(200 days)
Not Found
No
The summary describes a pneumatic compression system and does not mention any AI or ML components.
Yes
This device is identified as an external pneumatic compression system used to prevent deep vein thrombosis (DVT), which is a medical condition. Prevention and treatment of medical conditions fall under the definition of a therapeutic device.
No
The device is described as an external pneumatic compression system used to prevent deep vein thrombosis, not to diagnose it.
No
The device description explicitly states it is a "pump, coupled with the Flowtron DVT compression garments," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians." This is a therapeutic or preventative intervention applied directly to the patient's body (external pneumatic compression).
- Device Description: The device is described as an "external pneumatic compression system." This is a physical therapy or medical device used externally on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with bodily specimens or diagnostic testing.
Therefore, this device falls under the category of a medical device used for prevention/therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AC550 Flowtron®Excel pump, coupled with the Flowtron DVT compression garments, is an external pneumatic compression system used to prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians.
Product codes
Not Found
Device Description
The AC550 Flowtron®Excel pump, coupled with the Flowtron DVT compression garments, is an external pneumatic compression system used to prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians. External pneumatic compression has been in use for almost twenty years, and the HNE Healthcare predicate device, Flowtron®DVT, received premarket clearance in 1988.
The AC550 Flowtron Excel pump is the next generation of the Flowtron DVT AC500 pump. Each pump has been designed to be used with the currently marketed Flowtron DVT calf and call/thigh length compressible garments for the prevention of deep vein thrombosis (DVT). There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
The functional components of the pump (compressor, timing motor, valve) are the same. The predicate device, AC500, has an audible and visible (LED light) fault monitoring system that is comprised of logic electronics with a pressure switch input. The new device, AC550, also has an audible and visible (LED light and display) fault monitoring system, however, the input is from a pressure transducer that is microprocessor controlled. In both pumps, the alarm mechanism does not control the function of the pump, but provides a feedback of pump performance. Additionally, the new device will provide an indication of actual pump output pressures, which the predicate device does not do.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Flowtron®DVT
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
OCT 11 1996
510(k) Summary
Flowtron®Excel AC550
The AC550 Flowtron®Excel pump, coupled with the Flowtron DVT compression garments, is an external pneumatic compression system used to prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians. External pneumatic compression has been in use for almost twenty years, and the HNE Healthcare predicate device, Flowtron®DVT, received premarket clearance in 1988.
The AC550 Flowtron Excel pump is the next generation of the Flowtron DVT AC500 pump. Each pump has been designed to be used with the currently marketed Flowtron DVT calf and call/thigh length compressible garments for the prevention of deep vein thrombosis (DVT). There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
The functional components of the pump (compressor, timing motor, valve) are the same. The predicate device, AC500, has an audible and visible (LED light) fault monitoring system that is comprised of logic electronics with a pressure switch input. The new device, AC550, also has an audible and visible (LED light and display) fault monitoring system, however, the input is from a pressure transducer that is microprocessor controlled. In both pumps, the alarm mechanism does not control the function of the pump, but provides a feedback of pump performance. Additionally, the new device will provide an indication of actual pump output pressures, which the predicate device does not do.
There are no performance standards established for this category of medical device (Class II -Compressible Limb Sleeves). Voluntary standards met include UL listing and compliance with the European Medical Directive for electromagnetic compatability.
The Flowtron®Excel raises no new safety or effectiveness concerns.