Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

K171040 · Koelis · ITX · Jul 31, 2017 · Radiology

Device Facts

• Record ID: K171040
• Device Name: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
• Applicant: Koelis
• Product Code: ITX · Radiology
• Decision Date: Jul 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.

Device Story

Device consists of reusable needle guides (PERINE, NAIL, CON-LEAD, LIN-LEAD ranges) and a probe stabilization system (STEADY PRO). Needle guides attach to ultrasound transducers to provide a fixed, aligned path for 14-20 gauge needles during percutaneous interventions. STEADY PRO is a mechanical holding arm providing 6 degrees of freedom (rotation/translation) to maintain transrectal ultrasound probe position during biopsy or cancer treatment. Used in clinical settings by physicians. Guides align needle with ultrasound imaging plane; STEADY PRO locks probe position to facilitate stable imaging and intervention. Benefits include improved needle placement accuracy and stable probe positioning during procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, cleaning/disinfection effectiveness, and mechanical performance verification.

Technological Characteristics

Materials: Propylux (polymer) and stainless steel. Mechanical guidance/stabilization principle. Reusable, non-sterile (cleaned). STEADY PRO provides 6 degrees of freedom (160-340 degree rotation). No software, electronics, or energy sources.

Indications for Use

Indicated for diagnosis and treatment during ultrasound-guided interventions. PERINE range indicated for adult males. STEADY PRO range indicated for adult males requiring prostate biopsy mapping and cancer treatment using an endocavity ultrasound transducer.

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

• Ultrasound General Purpose Guidance System (K093713)
• AccuCARE™ product line (K131161)

Submission Summary (Full Text)

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Public Health Service

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

July 31, 2017

KOELIS % Mrs. Laetitia Gervais Ouality and Regulatory Affairs Manager 16. chemin du vieux chene 38240 Meylan FRANCE

Re: K171040

Trade/Device Name: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 11, 2017 Received: July 14, 2017

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

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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.

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" (21 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/Safety/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/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

**Indications for Use**

| 510(k) Number (if known) | K171040 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
| Indications for Use (Describe) | The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions. |

1. Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for
guiding needles during ultrasound-guided interventions for diagnosis and treatment.

1. a. CON-LEAD range and LIN-LEAD range

The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous
ultrasound-guided interventions for diagnosis and treatment.

1. b. PERINE range

The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions
for diagnosis and treatment on adult males.

1. Steady Pro range

The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an
endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.

| 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) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/0 description: The image contains the logo for KOELIS. The logo consists of a blue square with a yellow curved line running through it. To the right of the logo is the company name, "KOELIS", in blue sans-serif font.

| | TRADITIONAL 510(K) | | | | |
|--|--------------------|--|---------------|------------|--|
| | 510(k) Number: | | Version: 1.0 | | |
| | Pr-Name: | | Date: | 2017.07.10 | |

# 510(K) SUMMARY OR 510(K) STATEMENT

## 510(k) Summary

The 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

| 510(k) Owner | KOELIS<br>16, chemin du vieux Chêne<br>38240 Meylan<br>FRANCE<br>Phone : [phone]<br>Fax : [phone] |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Ms Laetitia GERVAIS<br>Quality and Regulatory Affairs Manager<br>Mail : [e-mail]<br>Phone : [phone]<br>Fax : [phone] |
| Date Prepared | 2017.07.10 |

#### Proposed Device:

| Trade Name | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
|---------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
| Classification Name | Diagnostic Ultrasonic Transducer |
| Device Class | II |
| Product Code | ITX |

## Cleared Device:

The devices of the reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are substantially equivalent to:

| 510(k) Number | Device Name |
|---------------|--------------------------------------------|
| K093713 | Ultrasound General Purpose Guidance System |
| K131161 | AccuCARE™ product line |

## Intended Use:

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.

| TITLE | 510(k) Summary | ID | K171040 | Page 1 of 9 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|

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Image /page/4/Picture/0 description: The image shows the logo for KOELN. The logo consists of a blue square with a yellow "K" shape inside of it. The text "KOELN" is written in blue, to the right of the square.

## Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.

## CON-LEAD range and LIN-LEAD range

The guides from CON-LEAD range and LIN-LEAD range are intended to guide a needle during ultrasound-guided interventions.

## PERINE range

The guides from the PERINE range are intended to guide a needle during ultrasound-guided interventions.

## Steady Pro range

The Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultrasound-guided interventions. Typical applications are biopsy or cancer treatment.

## Indications for Use:

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions.

## Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment.

#### CON-LEAD range and LIN-LEAD range

The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment.

#### PERINE range

The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males.

#### Steady Pro range

The STEADY PRO range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.

| TITLE | 510(k) Summary | ID | K171040 | Page 2 of |
|-------|----------------|----|---------|-----------|
|-------|----------------|----|---------|-----------|

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Image /page/5/Picture/0 description: The image shows a logo with a blue square tilted at an angle on the left side. Two yellow curved lines intersect the square, forming a stylized "K". To the right of the logo are the letters "KOE" in blue. The letters are in a simple, sans-serif font and are spaced evenly apart.

| TRADITIONAL 510(K) | | |
|--------------------|---------|---------|
| 510(k) Number: | K171040 | Version |
| Pr-Name: | - | Date: |

1.0

2017.07.10

#### Device Description:

#### CON-LEAD range and LIN-LEAD range

The guides from CON-LEAD range and LIN-LEAD range have an attachment system in which a perforated part is attached in order to place a needle. It is a system with removable parts (nails) to adapt to the different diameters of needles.

The guides from CON-LEAD range and LIN-LEAD range shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices.

It is delivered cleaned but not sterile.

#### PERINE range

The guides from the PERINE range have an attachment system in which a perforated part is attached in order to place a needle. For some applications, there is a system with removable parts (nails) to adapt to the different diameters of needles. There is a possibility to have a fix or a movable system depending on the guide chosen.

The guides from the PERINE range shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices.

It is delivered cleaned but not sterile.

#### Steady Pro range

The Steady Pro range is a system which holds a 2D/3D lateral-fire endocavitary or 2D/3D endfire endocavitary ultrasound probe. It is an accessory of KOELIS systems.

The main functions of the Steady Pro range are:

- -To move the probe freely inside the working space of the probe holder in unlocked state
- -To maintain the probe in a specific position for an extended time when locked
- -To provide 6 degrees of freedom (rotation + translation) for arm and probe positioning; more specifically, to provide 160 degrees of rotation around the principal axis of the probe for side-fire probes, and 340 degrees of rotation for end-fire probes,
- -Easy to use: setup and operation, probe installation/dismantling, locking/unlocking the position,
- -Sterilizable and cleanable, easy to cover and protect.

| TITLE | 510(k) Summary | ID K171040 | Page 3 of 9 |
|-------|----------------|------------|-------------|
|-------|----------------|------------|-------------|

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| Image: KOELIS logo | TRADITIONAL 510(K) |
|--------------------|-------------------------------------|
| | |
| | 510(k) Number: K171040 Version: 1.0 |
| | Pr-Name: - Date: 2017.07.10 |

## Technological Characteristics compared with the cleared device:

## CON-LEAD range and LIN-LEAD range

| Company | KOELIS | CIVCO |
|---------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Devices | CON LEAD (abdominal guide) range<br>Image: CON LEAD (abdominal guide) range | Ultrasound General Purpose<br>Guidance:System<br>(Ultra Pro II™)<br>Image: Ultrasound General Purpose Guidance:System (Ultra Pro II™) |
| | LIN LEAD (linear guide) range<br>Image: LIN LEAD (linear guide) range | |
| 510(k) number | Unknown | K093713 |
| Intended Use | The guides from CON-LEAD range<br>and LIN-LEAD range are intended to<br>guide a needle during ultrasound-<br>guided interventions. | Intended for directing instruments<br>such as catheters, electrodes and<br>needles into a targeted anatomical<br>location of a patient relative to the<br>imaging instrument for<br>percutaneous procedures.<br>Intended for percutaneous<br>ultrasound procedures |
| Design | Bracket adapted to the shape of the<br>ultrasound transducer. Space to<br>slide a nail in. | Bracket adapted to the shape of the<br>ultrasound transducer. Space to<br>slide a needle gauge insert in. |
| | Nail with an unchanging external<br>diameter and with an internal<br>diameter adapted to the needles. | Needle gauge insert with<br>unchanging external dimensions and<br>with an internal channel adapted to<br>the instrument. |

| TITLE | 510(k) Summary | ID | K171040 | Page 4 of 9 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|

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| Image: KOELIS logo | TRADITIONAL 510(k) | | |
|--------------------|--------------------|----------|------------|
| 510(k) Number: | K171040 | Version: | 1.0 |
| Pr-Name: | - | Date: | 2017.07.10 |

| Company | KOELIS | CIVCO |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Propylux (polymer) | Materials not specified in IFU or<br>website.<br>Assumed to be a polymer. |
| Effectiveness | The design ensures accurate needle<br>path and placement in relation with<br>the transducer.<br>Verification and validation were<br>performed to ensure that devices<br>meet requirements. | Verification was performed to<br>ensure that device meets specified<br>tolerances and works in conjunction<br>with specifically designed adapter<br>clip area. |

| TITLE | 510(k) Summary | ID | K171040 | Page 5 of 9 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|

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| Image: KOELIS logo | TRADITIONAL 510(K) | |
|--------------------|--------------------|----------------------|
| | 510(k) Number: | K171040 Version: 1.0 |
| | Pr-Name: - | Date: 2017.07.10 |

## PERINE guides

| Company | KOELIS | | CIVCO |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Perine Nail | Perine Grid | Disposable Template Grid |
| 510(k)<br>number | Unknown | | K131161 |
| Intended<br>Use | The guides from the PERINE range are<br>intended to guide a needle during<br>ultrasound-guided interventions. | | Accepting and guiding needles up<br>to 1.3 mm (18 gauge) in diameter<br>and providing coordinates as an<br>aid to needle loading and<br>positioning during radioactive<br>seed implantation, cryotherapy,<br>transperineal template-guided<br>biopsy, and/or fiducial marker<br>placement.<br>Intended for ultrasound<br>percutaneous (including<br>transperineal) procedures |
| Design | Clipping system to clip the guide on the<br>probe.<br>Perine Nail : vertical grid with opened<br>channels to slide a nail in.<br>Nail with an unchanging external<br>diameter and with an internal<br>diameter adapted to the needles. | Perine Grid : vertical grid with closed<br>channels to directly slide a needle in. | Notch to fit on the stepping unit.<br>Square grid with closed channels<br>to directly slide a<br>needle/instrument in.<br>- |

| TITLE | 510(k) Summary | ID | K171040 | Page 6 of 9 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|

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| Image: KOELIS logo | TRADITIONAL 510(K) | |
|--------------------|------------------------|------------------|
| | 510(k) Number: K171040 | Version: 1.0 |
| | Pr-Name: - | Date: 2017.07.10 |

| Company | KOELIS | CIVCO |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Material | Propylux (polymer) | ABS (polymer) |
| Effectiveness | The design ensures accurate needle path<br>and placement in relation with the<br>transducer.<br>Verification and validation were<br>performed to ensure that devices meet<br>requirements. | Validation was conducted to<br>confirm the device remains safe<br>and effective for its intended use. |

| TITLE | 510(k) Summary | ID | K171040 | Page 7 of 9 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|

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| Image: KOELIS logo | TRADITIONAL 510(K) |
|--------------------|-------------------------------------|
| | 510(k) Number: K171040 Version: 1.0 |
| | Pr-Name: - Date: 2017.07.10 |

## Steady Pro range

| Company | KOELIS | CIVCO |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Steady Pro range | Accucare™ micro-touch LP |
| 510(k) number | Unknown | K131161 |
| Intended Use | Intended to reliably maintain the<br>position of a transrectal ultrasound<br>probe during ultrasound-guided<br>interventions. Typical applications<br>are biopsy or cancer treatment. | Holding and manipulating<br>ultrasound imaging probes during<br>prostate brachytherapy,<br>cryotherapy, transperineal<br>template-guided biopsy, and/or<br>fiducial marker placement<br>procedures (including volume<br>determination of the prostate<br>gland), and/or the application of<br>radionuclide source(s) into the body<br>during brachytherapy. |
| Design | Metallic holding arm with probe<br>supports in polymer. | Metallic arm mounted on a table<br>with a stabilizer |
| Material | Propylux (polymer) and stainless<br>steel | Material is not specified in IFU or<br>website.<br>Assumed to be a metallic material. |
| Effectiveness | The design ensures accurate holding<br>of the transducer.<br>Verification and validation were<br>performed to ensure that devices<br>meet requirements. | Non-clinical performance testing<br>was conducted including verification<br>testing: Stepping Unit is able to<br>provide continuous (free)<br>longitudinal movement.<br>Validation was also conducted to<br>confirm the device remains safe and<br>effective for its intended use. |

| Carol & Company | E 1 0 / 1 / 1 / 0 / 1 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0<br>JImm<br>laru | | UNTAL C<br>(14) | Page '<br>or |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------|--------------|
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------|--------------|

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| | TRADITIONAL 510(K) | |
|--|--------------------|----------------------|
| | 510(k) Number: | K171040 Version: 1.0 |
| | Pr-Name: | - Date: 2017.07.10 |

## Summary of Non-Clinical Tests

The devices from the reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range have been evaluated for biocompatibility, cleaning and disinfection effectiveness and have been found to be compliant with applicable medical device safety standards. The devices and their applications comply with voluntary standards.

## Summary of Clinical Tests

The subject of this premarket submission did not require clinical studies to support substantial equivalence.

## Conclusion:

KOELIS considers the subject devices to be as safe, as effective and with performance substantially equivalent to the predicate devices.

| TITLE | 510(k) Summary | ID | K171040 | Page 9 of 9 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|