(77 days)
The TS3 Tubing Set serves as a fluid delivery pathway for anticoagulated whole blood from extracorporeal circuits to be delivered to and from a hemoconcentrator. The TS3 Tubing Set may be used in either of the following situations: a) As a conduit for conventional hemoconcentration during Cardiopulmonary Bypass surgery, or b) As a conduit for use with the HEMOBAG™ Blood Salvage Device as a hemoconcentration reservoir.
The TS3 Tubing Set serves as a fluid delivery pathway for anticoagulated whole blood from extracorporeal circuits to be delivered to and from a hemoconcentrator. The TS3 Tubing set may be used as a conduit with conventional hemoconcentration during Cardiopulmonary Bypass Surgery or as a conduit for use with the HEMOBAG "" Blood Salvage Device when the bag is used as a hemoconcentrating reservoir. The TS3 Tubing Set is designed with ¼" ID PVC tubing with standard dialysis luer fittings for connection to a commercially available hemoconcentrator. The TS3 Tubing Set is also designed with quick connect/disconnect fittings for easy attachment to the HEMOBAG™ Blood Salvage Device Reservoir. The tubing sets are manufactured with appropriately sized snap closing/occluding the tubing when appropriate.
The provided text describes safety and effectiveness testing for the TS3 Tubing Set. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Predicate Device Acceptance Criteria | TS3 Tubing Set Performance | Met? |
|---|---|---|---|
| Safety Testing (Biocompatibility) | Guidelines in ANSI/AAMI/ISO 10993, Vol. 4 for limited exposure medical devices with circulating blood. | Successfully passed all tests. | Yes |
| Cellular Damage & Hemolysis (Circulation with HEMOBAG™) | Cellular damage (hematocrit, platelet depletion, WBC count, plasma free hemoglobin, calculated % hemolysis) statistically insignificant difference compared to predicate device (Medtronic Venous Reservoir Bag + Baxter ¼" tubing). Acceptable hematologic parameters. | Difference between TS3 Tubing Set + HEMOBAG™ circuit and predicate device circuit was statistically insignificant. Demonstrated acceptable hematologic parameters. | Yes |
| Effectiveness (Fluid Pathway - Leaks) | Ability to serve as a fluid pathway during hemoconcentration. Withstand internal air pressure of 12psi for 30 seconds submerged in water without leaks. | Successfully tested for leaks by applying internal air pressure of 12psi, submerging under water for a 30-second test period, and observing no air leakage. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Cellular Damage & Hemolysis Test: Not explicitly stated, but the experiment involved "anticoagulated bovine whole blood" circulated through the devices. The sample size likely refers to the number of blood samples or replicates, which is not provided.
- Leak Test: The sample size for the leak test is not explicitly stated. It refers to "the device" (singular), implying at least one TS3 Tubing Set was tested.
- Data Provenance: The studies appear to be laboratory-based tests conducted by the manufacturer, Global Blood Resources, LLC, for premarket notification. The location or country of origin of the data is not specified beyond being generated by the applicant. These are likely prospective tests designed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: This product testing does not involve human experts establishing ground truth in the way a diagnostic AI device would. The ground truth for biocompatibility and mechanical performance tests are objective measurements and established standards, not expert consensus.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., medical image interpretation). For the described tests (biocompatibility, cellular damage, leak testing), the outcomes are determined by objective laboratory measurements and adherence to pre-defined criteria, not by human interpretation requiring 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
- No: This is not an AI device, and therefore, no MRMC study or AI-assisted human reader performance evaluation was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No: This is not an AI device, so there is no algorithm-only performance to assess. The device itself is a physical medical component.
7. The Type of Ground Truth Used
- Biocompatibility: Adherence to established international standards (ANSI/AAMI/ISO 10993, Vol. 4) determined through specific laboratory assays (e.g., cytotoxicity, sensitization, irritation, etc., though not detailed in the text).
- Cellular Damage & Hemolysis: Objective laboratory measurements of hematologic parameters (hematocrit, platelet count, WBC count, plasma free hemoglobin, % hemolysis) in comparison to established predicate device performance.
- Effectiveness (Leaks): Absence of visible air bubbles during a pressurized water submersion test.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" as this is not an AI/machine learning device. The device is a physical product, and its performance is evaluated through direct testing, not through a model trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this item is not relevant.
§ 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).