Elcam's High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended for single use only.

Device Description

Stopcocks and Manifolds are generally used for administration of fluids into the human. body. There is a wide use of Stopcocks as flow controls and sampling sites in I.V sets, critical care applications and monitoring kits. Stopcocks are used individually or in the form of Manifolds, units comprised of several Stopcocks joined together ("gang"). High pressure Stopcocks and Manifolds are used in cardiac angiography and angioplasty procedures in which fluids are administered under pressure. These procedures require stopcocks and manifolds which are robust under high pressures. The line of pressure resistant Stopcocks and Manifolds presented in this file includes four (4) products: i. High Pressure (HP) Stopcocks ii. Medium Pressure (MP) Stopcocks High Pressure (HP) Manifolds iii. Premium High Pressure (PHP) Manifolds iv.

AI/ML Overview

The provided document is a 510(k) summary for medical devices (stopcocks and manifolds), not an AI/ML device study. Therefore, most of the requested information (sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable or present in this type of regulatory submission.

However, I can extract the acceptance criteria and the stated performance relative to those criteria from the document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the proposed devices to legally marketed predicate devices, and by performing specific tests to demonstrate that the new devices, particularly in handling higher pressures, meet relevant safety and performance standards. The acceptance criteria are largely defined by adherence to specific ISO standards and the ability to withstand stated pressure ratings.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance
Pressure Rating	- HP Stopcocks: 1200 psi (82 Bar)	Proposed device designed to meet these pressure ratings.
	- MP Stopcocks: 500 psi (35 Bar)
	- HP Manifold: 600 psi (41.3 bar)
	- PHP Manifolds: 800 psi (54.6 bar)
High Pressure Performance	Conformity to ISO 8536-10 standard (Infusion equipment for medical use - Part 10: accessories for pressure infusion apparatus)	"High pressure performance tests for conformity to ISO 8536-10 standard" were performed.
Biocompatibility	Tests performed according to ISO 10993	"Tests performed according to ISO 10993"
Material/Functionality Integrity after EtO Sterilization	Materials and product functionality are not affected by EtO sterilization process or aging over rated lifetime.	"The materials and the product functionality are not affected by EtO sterilization process or as a result of aging over rated life time specification."
Sterilization and Sterile Package Integrity	Conformity to ISO 11135-1 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process) and ISO 11607-1/2 (Packaging for terminally sterilized medical devices)	"Tests performed according to: ISO 11135-1, ISO 11607-1 and ISO 11607-2."
General Performance Standards	Conformity to ISO 594-1 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements) and ISO 594-2 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 2: Lock fittings)	"Tests performed according to: ISO 594-1, ISO 594-2."

2. Sample size used for the test set and the data provenance:
Not applicable. This is a review of a 510(k) submission for physical medical devices, not a study involving a test set with patient data for an AI/ML algorithm. The "tests" mentioned are engineering and performance validation tests on the devices themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined in AI/ML studies is not relevant here. The "truth" is established by physical measurements and compliance with international standards.

4. Adjudication method for the test set:
Not applicable.

5. 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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.

7. The type of ground truth used:
The "ground truth" for the device's performance is established through physical testing and adherence to recognized international standards (e.g., ISO 8536-10, ISO 10993, ISO 11135-1, ISO 11607-1/2, ISO 594-1, ISO 594-2). These standards define the expected performance and safety characteristics.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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K123084

Image /page/0/Picture/1 description: The image contains a logo for Elcam Medical. The logo consists of a stylized letter "E" on the left, followed by the text "Elcam" in a bold, sans-serif font. Below "Elcam" is the word "MEDICAL" in a smaller, sans-serif font. Underneath the logo is the text "Where everything connects" in a smaller font.

Dec. 25, 2012

510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92

Submitter Information

Elcam Medical A.C.A.L. Kibbuts BarAm, M.P. Merom HaGalil, 13860, Israel Tel: (972) 4 6988120/1/2, Fax: (972) 4 6980777

Submission contact person:

Aharon Cohen Kibuz Bar Am 30889, Israel TEL: 972-4-6988324

Device Classification

Proprietary Device Name:	Elcam High and Medium Pressure Stopcocks and High andPremium High Pressure Manifolds.
Common name:	Stopcocks and Manifolds for I.V.
Product Code:	FMG
Classification Name:	Stopcock, I.V. Set
Classification Regulation:	21 CFR § 880.5440
Regulatory Class:	II

Identification of the legally Marketed Predicate Devices

Elcam's legally cleared Stopcock and Manifold devices (K11016) are indicated for flow control and delivery of I.V drugs and fluids used in I.V procedures. Devices are intended for normal pressures of gravity feed, sampling and bolus injection.

Scientific Device Manufacturer, LLC's cleared SDM Angiographic Manifold devices (K96031) are intended for I.V medium and high pressure fluids injection, used in angiography procedures.

Above legally Marketed Devices used as substantial equivalence to Elcam proposed High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds (modified version of the legally cleared Stopcock and Manifold devices - K111016)

Device Description

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High pressure Stopcocks and Manifolds are used in cardiac angiography and angioplasty procedures in which fluids are administered under pressure. These procedures require stopcocks and manifolds which are robust under high pressures.

The line of pressure resistant Stopcocks and Manifolds presented in this file includes four (4) products:

i. High Pressure (HP) Stopcocks
ii. Medium Pressure (MP) Stopcocks
High Pressure (HP) Manifolds iii.
Premium High Pressure (PHP) Manifolds iv.

Intended Use of Device

Safety & Effectiveness

The proposed and predicate devices are similar in design, materials of construction, components, intended use and labeling.

Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above, Elcam Medical believes that the proposed device safe & effectiveness is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues.

Rational for Substantial Equivalency

Substantial equivalency between the proposed devices, to its predicate devices was demonstrated by comparison in a tabular way of the intended use, indications, effectiveness, safety, performance and basic technological characteristics.

#	Comparisonparameter	Proposed device:Elcam Disposable HighPressure Stopcock/Manifold	Elcam Disposable Stopcock/Manifold	Scientific DeviceManufacturer, LLC-SDM AngiographicManifold
1	K No.	K123084	K111016	K960431
2	Owner	Elcam Medical A.C.A.L.	Elcam Medical A.C.A.L.	Scientific DeviceManufacturer, LLC
3	componentsmaterials	The device is composed of thefollowing materials:Body: Polycarbonate LEXANHandle: ACETAL-	The product is made of thefollowing materials:Body: Former LexanHandle: High Density	The product is made of thefollowing materials:- Handle - Acetal

SE discussion:

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#	Comparisonparameter	Proposed device:Elcam Disposable HighPressure Stopcock/Manifold	Elcam Disposable Stopcock/Manifold	Scientific DeviceManufacturer, LLC-SDM AngiographicManifold
		ULTRAFORMHigh Pressure Rotator:Polycarbonate LEXANO-Ring: Liquid SiliconeRubber (Apple Rubber)	Polyethylene	O-Ring- EthylenePropylene TerpolymerRubber (EPDM)Body-PolycarbonateHandle plugs -Polyethylene
2	PressureRating	HP Stopcocks - 1200 psi(82 Bar)MP Stopcocks - 500 psi )35Bar)HP Manifold - 600 psi (41.3bar)PHP Manifolds - 800 psi(54.6 bar)	Pressure is up to 3 bar (44 psi)	Pressure Ranges 500 -1200psi
3	Performanceparameters	Designed to withstand highpressure injections	Not designed to withstandhigh pressure injections	Designed to withstand highpressure injections
4	Integrity ofmaterials andfunctionalityafter EtOsterilization	The materials and the productfunctionality are not affectedby EtO sterilization process oras a result of aging over ratedlife time specification.	The materials and the productfunctionality are not affectedby EtO sterilization process oras a result of aging over ratedlife time specification.	The materials and the productfunctionality are not affectedby EtO sterilization process oras a result of aging over ratedlife time specification.
5	Biocompatibility standards	Tests performed according toISO 10993	Test performed according toISO 10993	Test performed according toISO 10993
6	PerformanceStandards	Tests performed according to:ISO 8536-10ISO 594-1ISO 594-2	Tests performed according to:ISO 594-1ISO 594-2	Unknown
7	Sterilizationand sterilepackageintegrity	Tests performed according to:ISO 11135-1ISO 11607-1 and ISO 11607-2	Tests performed according to:ISO 11135-1ISO 11607-1 and ISO 11607-2	Unknown

The above table compares similarities and differences between Elcam's High Pressure Stopcock/Manifold to legally cleared Elcam Stopcock and Manifold devices (K111016) and to Scientific Device Manufacturer, LLC-SDM Angiographic Manifold (K960431). The following summarizes the main tests performed to demonstrate substantial equivalence resulting from the use of different materials required for sustaining high pressure injection:

High pressure performance tests for conformity to ISO 8536-10 standard .
Biocompatibility .
Integrity of materials and functionality after EtO sterilization .
Sterilization and sterile package integrity tests for conformity to ISO 11135-1, ISO .
l 1607-1 and ISO 11607-2

Conclusion

The mentioned nonclinical tests and clinical use experience of Elcam's predicate legally marketed Disposable Stopcock/ Manifold demonstrate that the Disposable High Pressure Stopcock/Manifold is as safe, as effective, and performs as well as or better than the legally marketed devices identified in the K123084 submission.

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Substantial Equivalence Statement

Based on the above, it is Elcam Medical's opinion that the proposed Elcam High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are substantially equivalent in terms design principles, performance features and of safety & effectiveness to the legally cleared predicate devices : Elcam's Disposable Stopcocks/ Manifolds (K111016) and to Scientific Device Manufacturer, LLC's- SDM Angiographic Manifold (K960431), referred to in chapter 4 of this 510(K) submission executive summary document.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 23, 2013

Mr. Aharon Cohen Regulatory Affairs Manager Elcam Medical A.C.A.L. Kibbutz Bar-Am D.N. Merom Hagalil Israel 13860

Re: K123084

Trade/Device Name: Elcam High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: April 3, 2013 Received: April 25, 2013

Dear Mr. Cohen:

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.

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Page 2 - Mr. Cohen

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 (reporting of medical devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runner, DOSIA

Digitally signed by Mary S. Runner -S
ON: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner

0.9.2342.19200300.100.1.1=1300087950
Date: 2013.05.23 14:13:45 -04'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K.........................

Device Name: Elcam High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds

Indications for Use:

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/6/Picture/10 description: The image shows the FDA logo. The logo is made up of the letters FDA in a stylized font. The letters are outlined in black and the inside of the letters are white. The logo is simple and recognizable.

Richard C. Chapman 2013.05.23 13:56:27 -04'00'

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

Page 1 of 1

510(k) Number: K12084

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.