(181 days)
Not Found
No
The device description focuses on electromechanical components (compressor, timer, regulator, gage) and pneumatic operation. There is no mention of AI, ML, image processing, or data-driven algorithms for decision making or control.
Yes
The device is intended to treat specific medical conditions (pain, swelling, ulceration, risk of infection and amputation) by improving return circulation, which are therapeutic functions.
No
The device is described as a treatment device designed to improve circulation and reduce symptoms like pain, swelling, and ulceration by mechanically inflating a sleeve. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states it is an "electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance." This clearly indicates the presence of hardware components beyond 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 improve the return circulation of body fluid in extremities to reduce pain, swelling, etc. This is a therapeutic treatment applied directly to the patient's body.
- Device Description: The device is an electromechanical pneumatic device that inflates a sleeve on the patient's extremity. This is a physical therapy/rehabilitation type of device.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
The device described is clearly intended for therapeutic use to manage symptoms related to poor circulation in the extremities, not for diagnosing a condition.
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.
Product codes
74JOW
Device Description
This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 13 lbs.
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
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 pressure of prototype device was measured comparing on-board gauge reading to calibrated Hg manometer.
- Pressure in appliance reaches the prescribed setting 10 or more seconds before the end of the cycle.
clinical test data:
- not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
5. 510(k) Summary
5.1. submitter
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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 Solo VII
- 5.2.2. common name ...................................single-pression pump
- 5.2.3. classification name Compressible Limb Sleeve (Class II) 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 existing compression pump devices such as document K874688 Huntleigh Flowtron AC200/2, document K882683 Jobst Extremity Pump System 7000, and document K914775 Talley MicroSystem/Talley.
- As a single pressure system, the proposed device is simpler 5.3.1.1. than existing sequential pressure or gradient sequential pressure systems for treating "simple lymphedema" or mild patient cases.
5.4. description
- 5.4.1. This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance that fits over the patient's extremity.
- 5.4.2. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 13 Ibs.
- 5.5. 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. This treatment reduces debilitating pain, swelling, ulceration, and risk of
1
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 compression pump and appliance system which produces results similar to other single-pressure systems currently in use.
- 5.6.2. The proposed device is factory-preset for a maximum pressure less than 101 mm Hg.
- 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 pressure of prototype device was measured comparing on-board gauge reading to calibrated Hg manometer.
- 5.8.1.2. Pressure in appliance reaches the prescribed setting 10 or more seconds before the end of the cycle.
- 5.8.2. clinical test data
- 5.8.2.1. not applicable
- 5.8.1. non-clinical test data