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K Number
K032817
Device Name
EXTERNAL DRAINAGE SET
Manufacturer
INTEGRA NEUROSCIENCES IMPLANTS S.A.
Date Cleared
2003-10-06

(26 days)

Product Code
JXG
Regulation Number
882.5550
Type
Special
Panel
NE
Reference & Predicate Devices
K910853
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The External Drainage Sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.

Device Description

The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection. The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line.

The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps. CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag.

A hydrophobic vent filter is included in the graduated cylinder cap of the External Drainage Set. This vent filter allows air to enter the graduated cylinder to facilitate drainage from the graduated cylinder to the drainage bag while protecting the system from contamination.

AI/ML Overview

The provided text describes a 510(k) summary for an "External Drainage Set" and its substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert involvement, or any of the other specific study design elements typically associated with demonstrating performance for a medical device that might use AI or require extensive clinical validation.

Here's why and what information can be extracted:

  • 510(k) summaries primarily focus on demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device and doesn't raise new questions of safety or effectiveness. They are not typically elaborate clinical study reports.
  • The device in question ("External Drainage Set") appears to be a physical medical instrument for CSF drainage. The context does not suggest it uses AI or complex algorithms.

Given this, I can only fill in the table and address certain prompts based on what is available in the provided document. Many fields will be marked as "Not Applicable/Not Provided" because the document does not contain that type of information.

Acceptance Criteria and Device Performance

CriteriaAcceptance Criteria (Not explicitly stated as numerical targets)Reported Device Performance
Safety (Biological/Physical)- Must be sterile.
  • Bonded components must have adequate tensile strength.
  • Must withstand pressure and prevent leakage.
  • Must effectively drain CSF.
  • Must maintain package integrity.
  • Needleless sampling sites must reduce needlestick injuries and exposure to infected fluids (in compliance with Needlestick Safety and Prevention Act).
  • Must not raise new issues of safety. | - The External Drainage Set is provided sterile.
  • The External Drainage Set has been tested for tensile strength of bonded components.
  • The External Drainage Set has been tested for pressure and leakage.
  • The External Drainage Set has been tested for drainage.
  • The External Drainage Set has been tested for package integrity.
  • The needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids in compliance with the Needlestick Safety and Prevention Act, H.R.5178.
  • "The modifications do not affect... do not raise new issues of safety and effectiveness." (Implies meeting safety criteria by virtue of equivalence to predicate) |
    | Effectiveness (Intended Use) | - Must be able to perform cerebrospinal fluid (CSF) drainage.
  • Must be able to perform CSF sampling.
  • Must be able to perform CSF collection.
  • Must be substantially equivalent in function and intended use to the predicate device (K910853).
  • Must not raise new issues of effectiveness. | - "The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection."
  • "CSF can be collected and measured in the graduated cylinder..."
  • "A hydrophobic vent filter... allows air to enter the graduated cylinder to facilitate drainage..."
  • "The External Drainage Set is substantially equivalent in function and intended use to the Unmodified External Drainage Set which has been cleared to market under Premarket Notification 510(k) K910853."
  • "The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness." (Implies meeting effectiveness criteria by virtue of equivalence to predicate) |
    | Material/Design Specifications | - Connects to ventricular or lumbar catheter via Luer connection.
  • Graduated cylinder attached to IV pole, movable with Velcro straps.
  • Stopcock between graduated cylinder and drainage bag.
  • Hydrophobic vent filter in graduated cylinder cap. | - "The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line."
  • "The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps."
  • "CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag."
  • "A hydrophobic vent filter is included in the graduated cylinder cap..." |

Study Information

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

    • Sample Size: Not Applicable/Not Provided. The document mentions tests for tensile strength, pressure and leakage, drainage, and package integrity, but does not specify the sample sizes for these engineering or bench tests. It does not describe a clinical test set.
    • Data Provenance: Not Applicable/Not Provided. The tests described appear to be bench tests rather than clinical data from specific countries or populations. The manufacturer is based in France with an authorized agent in the US.

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

    • Not Applicable/Not Provided. The document describes engineering/performance tests, not a study requiring expert-established ground truth from, for example, image interpretation or clinical diagnosis.

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

    • Not Applicable/Not Provided. This is not a study design involving 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:

    • No. A MRMC comparative effectiveness study was not performed. This device is a physical drainage set and does not involve human readers or AI.

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

    • No. A standalone algorithm performance study was not performed. This device does not incorporate an algorithm or AI.

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

    • The "ground truth" for the tests mentioned (tensile strength, pressure, leakage, drainage, package integrity) would be based on engineering specifications and established test methods for material and device performance, rather than clinical consensus or outcomes data. For needle-stick prevention, the "ground truth" would be compliance with the specified Act.

  7. The sample size for the training set:

    • Not Applicable/Not Provided. This device does not involve a "training set" in the context of machine learning.

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

    • Not Applicable/Not Provided. This device does not involve a training set.

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).