The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" -- 0.038" diameter guide wires.

Device Description

The Y-Click connector is an accessory that can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters. The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without bleeding due to the intra-catheter human arterial pressure. The septum can be opened to an unsealed position in order to enable introducing of various angioplasty devices (such as; balloons and stents). Unlike similar devices, The Y-Click can also be opened to a semi unsealed position. The semi unsealed position reduces the friction during catheter manipulation and makes the device more ergonomic and easy to use. The septum is opened to a semi unsealed position by one push of the cover (a "click" is heard). Pushing the cover twice (two "clicks" are heard) opens the device to an unsealed position (full open position). In order to return to a closed position, the Y-Click's lever should be pressed once. A "click" is heard and the device returns to a closed position. The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm.

AI/ML Overview

This 510(k) submission for the Elcam Y-Click Connector is a medical device application. Unlike AI/software-as-a-medical-device (SaMD) clearances, which typically involve extensive performance studies with specific statistical metrics, acceptance criteria, and ground truth establishment, this submission focuses on demonstrating substantial equivalence to a predicate device through device description and intended use.

Therefore, many of the requested categories in your prompt related to clinical study design, AI performance metrics, and human-in-the-loop analysis are not applicable to this type of traditional medical device clearance. The document does not contain information about acceptance criteria in the context of statistical performance, reported device performance in those terms, sample sizes for test or training sets, ground truth establishment for such sets, expert adjudication, or MRMC studies.

Here's an analysis based on the information provided, emphasizing where the requested categories are not applicable or not detailed in this type of submission:

Acceptance Criteria and Study for Elcam Y-Click Connector (K060759)

This 510(k) submission for the Elcam Y-Click Connector is a traditional medical device submission, not specifically for software or an AI-powered device. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating substantial equivalence to an existing predicate device rather than achieving specific quantitative performance metrics through extensive clinical trials as one might expect for a novel AI diagnostic tool.

The core of the study is the comparison of the Y-Click Connector's features, intended use, and principle of operation with the predicate device. The "acceptance criteria" are implicitly met by demonstrating that the device does not raise new questions of safety and effectiveness compared to the predicate.

Given the nature of the device (a Y-connector hemostatic valve), the performance evaluation would primarily involve bench testing and possibly animal or in-vitro studies to confirm functional aspects, rather than human-centric clinical trials with ground truth experts.

Table of Acceptance Criteria and Reported Device Performance:

Criterion Type	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	The device has the same intended use and the same principle of operation as the predicate device (EasyPass™ US Y-Connector Haemostatic Valve from Millimed A/S, K042060), and does not raise new questions of safety or effectiveness.	The Y-Click Connector has the same intended use and the same principle of operation as the EasyPass™ of Millimed A/S (K042060). "The evaluation of the Y-Click Connector does not raise any additional concerns regarding safety and effectiveness." (Conclusion in document)
Intended Use	Intended to maintain hemostasis during introduction, use, and withdrawal of diagnostic and interventional devices used in angioplasty procedures; compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires.	"The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires." (Indications for Use)
Functionality	- Prevent blood loss through a septum. - Allow introduction of common guide-wires (0.014" to 0.038") through the slit septum without bleeding. - Septum can be opened to semi-unsealed and full-unsealed positions. - Allow injection of contrast media, saline flush, and blood pressure monitoring through the Y side arm.	The device description outlines these functionalities: "The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without bleeding..." "The septum can be opened to an unsealed position... The Y-Click can also be opened to a semi unsealed position." "The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm."
Mechanical Design	Connectable by a standard male luer-lock to any standard Angiographic catheter, up to 9 Fr guiding catheters.	"...can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters."

Sample sizes used for the test set and the data provenance:
- Not applicable / Not specified in this 510(k) summary. This type of device clearance typically relies on bench testing, comparison to the predicate, and adherence to relevant standards, not a "test set" in the context of AI or diagnostic accuracy studies. No specific sample sizes for a "test set" are mentioned in the provided document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified in this 510(k) summary. The clearance process described here does not involve establishing ground truth for a diagnostic test set by human experts. The "ground truth" for this device's safety and effectiveness is established by its similarity to a legally marketed predicate device and conformance to generally accepted engineering and medical device principles.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" or diagnostic reading adjudication method described in this submission.
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:
- No. An MRMC study is not relevant for this type of medical device (a hemostatic connector). This device does not involve human readers interpreting images or data, nor does it incorporate AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical connector, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of "ground truth" in this context is primarily related to the device's functional performance, material biocompatibility, and sterilization effectiveness (which would be assessed via standard laboratory testing, not human expert consensus for a diagnostic task). The primary "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate, meaning it performs as intended and is as safe and effective as the predicate.
The sample size for the training set:
- Not applicable / Not specified. This device does not employ machine learning or AI, and therefore does not have a "training set."
How the ground truth for the training set was established:
- Not applicable. No training set exists for this mechanical device.

In summary, the provided 510(k) summary is for a physical medical accessory (a connector), not a diagnostic or AI-powered device. Therefore, the criteria and study details are focused on technical specifications, intended use, and comparison to a predicate device, rather than the types of performance metrics and ground truth establishment typically associated with AI/SaMD products.

Summary

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K@60759
PG 1 OF 2

JUN 2 9 2006

510(K) SUMMARY FOR ELCAM Y-CLICK CONNECTOR

DATE PREPARED: JUNE 21, 2006

Company Name: Elcam Medical ACAL

Contact Person:

Ms. Tali Hazan RA Specialist Telephone: +972-4-698-8875 +972-4-632-0777 Fax: E-mail: tali@elcam.co.il

Authorized US Agent:

Mr. Ehud Raivitz – CEO Elcam Medical, Inc. 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA

Phone: 201-457-1120 201-457-1125 Fax: E-mail: ehud(@elcam-medical.com

Y-Click Connector Trade Name:

Classification name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Class: II Panel identification: Cardiovascular devices Product code: DTL Regulation number: 872.4290

Predicate Devices: EasyPass™ US Y-Connector Haemostatic Valve from Millimed A/S, Roskilde, Denmark cleared under 510(k) no. K042060

Device description:

Image /page/0/Picture/18 description: The image shows a logo for Elcam Medical. The logo consists of the words "Elcam Medical" stacked on top of each other on the left side of the image. To the right of the text is a stylized graphic that appears to be the letters "I" and "C" with a dot above the "I". The logo is black and white.

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K060759

Image /page/1/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of the words "Elcam Medical" in a bold, sans-serif font, with the word "Elcam" stacked on top of the word "Medical". Above the words is a stylized graphic that appears to be made up of small dots. The graphic has a vertical line and a curved line with a solid circle above it.

without bleeding due to the intra-catheter human arterial pressure. The septum can be opened to an unsealed position in order to enable introducing of various angioplasty devices (such as; balloons and stents). Unlike similar devices, The Y-Click can also be opened to a semi unsealed position. The semi unsealed position reduces the friction during catheter manipulation and makes the device more ergonomic and easy to use. The septum is opened to a semi unsealed position by one push of the cover (a "click" is heard). Pushing the cover twice (two "clicks" are heard) opens the device to an unsealed position (full open position). In order to return to a closed position, the Y-Click's lever should be pressed once. A "click" is heard and the device returns to a closed position.

The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm.

An illustration of the Y-Click connector and its parts is presented in Sections 10 and 11 of this submission.

Indications for Use:

Substantial Equivalence:

The Y-Click Connector has the same intended use and the same principle of operation as the EasyPass™of Millimed A/S, cleared under 510(k) no. K042060 and is therefore substantially equivalent to the predicate device.

Conclusion:

The evaluation of the Y-Click Connector does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device.

..............................................................................................................................................................................

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2006

Elcam Medical, ACAL c/o Ms. Tali Hazan R.A. Specialist Kibbutz BarAm MP Merom HaGalil 13860 ISRAEL

Re: K060759 Y-Click Connector Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock. Manifold, or Fitting Regulatory Class: Class II (Two) Product Code: DTL Dated: May 21, 2006 Received: May 24, 2006

Dear Ms. Hazan:

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 uc-recuse 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 max. therefore, market the device, subject to the general controls provisions of the Act. The peneral controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbrandon, alsulteration,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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. FIDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Tali Hazan

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 (2) CFR Paris 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of xyour device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtitler, general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdr/industry/support/index.html.

Sincerely yours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060759

Device Name: Y-Click Connector .

Indications for Use:

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

: ,

Division Sign-Off) ് vision of Cardiovascular

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.