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.

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).

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Disposable Guide KDNG00". The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, especially in the context of an AI/human-in-the-loop system, is not available in the provided text. The document explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

This device, a disposable guide for ultrasound-guided needle procedures, is a hardware accessory and not an AI or software-driven diagnostic tool. The "performance" discussed is primarily related to its physical characteristics, biocompatibility, and sterilization, which are evaluated through non-clinical testing and comparison to existing predicate devices.

Here's a breakdown of why each requested point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not available. The document demonstrates substantial equivalence through a comparison of technological characteristics, materials, and safety/effectiveness principles, not against a predefined set of performance metrics of an AI system.
Sample size used for the test set and the data provenance: Not applicable. No test set for an AI model or clinical study is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI model is established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or ground truth adjudication process is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth generation for an AI model is mentioned. The "effectiveness" mentioned refers to its mechanical function and secure fit, analogous to hardware performance, not diagnostic accuracy.
The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
How the ground truth for the training set was established: Not applicable. No ground truth for a training set is established.

The provided document details a 510(k) submission for a physical medical device. The "performance" is assessed through comparison to predicate devices, focusing on:

Intended Use and Indications for Use: Both the subject device and predicates provide a fixed path for the needle for transrectal ultrasound-guided procedures (Pages 4, 5).
Design: Plastic vs. Inox (stainless steel) with similar clipping mechanisms for stability (Page 6).
Materials: Polycarbonate (medical grade) for the subject device compared to stainless steel and thermoplastics for predicates (Page 6).
Safety (Biocompatibility): Tested for cytotoxicity, irritation, and sensitization in accordance with ISO 10993-1 and FDA Good Laboratory Practices (GLP). Sterilization effectiveness (EtO) tested per ISO 11135-1. These tests concluded the device is biologically safe (Pages 6-7).
Effectiveness (Mechanical): Designed for secure and aligned fit, accurate needle path, and contoured for patient comfort (Page 7).

The conclusion explicitly states: "KOELIS considers the subject device to be as safe, as effective and with performance substantially equivalent to the predicate devices." (Page 7)

Summary

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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 (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)

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:

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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	KOELIS16, chemin du Vieux Chêne38240 MeylanFrancePhone : +33(0)4 58 17 68 10 Fax : +33(0)4 58 17 68 24
Contact Name:	Ms Pauline NICOLERegulatory Affairs EngineerMail: gra@koelis.comPhone : +33(0)4 58 17 68 11Fax : +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

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 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 guideKDNG00	Reusable guide	Transrectal NeedleBiopsy Guide
510(k) Number	Unknown	K141334	K970514
Intended Use	Both subject and predicate devices provide a mechanical means forperforming transrectal needle guided procedures with the use of thediagnostic ultrasound endocavity transducer.The devices provide a fixed path for the needle that when coupled by theultrasound system software corresponds to on-screen imagingguidelines for visualizing guided instrument placement procedures.Intended for transrectal procedures
Design	Plastic guide designedto be clipped on anendocavity ultrasoundpobe.An entry cone to easilyintroduce the needleinto the tube.	Inox guide designed tobe clipped on anendocavity ultrasoundpobe.An entry cone to easilyintroduce the needleinto the tube.	Integrates themounting bracket andcannula into a single,disposablecomponent thatattaches externally,over the transducerwith a clip-on action.
	Fixation mechanism of the guide on the probe :A clip to allow theguide stability on thetransducer, and 2 pinsfor attachment in thenotches of the probe.	A clip to allow theguide stability on thetransducer, and 2 pinsfor attachment in thenotches of the probe.	A ring locks the guidearound the probethanks to a lateralscrew.
Material	Polycarbonate,medical grade	Stainless steel 304Stainless steel 316LSteel 17/4 PH	Thermoplastics (ABS,polycarbonate) andstainless steel (T304Hypodermic gradetubing)
Safety	Biological safety hasbeen evaluated usingbiocompatibility testsfor cytotoxicity,irritation andsensitization inaccordance with ISO	As the reusableguide's materials arewidely used, Koelisconducted a biologicalsafety evaluationbased on a risk-basedanalysis, the literature	Testing is inaccordance with ISO10993-1, FDA BlueBook Memorandum#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 guideKDNG00	Reusable guide	Transrectal NeedleBiopsy Guide
510(k) Number	Unknown	K141334	K970514
	10993-1 and FDA GoodLaboratory Practices(GLP).Biocompatibilitytesting hasdemonstrated that thedisposable guideKDNG00 is biologicallysafe as it has nocytotoxic, irritation orsensitization effects.The tests have beenconducted on steriledisposable guides.The EtO sterilizationprocedure has beentested according to ISO11135-1.The associated reportconcluded that thesedata were adequate todemonstrate thebiological safety.	data andmanufacturingprocess used,according to ISO10993-1.	Laboratory Practices(GLP).Materials andmanufacturingprocessing (includingEtO sterilization) havebeen biologicallyevaluated usingbiocompatibility testsfor cytotoxicity,irritation andsensitization.Testing hasdemonstrated deviceto be non-toxic, non-sensitizing and non-irritating.Biocompatibilitytesting wasconducted usingsterilized finisheddevices.
Effectiveness	Both the subject and predicate devices are designed for secure andaligned fit to the transducer, while not altering the transducer designintegrity or function.Positive registration features of the design ensures accurate needle pathand placement in relation with the transducer.Exterior shapes of the guide are contoured for patient comfort with nosharp 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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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.