(52 days)
No
The description focuses on mechanical processes (centrifugation, washing, pumping) and does not mention any computational or algorithmic decision-making that would suggest AI/ML.
No.
A therapeutic device is one that treats a disease or condition. This device collects, processes, and reinfuses autologous blood but does not treat a disease or condition itself.
No
Explanation: The device is an autotransfusion system designed for collecting, processing, and reinfusing autologous blood, not for diagnosing medical conditions. Its function is therapeutic/supportive, not diagnostic.
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 system with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the collection, processing, and reinfusion of autologous blood within the patient's body (peri-operatively and post-operatively). This is a therapeutic procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system for processing blood for reinfusion, not for analyzing blood components to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples to provide diagnostic information about a disease or condition.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is involved in a direct therapeutic intervention on the patient's blood.
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 intended use of this premarket notification has not changed from the autoLog 510(k) - K972894.
Product codes
CAC
Device Description
"The autoLog Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and post-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, and 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
A qualification was done to confirm that no functional differences between the predicate and the modified device exist. This testing was specific to the changes proposed.
Key Metrics
Not Found
Predicate Device(s)
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
| AUG 20 1998 | 510K Summary | K98275 | |
|---|---|---|---|
| Submitted by: | Medtronic Blood Management | ||
| 18501 E. Plaza Drive | |||
| Parker, CO 80134-9061 USA | |||
| Manufacturing Facility: | Medtronic Blood Management | ||
| 18501 E. Plaza Drive | |||
| Parker, CO 80134-9061 USA | |||
| Submitted Device: | Modification to existing device: This submission would allow the use of an | ||
| adjustable external vacuum regulator. | |||
| Trade Name: autoLog Autotransfusion System | |||
| 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 description of the device remains the same as 510k # K972894. | ||
| "The autoLog Autotransfusion System is an autotransfusion apparatus (including | |||
| disposable kit). The system is a centrifugal unit that is used to collect autologous | |||
| blood peri-operatively and post-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, | |||
| and may be reinfused to the patient." | |||
| Intended Use: | The intended use of the device has not changed from 510k # K972894. It remains | ||
| as follows: | |||
| "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 established for this device. |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of Substantial
Equivalence - Predicate
Device: | This device is substantially equivalent to the autoLog Autotransfusion System
(K972894). The modification concerns the use of an external adjustable vacuum
regulator in place of the current internal non-adjustable vacuum regulator. Except
for the ability to adjust the vacuum delivered to the reservoir bag, all other features,
specifications, operating principles and materials of the device are identical. There
are no changes that affect the biocompatability or the sterility of the system's
disposables. |
| Testing: | A qualification was done to confirm that no functional differences between the
predicate and the modified device exist. This testing was specific to the changes
proposed. |
.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1998
Mr. Stephen McKelvey QA Project Manager Medtronic Blood Management 18501 East Plaza Drive Parker, CO 80134-9061
Re : K982755 autoLog Autotransfusion System Regulatory Class: II (Two) Product Code: CAC Dated: June 26, 1998 Received: June 29, 1998
Dear Mr. McKelvey:
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 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, Druq, 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 Requlations, 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 requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
3
Page 2 - Mr. Stephen McKelvey
This letter will allow you to beqin 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" Other general information on your (21CFR 807.97). 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.qov/cdrh/dsma/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, 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): ¥ 98 2755
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
The intended use of this premarket notification has not changed from the autoLog 510(k) - K972894.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seeee E. Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_1 982755
Prescriptive Use
OR
Over-the-Counter Use