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Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in transendoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract.

Injection Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. The Injection Gold Probe Catheter also has irrigation capability. Any other use is not recommended.

The Gold Probe is a bipolar electrohemostasis catheter with irrigation capabilities. When passed through an endoscope and activated, it will deliver a bipolar current to cauterize tissue. The Gold Probe is available in 7 Fr and 10 Fr with a working length of 300cm (7 and 10 Fr) and 350cm (7 Fr), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.

The Injection Gold Probe is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.

This document is a 510(k) premarket notification for a medical device, specifically the Gold Probe Bipolar Electrohemostasis Catheter and the Injection Gold Probe Bipolar Electrohemostasis Catheter.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to AI/algorithm performance, human-in-the-loop studies, or detailed ground truth establishment. The document explicitly states:

"The proposed Gold Probe Bipolar Electrohemostasis Catheter and Injection Gold Probe Bipolar Electrohemostasis Cathter technological characteristics remain unchanged from predicate Gold Probe Bipolar Electrohemostasis Catheter (K970278) and Injection Gold Probe Bipolar Electrohemostasis Catheter (K133933) respectively; therefore, no further performance testing was required."

This statement indicates that the submission is based on substantial equivalence to previously cleared predicate devices, claiming that the technological characteristics are unchanged, and thus, no new performance testing was deemed necessary by the manufacturer for this 510(k) submission.

Therefore, I cannot populate the requested table and details because the provided document does not contain information about:

1. A table of acceptance criteria and reported device performance (in the context of an AI/algorithm study).
2. Sample sizes for a test set or data provenance for such a study.
3. Number and qualifications of experts for multi-reader studies or ground truth establishment in this context.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This 510(k) summary focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and indications for use, rather than presenting a performance study against specific acceptance criteria for a new or AI-enabled device.

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The HALO® System (including HALO® Ablation Catheter model 90-9100 and HALO® Energy Generator model 90-9000) is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

The HALO® Ablation Catheter model 90-9100 operates in conjunction with HALO® Energy Generator model 90-9000. There are no changes to the HALO® Ablation Catheter or HALO® Energy Generator implemented since the devices were cleared by K083737, K062723 and K062441. The product is also identical in principle of operation and energy density to the treatment site with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter. HALO® is substantially equivalent in construction with the predicate devices HALO360 Ablation Catheter, Stellartech Coagulation Catheter and Microvasive Gold Probe. The product is similar in performance with Olympus Heat Probe.

The provided 510(k) summary for BARRX's HALO System (K093008) indicates that no new performance testing was conducted for this submission.

The submission focuses on expanding the indications for use for the HALO® Ablation Catheter to include Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP) based on the substantial equivalence to previously cleared devices and existing clinical data.

Therefore, the following information cannot be extracted from the provided text as the study described is a review of existing clinical data, not a new performance study with acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not applicable, as no new performance testing was conducted.
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 for new performance testing. The clinical data supporting the expanded indications was "derived from publications and case studies." The provenance details are not specified.
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, as no new test set was created with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI/device assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the expanded indications, the clinical data relied upon was from "publications and case studies" which demonstrated the safety and effectiveness of the device when used for GAVE and RP. This implies that outcomes data from these existing sources served as the basis for substantiating safety and effectiveness for these new indications.
8. The sample size for the training set: Not applicable, as no new training set was explicitly mentioned for algorithmic development in this submission.
9. How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (expanded indications):

The submission argues for the substantial equivalence of the HALO® Ablation Catheter for the treatment of GAVE and RP by referencing:

• Technological Identity and Substantial Equivalence: The HALO® Ablation Catheter model 90-9100 is "technologically identical" to its cleared predicate (K083737, K062723). It also highlights substantial equivalence in principle of operation, energy density, construction, and performance with other predicate devices (HALO360 Ablation Catheter, Stellartech Coagulation Catheter, Microvasive Gold Probe, Olympus Heat Probe).
• Clinical Data Review: Clinical data was provided to FDA "to support the changes in the Instructions for Use associated with the use in the coagulation of bleeding sites for the HALO® Ablation Catheter for the treatment of GAVE and Radiation Proctitis." This data "demonstrated that, when used in accordance with those instructions, the HALO® Ablation Catheter used for the treatment of GAVE and Radiation Proctitis respectively is at least as safe and effective as the cleared HALO® Ablation Catheter for the treatment of bleeding sites in the gastrointestinal tract."
• Basis of Clinical Data: The clinical data supporting the additional indications (GAVE and RP) was "derived from publications and case studies" and facilitated "Physician's Instructions recommending specific treatment settings and selection criteria for the patients (Contraindications, Warnings and Cautions)."
• Similarity of Conditions: GAVE and RP are described as being similar to other already indicated bleeding conditions (esophageal ulcers, Mallory-Weiss tears, etc.) in that they are confined to the mucosal layer, associated with hemorrhage, and treated with coagulative therapy.

In essence, the "study" proving the device meets the acceptance criteria for expanded indications was a retrospective review of existing clinical data from publications and case studies, and an argument for substantial equivalence to previously cleared predicate devices for similar applications. No new pre-market performance study with defined acceptance criteria was conducted.

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The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract

The Habib Endoblate is a bipolar radiofrequency (RF) device that consists of a catheter with 3 contact electrodes and 1 ring electrode, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib Endoblate has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib Endoblate is designed for use in endoscopy and is a single use sterile device.

The provided text describes the Habib Endoblate device and its 510(k) clearance, but it does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria with quantitative metrics.

The document states: "Performance testing was undertaken to ensure that the Habib Endoblate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

This is a general statement required for 510(k) submissions, indicating that some testing was performed to demonstrate substantial equivalence to a legally marketed predicate device (Gold Probe catheter, K970278). However, the specific results of this performance testing, the acceptance criteria used, or the study details are not included in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided text.

The information that can be extracted relevant to your request is limited to:

• Predicate Device: Gold Probe catheter manufactured by Boston Scientific Inc. (K970278)
• Basis for Clearance: Substantial equivalence to the predicate device.
• Technological Characteristics: Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.

To obtain the detailed performance data, acceptance criteria, and study results, one would typically need to refer to the full 510(k) submission document or supporting technical files, which are not included here.

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RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The RadioMed™ Soft Tissue Marker is a non-sterile device, in the form of a gold coil that ranges in OD between 0.75mm and 1.2mm.

The RadioMed™ Soft Tissue Marker is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is achieved by exposure to steam autoclave.

The RadioMed™ Soft Tissue Marker will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.

The RadioMed™ Soft Tissue Marker will be delivered using either a 17 gauge or 18 gauge needle and stylet.

This document describes a 510(k) submission for the RadioMed™ Soft Tissue Marker, which is a medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against acceptance criteria in a comprehensive study.

Based on the provided text, there is no specific acceptance criteria table or a study proving the device meets distinct performance criteria in terms of accuracy, sensitivity, specificity, etc. This is because 510(k) submissions for devices like markers often rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance testing mentioned is related to manufacturing standards and visibility, not a clinical effectiveness study with defined performance metrics.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

Missing Information (Not Applicable to this 510(k) submission):

• 1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices and manufacturing quality, not a comparison against specific clinical performance metrics.
• 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of a clinical performance study as described in the prompt.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a physical marker, not an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Information that is present or can be inferred:

Overview of Evidence Presented:

The submission focuses on comparing the RadioMed™ Soft Tissue Marker to existing predicate devices (RadioMed™ Marker, Implanter/Adjustable/Anderson's Marker, Extracranial Marker) to demonstrate substantial equivalence. The key aspects of this comparison are:

• Intended Use: The intended use and indications for use have not changed from the predicate device.
  • Intended Use: "RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures."
• Technological Characteristics: The fundamental scientific technology of the modified device has not changed.
  • Material: The material (metallic gold) is identical to the Anderson Marker (K940121) and Extracranial Marker, and is widely used in other approved medical devices with a "safe history of use." This obviates the need for additional biocompatibility testing.
  • Design: The design is identical to the predicate RadioMed™ Marker (K022326) except for the outside diameter (OD) and material (gold vs. unspecified material in K022326). The new marker ranges in OD between 0.75mm and 1.2mm.
• Performance Testing (Non-Clinical):
  • Summary of standards achieved:
    • FDA QSR 21 CFR Part 820 Good Manufacturing Practices
    • AAMI Standard 11134-1994 Recommended practice for Steam Autoclave
  • Visibility Studies: "Visibility Studies (see section H - Performance Testing)" are mentioned, implying that the marker's visibility under radiographic imaging was assessed. However, no specific data, acceptance criteria, or experimental setup for these visibility studies are provided in this summary.

Conclusion from a 510(k) Perspective:

The FDA's letter (K031206) confirms that they have "determined the device is substantially equivalent...to legally marketed predicate devices." This determination is based on the information provided in the 510(k) submission, primarily focusing on the safety and effectiveness as demonstrated through comparison to predicates and adherence to manufacturing and sterilization standards, rather than direct clinical performance against novel acceptance criteria.

In summary, for this specific 510(k) submission, the "acceptance criteria" and "study" are intrinsically linked to demonstrating substantial equivalence through comparison with predicate devices and adherence to established manufacturing and safety standards, rather than a clinical trial proving specific performance metrics of an AI algorithm.

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