(126 days)
Not Found
No
The description focuses on mechanical processes (centrifugation, washing, pumping) and does not mention any AI/ML components or functions. The performance studies are related to biocompatibility, software validation (likely for control systems), and mechanical integrity, not AI/ML performance metrics.
Yes
The device is used to collect, concentrate, wash, and reinfuse autologous blood, which is a therapeutic intervention aimed at treating a patient's condition.
No
The device description indicates its purpose is to collect, concentrate, wash, and reinfuse autologous blood, which is a therapeutic process, not a diagnostic one.
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on 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 one.
- Device Description: The device description details a system for processing blood outside the body, but the purpose is to prepare it for reinfusion into the patient. It's a blood processing system for therapeutic use.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components for diagnostic purposes, identifying diseases, or providing information for diagnosis.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to prepare blood for reinfusion, which is a treatment-related activity.
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 necessarily limited to, the following:
- General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, . Obstetric/Gynecologic and Neurosurgical
- Postoperative treatment areas
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility and software validation test data were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
- Biocompatibility Testing
- Software Testing
- Manifold Bond Integrity Testing
- Fan Guard Cooling Testing
- Lipid Removal Characterization Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K0933535-
autoLog® Autotransfusion System Traditional 510(k)
510(k) Summary
| Date Prepared: | November 13, 2009 | |
|---|---|---|
| Submitter: | Medtronic Perfusion Systems | |
| 7611 Northland Drive | ||
| Minneapolis, MN 55428 | ||
| Establish Registration Number: 2184009 | MAR 2 2 2010 | |
| Contact Person: | Caralee Walton | |
| Senior Regulatory Affairs Specialist | ||
| Phone: (763) 514-9851 | ||
| Fax: (651) 367-8360 | ||
| Email: caralee.a.walton@medtronic.com |
Device Name and Classification:
| Trade Name: | autoLog® Autotransfusion System |
|---|---|
| Common Name: | Autotransfusion Apparatus |
| Regulation Number: | 21 CFR 868.5830 |
| Product Code: | CAC |
| Classification: | Class II |
Predicate Devices
autoLog® Autotransfusion System (K982755)
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.
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 necessarily limited to, the following:
- General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, . Obstetric/Gynecologic and Neurosurgical
- Postoperative treatment areas
1
Comparison to Predicate Devices
A comparison of the modified product and the currently marketed autoLog® Autotransfusion System indicates the following similarities to the system which received 510(k) clearance:
- Same indicated use .
- Same operating principle �
- . Same disposables (wash kit)
- Same shelf life for disposables .
- Same fluid path (patient-contacting) materials, while the manifold material is . changing from PVC to PETG, the PETG material is already in use in the disposable bowl
- Patient-contacting devices are packaged and sterilized using identical materials and . processes
Intended Use
There is no change to the intended use of the device.
Labeling
The Instructions for Use modifications include an itemized list of recovered and removed materials.
Summary of Performance Data
Biocompatibility and software validation test data were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
- Biocompatibility Testing .
- Software Testing .
- . Manifold Bond Integrity Testing
- Fan Guard Cooling Testing .
- Lipid Removal Characterization Testing �
Conclusion
The modifications to the autoLog® Autotransfusion System described in this submission result in a substantially equivalent device because the fundamental scientific principle, labeling and the intended use are unchanged as a result of these device modifications.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads facing right, representing the department's focus on individuals, families, and communities. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR 2 2 2010
Medtronic Inc. c/o Ms. Caralee Walton Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K093535
autoLog® Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: January 25, 2010 Received: January 26, 2010
Dear Ms. Walton:
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. 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.
3
Page 2 - Ms. Caralee Walton
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 (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 Part 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 for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Duna R. Lahner
B:
D
o Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _ K.0935355
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 necessarily limited to, the following:
- General, Cardiovascular, Orthopedic, Vascular, . Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical
- Postoperative treatment areas .
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. be lunes
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K093535
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