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Vaccines, Blood & Biologics

BK120029 Letter


Patient Safe™ Solutions, Inc.
Attention: Ms. Rebecca K. Pine
5375 Mira Sorrento Place, Suite 500  
San Diego, CA 92121 
Re:                                         BK120029
Device Name:                           Patient Touch™ Blood Product Administration System v3.2.1
Regulation Name:                    Stand Alone, Blood Bank Software
Regulatory Class:                    Unclassified
Product Code:                         MMH
Dated:                                     November 7, 2012
Received:                                November 7, 2012
Dear Ms. Pine:
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. Please note: CBER does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 807); labeling (21 CFR 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 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 on promotional labeling and advertisement for your device, please contact our Advertising and Promotional Labeling Staff (HFM-602) at (301) 827-3028.  Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 803), please go to: 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:
Sincerely yours,
Richard J. Davey, M.D.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research
Indications for Use
510(k) Number:           BK120029
Device Name:              Patient Touch™ Blood Product Administration System v3.2.1
Indications for Use:
The PatientTouch™ Blood Product Administration System is a point-of-care Transfusion Safety Management System composed of computers, a software application, wireless handheld barcode scanners and wireless printers.  The PatientTouch™ Blood Product Administration System is intended to assist in positive patient identification for the transfusion of blood products.  The system assists phlebotomists with correct labeling of specimen collection tubes at the patient's bedside, assists laboratory personnel in accurate matching of blood samples with correct blood products, and assists nurses in transfusing blood products to the correct patient. The PatientTouch™ Blood Product Administration System is intended to increase transfusion safety and is intended for use by healthcare professionals trained in the administration of blood transfusions.

The PatientTouch™ Blood Product Administration System is intended to:

  1. Assist the caregiver in assuring blood product administration patient safety by:
    1. Assisting phlebotomy personnel in assuring blood samples are drawn from the  correct patients.
      1. The system prompts the caregiver to confirm that the orders to draw blood are for the correct patient.
      2. The system matches patient wristband bar codes to blood sample label bar codes at time of blood sample draws.
    1. Assisting laboratory personnel in accurate matching of blood samples with correct blood / blood products.
      1. The system matches blood / blood product label bar codes and bar codes on blood specimen tubes.
      2. Prints an accessory “bag tag” for the blood / blood product which further identifies the blood / blood product for the correct patient.
      3. The system prompts the blood bank professional to confirm that the information on the blood bag label matches the information that is on the blood product tag prior to attaching the blood product tag to a blood product bag
    1. Assisting nursing personal to administer blood / blood product to the correct patient.
      1. The system matches blood / blood product bag label bar codes and bag tag label bar codes to bar codes on patient wristband.
      2. Assists with the witnessing of blood / blood product administration by requiring a second nurse badge to be scanned at time of administration (an optional feature).
  1. Assist in assuring complete and accurate documentation of blood/blood product administration
    1. Assists the caregiver by recording the exact time of blood / blood product release from the laboratory and assists with blood expiration date tracking
    2. Assists the caregiver by recording the exact time of blood / blood product administration start and stop.
    3. Provides alerts to the caregiver to check patient and user-defined intervals during the course of blood / blood product administration and prompts the caregiver to complete required documentation.
    4. Prints reports listing the start, stop and duration of blood product administration on a transfusion record.
  2.  Promote safety and efficiency in blood product pick-up process (an optional feature).
    1. Alerts the caregiver when blood is ready for pick-up in the blood storage area.
    2. Optionally prints a blood request form used to pick-up blood, which can reduce the risk of the wrong blood being obtained at the blood bank.
  1. Interface with the Hospital Information System and the Laboratory Information System.
    1. Patient data and lab orders are received and stored in the PatientTouch™ System database to prompt the healthcare personnel to complete predefined workflows.
    1. The PatientTouch™ System can be configured to print reports from the database. Instrument Manager is a software package intended to be used by trained laboratory personnel in a blood-banking environment as an aid in interfacing and managing data, between blood bank automated instruments and Blood Establishment Computer Software (BECS).

Page Last Updated: 11/15/2012
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