• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

BK110071 Letter

 

Terumo Medical Corporation
Attention: Ms. Lauren Clark
10811 West Collins Avenue
Lakewood, CO 80215-4440
 
Re:  BK110071
Trade/Device Name:     TSCD®II Sterile Tubing Welder with or without Trucise® Total System
Regulation Number:      21 CFR 864.9875
Regulation Name:         Set, Transfer (Blood/Plasma)
Regulatory Class:          Class II
Product Code:              KSB
Dated:                         September 7, 2012
Received:                    September 7, 2012
 
Dear Ms. Clark:
 
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 (the 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 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.
 
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
 
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 
 
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638‑2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
 
 
Sincerely yours,
 
 /s/
 
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research
 
 
Enclosure


Indications for Use                                                                            

510(k) Number: BK110071
 
Device Name: TSCD®II Sterile Tubing Welder with or without Trucise® Total System
 
Indications For Use:
 
The Terumo Sterile Connecting Device (TSCD-II) is used to connect two closed internally sterile components such as a blood collection container, apheresis set, transfer set or needle set by making a sterile weld in the tubing connected to these components.  These welds may consist of dry-to-dry, wet-to-dry or wet-to-wet connections.  The resulting sterile component may be used in blood collection, blood component processing or transfusion applications. Uses include, but are not limited to:
  • Attaching additional blood component containers to a blood collection set to enable component separation or division of the original component into smaller aliquots
  • Attaching containers of processing or additive solutions to a blood component to perform a process such as cell washing or freezing or to extend the storage time of the component
  • Attaching blood component containers to a pooling set to enable pooling of components from multiple donations
  • Attaching a leukocyte reduction filter to a red blood cell or platelet component container to enable removal of leukocytes from the component
  • Attaching a sampling pouch to a blood component container to enable the removal of samples of the component for testing
  • Replacing the original needle on a collection set with a new needle of the same or smaller gauge to enable the use of the set or to facilitate a therapeutic procedure such as plasma exchange
The TSCD®-II device is not to be used with tubing connected to a person.
This device is for use by trained individuals in such settings as blood bank laboratories and hospitals.
 
The Trucise is an optional accessory information system device intended for use with the Terumo Sterile Tubing welders, TSCDII and TSCD, to electronically collect information and provide traceability of each sterile connection made by the welder.  The system design and requirements add process control capability to the sterile connection process.