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.

Device Description

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.

AI/ML Overview

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.

Summary

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JUN 2 6 2003

K031151

Pill

510(k) SUMMARY

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.

SAFETY TESTING

The sterile TS3 Tubing Set was subjected to Biological Evaluation (biocompatibility testing) using the quidelines provided in ANSI/AAMI/ISO 10993, Vol. 4 for limited exposure medical devices that have contact with circulating blood used in Cardiopulmonary Bypass and extracorporeal circuits. The device successfully passed all of these tests.

The TS3 Tubing set was evaluated together with the HEMOBAG™ to determine whether or not the devices introduced more trauma to the blood than the predicate devices (the predicate device for the HEMOBAG ™ is the Medtronic Venous Reservoir Bag). The evaluation was performed by determining the cellular depletion and hemolysis of anticoagulated bovine whole blood that had been circulated through the HEMOBAG™ and TS3 Tubing Set at a rate of approximately 1.2 liters per minute for a 1-hour period. An identical evaluation was performed on the anticoaqulated blood that had been circulated through the predicate devices (Medtronic Venous Reservoir Bag and Baxter ¼": tubing) in the same manner. The results of these tests proved that the difference between the amount of cellular damage noted in the blood that had been circulated through the HEMOBAG™ TS3 Tubing Set circuit and that which had been circulated through the predicate device circuit was statistically insignificant. Cellular damage was measured by change in hematocrit, platelet depletion, white blood cell count, plasma free hemoglobin evaluation and calculated percent (%) hemolysis. Blood in the test circuits was evaluated and found to have demonstrated acceptable hematologic parameters during the test period. Since the test parameters used are far worse than the parameters that will be used in clinical use, this device is considered safe with respect to cellular damage and hemolysis when used under abnormal stressful conditions.

EFFECTIVENESS

The function and purpose of this device is to allow fluid to flow to and from the hemoconcentrator during conventional hemoconcentration as an adjunct to the Cardiopulmonary Bypass Circuit or as a fluid pathway between the hemoconcentrator and the HEMOBAG™ Blood Salvage Device Reservoir during closed circuit hemoconcentration. The TS3 Tubing set was designed using materials, components and processes that will allow the tubing set to be attached to any commercially available hemoconcentrator and the HEMOBAG™ Blood Salvage Device Reservoir. The TS3 Tubing Set is intended to be used as a fluid pathway for fluid that is circulating at a rate of 300 - 500 ml per minute for approximately 10 - 15 minutes. The device was successfully tested for leaks by applying internal air pressure of 12psi, submerging under water for a 30-second test period and observing the set for air leakage. Since the test parameters represent a scenario far worse than those seen in clinical use, the device is considered effective with respect to its ability to serve as a fluid pathway during hemoconcentration.

APPENDIX D

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2003

Global Blood Resources, LLC Mr. Keith Samolyk, CCP President & CEO 998 Windsor Avenue Windsor, CT 06096

Re: K031151

Trade/Device Name: TS3 Tubing Set Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 7, 2003 Received: April 10, 2003

Dear Mr. Samolyk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Keith A. Samolyk, CCP.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Юееетм

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) - Unknown

Device Name: TS3 Tubing Set

Indications For Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

N. Ocattich

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K031151

Prescription Use Only

Regulation Number and Section

§ 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).