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For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.

The Powered EZ-IO® Pediatric Bone Marrow Aspiration System consists of a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device fcleared under 510(k) K032885] connected to a disposable, single use intraosseous aspiration needle set assembly. Upon activation, the drill assists the operator with needle set insertion into the bone. The driver is then separated from the hub of the needle set assembly, leaving the needle set securely seated in the bone. The trocar/stylet is then removed from the needle set leaving the 15 gauge catheter. A standard Luer lock (part of the catheter hub) then permits attachment of standard syringe for aspirating bone marrow samples. The needle set is 25mm in length [previously cleared for IO use in adults via 510(k] number K032885). This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications.

It seems there's a misunderstanding in the request or the provided document. The provided text is a 510(k) summary for the "Powered EZ-IO Pediatric Bone Marrow Aspiration System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, test sets, ground truth establishment, or multi-reader multi-case studies, as would be expected for a novel AI/software-as-a-medical-device.

The document states: "This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications." It further emphasizes that the device was compared to predicates and found to have "similar technological characteristics and to be equivalent" in several areas.

Therefore, the information requested in points 1-9 (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided 510(k) summary because this type of detailed performance study is not typically required or included for a 510(k) seeking a new indication for an already cleared device through substantial equivalence.

Based on the provided text, I can extract the following relevant information, but I cannot fulfill the request for a detailed performance study description:

Summary of Device and Regulatory Status:

• Device Name: Powered EZ-IO® Pediatric Bone Marrow Aspiration System
• Submitter: Vidacare Corporation
• 510(k) Number: K070759
• Date Prepared: March 16, 2007
• Classification Name: Gastroenterology-urology biopsy instrument
• Regulatory Class: II
• Product Code: FCF
• Predicate Devices:
  • K062833: Powered EZ-IO® Bone Marrow Aspiration System (Vidacare Corp.)
  • K051506: MIELO-CAN® (Sterylab)
  • K032885: VidaPort Intraosseous Infusion System (Powered Adult IO) (Vidacare Corp.)
  • K51992: Powered Pediatric IO (PD-IO) (Vidacare Corp.)

Indications for Use:

• For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.

Description of the Device:

• Consists of a reusable battery-powered driver (previously cleared for aspiration in adults via K062833) and a 25mm intraosseous (IO) device (cleared under K032885) connected to a disposable, single-use intraosseous aspiration needle set assembly.
• The driver assists with needle set insertion into the bone.
• Driver is separated, trocar/stylet removed, leaving a 15 gauge catheter.
• Standard Luer lock permits attachment of a syringe for aspirating bone marrow samples.
• The needle set is 25mm in length (previously cleared for IO use in adults via K032885).

Basis for Substantial Equivalence:

The technological characteristics of the Powered EZ-IO® Pediatric Bone Marrow Aspiration System were compared to the predicate devices and found to be similar and equivalent in the following areas:

• Indications for Use
• Target Population
• Driver Design Features
• Needle Design
• Technique
• Sterility
• Biocompatibility
• Anatomical Sites Where Used

In conclusion, for a 510(k) submission based on substantial equivalence for a new indication for an existing device, a detailed "study that proves the device meets the acceptance criteria" in the way you've described (with test sets, ground truth, experts, etc.) is not typically performed or presented. The primary evidence presented is the comparison to legally marketed predicate devices to demonstrate equivalent technological characteristics and safety/effectiveness.

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For Bone Marrow Aspiration of the Iliac Crest.

The Powered EZ-IO Bone Marrow Aspiration System consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then is separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringe for aspiration. The needle is 15 gauge and 60mm long.

This document is a 510(k) summary for the Powered EZ-IO Bone Marrow Aspiration System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full study to establish performance against acceptance criteria. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies or specific acceptance criteria performance) is not typically found in these types of submissions.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense with performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing their "technological characteristics." The "performance" is implied through this equivalence, suggesting the device performs comparably to already approved devices.

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

The document does not describe a performance "test set" in the traditional sense involving human subjects or patient data. The evaluation is based on comparing design characteristics and intended use with predicate devices. Therefore, there is no information provided on sample size or data provenance for a test set.

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

Since no clinical or performance "test set" is described, there's no mention of experts establishing ground truth. The substantial equivalence assessment is typically conducted by the manufacturer and reviewed by regulatory bodies (like the FDA).

4. Adjudication Method for the Test Set:

Not applicable, as no test set or clinical study requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, there is no mention of an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric.

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

Not applicable. The device is a physical medical instrument, not a software algorithm, so the concept of "standalone performance" in that context does not apply. The performance is assessed based on its functional design and equivalence to existing devices.

7. The Type of Ground Truth Used:

Ground truth, in the context of substantial equivalence for a physical device like this, refers to the established safety and effectiveness of the predicate devices. The "ground truth" is that these predicate devices are already legally marketed and considered safe and effective for their intended use. The new device is then compared to this established "truth." No specific "pathology" or "outcomes data" is referenced for the comparison, but rather the functional and design characteristics.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device (aspiration system), not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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The Barrett's Cytology Device is intended to collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus.

The Barrett's Cytology Device is a catheter that is advanced into the esophagus much like a gastric lavage catheter. The catheter with the aid of common intubation techniques is further advanced into the stomach. The placement into the stomach is confirmed by the use of a distal inflatable balloon which is used to identify the lower esophageal sphincter (LES). Identification of the LES is required because the target sample location is typically the distal esophagus. Once the LES is identified an external slide disc on the catheter is used to mark the length of the patient's esophagus from the dental arches. At this time the balloon will be deflated and the catheter withdrawn away from the LES into the esophagus using the slide disc and catheter markings for distance reference as to how far back the catheter is to be withdrawn. When the catheter is withdrawn to the desired location to sample a cytology brush contained within the catheter is deployed out the distal end of catheter and the cytologic brushing commences. Once the brushing of the esophagus is completed the brush is withdrawn back inside the catheter to contain the cell harvest within the catheter lumen. The entire catheter is withdrawn from the patient and the cytology brush is again deployed to prepare microscopic slides for analysis.

The provided document is a 510(k) summary for the "Barrett's Esophageal Cytology Device" and primarily focuses on its intended use and general regulatory information. It does not include detailed studies or data regarding specific acceptance criteria and device performance as requested.

Therefore, I cannot provide the complete answer based solely on the provided text. The document states that the "Summary of Safety and Effectiveness...reflects data available and presented at the time the submission was prepared," but the actual data and study details are not present in this excerpt.

However, I can extract the available information and highlight what is missing:

Acceptance Criteria and Device Performance Study

As per the provided 510(k) summary, specific acceptance criteria for device performance (e.g., sensitivity, specificity for detecting Barrett's Esophagus or dysplasia) and a detailed study proving the device meets these criteria are not included. The document describes the device's function and intended use but does not present a formal study with statistical data to validate its diagnostic accuracy.

Available Information and Missing Details:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the given text. The document describes the device's purpose to "collect cytologic samples...for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus," but does not quantify performance metrics like sensitivity, specificity, or accuracy against specific criteria.

2. Sample Size used for the test set and the data provenance: This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the given text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the given text.

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 provided. The device described is a cytology collection device, not an AI-assisted diagnostic tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided. Again, this device is for sample collection, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided in the given text. The device aims to collect samples for "cytologic analysis," implying the ground truth would be based on pathology/cytology reports, but the method for establishing it in a study is not detailed.

8. The sample size for the training set: This information is not provided in the given text.

9. How the ground truth for the training set was established: This information is not provided in the given text.

Summary of Device and Context from the Text:

• Device Name: Barrett's Esophageal Cytology Device
• Intended Use: To collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus.
• Regulatory Clearance: K984168 (cleared on Dec 7, 1999)
• Classification: Class II, 21 CFR 876.1075 / Procode: 78 FCF
• Predicate Device: The submission implies comparison to legally marketed predicate devices, but specific details of the predicate device performance used for substantial equivalence are not provided in this excerpt.
• Methodology: Combines non-endoscopic intubation catheter methods and cytology brush technology. Involves advancing a catheter with an inflatable balloon to identify the LES, marking the esophagus length, withdrawing the catheter to the desired sampling location, deploying a cytology brush, and collecting cells.

Conclusion based on provided text:
The provided 510(k) summary describes the device and its intended use for collecting cytology samples. However, it does not contain the detailed study results, acceptance criteria, sample sizes, ground truth establishment methods, or expert qualifications that would typically be found in a study report proving the device meets specific performance criteria. The document refers to "data available and presented at the time the submission was prepared," but these specific data points are absent from the provided excerpt.

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