(80 days)
The HALO® ULTRA Ablation Catheter (used with the HALOEEK Energy Generator, model 1190A-115A) 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 subject device, HALO® ULTRA Ablation Catheter (hereafter referred to as "modified ULTRA") is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. It is used exclusively with HALOFES Energy Generator model 1190A-115A (cleared under K092487).
The provided text describes a 510(k) premarket notification for a medical device, the HALO90 ULTRA Ablation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and bench testing.
Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the document, as it is a 510(k) submission, not a study report demonstrating clinical performance against specific acceptance criteria.
The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving a device meets new performance acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.
Here's why the requested information is absent:
- Acceptance Criteria & Reported Performance: The document doesn't define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) that an AI device would typically have. It's comparing the technological characteristics and bench test results of the modified device to the predicate.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts relevant to studies evaluating the clinical performance of a diagnostic or AI-driven device, particularly when assessing its ability to detect or diagnose conditions. This document is for an ablation catheter, which treats conditions, and its filing is based on demonstrating safety and efficacy through equivalence to existing devices, supported by bench testing of physical characteristics.
Specifically addressed, based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence based on technological characteristics and bench testing (migration, deflection, catheter distal integrity, detachment). No clinical performance acceptance criteria are mentioned.
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" refers to bench testing, not a clinical data set. The document lists the specific bench tests performed without providing sample sizes as would be relevant for clinical data, nor does it discuss data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses, often established by expert consensus or pathology. This document describes bench testing where "ground truth" would be engineering specifications or physical measurements, not expert clinical interpretation.
- Adjudication method for the test set: Not applicable. Adjudication is used to resolve discrepancies in expert interpretation of clinical data. This is a bench test submission.
- 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 for an ablation catheter, not an AI diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for a physical medical device (catheter), not an algorithm.
- The type of ground truth used: For the bench testing, the "ground truth" would be the expected physical properties and performance metrics of the catheter as measured against engineering standards. This is not explicitly detailed but is implied by the nature of bench tests like "Migration," "Deflection," "Catheter Distal Integrity," and "Detachment."
- The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable. See point 8.
Summary of Device and Evidence Presented in the 510(k):
The HALO90 ULTRA Ablation Catheter is a modification of an existing device (original ULTRA). The submission aims to prove substantial equivalence to its predicate devices, not to establish new performance criteria through a de novo clinical study.
Evidence presented for substantial equivalence:
- Technological Characteristics: The modified ULTRA has the "same construction, principles of operation, materials and energy density" as the original ULTRA. The differences are described as "a slight change in the manufacturing process of the endoscope mounting strap, as well as dimensional modification on the pivot mechanism components."
- Bench Testing: The minor differences were evaluated via the following bench tests to ensure no new questions of safety and effectiveness were raised:
- Migration
- Deflection
- Catheter Distal Integrity
- Detachment
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.