(265 days)
Sequestra, ELMD 500
Despite there being a section titled "Reference Device(s)," the text explicitly states "Not Found" within that section. Therefore, there are no reference devices to list.
No
The description focuses on mechanical processes (centrifugation, washing) and does not mention any AI/ML terms or functionalities.
Yes
The device is used for the collection, processing, and reinfusion of autologous blood, which is a therapeutic intervention aimed at treating the patient by returning their own blood.
No
Explanation: The device is described as an "autotransfusion apparatus" that collects, processes, and reinfuses autologous blood. Its purpose is therapeutic (blood reinfusion) rather than diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is an "autotransfusion apparatus (including disposable kit)" and describes physical processes like centrifugation, washing, and pumping, indicating it is a hardware device with associated software.
Based on the provided text, the autoLog™ is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the collection, concentration, washing, and reinfusion of autologous blood back into the patient. This is a process performed on blood within the patient's circulatory system (or intended to be returned to it), not for analyzing blood outside the body to diagnose a condition.
- Device Description: The description details a system for processing blood for reinfusion, not for performing tests or analyses on blood samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood components for diagnostic purposes.
- Using reagents or assays to detect specific substances.
- Providing information for diagnosis, monitoring, or screening.
The autoLog™ is clearly described as an autotransfusion apparatus, which is a medical device used in surgical and post-operative settings to process and reinfuse a patient's own blood. This falls under the category of devices used for therapeutic or supportive purposes, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
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 .
Product codes
CAC
Device 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.
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)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The autoLog™ is substantially equivalent to the Sequestra and the ELMD 500 autotransfusion apparatus in construction and function.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).
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