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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

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.

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The HEMOBAG™ is a blood circulating storage reservoir designed to collect anticoagulated whole blood salvaged from extracorporeal circuits after the patient has been disconnected from the circuit. When used in connection with the TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAG™ serves as a reservoir for circulating and hemoconcentrating blood in a closed circuit recovery loop.

The HEMOBAG™ Blood Salvage Device is a storage reservoir for blood that can be held, circulated and hemoconcentrated. It is designed for use in salvaging anticoagulated whole blood from extracorporeal circuits. When used in conjunction with a TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAG™ serves as a hemoconcentrating reservoir for use in a closed circuit recovery loop for removal of excess plasma water and low molecular weight solutes. The richly concentrated, anticoaqulated, autologous whole blood is then quickly made available to the patient for gravity transfusion.

The HEMOBAG™ is designed with a universal (1/4" – 3/8″) stepped connector on the arterial infusion port to allow lines of varying sizes to be attached to the bag. The inlet and outlet ports of the bag are designed with quick connect/disconnect ¼" connectors to mate with the TS3 Tubing set for fluid delivery to and from the hemoconcentrator. The HEMOBAG™ is equipped with a needleless port for ease of access. The HEMOBAG™ has been designed with a spike port to facilitate gravity transfusion. A baffle has been positioned inside the bag to allow the blood from the hemoconcentrator to enter the bag and circulate toward the top of the bag and down again to the outlet port allowing proper mixing and flow during hemoconcentration.

The provided text details a 510(k) summary for the HEMOBAG™ Blood Salvage Device. It includes information on safety and effectiveness testing.

Here's an analysis of the provided information against your requested criteria:

Study Information Pertaining to the HEMOBAG™ Blood Salvage Device

• Device successfully passes biological evaluation (biocompatibility testing) per ANSI/AAMI/ISO 10993, Vol. 4 for limited exposure medical devices with circulating blood contact.
• Cellular damage (change in hematocrit, platelet depletion, white blood cell count, plasma free hemoglobin, and calculated % hemolysis) introduced by the device during blood circulation should not be statistically significant compared to a predicate device.
• Acceptable hematological parameters are maintained during testing.

Effectiveness Acceptance Criteria:

• Device must accommodate and hold up to 2000ml of anticoagulated whole blood.
• Device must function as a reservoir for hemoconcentration by ultrafiltration.
• Device must allow circulation of fluid at a rate of 300-500ml/minute for 10-15 minutes (design specification for blood).
• Device must maintain structural integrity (no leaks/failure) when overfilled with warm water by 10-20% and hung for 2 hours, and during water circulation at 2000 ml/minute for 2 hours (stressed conditions).
• Rounded corners and baffle must facilitate proper mixing and flow during hemoconcentration.

Reported Device Performance:

• Biocompatibility: The device successfully passed all specified biocompatibility tests.
• Cellular Trauma (Safety): The difference in cellular damage between the HEMOBAG™ and the predicate device was statistically insignificant. Hematological parameters were acceptable.
• Holding Capacity (Effectiveness): The device successfully held up to 2000ml of fluid.
• Circulation & Reservoir Function (Effectiveness): The device successfully circulated fluid at a rate of 2000 ml/minute for 2 hours (exceeding blood circulation design targets of 300-500ml/min for 10-15 min). It withstood overfilling and hanging.
• Mixing and Flow (Effectiveness): Rounded corners and interior baffle allow for proper mixing and flow. |
  | 2. Sample Size & Data Provenance (Test Set) | Safety Testing:
• A single evaluation was performed comparing the HEMOBAG™ to a predicate device using "anticoagulated bovine whole blood." The specific number of test runs or samples is not explicitly stated, but it implies a direct comparison on a test circuit.
• Data provenance: In vitro testing using bovine blood. Country of origin not specified, but likely within the US given the submission to the FDA. Retrospective or prospective is not applicable as it is laboratory testing.

Effectiveness Testing:

• The functionality was "successfully tested." This implies a series of tests, but the exact number of HEMOBAG™ devices or test runs is not specified.
• Data provenance: In vitro testing using warm water. Country of origin not specified. Retrospective or prospective is not applicable. |
  | 3. Number & Qualifications of Experts for Ground Truth (Test Set) | Not applicable. This device's testing involves direct measurement of physical and biological parameters (e.g., cell counts, fluid volume, flow rates) and in vitro biocompatibility tests, not subjective expert assessment of images or clinical outcomes. The "ground truth" is established by laboratory measurements and adherence to specified performance metrics. |
  | 4. Adjudication Method (Test Set) | Not applicable, as there's no subjective assessment requiring adjudication. The evaluation relies on quantitative measurements. |
  | 5. MRMC Comparative Effectiveness Study | No. This device is a blood salvage and storage reservoir, not an AI diagnostic tool or imaging device that would typically undergo an MRMC study. The comparison made was between the device's impact on blood components and a predicate device. |
  | 6. Standalone (Algorithm Only) Performance Study | Yes, in a sense. The entire testing described focuses on the device's standalone performance (i.e., how it performs as a physical product) without a human operator's variable input being the primary focus of the evaluation. There is no algorithm, so "algorithm only" is not applicable, but the device's functionality and safety were assessed independently. |
  | 7. Type of Ground Truth Used | - Safety Testing: Laboratory measurements of cellular depletion, hemolysis (plasma free hemoglobin, calculated % hemolysis), hematocrit changes, platelet depletion, and white blood cell count. Comparison to a predicate device served as a comparative benchmark. Successful passage of standardized biocompatibility tests.
• Effectiveness Testing: Direct measurement of fluid containment, circulation rates, and structural integrity under stress, against defined performance specifications. |
  | 8. Sample Size for Training Set | Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set." |
  | 9. Ground Truth for Training Set | Not applicable, as there is no training set for a physical device. |

Summary of Device Performance to Acceptance Criteria:

The HEMOBAG™ successfully met all stated acceptance criteria for both safety and effectiveness based on the described in vitro studies.

• Safety: It passed biocompatibility tests and demonstrated statistically insignificant cellular damage compared to a predicate device under stressed circulation conditions.
• Effectiveness: It successfully held and circulated fluid at or above specified rates under stressed conditions, confirming its functionality as a storage and hemoconcentration reservoir.

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