ELCAM STOPCOCKS AND MANIFOLDS

K141254 · Elcam Medical Acal · FMG · Jul 30, 2014 · General Hospital

Device Facts

• Record ID: K141254
• Device Name: ELCAM STOPCOCKS AND MANIFOLDS
• Applicant: Elcam Medical Acal
• Product Code: FMG · General Hospital
• Decision Date: Jul 30, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

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 Story

Stopcocks and manifolds with integrated male luer lock rotator; used for fluid flow control, pressure monitoring, IV administration, and transfusion. Safe2 Rotator component features internally threaded rotator fixed to stopcock body; allows free rotation on male connector axis. Prevents IV tubing kinks/twists; provides convenient access to side ports during injection/aspiration. Used in clinical settings by healthcare providers. Rotator ensures secure connection to tubing sets, preventing inadvertent disconnection. Benefits include improved ease of use for clinicians and reduced risk of line complications.

Clinical Evidence

Bench testing only. Evaluated design modification via ISO 594-2 functional requirements: initial/secondary twisting force, liquid pressure resistance, and disconnection force. Results confirmed device meets specifications and is as safe and effective as the predicate.

Technological Characteristics

Stopcock and manifold assembly with male luer lock rotator. Materials: standard medical-grade plastics. Sensing/actuation: mechanical fluid flow control. Connectivity: none. Sterilization: not specified. Software: none. Compliance: ISO 594-2 (lock fitting).

Indications for Use

Indicated for patients requiring fluid flow directional control, pressure monitoring, intravenous fluid administration, or transfusion. No specific age or gender restrictions stated.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Elcam stopcocks and manifold (K022895)

Submission Summary (Full Text)

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JUL 3 0 2014

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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: [e-mail]

Contact Mrs. Natasha Branzburg person: Q.A. and R.A. Engineer Elcam Medical ACAL T: (972) - 77-2568-625 F: (972) - 4698-0777 Email: [e-mail]

Elcam Mr. Amir Halperin Medical's President of Elcam Medical, Inc. U.S. agent: 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA T: [phone] F: [phone] Email: [e-mail]

#### 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: [phone] Baram 13860, Israel | [e-mail] 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 |
|-------------------------------------|--------------|-------------|------------------|
| Intravascular<br>administration 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

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.

#### 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 ([e-mail]). 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 [e-mail]. 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 [phone] or [phone] 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 [phone] or [phone] 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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