K961166 · Hne Healthcare, Inc. · JOW · Oct 11, 1996 · Cardiovascular
Device Facts
Record ID
K961166
Device Name
FLOWTRON EXCEL PUMP
Applicant
Hne Healthcare, Inc.
Product Code
JOW · Cardiovascular
Decision Date
Oct 11, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.5800
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
External pneumatic compression system; consists of AC550 pump and Flowtron DVT compression garments (calf/thigh). Used in clinical settings to prevent DVT. Pump utilizes compressor, timing motor, and valves to inflate garments. Microprocessor-controlled pressure transducer monitors output; provides audible/visible fault alarms and real-time pressure display. Physician-prescribed; operator-managed. Output informs clinician of system performance and pressure delivery; aids in DVT prophylaxis.
Clinical Evidence
No clinical data provided; bench testing only. Device relies on established history of external pneumatic compression therapy.
Technological Characteristics
Pneumatic compression pump; microprocessor-controlled pressure transducer; audible/visible LED fault monitoring; real-time pressure display. Compliance: UL listed, European Medical Directive (EMC).
Indications for Use
Indicated for patients at risk of deep vein thrombosis (DVT) requiring external pneumatic compression therapy.
Regulatory Classification
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.
Predicate Devices
Flowtron®DVT (K88xxxx)
Flowtron DVT AC500
Submission Summary (Full Text)
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K961166
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 calf/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 compatibility.
The Flowtron®Excel raises no new safety or effectiveness concerns.
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