(11 days)
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No
The document describes a mechanical autotransfusion system and its disposable components, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is used to process blood for reinfusion, which falls under therapeutic use for replacing lost blood components.
No
The device is described as an "Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion." Its function is to process blood, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly lists physical components such as blood-washing chambers, adapters, lines, and bags, indicating it is a hardware-based medical device with associated disposable sets.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The primary intended use is the processing of autologous shed blood collected during or after surgery to obtain washed packed red blood cells for reinfusion into the same patient. This is a therapeutic procedure involving the patient's own blood.
- Device Description: The devices are described as components of an autotransfusion system used for processing blood for reinfusion and separation of blood components.
- Lack of Diagnostic Purpose: There is no mention of these devices being used to examine specimens in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. They are used to prepare blood for reintroduction into the patient.
IVDs are typically used to analyze samples like blood, urine, or tissue to detect diseases, measure substances, or assess a patient's health status. These devices are focused on processing blood for therapeutic use (reinfusion).
N/A
Intended Use / Indications for Use
The Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
The Fresenius Plasma Sequestration Direction Draw Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
The AT1 Autotransfusion Set includes the blood-washing chamber, adapters for mounting the set into the C.A.T.S. device, blood inlet line with stepped adapter, fluid lines; and the waste and reinfusion bags.
The Plasma Sequestration Set (PSQ) includes the bags required for collection of plasma and platelet rich plasma and the lines/connectors for connection to the whole blood bag and connection to the AT1 Autotransfusion Set.
The Plasma Sequestration Direct Draw Set (PSQ-DD) includes all the components included in the standard PSQ Set and additionally, a blood drawing/anticoagulant line assembly.
The C.A.T.S Continuous Autotransfusion System device is an autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Pack Red Cells (PRC), Plasma (PLS) and Platelet i Rich Plasma (PRP).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Fresenius C.A.T.S: ATI Autotransfusion Set Regulation Number: 868.5830 Regulatory Class: II Product Code: CAC Dated: July 11, 2001 Received: July 12, 2001
Dear Mr. Trotter:
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, 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, labeling, and prohibitions against 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 regulations 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.
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Page 2 - Mr. Tom Trotter
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) 594-4586. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard III
Division of Cardiovascular and
Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
Device Name: Fresenius AT1 Autotransfusion Set
The Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Indications for Use: Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Device Name: Fresenius Plasma Sequestration Set
The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Indications for Use: Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
Device Name: Fresenius Plasma Sequestration Direction Draw Set
The Fresenius Plasma Sequestration Direction Draw Set is a component of Indications for Use: the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012178
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use