(54 days)
The ER-REBOA Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
The ER-REBOA™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a compliant occlusion with an atraumatic distal tip (P-tip®), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The cather has a unibody design and is designed to be used without a guidewire. A peel away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip® into an introducer sheath hemostasis valve. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device. The distal tip (P-tip®) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A co-axial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheter's two lumens. The peel-away sheath can be separated from the catheter shaft after insertion if needed.
Here's an analysis of the provided text regarding the ER-REBOA Catheter (K172790), focusing on acceptance criteria and supporting study details:
Summary of Acceptance Criteria and Device Performance (as inferable from the document):
The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics for the device itself (e.g., burst pressure, inflation time, etc.). However, the primary "acceptance criteria" discussed relate to equivalence to a predicate device and the justification for removing a pregnancy contraindication.
The performance data section focuses on demonstrating the safety and effectiveness of using the REBOA catheter in pregnant patients, which implicitly means the device performs acceptably in this population.
| Acceptance Criteria Category | Reported Device Performance / Justification |
|---|---|
| Equivalence to Predicate Device | The ER-REBOA™ Catheter is identical to the predicate device (ER-REBOA™ Catheter, K170411) in terms of technological characteristics. Conclusion: Substantially Equivalent. |
| Safety and Effectiveness in Pregnant Patients (justification for removing contraindication) | 1. Clinical Rationale: Radiation risk of fluoroscopy (often a concern for pregnant patients during interventional procedures) is not applicable to the ER-REBOA™ Catheter. |
- Clinical Study: A retrospective case series study of 36 patients treated with fluoroscopy-free REBOA for severe postpartum hemorrhage.
- REBOA success rate: 100%
- REBOA-related mortality: 0% |
Detailed Analysis of the Study and Ground Truth:
The document describes a single study related to the change in labeling regarding pregnancy.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 36 patients
- Data Provenance: Retrospective case series study. The country of origin is not specified.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not specified. The study is a "case series," which implies clinical outcomes were observed and recorded by treating physicians, but the process of establishing a formal "ground truth" by independent experts for the purpose of the submission is not detailed. The "REBOA success rate" and "REBOA related complications" likely refer to the clinical assessment of the treating medical teams.
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Adjudication Method for the Test Set:
- Not specified. Given it's a retrospective case series, a formal adjudication method by a separate panel for the purpose of this submission is unlikely to have been carried out or documented in this summary.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study (MRMC) is typically used for diagnostic or imaging-based devices where different readers interpret data. The ER-REBOA Catheter is an interventional therapeutic device. The study described focuses on clinical outcomes in a specific patient population.
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If a Standalone Study Was Done:
- Yes, implicitly. The retrospective case series assessed the outcomes of the REBOA procedure using the device in a specific clinical context (postpartum hemorrhage) without comparing it directly to human readers or other diagnostic methods. It evaluated the device's performance in a clinical setting.
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The Type of Ground Truth Used:
- Clinical Outcomes/Expert Judgment (Implicit): The "REBOA success rate" and "no patients died from REBOA related complications" are based on clinical assessments and outcomes reported by the medical professionals involved in the care of those 36 patients. This is essentially ground truth established by the treating clinicians through observation of patient response and medical records.
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The Sample Size for the Training Set:
- Not applicable. The described study is a case series for proving clinical benefit/safety in a specific population for labeling purposes, not a study to train a machine learning algorithm. The ER-REBOA Catheter is a physical medical device, not an AI/ML algorithm.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).