REUSABLE GUIDE

K141334 · Koelis · ITX · Jul 11, 2014 · Radiology

Device Facts

• Record ID: K141334
• Device Name: REUSABLE GUIDE
• Applicant: Koelis
• Product Code: ITX · Radiology
• Decision Date: Jul 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

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.

Device Story

Reusable stainless steel guide; clips onto ultrasonic endocavity probe; provides fixed path for needle/instrument insertion. Used in transrectal ultrasound-guided procedures; physician-operated. Device includes entry cone for needle introduction; fixation clip/notches ensure stability on transducer. When coupled with ultrasound system software, provides on-screen imaging guidelines for instrument placement. Facilitates accurate needle/instrument path; aids physician in visualizing guided procedures; improves procedural precision. Device is cleaned and re-sterilized between uses.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and functional comparison to predicate device. Biological safety evaluated via risk-based analysis and literature review per ISO 10993-1.

Technological Characteristics

Materials: Stainless steel 304, 316L, and 17/4 PH. Design: Linear tube with cannula, entry cone, and fixation clip/notches. Connectivity: Mechanical attachment to ultrasound transducer. Sterilization: Reusable (cleaned/re-sterilized).

Indications for Use

Indicated for transrectal diagnostic ultrasound needle/instrument guided procedures.

Regulatory Classification

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.

Predicate Devices

• Transrectal Needle biopsy Guide (K875128/A)

Submission Summary (Full Text)

{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<br>5, avenue du Grand Sablon<br>38700 La Tronche<br>FRANCE<br>Phone: [phone] | Fax: [phone] |
|---------------|---------------------------------------------------------------------------------------------|----------------------|
| Contact Name: | Mrs Laetitia GERVAIS<br>Quality Manager<br>Mail: [e-mail] | |
| 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:

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
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| 510(k) Number | |
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| K875128/A<br>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 [phone] yevy knelis com @KOELIS SAS, RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenoble. Code APE 7112B

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| Image: logo | TRADITIONAL 510(K) | |
|-------------|---------------------------------------------------|----------------------------------|
| K O E L I S | 510(k) Number: UNKNOWN<br>Pr-Name: REUSABLE GUIDE | Version: 1.0<br>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 (<24hours)

# Technological Characteristics compared with the cleared device:

| Company | KOELIS. | CIVCO |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Device: | Reusable guide | Transrectal Needle biopsy Guide |
| 510(k) number | | K875128/A |
| Intended.Use | Both subject and predicate devices provide a mechanical means for<br>performing transrectal needle/instrument guided procedures with the use of<br>the diagnostic ultrasound endocavity transducer.<br>The devices provide a fixed path for the needle or instrument that when<br>coupled by the ultrasound system software corresponds to on-screen imaging<br>guidelines for visualizing guided instrument placement procedures. | |
| | Intended for transrectal procedures | Intended for transrectal procedures |
| Design | Both subject and predicate devices include a linear tube with a stainless steel<br>cannula attached external to the transducer at a fixed position. | |
| | An entry cone to easily introduce the<br>needle into the tube | |
| | Fixation mechanism of the guide on the probe : | |
| | a clip welded on the tube, that<br>allows the stability of the guide on<br>the transducer and 2 fixing notches | a ring locks the guide around the<br>probe thanks to a lateral screw. |

#### Substantial Equivalence Comparison Chart

| A STATULAR AND STATE A LA LEAST CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION<br>QMS TITLE | Comments of the control control and control control control a province a comments of consistence of the proposition of the program and consistence of the proposition of the p<br>Traditional 510(k) | | ID FOR8302 | Page 9 of 31 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|--------------|--|
| 1 to management of the first of the first of the first of the first of the first and the many of<br>A Canada Career Station Comments of Children<br>KOEUS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel [phone] www.knelis.com | | | | | |
| OKOEUS SAS. RCS Grenoble 492 218 375, 8 rue du Duployé 38100 Grenable. Code APE 71128 | | | | | |

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K141334
Page 3 of 3

| | TRADITIONAL 510(K) | | | |
|--------|--------------------|----------------|----------|------------|
| KOELIS | 510(k) Number: | UNKNOWN | Version: | 1.0 |
| | Pr-Name: | REUSABLE GUIDE | Date: | 2014.05.12 |

| Company | KOELIS | CIVCO |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Reusable guide | Transrectal Needle biopsy Guide |
| 510(k) number | - | K875128/A |
| Material | Stainless steel 304<br>Stainless steel 316L<br>Steel 17/4 PH<br>These materials are widely used in<br>medical applications for implants and<br>ancillaries. | Stainless steel 304 |
| Safety | As these materials are widely used,<br>Koelis conducted a biological safety<br>evaluation based on a risk-based<br>analysis, the literature data and<br>manufacturing process used<br>according to ISO10993-1. The<br>associated report concluded that<br>these data were adequate to<br>demonstrate the biological safety. | Biological safety has been evaluated<br>using biocompatibility tests in<br>accordance with ISO 10993-1. Testing<br>has demonstrated t the biological<br>safety of the device |
| Effectiveness | Both the subject and predicate devices are designed for secure and aligned fit<br>to the transducer, while not altering the transducer design integrity or<br>function.<br>Positive registration features of the design ensures accurate needle /<br>instrument path and placement in relation with the transducer.<br>Exterior shapes of the guide are contoured for patient comfort with no sharp<br>edges. | |

| I<br>QMS TITLE | Commended on the Commend Comments of Concession<br>while and and the research and the commended to the commended to the commend of<br>Traditional 510(k) | | Annual manufacturer and and and a bill be half the many and the comments of the comments of the may of the may<br>ID FOR8302 | STATE FOR STATE A STATULAR STORE THE SECTION CONSULTION OF THE CONSULTION OF THE CONSTITUTION OF THE CONSTITUTION OF THE CONSTITUTION OF THE CONSTITUTION OF THE CONSTITUTION<br>Page 10 of 31 | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>KOEUS 5 aunnue du Grand Sablon 38700 La Tronche ERANCE Tel [phone] www.knelis.com | | | | | | | |

・

KOEUS, 5 avenue du Grand Sablon 38700 La Tronche FRANCE. Tel +33 (0)[phone] سیلاطویلندیو

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three thick, curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2014

KOELIS % LAETITIA GERVAIS QUALITY MANAGER 5 AVENUE DU GRAND SABLON LA TRONCHE 38700 FRANCE

Re: K141334

Trade/Device Name: Reusable Guide Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 1, 2014 Received: July 2, 2014

Dear Mrs. Gervais:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mrs. Gervais

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aredrew D. O'Hara

l·or

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510{k} Number (if known) tinkmown K141334

Device Name REUSABLE GUIDE

Indications for Use (Describe)

The reusable guide is dedicated for transrectal diagnosis ultrasound needle finstrument guided procedure.

Type of Use (Select one or both. as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D. O'Hara

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