similar" or "Identical" technological characteristics across various categories when compared to the predicate device.

Summary of Device Performance: The device's performance is reported as "Similar" or "Identical" across all relevant technological characteristics when compared to the predicate device, K820247. This fulfills the implicit acceptance criteria for substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

The provided document does not describe a specific "test set" in the context of an algorithm's performance evaluation. This submission is a 510(k) premarket notification for a medical device (a CSF drainage set), not an AI/ML software device. Therefore, there is no discussion of a test set, sample size for a test set, or data provenance in the way one would analyze an AI/ML algorithm.

The demonstration of safety and effectiveness relies on comparison to a predicate device, assuming similar engineering, materials, and clinical indications imply similar safety and efficacy.

3. Number of Experts and Qualifications for Ground Truth of Test Set

As this is a 510(k) for a physical medical device and not an AI/ML algorithm, there is no mention or requirement for ground truth established by experts for a test set. The substantial equivalence is determined by reviewing the technological characteristics and intended use in comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Since there is no "test set" for an algorithm's performance, no adjudication method is described or relevant in this 510(k) submission.

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

An MRMC comparative effectiveness study is typically relevant for evaluating the impact of AI systems on human reader performance (e.g., radiologists interpreting images). This submission does not discuss an MRMC study, as it is for a physical medical device (CSF drainage set) and not an AI/ML diagnostic or assistive tool. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone Algorithm Performance Study

A standalone performance study (algorithm only, without human-in-the-loop) is a concept applicable to AI/ML software devices. This submission does not include or refer to a standalone algorithm performance study as the device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

For a physical medical device like the CSF drainage set, the "ground truth" for demonstrating safety and effectiveness is generally derived from:

• Established engineering principles and testing: Verifying material properties, mechanical integrity, sterility, biocompatibility, etc., against recognized standards.
• Clinical experience with predicate devices: Relying on the known safety and efficacy profile of a substantially equivalent device already on the market.
• Performance testing: While not explicitly detailed as "ground truth," performance characteristics like flow rates, volume measurements, and prevention of reflux would be validated through engineering tests.

The document's statement: "This device is safe and effective as the other predicate device cited above" indicates that the ground truth for safety and effectiveness is tied to the established safety and effectiveness of the predicate device (K820247).

8. Sample Size for the Training Set

The concept of a "training set" applies to machine learning algorithms. This 510(k) submission for a physical medical device does not involve or mention a training set.

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

As there is no training set mentioned or applicable for this type of device submission, there is no discussion of how ground truth for a training set was established.

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LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin.

LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin. It is supplied in 250 grams dispensers with a 3-year shelf life.

The provided text is a 510(k) Summary for a medical device called LEKTROGEL™ (Model LK3001), an electroconductive gel media. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting full performance study data with specific acceptance criteria and detailed study designs.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims identical performance to the predicate device. Therefore, the "acceptance criteria" appear to be defined by the performance characteristics of the predicate device. However, no specific quantitative acceptance criteria or numerical performance metrics are provided for either device.

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

The document does not describe a specific test set or a study with a sample size in the traditional sense of clinical or performance testing. The basis for the substantial equivalence claim is the asserted "identical" nature of the device to its predicate. There's no mention of country of origin for test data, or whether it was retrospective or prospective, as no such study is detailed.

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

Not applicable. As no independent test set with performance evaluation is described, there's no mention of experts establishing ground truth for such a set. The "ground truth" for the submission is the established characteristics and performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is 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

Not applicable. This device is an electroconductive gel, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and not discussed.

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

Not applicable. This is a physical medical device (gel), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is the established characteristics, safety, and performance of the legally marketed predicate device (Contact Conductive Adhesive Gel from Parker Laboratories, Inc., 510k # K852956). The entire submission argues that LEKTROGEL™ is "IDENTICAL" to this predicate.

8. The Sample Size for the Training Set

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

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

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

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or evidence provided to prove the device meets acceptance criteria is based on a comparative analysis of technological characteristics between LEKTROGEL™ and a predicate device (Contact Conductive Adhesive Gel from Parker Laboratories, Inc., 510k # K852956). The submission asserts that the new device is "IDENTICAL" to the predicate device across all critical technological characteristics, including indications for use, design, materials, performance, sterility, biocompatibility, safety, and other factors.

The acceptance criteria are implicitly defined as matching all characteristics of the predicate device. By demonstrating identity, the manufacturer aims to prove substantial equivalence, thereby meeting the regulatory requirements without needing to conduct extensive independent performance studies that would be required for a novel device. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the FDA accepted the claim of identical characteristics as sufficient evidence for substantial equivalence in this context.

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ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.

ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. It is supplied in 250 grams and 5 Kilograms containers with a 3-year shelf life.

The provided text describes a 510(k) submission for a medical device called ULTRAEKOGEL™, an ultrasound gel. The submission claims substantial equivalence to a predicate device, AQUASONIC 100.

Here's an analysis of the acceptance criteria and the study (or lack thereof) proving device performance, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of numerical performance metrics. Instead, it claims identicality across a range of technological characteristics when compared to the predicate device, AQUASONIC 100 (510k # K802146). The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate.

Study to prove the device meets acceptance criteria:

The study proving the device meets the acceptance criteria is generally implied to be a comparison of technological characteristics against the predicate device. The document explicitly states: "Indeed, this device is IDENTICAL to the predicate device." This is the core of their argument for substantial equivalence.

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

The document does not describe a "test set" in the traditional sense of a clinical or performance study involving a sample of patients or physical measurements. The claim of "identical" performance is based on the assertion that the technological characteristics, including performance, are the same as the predicate device. Therefore, no specific sample size for a test set is mentioned. The data provenance would be derived from the specifications and characteristics of both the proposed device (ULTRAEKOGEL™) and the predicate device (AQUASONIC 100), likely through internal testing and material analysis to confirm the stated identicality. The country of origin of this internal data is not specified, nor is whether it was retrospective or prospective.

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

As no distinct "test set" or clinical study is described, no information is provided regarding the number of experts or their qualifications used to establish a ground truth.

4. Adjudication method for the test set

Since no test set is described, no adjudication method is mentioned.

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 device is an ultrasound gel, not an AI-powered diagnostic system. Therefore, no MRMC comparative effectiveness study was done, and the concept of human readers improving with or without AI assistance is not applicable.

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

This device is an ultrasound gel and does not involve an algorithm. Therefore, no standalone algorithm performance study was conducted.

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

For an ultrasound gel, the "ground truth" for performance would likely revolve around its physical and chemical properties that enable effective ultrasound imaging (e.g., acoustic impedance, viscosity, stability, biocompatibility). The document implies that these properties are identical to the predicate device's established characteristics. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device in this submission.

8. The sample size for the training set

This device is an ultrasound gel and does not involve machine learning or AI. Therefore, there is no training set and no sample size is applicable or mentioned.

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

As there is no training set, this question is not applicable.

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