(77 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and fluid dynamics of a tubing set, with no mention of data processing, algorithms, or learning capabilities.
No
The device is a tubing set that serves as a fluid delivery pathway to and from a hemoconcentrator, which is a device that removes excess fluid from the blood. The tubing itself does not directly treat a disease or condition.
No
The device is a tubing set for fluid delivery in extracorporeal circuits, specifically for hemoconcentration, and does not perform diagnostic functions. It is used to transport blood, not to analyze it for diagnostic purposes.
No
The device description clearly states it is a "Tubing Set" made of "PVC tubing" with "luer fittings" and "quick connect/disconnect fittings," indicating it is a physical, hardware-based medical device.
Based on the provided information, the TS3 Tubing Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to serve as a fluid delivery pathway for blood during extracorporeal circuits and hemoconcentration. This is a mechanical function related to blood handling outside the body.
- Device Description: The description focuses on the physical components of the tubing set (PVC tubing, fittings, quick connects, snap closures) and its function in facilitating fluid flow.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other biological samples to provide diagnostic information about a patient's health or condition. The performance studies focus on the device's safety and effectiveness in handling blood without causing damage, not on its ability to diagnose.
- Key Metrics: The key metrics measured (hematocrit, platelet depletion, etc.) are related to the impact of the device on the blood itself, not on providing a diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The TS3 Tubing Set's function is purely mechanical in facilitating the movement of blood during a medical procedure.
N/A
Intended Use / 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.
Product codes
DWF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JUN 2 6 2003
Pill
510(k) SUMMARY
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.
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
1
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.
2
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
3
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