(174 days)
Not Found
No
The description details a mechanical pneumatic compression system with sequential inflation, and there are no mentions of AI, ML, or any related concepts in the provided text.
Yes
The device is intended to aid in the reduction and management of peripheral edema, lymphedema, and ulceration associated with vascular insufficiency, which are conditions that require therapeutic intervention. Its function as an external pneumatic compression device further supports its role in treating these conditions.
No
The device's intended use is to "aid in the reduction and management of peripheral edema," which describes a therapeutic or management function rather than identifying or diagnosing a condition.
No
The device description explicitly states it consists of a pump, an inflatable sleeve, and connection tubing, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency." This describes a therapeutic or physical treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an "external pneumatic compression device" that applies pressure to the body. This is a physical therapy modality, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the Sof.Press EPC 51 System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency.
Product codes
Not Found
Device Description
The Sof.Press EPC 51 System is an external pneumatic compression device that consists of a pump, an inflatable three cell sleeve, and connection tubing. Each cell of the sleeve is inflated sequentially with the highest pressure applied distally and with successively lesser pressures applied proximally.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The following tables, Sof.Press Product Comparison Chart and the Safety Summary Chart, summarize the technological characteristics and the nonclinical performance data upon which the substantial equivalence submission was made to the Food and Drug Administration.
Key Metrics
Not Found
Predicate Device(s)
Jobst Extremity Pump System 7500 and Huntleigh Flowpress AC300
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
JAN ≥8 1997
K9630667
| GAYMAR ® | |
|---|---|
| GAYMAR INDUSTRIES, INC. |
Premarket Notification [510(K)] Summary
| Submitter: | Peter Scott |
|---|---|
| Phone: | 716/662-2551, ext. 676 |
| FAX: | 716/662-8763 |
| Date Summary | |
| Prepared: | July 26, 1996 |
| Device Name: | Sof.Press EPC 51 System |
| Common Name: | Pneumatic Sequential Pump |
| Classification Name: | Compressible Limb Sleeve per 21 CFR, Section 870.5800 |
| Predicate Device: | Jobst Extremity Pump System 7500 and |
| Huntleigh Flowpress AC300 |
Intended Use of Device:
To aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency.
Description:
The Sof.Press EPC 51 System is an external pneumatic compression device that consists of a pump, an inflatable three cell sleeve, and connection tubing. Each cell of the sleeve is inflated sequentially with the highest pressure applied distally and with successively lesser pressures applied proximally.
Substantial Equivalence:
The following tables, Sof.Press Product Comparison Chart and the Safety Summary Chart, summarize the technological characteristics and the nonclinical performance data upon which the substantial equivalence submission was made to the Food and Drug Administration.
10 CENTRE DRIVE ORCHARD PARK, NY 14127 (716) 662-2551 / (800) 828-7341 FAX #: (716) 662-6120
1
SAFETY SUMMARY CHART
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| Sof.Press | Jobst 7500 | HNE 300 | |
|---|---|---|---|
| Biocompatibility | |||
| Primary skin irritation | |||
| Delayed contact sensitization | |||
| Cytotoxicity | pass | ||
| pass | |||
| pass | unknown | ||
| unknown | |||
| unknown | unknown | ||
| unknown | |||
| unknown | |||
| Flammability | pass | unknown | unknown |
| UL Approvals | UL 544 | personal | |
| health care | |||
| appliance | |||
| UL 1431 | UL 544 | ||
| Pressure Relief Valve | yes | yes | no |
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