AUTOTRANSFUSION APPARTUS (AUTOLOG)

{0}------------------------------------------------ KG72894 ## APR 2 7 1998 510(k) SUMMARY Submitted by: Medtronic Blood Management 18501 E. Plaza Drive Parker. Colorado 80134 Manufacturing Facility: Medtronic Blood Management 18501 E. Plaza Drive Parker. Colorado 80134 Submitted Device: autoLog™ Autotransfusion System Trade Name: Common Name: Autotransfusion Apparatus Device Classification: Class II 21 CFR § 868.5830 "Autotransfusion Apparatus" which is identified as, "an autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma." Product Description: The autoLog™ is an autotransfusion apparatys (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and ppst-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline are pumped to a transfer bag that may be reinfused to the patient. Intended Use: The autoLog™ is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following: General, Cardiovascular, . Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical Postoperative treatment areas {1}------------------------------------------------ | Performance Standards: | Per section 514 of the Food , Drug and Cosmetics Act, there are no specific performance standards for this device. | |------------------------|--------------------------------------------------------------------------------------------------------------------| |------------------------|--------------------------------------------------------------------------------------------------------------------| The autoLog™ is substantially equivalent to the Sequestra and Statement of substantial : the ELMD 500 autotransfusion apparatus in construction and equivalence - Predicate Device function. | FEATURES | AUTOLOG | ELMD 500 | SEQUESTRA | | | | | | | | | | | | | | | | | | | | | |-----------------------------|--------------|---------------|---------------|-------------------|--------------|----------|----------|--|----------|----------|----------|--------------------------|-----|-----|-----|-----------------------------|---------|---------|---------|--------------------|--------|-----------|-----------| | Microprocessor Controlled | Yes | Yes | Yes | | | | | | | | | | | | | | | | | | | | | | Automatic Operation | Yes | Yes | Yes | | | | | | | | | | | | | | | | | | | | | | Number of Programs | 1 | 5 | 6 | | | | | | | | | | | | | | | | | | | | | | Manual Operation | Yes | Yes | Yes | | | | | | | | | | | | | | | | | | | | | | Continuous Wash Program | Yes | No | Yes | | | | | | | | | | | | | | | | | | | | | | Blood Level Sensor | Yes | Yes | Yes | | | | | | | | | | | | | | | | | | | | | | Air Bubble Detector | Yes | Yes | Yes | | | | | | | | | | | | | | | | | | | | | | Centrifuge Drive | Direct | Direct | Direct | | | | | | | | | | | | | | | | | | | | | | Centrifuge Speed (RPM) | 10000 | 1000-5600 | 1000-5600 | | | | | | | | | | | | | | | | | | | | | | Digital Display | Yes | Yes | Yes | | | | | | | | | | | | | | | | | | | | | | Data Input | Push Button | Touch Screen | Touch Screen | | | | | | | | | | | | | | | | | | | | | | Blood Pump Flow (ml/min) | 0-1000 | 50-500 | 10-1000 | | | | | | | | | | | | | | | | | | | | | | Bowl Size (ml) | 135 | 125, 225, 375 | 125, 225, 375 | | | | | | | | | | | | | | | | | | | | | | I.V. Poles | 1 | 2 | 2 | | | | | | | | | | | | | | | | | | | | | | Construction | Metal | Metal | Metal | | | | | | | | | | | | | | | | | | | | | | Built in Vacuum | Yes | No | Yes | | | | | | | | | | | | | | | | | | | | | | Waste Bag (liters) | 10 | 10 | 10 | | | | | | | | | | | | | | | | | | | | | | Voltage | 100/110/220/ | 100/110/220/ | 100/110/220/ | | | | | | | | | | | | | | | | | | | | | | | 240 | 240 | 240 | Operating Current | 0.8-1.6 amps | 4/2 amps | 4/2 amps | | 50/60 Hz | 50/60 Hz | 50/60 Hz | Power Disspation (watts) | 200 | 500 | 500 | Operating Temperature Range | 10-30 C | 10-27 C | 10-27 C | Operating Humidity | 10-95% | up to 95% | up to 95% | | | 240 | 240 | 240 | | | | | | | | | | | | | | | | | | | | | | Operating Current | 0.8-1.6 amps | 4/2 amps | 4/2 amps | | | | | | | | | | | | | | | | | | | | | | | 50/60 Hz | 50/60 Hz | 50/60 Hz | | | | | | | | | | | | | | | | | | | | | | Power Disspation (watts) | 200 | 500 | 500 | | | | | | | | | | | | | | | | | | | | | | Operating Temperature Range | 10-30 C | 10-27 C | 10-27 C | | | | | | | | | | | | | | | | | | | | | | Operating Humidity | 10-95% | up to 95% | up to 95% | | | | | | | | | | | | | | | | | | | | | ## COMPARISON TO PREDICATE DEVICES Testing: Testing was done to confirm system and software performance. These included, but were not limited to; system/software risk analysis, functional system qualification, and "system black box testing". {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## APR 27 1998 Ms. Joyce Thomas Quality Systems and Regulatory Affairs Manager Medtronic Blood Management 18501 E. Plaza Drive Parker, CO 80134-9061 Re : K972894 autoLog™ Autotransfusion Regulatory Class: II (Two) Product Code: CAC Dated: March 10, 1998 Received: March 11, 1998 Dear Ms. Thomas: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, labelinq, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Ms. Joyce Thomas This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html." Sincerely yours, Thomas J. Callihan Thomas J. Callanan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INTENDED USE STATEMENT 510(k) Number (if known): Device Name: autoLog™ Autotransfusion System Indications For Use: The autoLog™ is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following: - . General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical - Postoperative treatment areas . (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dece & Dece C. (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 972894 Prescriptive Use OR 510(k) Number_ Over-the-Counter Use - - - AutoLog 510(k) submission