Disposable guides KDNG00

K180970 · Koelis · ITX · Jul 10, 2018 · Radiology

Device Facts

• Record ID: K180970
• Device Name: Disposable guides KDNG00
• Applicant: Koelis
• Product Code: ITX · Radiology
• Decision Date: Jul 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The disposable guide KDNG00 provides a fixed path for the needle that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures.

Device Story

Disposable plastic guide clips onto endocavity ultrasound probe (K3DEC00/K3DEC00-2); provides fixed mechanical path for linear instruments during transrectal needle-guided procedures. Device features entry cone for needle introduction; clip and pin mechanism ensures stability on transducer. Used in clinical/hospital settings by clinicians/assistants. Output is physical needle guidance; system software overlays imaging guidelines on ultrasound display to assist instrument placement. Benefits include secure, aligned needle path and patient comfort via contoured design.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (cytotoxicity, irritation, sensitization) and EtO sterilization validation.

Technological Characteristics

Medical grade polycarbonate construction; clip-on attachment mechanism with pins for probe alignment; sterile, single-use; EtO sterilization per ISO 11135-1; biocompatibility per ISO 10993-1. Mechanical guidance device; no internal electronics or software.

Indications for Use

Indicated for endocavity diagnosis ultrasound needle guided procedures. Intended for use by clinicians and assistants in clinics and hospitals to guide linear instruments via a transrectal approach.

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

• Reusable Guide (K141334)
• Transrectal Needle Biopsy Guide (K970514)

Submission Summary (Full Text)

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KOELIS % Ms. Pauline Nicole Regulatory Affairs Engineer 16, chemin du vieux chêne Mevlan. Isere 38240 FRANCE

July 10, 2018

Re: K180970

Trade/Device Name: Disposable Guide KDNG00 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: June 13, 2018 Received: June 18, 2018

Dear Ms. Nicole:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K180970

Device Name

Disposable guide KDNG00

Indications for Use (Describe)

The disposable guide KDNG00 is dedicated for endocavity diagnosis ultrasound needle guided procedure. It is intended for clinicians and assistant clinic and hospital, to guide linear instrument with a transrectal approach.

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

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| Image: KOELIS logo | TRADITIONAL 510(K) | |
|--------------------|----------------------------------|------------------|
| | 510(k) Number: K180970 | Version: 1.0 |
| | Pr-Name: DISPOSABLE GUIDE KDNG00 | Date: 2018.06.12 |

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

#### 510(k) Summary for Disposable Guide KDNG00

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] Fax : [phone] |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Ms Pauline NICOLE<br>Regulatory Affairs Engineer<br>Mail: [e-mail]<br>Phone : [phone]<br>Fax : [phone] |
| Date Prepared | 2018.06.12 |

#### Proposed Device

| Trade Name | Disposable Guide KDNG00 |
|---------------------|----------------------------------------------|
| Common Name | Disposable Guide KDNG00 |
| Classification Name | Ultrasound Diagnostic Transducer Accessories |
| Device Class | II |
| Product Code | ITX |

#### Cleared Device

The disposable guide KDNG00 is substantially equivalent to:

| 510(k) Number | Device Name |
|---------------|----------------------------------------------------|
| K141334 | Reusable Guide (primary predicate device) |
| K970514 | Transrectal Needle Biopsy Guide (reference device) |

#### Intended Use of the subject device

The disposable guide KDNG00 provides a fixed path for the needle that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures.

#### Indications for Use of the subject device

The disposable guide KDNG00 is dedicated for endocavity diagnosis ultrasound needle guided procedure. It is intended for clinicians and assistant clinic and hospital, to guide linear instrument with a transrectal approach.

| TITLE | 510(k) Summary | ID | K180970 | Page 1 of 5 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|

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| Image: KOELIS logo | TRADITIONAL 510(K) | | |
|--------------------|-------------------------|----------|------------|
| | | | |
| 510(k) Number: | K180970 | Version: | 1.0 |
| Pr-Name: | DISPOSABLE GUIDE KDNG00 | Date: | 2018.06.12 |

#### Subject device description

The products concerned are plastic guides designed to be clipped on an endocavity ultrasound probe (KOELIS probes K3DEC00/K3DEC00-2 cleared under K170521), to guide a linear instrument through transrectal access.

The disposable guides KDNG00 are packaged individually in pouches and delivered sterile. Pouches are then gathered in dispenser boxes (24 guides/dispenser box).

| TITLE | 510(k) Summary | ID | K180970 | Page 2 of 5 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|

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| Image: KOELIS logo | TRADITIONAL 510(K) | |
|--------------------|----------------------------------|------------------|
| | 510(k) Number: K180970 | Version: 1.0 |
| | Pr-Name: DISPOSABLE GUIDE KDNG00 | Date: 2018.06.12 |

### Technological Characteristics compared with the cleared device

| Company | KOELIS | KOELIS | CIVCO |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Disposable guide<br>KDNG00 | Reusable guide | Transrectal Needle<br>Biopsy Guide |
| 510(k) Number | Unknown | K141334 | K970514 |
| Intended Use | Both subject and predicate devices provide a mechanical means for<br>performing transrectal needle guided procedures with the use of the<br>diagnostic ultrasound endocavity transducer.<br>The devices provide a fixed path for the needle that when coupled by the<br>ultrasound system software corresponds to on-screen imaging<br>guidelines for visualizing guided instrument placement procedures.<br>Intended for transrectal procedures | | |
| Design | Plastic guide designed<br>to be clipped on an<br>endocavity ultrasound<br>pobe.<br>An entry cone to easily<br>introduce the needle<br>into the tube. | Inox guide designed to<br>be clipped on an<br>endocavity ultrasound<br>pobe.<br>An entry cone to easily<br>introduce the needle<br>into the tube. | Integrates the<br>mounting bracket and<br>cannula into a single,<br>disposable<br>component that<br>attaches externally,<br>over the transducer<br>with a clip-on action. |
| | Fixation mechanism of the guide on the probe :<br>A clip to allow the<br>guide stability on the<br>transducer, and 2 pins<br>for attachment in the<br>notches of the probe. | A clip to allow the<br>guide stability on the<br>transducer, and 2 pins<br>for attachment in the<br>notches of the probe. | A ring locks the guide<br>around the probe<br>thanks to a lateral<br>screw. |
| Material | Polycarbonate,<br>medical grade | Stainless steel 304<br>Stainless steel 316L<br>Steel 17/4 PH | Thermoplastics (ABS,<br>polycarbonate) and<br>stainless steel (T304<br>Hypodermic grade<br>tubing) |
| Safety | Biological safety has<br>been evaluated using<br>biocompatibility tests<br>for cytotoxicity,<br>irritation and<br>sensitization in<br>accordance with ISO | As the reusable<br>guide's materials are<br>widely used, Koelis<br>conducted a biological<br>safety evaluation<br>based on a risk-based<br>analysis, the literature | Testing is in<br>accordance with ISO<br>10993-1, FDA Blue<br>Book Memorandum<br>#G95-1 and FDA Good |
| TITLE | 510(k) Summary | ID K180970 | Page 3 of 5 |

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| | TRADITIONAL 510(K) | | | |
|--|--------------------|-------------------------|----------|------------|
| | 510(k) Number: | K180970 | Version: | 1.0 |
| | Pr-Name: | DISPOSABLE GUIDE KDNG00 | Date: | 2018.06.12 |

| Company | KOELIS | KOELIS | CIVCO | |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device | Disposable guide<br>KDNG00 | Reusable guide | Transrectal Needle<br>Biopsy Guide | |
| 510(k) Number | Unknown | K141334 | K970514 | |
| | 10993-1 and FDA Good<br>Laboratory Practices<br>(GLP).<br>Biocompatibility<br>testing has<br>demonstrated that the<br>disposable guide<br>KDNG00 is biologically<br>safe as it has no<br>cytotoxic, irritation or<br>sensitization effects.<br>The tests have been<br>conducted on sterile<br>disposable guides.<br>The EtO sterilization<br>procedure has been<br>tested according to ISO<br>11135-1.<br>The associated report<br>concluded that these<br>data were adequate to<br>demonstrate the<br>biological safety. | data and<br>manufacturing<br>process used,<br>according to ISO<br>10993-1. | Laboratory Practices<br>(GLP).<br>Materials and<br>manufacturing<br>processing (including<br>EtO sterilization) have<br>been biologically<br>evaluated using<br>biocompatibility tests<br>for cytotoxicity,<br>irritation and<br>sensitization.<br>Testing has<br>demonstrated device<br>to be non-toxic, non-<br>sensitizing and non-<br>irritating.<br>Biocompatibility<br>testing was<br>conducted using<br>sterilized finished<br>devices. | |
| Effectiveness | Both the subject and predicate devices are designed for secure and<br>aligned fit to the transducer, while not altering the transducer design<br>integrity or function.<br>Positive registration features of the design ensures accurate needle path<br>and placement in relation with the transducer.<br>Exterior shapes of the guide are contoured for patient comfort with no<br>sharp edges. | | | |

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| | TRADITIONAL 510(K) | |
|--|--------------------|------------------------------------------|
| | 510(k) Number: | K180970 Version: 1.0 |
| | Pr-Name: | DISPOSABLE GUIDE KDNG00 Date: 2018.06.12 |

#### Summary of non-clinical testing

The disposable guides KDNG00 has been evaluated for biocompatibility and sterilization effectiveness, and has been found to be compliant with applicable medical device safety standards. The disposable guide KDNG00 and its applications comply with voluntary standards.

#### Summary of clinical testing

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

#### Conclusion

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

| TITLE | 510(k) Summary | ID | K180970 | Page 5 of 5 |
|-------|----------------|----|---------|-------------|
|-------|----------------|----|---------|-------------|