(144 days)
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No
The summary describes a mechanical compression device and its upgrade, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML technologies in medical devices.
Yes
The device's intended use is to prevent deep vein thrombosis and pulmonary embolism, which are medical conditions, by increasing venous blood flow. This indicates a therapeutic purpose.
No
The device is described as an upgrade to a pump system that prevents deep vein thrombosis and pulmonary embolism by increasing blood flow through intermittent compression, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is an "upgrade of the Jobst Athrombic Pump System 2000 to the System 2100" and covers the use of "thigh length sleeves." It is also classified as a "compressible limb sleeve" under 21 CFR 870.5800. These descriptions clearly indicate a physical hardware component (the pump system and sleeves) is involved, not just software.
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 and pulmonary embolism by physically compressing the lower extremities. This is a mechanical action on the body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The device is described as a "compressible limb sleeve" and is classified under 21 CFR 870.5800, which is for "Compressible limb sleeve". This classification is for devices that apply external pressure to the limbs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing any kind of diagnostic test on bodily fluids or tissues.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device operates externally on the body to improve blood flow.
N/A
Intended Use / Indications for Use
Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremittles. This is accomplished by intermittent compression of the muscles in the calf and thigh.
Product codes
870.5800
Device Description
This submission covers the upgrade of the Jobst Athrombic Pump System 2000 to the System 2100. It also covers the use of thigh length sleeves with the System 2100. This device is classified as a compressible limb sleeve under 21 CFR 870.5800.
The Jobst Athrombic Pump console for the System 2100 is almost identical to the pump console for the System 2000 previously cleared, except for a few minor modifications that are clearly identified in this submission.
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
lower extremittles, calf and thigh
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
The Jobst Athrombic Pump System 2000 with calf sleeve and the Flowtron DVT/thigh sleeve systems have both proven effective for several years.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 27 1997
K963929
510(k) Summary of Safety and Effectiveness
This submission covers the upgrade of the Jobst Athrombic Pump System 2000 to the System 2100. It also covers the use of thigh length sleeves with the System 2100. This device is classified as a compressible limb sleeve under 21 CFR 870.5800.
The System 2100 with the thigh length sleeve is substantially equivalent to the Flowtron DVT/thigh sleeve system marketed by Huntleigh Healthcare in the mode of operation and the indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremittles. This is accomplished by intermittent compression of the muscles in the calf and thigh.
Furthermore, the Jobst Athrombic Pump console for the System 2100 is almost identical to the pump console for the System 2000 previously cleared, except for a few minor modifications that are clearly identified in this submission.
The Jobst Athrombic Pump System 2000 with calf sleeve and the Flowtron DVT/thigh sleeve systems have both proven effective for several years. The System 2100 combines the benefits of the two systems and provides a device that is safe and effective.
Date: August 16, 1996
Prepared by: Angelo R. Pereira Beiersdorf-Jobst. Inc. 5825 Camegie Boulevard Charlotte, NC 28209 Phone: (704) 551-7178