Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on a physical guide for ultrasound procedures. There is no mention of software, image processing, AI, or ML.

Therapeutic

No
The device is described as a disposable guide for endocavity diagnosis ultrasound needle-guided procedures, specifically to guide a linear instrument. Its intended use is diagnostic, not therapeutic.

Diagnostic

No

The device is a guide for a linear instrument used during an ultrasound needle-guided procedure. It facilitates the procedure but does not perform the diagnosis itself. The ultrasound is the diagnostic device, and this device is an accessory to guide an instrument, likely for biopsy (as indicated by the reference device "Transrectal Needle Biopsy Guide"), which is a interventional procedure, not purely diagnostic.

SaMD (Software as a Medical Device)

No

The device is a physical, disposable plastic guide designed to be clipped onto an ultrasound probe. It is described as a hardware component used to guide a linear instrument.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to guide a linear instrument (likely a needle for biopsy or other procedures) during an ultrasound-guided procedure. This is a surgical or interventional aid, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The device is a plastic guide that clips onto an ultrasound probe. It facilitates a physical procedure (guiding an instrument), not an in vitro test.
Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.

Therefore, the disposable guide KDNG00 is a medical device used in a clinical setting to assist with a procedure, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

ITX

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

transrectal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinicians and assistant clinic and hospital

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141334

Reference Device(s)

K970514

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq 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."

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
16, chemin du Vieux Chêne
38240 Meylan
France
Phone : +33(0)4 58 17 68 10 Fax : +33(0)4 58 17 68 24 |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Ms Pauline NICOLE
Regulatory Affairs Engineer
Mail: gra@koelis.com
Phone : +33(0)4 58 17 68 11
Fax : +33(0)4 58 17 68 24 |
| 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
KDNG00	Reusable guide	Transrectal Needle
Biopsy Guide
510(k) Number	Unknown	K141334	K970514
Intended Use	Both subject and predicate devices provide a mechanical means for
performing transrectal needle guided procedures with the use of the
diagnostic ultrasound endocavity transducer.
The devices provide 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.
Intended for transrectal procedures
Design	Plastic guide designed
to be clipped on an
endocavity ultrasound
pobe.
An entry cone to easily
introduce the needle
into the tube.	Inox guide designed to
be clipped on an
endocavity ultrasound
pobe.
An entry cone to easily
introduce the needle
into the tube.	Integrates the
mounting bracket and
cannula into a single,
disposable
component that
attaches externally,
over the transducer
with a clip-on action.
	Fixation mechanism of the guide on the probe :
A clip to allow the
guide stability on the
transducer, and 2 pins
for attachment in the
notches of the probe.	A clip to allow the
guide stability on the
transducer, and 2 pins
for attachment in the
notches of the probe.	A ring locks the guide
around the probe
thanks to a lateral
screw.
Material	Polycarbonate,
medical grade	Stainless steel 304
Stainless steel 316L
Steel 17/4 PH	Thermoplastics (ABS,
polycarbonate) and
stainless steel (T304
Hypodermic grade
tubing)
Safety	Biological safety has
been evaluated using
biocompatibility tests
for cytotoxicity,
irritation and
sensitization in
accordance with ISO	As the reusable
guide's materials are
widely used, Koelis
conducted a biological
safety evaluation
based on a risk-based
analysis, the literature	Testing is in
accordance with ISO
10993-1, FDA Blue
Book Memorandum
#G95-1 and FDA Good
TITLE	510(k) Summary	ID K180970	Page 3 of 5

6

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