(423 days)
The IBC Cardiac Suction Wand is intended for use by a Cardiac Surgeon during open heart surgery for the collection of blood and other fluids from the sterile surgical field for filtering and return to the patient via the Cardiotomy line. It is also intended for use by surgeons for the removal of waste fluids from the surgical field.
The IBC Cardiac Suction Wand is a single use, sterile, disposable surgical instrument intended for the collection of blood and other fluids from the surgical field for return the cardiotomy system during open heart surgery.
The provided 510(k) summary for the IBC Cardiac Suction Wand does not include specific acceptance criteria or details of a study proving the device meets acceptance criteria in the way typically expected for performance-based medical device studies. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a "Table of Comparison" which outlines characteristics of the new device (IBC Cardiac Suction Wand) and the predicate device (Research Medical Intracardiac Sucker). This table serves as the primary means to demonstrate that the new device meets the implicit acceptance criteria of being "substantially equivalent" to an already legally marketed device.
| CHARACTERISTIC | IBC CARDIAC SUCTION WAND | RESEARCH MEDICAL INTRACARDIAC SUCKER | Acceptance Criteria (Implicit) | Performance (IBC Cardiac Suction Wand) |
|---|---|---|---|---|
| Components | 4 | 4 | Must have comparable number and function of components | 4 |
| Tube | Passivated Stainless Steel | Passivated Stainless Steel | Material must be identical or clinically equivalent | Passivated Stainless Steel |
| Handle | Overmolded Plastic | Overmolded Plastic | Material must be identical or clinically equivalent | Overmolded Plastic |
| Tubing Adapter | Overmolded Plastic | Molded and Bonded Plastic | Material/construction must be clinically equivalent (differences noted as cosmetic) | Overmolded Plastic |
| Cardiac Tip | Molded Plastic Bonded | Molded Plastic Bonded | Material/construction must be identical or clinically equivalent | Molded Plastic Bonded |
| Proximal Bend Angle | 35 Degrees | 35 Degrees | Geometric specifications must be identical or clinically equivalent | 35 Degrees |
| Distal Bend Angle | 35 Degrees | 35 Degrees | Geometric specifications must be identical or clinically equivalent | 35 Degrees |
| Blood Compatibility | Non-Hemolytic | Non-Hemolytic | Must demonstrate non-hemolytic properties | Non-Hemolytic |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Sterilization method must be identical or validated as equivalent | Ethylene Oxide |
| Toxicity | Tripartite Guidelines | Tripartite Guidelines | Must meet toxicity guidelines (e.g., ISO 10993 or equivalent) | Tripartite Guidelines |
Discussion of Similarities and Differences: The submission explicitly states: "The IBC Cardiac Suction Wand is in most ways identical to the Research Medical Intracardiac Sucker." It acknowledges minor differences in the stainless steel tube (larger flow diameter, electropolished) and the tubing adapter construction ("overmolded" vs. "molded and bonded"), but asserts these differences are "primarily cosmetic" and do not affect the intended use or safety/effectiveness. This assertion implicitly serves as the "proof" that the device meets acceptance criteria, specifically non-inferiority to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not describe a specific test set or clinical study with a defined sample size in the traditional sense (e.g., number of patients, number of devices tested in a clinical setting). The "testing" appears to be based on design specifications, material comparisons, and adherence to recognized standards for biocompatibility and sterilization.
- Data Provenance: Not applicable, as there's no clinical trial data presented. The "data" consists of design specifications and characteristics of the device itself and its predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. There is no mention of external experts consolidating ground truth for a test set. The ground truth for this type of submission is the documented performance and characteristics of the legally marketed predicate device, and the manufacturer's own assessment that their new device aligns with these.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there is no test set in the clinical evaluation sense that would require adjudication.
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
- MRMC Study: No. This device is a surgical instrument (suction wand), not an AI-powered diagnostic or imaging tool. An MRMC study is completely irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, not applicable. This is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is the documented characteristics, safety, and effectiveness of the legally marketed predicate device, the Research Medical Intracardiac Sucker. The IBC Cardiac Suction Wand demonstrates substantial equivalence by showing its own characteristics align with this established predicate. Additional "ground truth" comes from adherence to established standards for materials (e.g., passivated stainless steel, non-hemolytic materials), sterilization (Ethylene Oxide), and toxicity testing (Tripartite Guidelines).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not use machine learning or AI models, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. There is no training set for this type of device.
§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
(a)
Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.