(51 days)
K875128/A
Not Found
No
The summary describes a physical guide for ultrasound procedures and does not mention any software or algorithms that would incorporate AI/ML.
No
Explanation: A therapeutic device is one that treats a disease or condition. This device is a reusable guide for needle/instrument guided procedures, used for diagnosis (as stated in "dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure"). It facilitates a diagnostic procedure rather than directly providing therapy.
No
The device is a needle guide for ultrasound-guided procedures; its intended use is to facilitate instrument placement, not to diagnose a condition itself. The text states its use is "for transrectal diagnosis ultrasound needle /instrument guided procedure," which indicates it is used during a diagnostic procedure, but it is not the diagnostic device.
No
The device description explicitly states it is a "reusable guide" designed to be "clipped onto an ultrasonic endocavity probe" and "cleaned and re-sterilized after use," indicating it is a physical hardware component.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a reusable guide intended to assist physicians in performing needle/instrument guided procedures using an ultrasound transducer. It provides a physical path for the needle and helps visualize its placement on the ultrasound screen.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical and procedural, aiding in the physical placement of instruments within the body.
Therefore, this device falls under the category of a surgical or procedural accessory rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The reusable guide is intended to provide physicians a tool for performing needle/instrument guided procedures with the use of the ultrasound endocavity transducer.
The guide is attached over the endocavity transducer/probe/scanhead instruments. This device provides a fixed path for the needle or the instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures. KOELIS endorectal ultrasound guides are supplied cleaned and are reusable.
The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The reusable guide is designed to be clipped onto an ultrasonic endocavity probe, to guide a needle along the said probe, and to be cleaned and re-sterilized after use.
The intended use and the indication for use place the Koelis reusable guide in device body contact category as follow : Surface devices, intact sin/mucosal membranes limited contact (
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
| Image: KOELIS logo | TRADITIONAL 510(K) | |
|---|---|---|
| 510(k) Number: UNKNOWN | Version: 1.0 | |
| Pr-Name: REUSABLE GUIDE | Date: 2014.05.12 |
5 510(K) SUMMARY OR 510(K) STATEMENT
510(k) Summary for REUSABLE GUIDE
The 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Owner | KOELIS
5, avenue du Grand Sablon
38700 La Tronche
FRANCE
Phone: +33 476 637 588 | Fax: +33 476 549.561 |
|---------------|---------------------------------------------------------------------------------------------|----------------------|
| Contact Name: | Mrs Laetitia GERVAIS
Quality Manager
Mail: gervais@koelis.com | |
| Date Prepared | 2014.05.12 | |
Proposed Device:
| Trade Name | Reusable guide |
|---|---|
| Common Name | Ultrasound transducer needle/instrument guide |
| Classification Name | Ultrasonic Diagnostic Transducer accessories |
| Device Class | II |
| Product Code | ITX |
Cleared Device:
The reusable guide is substantially equivalent to:
| 11.6 11 Market 1 13 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 | Propertion from the program Price of the firm and the driver a |
|---|---|
| ( | " = $, pe = = = = = = = = = |
| 510(k) Number | |
| " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " | ال Device (vame) |
| K875128/A | |
| AN ANNAGER AND AN ALLAND A BOOK | fransrectal Needle biopsy Guide |
Intended Use:
The reusable guide is intended to provide physicians a tool for performing needle/instrument guided procedures with the use of the ultrasound endocavity transducer.
The guide is attached over the endocavity transducer/probe/scanhead instruments. This device provides a fixed path for the needle or the instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures. KOELIS endorectal ultrasound guides are supplied cleaned and are reusable.
Traditional 510(k) FOR8302 QMS TITLE ID Page 8 of 31 KOEUS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)476 637 587 yevy knelis com @KOELIS SAS, RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenoble. Code APE 7112B
1
| Image: logo | TRADITIONAL 510(K) | |
|---|---|---|
| K O E L I S | 510(k) Number: UNKNOWN | |
| Pr-Name: REUSABLE GUIDE | Version: 1.0 | |
| Date: 2014.05.12 |
Indications for Use:
The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.
Device Description:
The reusable guide is designed to be clipped onto an ultrasonic endocavity probe, to guide a needle along the said probe, and to be cleaned and re-sterilized after use.
The intended use and the indication for use place the Koelis reusable guide in device body contact category as follow :
Surface devices, intact sin/mucosal membranes limited contact ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."