(376 days)
Not Found
No
The summary describes a pneumatic compression device with a microprocessor-controlled pump, but there is no mention of AI or ML capabilities.
Yes.
The device is intended to treat lymphedema, which is a medical condition, making it a therapeutic device.
No
The device description indicates it is a pneumatic pump with garments, and the intended use is for treating lymphedema and for surgical phases. There is no mention of diagnostic functions like imaging, analysis, or detection of medical conditions.
No
The device description explicitly states it includes a pneumatic unit with a pump and control panel, and physical garments (leg boots, arm sleeves), indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the EUREDUC TP05 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the treatment of lymphedema and surgical phases. This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a pneumatic unit, pump, control panel, and garments. This aligns with a physical therapy or rehabilitation device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the EUREDUC TP05 is a therapeutic device used for pneumatic compression, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EUREDUC TP05 is intended for:
- Lymphedema of lower extremities; post surgical or congenital;
- Postmastectomy lymphedema ;
- Pre, intra, post phases of surgery.
Product codes
74JOW
Device Description
a pneumatic unit in a metal casing with
- a microprocessor controlled pump;
- a control panel
- a range of garments connectable to the unit:
- leg boots;
- arm sleeves;
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, arm
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
1996-06-15 Page 11 AMENDED 510(k) EUREDUC TP05
Oct. 28, 1996
... / ...
510(k) SUMMARY as required by 807.92 (c) 5-
| Submitter's name | EUREDUC |
|---|---|
| Submitter's address | 35, rue des Broderies |
| 78310 COIGNIERES | |
| FRANCE | |
| Phone # (33) 1 34 61 01 61 Fax # (33) 1 34 61 40 61 | |
| Name of contact person: | Mr. Didier CAUZOT |
| Device Trade name: | EUREDUC TP05 |
| Device common name: | Pneumatic Drainage System |
| Classification name: | Sleeve Limb Compressible 74JOW CFR Section 870 58 00 |
| Predicate device name: | JOBST EXTREMITY PUMP(R) SYSTEM 7500 |
| Predicate device 510(k): | K882683 |
| EUREDUC TP05 is comprised of: | a pneumatic unit in a metal casing with |
-
a microprocessor controlled pump; |
-
a control panel
-
a range of garments connectable to the unit:
-
leg boots;
-
arm sleeves;
The EUREDUC TP05 is intended for:
- Lymphedema of lower extremities; post surgical or congenital;
- Postmastectomy lymphedema ;
- Pre, intra, post phases of surgery.