Elcam Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Device Description

Elcam Stopcocks and Manifolds with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family. The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path. The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.

AI/ML Overview

The provided document describes a 510(k) submission for Elcam Medical Stopcocks and Manifolds with Safe2 Rotator. This is a medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document discusses performance data in the context of the device's physical functionality and substantial equivalence to a predicate device.

Here's the relevant information extracted from the document:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Functional Requirements of ISO 594-2)	Reported Device Performance
Initial twisting force	"demonstrated that it meets its specifications"
Secondary twisting force	"demonstrated that it meets its specifications"
Liquid pressure resistance	"demonstrated that it meets its specifications"
Disconnection force	"demonstrated that it meets its specifications"
Overall Conclusion	"modified device is as safe and effective as its predicate" and "meets its specifications"

2. Sample size used for the test set and the data provenance:

The document states that "non-clinical tests" were conducted.
It does not specify the sample sizes used for each test.
The data provenance (country of origin, retrospective/prospective) is not detailed. However, the manufacturer, Elcam Medical, is based in Israel, so it can be inferred that testing was conducted either internally or by a contracted lab, adhering to international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the document describes physical device testing for functionality, not diagnostic/prognostic algorithm performance requiring expert-established ground truth. The "ground truth" here is objective physical measurements against established engineering standards (ISO 594-2).

4. Adjudication method for the test set:

This question is not applicable for the same reasons as #3.

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:

This question is not applicable as this is not an AI/ML device.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:

This question is not applicable as this is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this device's performance testing is defined by established engineering standards (specifically ISO 594-2 for various mechanical properties like twisting force, liquid pressure resistance, and disconnection force). These are objective, measurable criteria.

8. The sample size for the training set:

This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."

9. How the ground truth for the training set was established:

This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."

Summary of what the study did prove:

The study conducted for the Elcam Medical Stopcocks and Manifolds with Safe2 Rotator involved a series of non-clinical bench tests. These tests were designed to evaluate the physical functionality and safety of the modified device, particularly the new Safe2 Rotator component. The tests demonstrated that the device meets its specifications and complies with the functional requirements outlined in ISO 594-2 for lock fitting (initial twisting force, secondary twisting force, liquid pressure resistance, and disconnection force). Based on these results, the manufacturer concluded that the "modified device is as safe and effective as its predicate."

Summary

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Image /page/0/Picture/3 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol to the left of the text "Elcam MEDICAL". Below the text is the tagline "Where everything connects".

Special 510(k) summary for Elcam Medical Stopcocks and Manifolds with Safe2 Rotator

In accordance with 21 CFR 807.92 the following summary of information is provided

1. Date prepared:

May 07, 2014

2. Contact information for the 510(k) submission:

Owner: Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 1386000, Israel T: (972) - 4698-8120/1 F: (972) - 4698-0777 Email: sales@elcam.co.il

Contact Mrs. Natasha Branzburg person: Q.A. and R.A. Engineer Elcam Medical ACAL T: (972) - 77-2568-625 F: (972) - 4698-0777 Email: natasha.ev@elcam.co.il

Elcam Mr. Amir Halperin Medical's President of Elcam Medical, Inc. U.S. agent: 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA T: (201) 457-1120 F: (201) 457-1125 Email: amir.halperin@elcam-medical.com

3. Device name:

Proprietary/ Trade name: Elcam Stopcocks and Manifolds with Safe2 Rotator

Common/ usual name: Stopcocks and manifolds with male luer lock rotator.

Classification: Elcam Stopcocks and Manifolds with Safe2 Rotator have been classified as Class II devices under the following classification names:

el: 972-4-698-8120/1/2 www.elcam-medical.com Fax: 972-4-698-0777 Baram 13860, Israel | sales@eicam.co.il Elcam Stopcocks El Lucomed Mass Injectech

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Image /page/1/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" on the left, followed by the words "Elcam" and "MEDICAL" stacked on top of each other. Below the words is the tagline "Where everything connects."

Classification name	Product code	21 CFR ref.	Panel
Intravascularadministration set	FMG	880.5440	General Hospital

4. Predicate Device

Elcam Stopcocks and Manifolds with Safe2 Rotator were found to be substantially equivalent to Elcam's stopcocks and manifold.

Elcam's stopcocks and manifolds are legally marketed devices which are cleared under 510(k) number K022895.

Device Description 5.

Elcam Stopcocks and Manifolds with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family.

The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path.

The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.

6. Intended use

7. Technological characteristics and substantial equivalence

Elcam Stopcocks and manifolds with Safe2 Rotator are substantially equivalent to Elcam stopcocks and manifolds cleared under 510(k) number K022895. This new stopcocks variation has the same indication for use, principle of operation.

overall shape, sterilization method and shelf life as its predicate. Without changing the way of use from the health care provider perspective, Safe2

Rotator component ensures a secured connection of the stopcocks with other tubing set components preventing inadvertent disconnection and allows performing easy injection/ aspiration through the male luer by twisting the rotator towards a health care provider.

There were no new questions regarding Elcam Stopcocks and Manifolds with Safe2 Rotator safety and effectiveness that were raised due to this modification. Therefore, the modified and the original devices were judged as substantially equivalent.

Image /page/1/Picture/17 description: The image shows contact information and brand names. The contact information includes a telephone number (972-4-698-8120/1/2), fax number (972-4-698-0777), website (www.elcam-medical.com), physical address (Baram 13860, Israel), and email address (sales@elcam.co.il). The brand names listed are Elcam Stopcocks, Lucomed, and Injectech.

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Image /page/2/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol to the left of the word "Elcam" in a bold, sans-serif font. Below "Elcam" is the word "MEDICAL" in a similar font, and below that is the tagline "Where everything connects."

8. Performance data

Testing related to functionality of Elcam Stopcocks and Manifold with Safe2 Rotator has been conducted in a series of non-clinical tests. It has demonstrated that the modified device is as safe and effective as its predicate.

Following is a list of the bench tests that were conducted following risk management process to evaluate the effect of the design modification:

Compliance with the functional requirements of ISO 594-2 (lock fitting) ı

Initial twisting force
Secondary twisting force
Liquid pressure resistance
Disconnection force

Conclusion 9.

The evaluation of our modified device performances demonstrated that it meets its specifications, labeling claims and that it is as safe and as effective as the predicate devices.

Image /page/2/Picture/12 description: This image contains contact information for Elcam Medical. The image includes the telephone number 972-4-698-8120/1/2 and fax number 972-4-698-0777. The website is www.elcam-medical.com and the email address is sales@elcam.co.il. The address is Baram 13860, Israel.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

July 30, 2014

Elcam Medical ACAL Natasha Branzburg Q.A. and R.A. Engineer Kibbutz Bar-Am MP Merom Hagalil lsrael 13860

Re: K141254

Trade/Device Name: Eleam Stopcocks and Manifolds with Safe2 Rotator Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FMG Dated: July 6, 2014 Received: July 9, 2014

Dear Mrs. Branzburg:

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 - Mrs. Branzburg

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 device-related 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySRunner-S

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141254

Device Name

Elcam Stopcocks and Manifolds with Safe2 Rotator

Indications for Use (Describe)

Elcam Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions.

Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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Digitally signed by Richard C. Chapman -S Date: 2014.07.29 13:06:05 -04'00'

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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.