ELCAM STOPCOCKS AND MANIFOLDS

K022895 · Medical Device Consultants, Inc. · FMG · Oct 18, 2002 · General Hospital

Device Facts

• Record ID: K022895
• Device Name: ELCAM STOPCOCKS AND MANIFOLDS
• Applicant: Medical Device Consultants, Inc.
• Product Code: FMG · General Hospital
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Elcam Stopcocks and Manifolds 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

Elcam Stopcocks and Manifolds are manual fluid management components used in clinical settings for directional control of fluid flow and access for solution administration. The device consists of a body with two or three ports, a handle, and luer connectors (male/female) with a locking nut. A small amount of lubricant is applied between the body and handle. Clinicians operate the device to manage pressure monitoring, IV fluid administration, or blood transfusions. The device facilitates connection between various medical components, allowing the provider to switch flow paths manually. It provides a physical interface for fluid delivery, benefiting patients by enabling controlled, multi-source access to the vascular system.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including functional and stress-testing related to product label claims, performance comparisons with existing products, and biocompatibility assessment of patient-contact and fluid-path materials with satisfactory results.

Technological Characteristics

Device consists of a body, handle, and ports with luer fittings. Materials include unspecified plastics with internal lubricant. Available in various configurations with varying inner diameters. Sterile. Manual operation via handle rotation. No electronic or software components.

Indications for Use

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

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/RAM Development stopcocks (K862691)

Submission Summary (Full Text)

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K022895

# OCT 1 8 2002

# 510(k) Summary for Elcam Stopcocks and Manifolds

#### 1. SPONSOR

Elcam Plastic Kibbutz BarAm Merom Hagalil 13860 Israel

Contact Person: Shachar Regev

#### 2. Device Name

Proprietary Name: Elcam Stopcocks and Manifolds Stopcocks and Manifolds Common/Usual Name: Classification Information:

Stopcocks have been classified as Class II devices under the following classification name:

| Name | Product Code | 21 CFR Ref. | Panel |
|--------------------------|--------------|-------------|------------------|
| Intravenous Stopcock Set | FMG | 880.5440 | General Hospital |

#### 3. PREDICATE DEVICES

Elcam Stopcocks and Manifolds are substantially equivalent to Elcam/RAM Development stopcocks, 510(k) No. K862691.

#### DEVICE DESCRIPTION 4.

Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.

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### 5. INTENDED USE

Elcam Stopcocks and Manifolds 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.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Elcam Stopcocks and Manifolds and Elcam/RAM Development stopcocks have the same indications for use. They have the same basic shape and both use luer fittings. Elcam Stopcocks and Manifolds have additional materials, are available sterile and have a wider range of inner diameters.

#### PERFORMANCE TESTING 7.

Standard testing relating to function and stress-testing has been conducted on Elcam Stopcocks and Manifolds, including testing related to product label claims and testing comparing performance with existing products or materials.

A biocompatibility assessment was performed on the patient-contact and fluid-path materials of Elcam Stopcocks and Manifolds with satisfactory results.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel J. Dillon Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K022895

Trade/Device Name: Elcam Stopcocks and Manifolds Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: August 30, 2002 Received: September 3, 2002

Dear Mr. Dillon:

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.

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, FDA may publish further announcements concerning your device in the Federal Register.

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.

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Page 2 - Mr. Dillon

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 begin 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 21 CFR 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy . Ulatowski 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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K022895

510(k) Number (if known):

Device Name: Elcam Stopcocks and Manifolds Dorios Plants: 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -

Elcam Stopcocks and Manifolds 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Valeria A. (en) RAC

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

510(k) Number: 0223617

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)