CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK

K060231 · Elcam Medical Acal · FMG · Apr 13, 2006 · General Hospital

Device Facts

• Record ID: K060231
• Device Name: CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
• Applicant: Elcam Medical Acal
• Product Code: FMG · General Hospital
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Elcam Closed Swabable Stopcock (or MRVLS) is 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

Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock) functions as a fluid control device for IV sets. Device integrates a needleless luer-activated valve into a stopcock; valve automatically opens upon male luer insertion and closes upon removal, eliminating need for caps and reducing contamination risk. MRVLS variant features modified handle design and flow guide to enable continuous fluid flow through side ports, significantly reducing residual volume. Used in clinical settings by healthcare providers for pressure monitoring, fluid administration, and blood sampling. Healthcare providers manually operate stopcock handle and swab valve with aseptic fluid prior to use. Benefits include reduced residual volume, improved fluid path cleanliness, and simplified access for injections/sampling.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with device specifications; all acceptance criteria met. Biocompatibility and chemical testing performed per ISO 10993-1:2003 and FDA Memorandum #G95-1 with satisfactory results.

Technological Characteristics

Stopcock with integrated luer-activated valve. MRVLS variant includes modified handle and flow guide for reduced residual volume. Materials evaluated for biocompatibility per ISO 10993-1:2003. Mechanical fluid control device; no software or energy source.

Indications for Use

Indicated for patients requiring fluid flow directional control, pressure monitoring, IV 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's Stopcocks and Manifolds (K022895)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of the words "Elcam Medical" stacked on top of each other, with the letters "l" and "c" stacked on top of each other to the right of the words. There is a black circle above the "l" and "c". The logo is black and white.

## APR 1 3 2006

## SPECIAL 510(K) SUMMARY FOR ELCAM'S CLOSED SWABABLE STOPCOCK (OR MRVLS)

## DATE PREPARED: APRIL 7, 2006

#### 510(K) OWNER NAME 1.

Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 13860, Israel

Submitter person name: Ms. Tali Hazan - R.A Specialist Telephone: [phone], Fax: [phone], E-mail: [e-mail]

ELCAM MEDICAL'S U.S AGENT: Elcam Medical, Inc. 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA

Contact Person: Mr. Ehud Raivitz - CEO Telephone: [phone], Fax: [phone], E-mail: [e-mail]

#### 2. DEVICE NAME

Common/Usual Name: Closed Swabable Stopcock and *MRVLS Proprietary/Trade name: Closed Swabable Stopcock and MRVLS MRVLS = Minimal Residual Volume Luer-activated Swabable-stopcock

Classification: Elcam's Closed Swabable Stopcock (or MRVLS) has been classified as Class II devices under the following classification names:

| Classification Name | Product Code | 21 CFR Ref. | Panel |
|---------------------|--------------|-------------|------------------|
| Stopcock, I.V. Set | FMG | 880.5440 | General Hospital |

#### 3. PREDICATE DEVICES

Elcam's Closed Swabable Stopcock (or MRVLS) is substantially equivalent to Elcam's Stopcocks and Manifolds cleared under 510(k) number K022895.

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Image /page/1/Picture/1 description: The image shows the 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 words is a stylized graphic that appears to be the letters "I" and "C" with a circle above them. The logo is black and white.

#### 4. DEVICE DESCRIPTION

Modified Device and change Description: Elcam Medical's Closed Swabable Stopcock and MRVLS is a similar version of Elcam legally marketed stopcock. cleared under 510(k) number K022895.

The Closed Swabable Stopcock includes an addition of a component that functions as a closed luer-activated valve.

The valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap, in order to avoid leakage and/or port's contamination. Once a male luer is introduced into the closed port the fluid path automatically opens to allow injection or blood sampling. Once the male luer is taken out, the female port is automatically closed.

The valve actually serves as a needleless injection site integrated in the stopcock. The only change from the end user point of view is the need to swab the valve's top (injection site) with aseptic fluid such as alcohol prior to male luer insertion.

The MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock) feature, is an additional option that can be added to the Closed Swabable Stopcock, described above, and provides a stopcock with a minimal residual volume.

Conventional stopcocks are made of a body and a handle with a fluid path bore that allows the fluid to flow only through the handle. Therefore, it leaves other areas in the stopcock without a continuous flow through the stopcock fluid path and especially through the side port female luer. The MRVLS feature enables fluid flow around the handle so the fluid constant flow accesses the entire stopcock's internal volume and enables a continuous flow through the stopcock fluid path and through the side female luer during the medical procedure. This feature significantly reduces the "residual volume" in the stopcock and helps to keep the cleanliness of the stopcock's fluid path when it is in use.

The feature of minimal residual volume is achieved thanks to a modification in the stopcock handle design, which changes the fluid path and a flow guide formed therein.

The minimal residual volume design, together with the luer-activated valve creates the Minimal Residual Volume Luer-activated Swabable-stopcock (MRVLS).

Elcam Medical BarAm 13860, Israel Tel: [phone], Fax: [phone] [e-mail]

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

www.elcam-medical.com

Elcam Medical Special 510(k) revised Summary Elcam Closed Swabable Stopcock and MRVLS

April 7, 2006

CONFIDENTIAL Page 2 of 4

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Image /page/2/Picture/1 description: The image shows a logo for Elcam Medical. The logo consists of the words "Elcam Medical" stacked on top of each other, with the letters "IC" in a stylized font to the right of the words. There is a black circle above the "IC" letters. The logo is in black and white.

The colorant and raw materials changed and/or added are all validated to their intended use and evaluated for biocompatibility.

All body/fluid contact materials that compose the modified device: Closed Swabable Stopcock and MRVLS were tested for biocompatibility in accordance to FDA's Memorandum – #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices – Part 1: Evaluation and testing with acceptable results.

#### ડ. INTENDED USE

Elcam Closed Swabable Stopcock (or MRVLS) is 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.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Elcam's Closed Swabable Stopcock (or MRVLS) is substantially equivalent to Elcam's conventional legally marketed Stopcock cleared by 510(k) number K022895. Elcam's new product and the predicate devices have the same indication for use, same basic shape, characteristics, materials, manufacturing technology and design.

The modified device differs from the predicate device in some characteristics such as the addition of the valve assembly and the design change in the MRVLS handle. These differences are not affecting the device's intended use or alter the device's fundamental scientific technology. The device is, therefore, as safe and as effective as the predicate device.

#### 7. NONE CLINICAL PERFORMANCE DATA

Tests results are supporting all labeling claims and substantial equivalency. The modified device was tested with accordance to Elcam's legally marketed device specification and all acceptance criteria were met.

Biocompatibility and chemical tests, material characterization and risk assessment were performed on the patient-contact and fluid path materials of Elcam's modified device with satisfactory results.

Elcam Medical BarAm 13860, Israel Tel: [phone], Fax: [phone] [e-mail]

www.elcam-medical.com

.............................................................................................................................................................................. Elcam Medical Special 510(k) revised Summary Elcam Closed Swabable Stopcock and MRVLS

April 7, 2006

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Image /page/3/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 above the word "Medical". To the right of the words is a stylized graphic that appears to be the letters "i" and "c" with a circle above them.

#### 8. CONCLUSIONS

The evaluation of Elcam's Closed Swabuble Stopcock (or MRVLS) non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device. Therefore, we believe it is substantially equivalent to the Elcam's legally marketed device.

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2006

Ms. Tali Hazan Elcam Medical A.C.A.L. Kibbutz BarAm D.N. Merom Hagalil, 13860 Israel

Re: K060231

Trade/Device Name: Closed Swabable Stopcock and Minimal Residual Volume Luer - activated Swabable-stopcock Regulation Number: 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FMG Dated: March 13, 2006 Received: March 16, 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 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 (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.

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 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 (21 CFR Part 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 continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Clive

Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, 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):

Device Name: Closed Swabable Stopcock and MRVLS)

MRVLS - Minimal Residual Volume Luer-activated Swabable-Stopcock

Indications for Use: Elcam Closed Swabable Stopcock and MRVLS is 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.

> Prescription Use Prescription Ose ------------------------------------------------------------------------------------------------------------------------------------------------------------- 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)

Page _1_of_1_

(Posted November 13, 2003)

Anthony D. Watson

,
, General Hospital
Control Dental Devices

K4E0231