(181 days)
K830577B
Not Found
No
The description focuses on electromechanical components and calibrated pressure delivery, with no mention of AI/ML terms or functionalities.
Yes.
The device's intended use is to treat various medical conditions such as pain, swelling, and ulceration by improving fluid circulation, which categorizes it as therapeutic.
No
Explanation: The device is described as an electromechanical pneumatic device used for treatment, specifically to improve return circulation and reduce pain, swelling, etc., by sequentially inflating a sleeve. It does not perform any diagnostic function.
No
The device description explicitly states it is an "electromechanical pneumatic device that employs a compressor and precision timers, regulators, and gages" and has physical dimensions and weight, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that this device is an electromechanical pneumatic device that applies external pressure to a patient's extremity using an inflatable sleeve. It works by physically compressing the limb to improve fluid circulation.
- Lack of Sample Analysis: The device does not involve the collection or analysis of any biological samples from the patient. It directly interacts with the patient's body externally.
Therefore, based on the intended use and device description, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders.
Product codes
74JOW
Device Description
This is an electromechanical pneumatic device that employs a compressor and precision timers, regulators, and gages to sequentially inflate a sleeve appliance that fits over the patient's extremity. This unit delivers a calibrated gradient pressure. The device is approximately 10"W x 6.75"H x 5.6"D and weighs less than 15 Ibs. This device is a new state-of-the-art sequential gradient compression pump and appliance system which produces better results than non-gradient sequential or single-pressure systems currently in use. This device allows the adjustment of individual cell pressures and dwell times. The proposed device is factory-preset for a maximum pressure less than 101 mm Hg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
patient's extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
non-clinical test data:
- Cell pressures of prototype device were measured comparing on-board gauge readings to a calibrated Hg manometer.
- Pressures in each individual cell reach the prescribed setting within ±5mm Hg from the panel gage reading.
- Pressures in each cell reach the prescribed setting for that individual cell 10 or more seconds before the next cell is activated.
- Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and, thus, sustained.
clinical test data: not applicable
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.
K830577B
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
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
NOV - 6 1996
510(k) Summary 5.
- 5.1. submitter
- 5.1.1. Wright Linear Pump, Inc. 303 Robinson Road Imperial. PA 15126
412 695-0800 FAX 412 695-0406
- 5.1.2. contact Edward J. Wright
- 5.1.3. prepared 5-May-96
5.2. product identification
- 5.2.1. trade name .................................................................................................. WLP Pro Lite
- 5.2.2. common name ...................... gradient sequential compression pump
- Compressible Limb Sleeve (Class II) 5.2.3. classification name
- 21 CFR 870.5800
- · 5.2.4. product number ................................................................................................ 74JOW
5.3. equivalence
- 5.3.1. The proposed device is similar in design, function, and composition to the existing compression pump from Wright Linear Pump gradient, document K830577B.
- 5.3.1.1. The proposed device will make use of updated, smaller, lighter components. It is in all ways functionally equivalent to the existing pump and delivers similar performance. This unit takes advantage of advances in component design.
5.4. description
- 5.4.1. This is an electromechanical pneumatic device that employs a compressor and precision timers, regulators, and gages to sequentially inflate a sleeve appliance that fits over the patient's extremity. This unit delivers a calibrated gradient pressure.
- 5.4.2. The device is approximately 10"W x 6.75"H x 5.6"D and weighs less than 15 Ibs.
- ર.5. intended use
- 5.5.1. The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities.
510(k) -- Updated Gradient Sequential Compression Therapy Device 05 May 1996 01996 Wright Linear Pump, Inc. contains CONFIDENTIAL materia
1
This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
- 5.5.2. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders.
- 5.5.3. Complies with physician-prescribed treatment pressures.
- section 513, 801(b), 52 Stat. 1055, 90 Stat. 540-546 (21 5.5.3.1. U.J.C. 360C 371(A)
- 5.6. technological characteristics
- 5.6.1. This device is a new state-of-the-art sequential gradient compression pump and appliance system which produces better results than non-gradient sequential or single-pressure systems currently in use.
- 5.6.1.1. This device allows the adjustment of individual cell pressures and dwell times.
- 5.6.2. The proposed device is factory-preset for a maximum pressure less ----------------------------------------------------------------------------------------------------than 101 mm Hg.
- 5.6.1. This device is a new state-of-the-art sequential gradient compression pump and appliance system which produces better results than non-gradient sequential or single-pressure systems currently in use.
- 5.7. summary of comparison
- 5.7.1. The proposed device is similar in terms of medical efficacy and operational function to the cited devices. The proposed device employs similar controls and features similar pressure ranges, degrees of accuracy, cycle times, and so on to those of the cited devices.
- 5.8. safety and effectiveness performance data
- 5.8.1. non-clinical test data
- 5.8.1.1. Cell pressures of prototype device were measured comparing on-board gauge readings to a calibrated Hg manometer.
- 5.8.1.2. Pressures in each individual cell reach the prescribed setting within ±5mm Hg from the panel gage reading.
- Pressures in each cell reach the prescribed setting for that 5.8.1.3. individual cell 10 or more seconds before the next cell is activated.
- 5.8.1.4. Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and, thus, sustained.
- 5.8.2. clinical test data
- 5.8.2.1. not applicable
- 5.8.1. non-clinical test data