(30 days)
Not Found
No
The description focuses on mechanical and automated processes (centrifugation, pumping, optical sensors) and does not mention any AI or ML components.
Yes
The device is used for the collection, concentration, washing, and reinfusion of autologous blood, which directly contributes to the treatment of a patient.
No
This device is designed for the collection, processing (concentration, washing), and reinfusion of autologous blood. Its function is to prepare blood for reinfusion, not to diagnose a condition or disease.
No
The device description clearly outlines a system that includes physical components such as an instrument with an integrated vacuum pump, roller pump, valve, and centrifuge. It also requires disposable hardware components like a wash kit, collection reservoir, and suction line. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "collection, concentration, washing, and reinfusion of autologous blood." This describes a process performed on the patient's blood outside the body for the purpose of reinfusion, not for diagnostic testing.
- Device Description: The description details the mechanical process of collecting, processing (centrifugation and washing), and preparing blood for reinfusion. It focuses on the physical manipulation of the blood components.
- Lack of Diagnostic Purpose: There is no mention of analyzing the blood for diagnostic information, identifying diseases, or monitoring health conditions. The goal is to prepare the blood for reintroduction into the patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's purpose is therapeutic (reinfusion of blood), not diagnostic.
N/A
Intended Use / Indications for Use
The autoLog IQ autotransfusion system and Medtronic wash kit are in the collection, concentration, washing, and reinfusion of autologous blood. Areas of application may include, but are not limited to, the following:
. Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and neurological
Postoperative treatment areas
Product codes
CAC
Device Description
The autoLog IQ Autotransfusion System is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. The system refers to the instrument (the subject of this submission); disposable devices are also required to operate the system: the Medtronic wash kit, collection reservoir, and suction line. This autologous blood is first filtered through the prefilter in the collection reservoir, and 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. The autoLog IQ Autotransfusion System (also referred to as the "instrument" or the "system") is not patient contacting. However, the disposable devices needed to operate the system - the Medtronic wash kit, collection reservoir, suction line - are patient contacting, and are the same disposables used by the predicate autoLog Autotransfusion System device (K093535).
The collection and concentration/washing of patient blood are handled independently by the system. The collection process requires the installation of a disposable reservoir and the activation and use of the integrated vacuum pump, which is built into the system, or an external vacuum source. The system has an integrated internal regulator which ensures safe vacuum levels. The blood is aspirated through a disposable collection suction tip/cannula and disposable suction line to the reservoir. Anticoagulant is delivered at the cannula through the anticoagulant line.
The system's concentration/washing process requires the installation of the Medtronic wash kit and the activation and use of a pump, valve, and centrifuge. When the self-start switch registers a sufficient quantity of blood in the reservoir, the system automatically starts operation. The processing includes one cycle of filling the centrifuge bowl and concentrating the red cells (while transferring effluent waste to the waste bag), one cycle of washing the red cells with saline and one cycle of transferring the packed, washed red cells to the sterile holding bag. The pump pulls blood from the reservoir into the centrifuge bowl until the optical sensor detects a full bowl; then the roller pump stops and the wash solution is pumped into the packed red cell mass. After the washing cycle, the pump transfers the washed, packed red cells to the holding bag.
Medical personnel complete the final reinfusion of the collected and washed blood to the patient. Hospital personnel are instructed to dispose the waste bag (containing plasma waste, saline, and contaminating debris) in accordance with hospital guidelines.
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
Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and neurological
Postoperative treatment areas
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
Testing has demonstrated that the autoLog IO Autotransfusion System is substantially equivalent to the predicate.
The following tests were conducted:
- Software Unit, Integration, and System - Pass
- Setup and Breakdown - Pass
- Enclosure and Chassis - Pass
- Cleanability - Pass
- Unpackaged Transport - Pass
- Vacuum - Pass
- Roller Pump, Valve, and Weight Sensor - Pass
- EE & Power Subsystem - Pass
- Operating Conditions - Pass
- Blood Washing Performance - Pass
- Usability (Human Factors) - Pass
- IEC 60601-1, IEC 60601-1-6, IEC 60529 - Pass
- IEC 60601-1-2 - Pass
- Packaging and Transport - Pass
Key Metrics
Not Found
Predicate Device(s)
autoLog Autotransfusion System, 510(k) K093535
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 22, 2018
Medtronic Perfusion Systems Sue Fidler Senior Regulatory Affairs Supervisor 7611 Northland Drive Brooklyn Park. Minnesota 55428
Re: K181954
Trade/Device Name: autoLog IQ Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: July 17, 2018 Received: July 23, 2018
Dear Sue Fidler:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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: CDRH 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Fernando Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181954
Device Name autoLog IQ™ Autotransfusion System
Indications for Use (Describe)
The autoLog IQ autotransfusion system and Medtronic wash kit are in the collection, concentration, washing, and reinfusion of autologous blood. Areas of application may include, but are not limited to, the following: · Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and neurological
· Postoperative treatment areas
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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Page of
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5.0 510(k) Summary
| Date Prepared: | July 17, 2018 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Chelsea Pioske |
| Senior Regulatory Affairs Supervisor | |
| Phone: 763.514.9838 | |
| Fax: 763.367.8361 | |
| E-mail: chelsea.pioske@medtronic.com | |
| Alternate Contacts: | |
| Jake Roeller | |
| Senior Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: 763.526.0404 | |
| Fax: 763.367.8360 | |
| Email: jake.w.roeller@medtronic.com | |
| Sue Fidler | |
| Senior Regulatory Affairs Program Manager | |
| Medtronic Perfusion Systems | |
| Phone: 763.514.9839 | |
| Fax: 763.367.8360 | |
| Email: susan.c.fidler@medtronic.com | |
| Trade Name: | |
| Common Name: | |
| Product Code: | |
| Regulation Number: | |
| Classification: | |
| Classification Panel: | |
| Special Controls: | autoLog IQ Autotransfusion System |
| Autotransfusion apparatus | |
| CAC | |
| 21 CFR 868.5830 | |
| Class II | |
| Anesthesiology | |
| To date, no special controls or performance standards have been | |
| established for these devices. |
Name of Predicate Device:
autoLog Autotransfusion System, 510(k) K093535
K181954 510(k) Summary Page 1
4
Device Description
The autoLog IQ Autotransfusion System is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. The system refers to the instrument (the subject of this submission); disposable devices are also required to operate the system: the Medtronic wash kit, collection reservoir, and suction line. This autologous blood is first filtered through the prefilter in the collection reservoir, and 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. The autoLog IQ Autotransfusion System (also referred to as the "instrument" or the "system") is not patient contacting. However, the disposable devices needed to operate the system - the Medtronic wash kit, collection reservoir, suction line - are patient contacting, and are the same disposables used by the predicate autoLog Autotransfusion System device (K093535).
The collection and concentration/washing of patient blood are handled independently by the system. The collection process requires the installation of a disposable reservoir and the activation and use of the integrated vacuum pump, which is built into the system, or an external vacuum source. The system has an integrated internal regulator which ensures safe vacuum levels. The blood is aspirated through a disposable collection suction tip/cannula and disposable suction line to the reservoir. Anticoagulant is delivered at the cannula through the anticoagulant line.
The system's concentration/washing process requires the installation of the Medtronic wash kit and the activation and use of a pump, valve, and centrifuge. When the self-start switch registers a sufficient quantity of blood in the reservoir, the system automatically starts operation. The processing includes one cycle of filling the centrifuge bowl and concentrating the red cells (while transferring effluent waste to the waste bag), one cycle of washing the red cells with saline and one cycle of transferring the packed, washed red cells to the sterile holding bag. The pump pulls blood from the reservoir into the centrifuge bowl until the optical sensor detects a full bowl; then the roller pump stops and the wash solution is pumped into the packed red cell mass. After the washing cycle, the pump transfers the washed, packed red cells to the holding bag.
Medical personnel complete the final reinfusion of the collected and washed blood to the patient. Hospital personnel are instructed to dispose the waste bag (containing plasma waste, saline, and contaminating debris) in accordance with hospital guidelines.
Intended Use
The autoLog IQ autotransfusion system and Medtronic wash kit are intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Areas of application may include, but are not limited to, the following:
- . Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and neurological
- Postoperative treatment areas
5
Contraindications
The process of blood recovery is associated with few complications. The surgical team must consider the risks and relative contraindications of autotransfusion in any surgical procedure before proceeding with autotransfusion.
Comparison to Predicate Device
A comparison of the autoLog IQ Autotransfusion System to the predicate device (the autoLog Autotransfusion System) indicates the following similarities:
- Intended Use: The intended use is the same as predicate device. ●
- . Design: The general device design is the same as the predicate device.
- Interaction with Disposables: The device uses the same disposable devices as the predicate device, for the same intended purpose, and with the same basic physical interfaces with the disposables as the predicate.
- . Principles of Operation and Technology: The principles of operation are the same as the predicate device.
- . Performance: The performance is substantially equivalent to the predicate and/or reference device.
Summary of Testing
Testing has demonstrated that the autoLog IO Autotransfusion System is substantially equivalent to the predicate.
The following tests were conducted:
| Verification/Validation Test | Result |
|---|---|
| Software Unit, Integration, and System | Pass |
| Setup and Breakdown | Pass |
| Enclosure and Chassis | Pass |
| Cleanability | Pass |
| Unpackaged Transport | Pass |
| Vacuum | Pass |
| Roller Pump, Valve, and Weight Sensor | Pass |
| EE & Power Subsystem | Pass |
| Operating Conditions | Pass |
| Blood Washing Performance | Pass |
| Usability (Human Factors) | Pass |
| IEC 60601-1, IEC 60601-1-6, IEC 60529 | Pass |
| IEC 60601-1-2 | Pass |
| Packaging and Transport | Pass |
Conclusion
The summary of the data, included in this submission, is sufficient to show that the autoLog IQ Autotransfusion System is substantially equivalent to the legally marketed predicate device, the autoLog Autotransfusion System.