FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Baladi Inverter™ with Coaxial Aortic Punch is intended for use by cardiac surgeons during Coronary Artery Bypass Grafting procedures to maintain hemostasis and punch a hole in the aorta to facilitate the completion of the proximal anastomosis.

Device Description

The Baladi Inverter™ with Coaxial Aortic Punch is used to create hemostasis and punch a hole in the aorta to facilitate the anastomosis during coronary arterial bypass grafting (CABG) procedures.

AI/ML Overview

The provided 510(k) notification for the Baladi Inverter™ with Coaxial Aortic Punch is for a mechanical surgical device, not a diagnostic or AI-powered device. Therefore, many of the requested categories related to algorithm performance, training sets, ground truth establishment, and expert involvement for AI/diagnostic studies are not applicable to this submission.

However, I can extract information related to the device's performance, testing, and acceptance criteria as described in the document.

Acceptance Criteria and Device Performance

The acceptance criteria for this type of mechanical device are primarily focused on safety, effectiveness in performing its intended function, and substantial equivalence to predicate devices. The "reported device performance" is essentially a statement that the device met these criteria based on the non-clinical and clinical studies conducted.

Acceptance Criteria Category	Reported Device Performance
Safety	No adverse effects (Animal Clinical Study). No new issues of Safety (Cadaver Study). No complications or adverse events (Human Clinical Studies). Hazard Analysis resulted in a "Very Low (VL)" rating, presenting "no new issues of safety." Device is considered safe.
Effectiveness (Hemostasis)	Successfully maintained hemostasis (Animal Clinical Study). Performed clinically as expected (Human Clinical Studies). Substantially equivalent to predicate vascular clamps.
Effectiveness (Aortic Punch)	Successfully punched the aorta facilitating anastomosis (Animal Clinical Study). Performed clinically as expected (Human Clinical Studies). Substantially equivalent to predicate aortic punches.
Biocompatibility	Met qualifications (Non-Clinical Testing). Histopathology revealed no device-related issues (Animal Clinical Study).
Sterilization	Met qualifications (Non-Clinical Testing).
Design Verification	Met qualifications (Non-Clinical Testing).
Substantial Equivalence	Considered substantially equivalent to legally marketed predicate devices (FDA Conclusion).

Study Details (Applicable to a Mechanical Device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Animal Clinical Study: Sample size not specified.
- Cadaver Study: Sample size not specified.
- Human Clinical Studies: Sample size not specified.
- Data Provenance: Not specified, but generally, 510(k) studies for devices intended for the US market would involve data generated under US regulatory guidelines, though the specific location of study conduct is not stated. The studies are prospective in nature, as they assess the device's function and safety during use.
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)
- For a mechanical device, "ground truth" is typically established through direct observation of the device's mechanical function, surgical outcomes, and histopathological analysis. The document doesn't specify the exact number or qualifications of experts for defining "ground truth" in the way it would for a diagnostic AI. However, implicit "experts" involved would include:
  - Veterinary staff/surgeons: For the animal study.
  - Anatomists/Pathologists: For the cadaver study.
  - Cardiac surgeons: For the human clinical studies, who would assess the device's performance, ease of use, and any complications.
  - Pathologists: For histopathology results.
- No specific years of experience are detailed for these experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this mechanical device study. Adjudication methods like 2+1 or 3+1 are typically used for interpreting ambiguous diagnostic findings or images, which is not the primary focus here. Assessment of device function and safety would be direct observation and outcome measurement.
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 a mechanical surgical device and not a diagnostic device requiring human reader interpretation or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical surgical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this mechanical device, the "ground truth" was established using a combination of:
  - Direct observation of mechanical function: In animal, cadaver, and human studies (e.g., successful hemostasis, successful aortic punch).
  - Pathology/Histopathology: To assess tissue response and rule out device-related issues.
  - Surgical Outcomes Data: Absence of complications, adverse events, and expected clinical performance in human studies.
The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.

Summary

Regulation Number and Section

§ 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).