(120 days)
The TandemHeart Transseptal Cannula Set - EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
The TandemHeart Transseptal Cannula Set-EF consists of three components, as shown in Figure 1: (1) 21 Fr Transseptal Cannula, (2) 14 Fr Obturator, and (3) 14/21 Fr Two-stage Dilator. The Obturator and Dilator are designed to accept a standard 0.035 in. guidewire.
The 21 Fr Transseptal Cannula allows for drainage of the left atrium during left ventricular bypass. It has 14 side holes in addition to the tip opening for unimpeded inflow of blood at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Cannula also includes a Suture Wing to provide a means for securing the Cannula to the patient. The 21 Fr body of the Cannula includes a wire-reinforced area for clear visualization under fluoroscopy and for resistance to kinking. The wire-reinforcing also permits a thin-walled construction. This feature allows for a larger inside diameter (lumen) while maintaining the predicate CAI cannula's outside diameter. Consequently, greater flow can be achieved with the same pressure drop across the cannula versus the predicate CAI cannula. Printing on a region of the cannula which is not wire-reinforced indicates the area where a clamp should be applied as needed during the set-up or removal process. The distal end of the Cannula is curved for natural anatomical placement from the inferior vena cava into the left atrium. The printing on the cannula is oriented to show the clinician that the distal tip curves to the right when the printing is on the top of the cannula body.
The 14 Fr Obturator is used to advance the Cannula over a guidewire to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a Luer hub and flush side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to confirm final positioning of the Cannula. An hemostasis cap prevents excessive blood loss when the Cannula/Obturator assembly is inserted into the femoral vein. The Obturator body is fabricated of radionaly is fa for easy visualization under fluoroscopy.
The 14/21 Fr. Dilator is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique and a guidewire has been placed into the left atrium. The stepped design of the distal tip of the Dilator provides tactile feedbak to the clinician as the dilation is achieved. The Dilator is fabricated of radiopaque material for easy visualization under fluoroscopy.
The provided text describes a 510(k) summary for the CardiacAssist Transseptal Cannula Set-EF. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving that a new device meets specific acceptance criteria in terms of clinical performance as one might expect for an AI/ML device study.
Therefore, the requested information elements related to AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this document. The provided text details the device's technical characteristics and performance testing against a predicate device to establish substantial equivalence.
Here's the information that can be extracted from the provided text, adapted to the closest relevant categories:
Acceptance Criteria and Device Performance (for Substantial Equivalence)
The "acceptance criteria" here are implicitly tied to demonstrating that the new device's performance is either "substantially better than," "met or exceeded," or "substantially equivalent to" the predicate devices. The study is a comparison to predicate devices, not an absolute measure against pre-defined clinical performance targets.
| Acceptance Criteria (Implicit from Comparison to Predicate) | Reported Device Performance |
|---|---|
| Flow vs. Pressure Drop (HQ): Achieve comparable or improved flow at given pressure drop compared to predicate CAI cannula. | Substantially better: The Transseptal Cannula-EF HQ performance after six hour use was substantially better than that of the predicate CAI cannula. (The text states a larger inside diameter allows for greater flow with the same pressure drop). |
| Kink Radius Performance: Comparable or improved resistance to kinking compared to predicate CAI cannula. | Substantially better: The Transseptal Cannula-EF kink radius performance after six hour use was substantially better than that of the predicate CAI cannula. (The device includes a wire-reinforced area for resistance to kinking). |
| Tensile Strength: Meet or exceed predicate CAI cannula's tensile strength. | Met or exceeded: The results of the tensile strength testing indicated that the Transseptal Cannula-EF met or exceeded the predicate CAI cannula testing thresholds. The obturator for the Transseptal Cannula Set-EF was shown to have tensile strength that met or exceeded the predicate CAI obturator testing threshold. |
| Leak Testing: Meet or exceed predicate CAI cannula's leak testing thresholds. | Met or exceeded: The results of the leak testing indicated that the Transseptal Cannula-EF met or exceeded the predicate CAI cannula testing thresholds. |
| Deflection Testing: Comparable deflection performance to predicate CAI cannula. | Substantially equivalent: Deflection testing indicated that the Transseptal Cannula-EF performed substantially equivalent to the predicate CAI cannula. |
| Materials and Construction: Substantially equivalent to predicate MDT cannula. | Substantially equivalent: The Transseptal Cannula for the Transseptal Cannula Set-EF is made of the same materials and in substantially the same way as the predicate MDT cannula. (The Transseptal Cannula Set-EF contains a stainless-steel-wire-reinforced, polyurethane Transseptal Cannula, similar to the predicate MDT cannula which is also stainless-steel-wire-reinforced, polyurethane). Its materials and method of construction are explicitly stated as substantially equivalent to the predicate MDT cannula. |
Information Not Applicable to this Document (for AI/ML devices)
- Sample size used for the test set and the data provenance: Not applicable. This is a medical device comparison to predicates, not an AI/ML study. The "test set" would refer to the physical devices tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance tests (e.g., flow, strength) is based on engineering measurements, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML device intended for human reader assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing: engineering measurements/specifications of physical properties (e.g., flow rates, pressure drops, tensile strength, resistance to kinking, deflection properties).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (as described in the document):
The study was a series of engineering and performance tests designed to compare the CardiacAssist Transseptal Cannula Set-EF against two predicate devices: the CardiacAssist Transseptal Cannula Set (K030398) and the MDT Biomedicus Femoral Cannula 96670-021 (K924642).
- Objective: To demonstrate "substantial equivalence" of the new device to the predicate devices in terms of design characteristics, performance, and intended use as required for a 510(k) submission.
- Assessment Methods:
- Flow vs. Pressure Drop (HQ): Measured the flow characteristics and pressure drop of the new cannula, comparing it to the predicate CAI cannula.
- Kink Radius Performance: Tested the device's resistance to kinking, comparing it to the predicate CAI cannula.
- Tensile Strength: Evaluated the tensile strength of the Transseptal Cannula-EF and its obturator, comparing against predicate CAI cannula and obturator thresholds.
- Leak Testing: Assessed the leak integrity of the Transseptal Cannula-EF, comparing against predicate CAI cannula thresholds.
- Deflection Testing: Compared the deflection performance of the Transseptal Cannula-EF to the predicate CAI cannula.
- Materials and Method of Construction: Explicitly stated comparison of the new cannula's materials (stainless-steel-wire-reinforced, polyurethane) and construction to the predicate MDT cannula.
The study concluded that the Transseptal Cannula Set-EF is substantially equivalent to the CardiacAssist Transseptal Cannula Set in design characteristics, performance, and intended use, and substantially equivalent to the predicate MDT cannula in materials and method of construction. This conclusion allowed the FDA to issue a substantial equivalence determination (K052570).
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).