(53 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 balloon 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 catheter has a uni-body design and is designed to be used without a quidewire. 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 coaxial 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 center of 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 peelaway sheath can be separated from the catheter shaft after insertion if needed.
This is an excellent question that breaks down the specifics needed to understand the validity and scope of a medical device's approval! Unfortunately, the provided text describes the regulatory clearance of a medical device (ER-REBOA™ Catheter) through the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to establish new safety and effectiveness claims.
Therefore, the document does not contain the detailed information you're asking for regarding acceptance criteria, specific study design elements (like sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance). This type of information is typically found in full clinical study reports, scientific publications, or de novo submission summaries, which are not provided here for this 510(k) clearance.
Here's what can be extracted and what cannot:
What the document does provide:
- Device Name: ER-REBOA™ Catheter
- Purpose of Clinical Data: To demonstrate substantially equivalent safety and effectiveness compared to the predicate device when used as labeled, particularly regarding the added specific indication for "patients requiring emergency control of hemorrhage."
- Type of Clinical Data:
- Real-world clinical data from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry (prospective).
- A case series report of ER-REBOA™ Catheter use in an austere military environment.
- Outcome Measured: Successful aortic occlusion.
- Reported Performance:
- Successful aortic occlusion: 95.7% in the AORTA registry, 100% in the case series.
- No instances of extremity ischemia, distal embolism, or retroperitoneal hemorrhage as complications of the device.
What the document does not provide (and why):
Since this is a 510(k) submission and not a de novo or PMA application with a dedicated clinical trial to establish new performance metrics for a novel technology (like an AI algorithm), the detailed information about acceptance criteria for an AI device, sample sizes for training/test sets, ground truth methodology, expert qualifications, or MRMC studies is not applicable and therefore not present in this document.
The "acceptance criteria" discussed in the document relate to the shelf life extension and demonstrating that the device adheres to the same acceptance criteria used in the original 510(k) after aging equivalent to 3 years (non-clinical testing). For clinical performance, the criterion is essentially "substantial equivalence" to the predicate, supported by the observed success rates and lack of complications.
If this were an AI device, here's how the provided information would map (and what's missing):
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable thresholds for an AI device's specific performance metrics (e.g., "sensitivity ≥ 90%, specificity ≥ 80%"). Instead, the document frames "acceptance" around substantial equivalence and previous 510(k) criteria for device functionality and safety.
- Reported Device Performance:
- Successful aortic occlusion: 95.7% (AORTA registry), 100% (case series).
- Complications (extremity ischemia, distal embolism, retroperitoneal hemorrhage): 0%
- This is performance for the catheter itself in its intended use, not an AI's diagnostic performance.
2. Sample sized used for the test set and the data provenance
- Test Set Description:
- AORTA Registry: Prospectively identified trauma patients requiring aortic occlusion from eight ACS Level 1 centers.
- Case Series: ER-REBOA™ Catheter use in an austere military environment.
- Sample Size (Number of Cases): Not explicitly stated, just that 27.7% of placements in the registry were without medical imaging and 68.1% with plain x-ray, and all case series placements were without medical imaging. This implies a number of patients, but the exact count isn't provided.
- Data Provenance: USA (AORTA registry), unspecified "austere military environment."
- Retrospective/Prospective: AORTA registry is prospective; case series is likely retrospective reporting, though it's not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. This information is for AI algorithm validation where expert consensus might define the "correct" diagnosis or finding. Here, the "ground truth" for the catheter's performance is whether it successfully occluded the aorta as determined by the treating clinicians in a real-world setting.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This pertains to how disagreements among expert readers are resolved for AI ground truth.
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
- No, not done/not mentioned. This is specific to AI-assisted reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not mentioned. The device itself is a physical catheter, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Outcomes Data: The "successful aortic occlusion" and "no complications" are based on clinical outcomes observed by the treating medical staff.
8. The sample size for the training set
- Not applicable/Not mentioned. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned. There is no AI algorithm being trained.
In summary, this document is for a medical device (catheter) clearance and therefore lacks the detailed AI-specific validation information you're seeking.
§ 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).