(259 days)
Not Found
No
The device description focuses on mechanical inflation and deflation of leg wraps, and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is described as aiding in the prevention of embolisms by expelling pooled blood, which indicates a therapeutic purpose. Additionally, the predicate device names like "Athrombic Pump System" and "Pulsatile Anti-Embolism System" further support its therapeutic intent.
No
The device description clearly states its mechanical function of inflating and deflating bladders to apply pressure to the calf area, which helps to prevent embolisms. There is no mention of it collecting data, analyzing patient conditions, or providing diagnostic information. Its purpose is therapeutic/prophylactic rather than diagnostic.
No
The device description clearly outlines physical components like inflatable bladders, fabric covers, Velcro fasteners, and an inflation pump, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the PAS Wrap System is a mechanical device that applies pressure to the calf area of the leg to prevent blood clots. It does not involve the analysis of any biological samples.
- Intended Use: The intended use is to prevent embolisms by mechanically aiding blood flow, not by analyzing biological markers.
Therefore, the PAS Wrap System falls under the category of a therapeutic or preventative medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use and the contraindication are listed separately in this application.
Product codes
Not Found
Device Description
The PAS Wrap System is composed of two leg wrap members constructed of an inflatable bladder enclosed in a fabric cover with an outside surface that will accept a Velcro fastener hook strip. Extending from one side of this enclosed bladder is an elastic fabric cut to conform to the shape of the calf area of the leg. This fabric is wrapped around the back of the calf and is attached to the other side of the bladder with a Velcro fastener. The Velcro fastener allows for a tight fit on various size legs. The inflation pump is attached to the bladders and is energized. The bladder on each leg is alternately inflated and deflated to yield approximately 65mm Hg pressure on the calf area of the leg. This pressure causes pooled blood to be expelled from the calf and to proceed toward the heart. This helps to prevent embolisms from forming in the calf area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calf area of the leg
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)
Following is a summary of articles showing the benefits of this device and also MDR's and adverse experience reports.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Jobst Athrombic Pump System 2000
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
Y961403
DEC 2 6 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ALBA-WALDENSIAN, INC.
201 St. Germain Avenue, S.W. Valdese. NC 28690
Telephone: 704-879-6500 Fax: 704-879-6595
Contact Person: Victor H. Garrou
Date Prepared: March 22, 1996
The following is a summary of Safety and Effectiveness for the albahealth PAS Wrap System.
The PAS Wrap System is composed of two leg wrap members constructed of an inflatable bladder enclosed in a fabric cover with an outside surface that will accept a Velcro fastener hook strip. Extending from one side of this enclosed bladder is an elastic fabric cut to conform to the shape of the calf area of the leg. This fabric is wrapped around the back of the calf and is attached to the other side of the bladder with a Velcro fastener. The Velcro fastener allows for a tight fit on various size legs. The inflation pump is attached to the bladders and is energized. The bladder on each leg is alternately inflated and deflated to yield approximately 65mm Hg pressure on the calf area of the leg. This pressure causes pooled blood to be expelled from the calf and to proceed toward the heart. This helps to prevent embolisms from forming in the calf area.
The albahealth PAS Wrap System is applied to the leg in the same manner as the Jobst Athrombic Pump System 2000. It uses the albahealth Pulsatile Anti-Embolism System pump to supply the pressure to the calf of the leg at the same values as the PAS-Pulsatile Anti-Embolism System. The indications for use and the contraindication are listed separately in this application.
Following is a summary of articles showing the benefits of this device and also MDR's and adverse experience reports.
HEALTH PRODUCTS Division of Alba Waldensian, Inc 201 St. Germain Avenue Valdese, NC 28690 704-879-6500 Fax 704-879-6595