INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)

K032393 · Elcam Medical Acal · FMG · Sep 12, 2003 · General Hospital

Device Facts

• Record ID: K032393
• Device Name: INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
• Applicant: Elcam Medical Acal
• Product Code: FMG · General Hospital
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Elcam Induction & Sampling Manifold or Stopcock is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.

Device Story

Induction & Sampling (I&S) Manifold/Stopcock; flow control and conduit device for IV fluid/drug delivery. Input: IV fluids/drugs; Output: controlled delivery to patient vascular system. Components: body, ports, handles, elastomer (pressure-activated valve), check valve (prevents reflux), rotor (luer locking). Used in clinical settings by clinicians. Benefits: enables gravity feed, sampling, bolus injection, and reflux prevention. Operation: manual manipulation of handles/stopcocks to direct flow.

Clinical Evidence

Bench testing only. Includes functional testing related to product label claims and performance comparisons against predicate devices. Biocompatibility assessment performed on patient-contact and fluid path materials with satisfactory results.

Technological Characteristics

Manifold/stopcock assembly; materials include elastomer (valve) and UV adhesive (bonding). Features pressure-activated valve, check valve for reflux prevention, and rotor for luer locking. Manual operation; no energy source. Sterilization method not specified.

Indications for Use

Indicated for patients requiring intravenous fluid or drug delivery, sampling, or bolus injection via a flow control conduit system.

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

• Porex (KippGroup) 2 & 3 Port Manifold with back check valve (K000152)
• Elcam Manifold (K022895)

Submission Summary (Full Text)

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Ko32393

SEP 1 2 2003

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# 510(k) Summary for Elcam Induction & Sampling Manifold for Stopcock)

#### 1. SPONSOR

Elcam Medical ACAL Kibbutz BarAm Merom HaGalil 13860 Israel

Submitter & Contact person name: Tali Hazan - R.A Coordinator Contact Person: Shachar Regev - Q.A Manager

Telephone: [phone] Fax: [phone] E-mail: [e-mail] or [e-mail]

U.S AGENT

Elcam Medical, Inc. 7600 North 15th St., Suite 217 Phoenix, AZ 85020

Bruce Ward -- General Manager Contact Person:

Telephone: [phone] Fax: [phone] E-mail: [e-mail]

#### 2. DEVICE NAME

Common/Usual Name: Induction & Sampling Manifold Proprietary/Trade name: Induction & Sampling Manifold Classification Name: Elcam Induction & Sampling Manifold has been classified as Class II devices under the following classification names:

| Name | Product Code | 21 CFR Ref. | Panel |
|----------------------------------|--------------|-------------|------------------|
| Intravascular Administration Set | FPA | 880.5440 | General Hospital |

…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Elcam Medical 510(k) July 22, 2003 Elcam Induction & Sampling Manifold -- APPENDIX E --

CONFIDENTIAL Page E-1

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#### 3. PREDICATE DEVICES

Elcam's I&S Manifold is substantially equivalent to Porex (KippGroup) 2 & 3 Port Manifold with back check valve,

Part Number: MTPC-XXX-XX. 510(k) No. K000152 cleared on 29-February-2000.

It is also substantially equivalent to Elcam's Manifold, which was submitted by MDCI on behalf of Elcam Plastic (Kibbutz BarAm, Merom Hagalil, Israel) for Elcam Stopcocks and Manifolds. 510(k) No. K022895 cleared on 03-September-2002.

Note: Elcam Plastic has changed its name on January-2003 to Elcam Medical ACAL. No other change took place as a result of the Name Change.

#### 4. DEVICE DESCRIPTION

All information referring Elcam I&S Manifold respectively refers to Elcam I&S Stopcock as well.

Elcam I&S Manifold is composed of a body that fits for number of ports assembly (by bonding) and handles which are assembled into the ports bodies.

Between each handle and port body an Elastomer is placed to function as a pressure activated valve. A small amount of UV Adhesive is applied in order to bond the product body to the female side ports. A check valve is assembled to the product body end (which is connected to the I.V Set) in order to eliminate back flow (reflux). A Rotor is assembled to the male luer (which is connected toward the patient) in order to enable connection locking. A small amount of lubricant is applied between the Elastomer and the port body.

Same concept can be available for one single Stopcock (single I&S Stopcock will not include Check Valve unless otherwise required by end user).

Elcam I&S Manifold will be available in a wide variety of configurations for use according to particular situation and the clinician's preference.

#### న్. INTENDED USE

Elcam Induction & Sampling Manifold or Stopcock is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.

Image /page/1/Picture/15 description: The image shows a CE marking with the number 0483 underneath it. To the right of the CE marking are the text "ISO 13485" and "ISO 9001", stacked on top of each other. The CE marking and the ISO texts are enclosed in square brackets.

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#### TECHNOLOGICAL CARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Elcam's Induction & Sampling Manifold [or Stopcock] and Porex (KippGroup) 2 & 3 Port Manifold with back check valve and Elcam's Manifold, have the same indication for use. They have the same basic shape and use luer fittings. Elcam I&S Manifolds and Stopcocks have additional properties, which combine the two predicate devices into the Elcam I&S Manifold. Questions regarding new product safety and effectiveness were not raised due to non-identical technological characteristics.

#### 7. PERFORMANCE TESTING

. -

- Standard testing relating functionality of the new product has been conducted on Elcam I&S Manifold, including testing related to product label claims and testing comparing performance with the predicate devices.
A biocompatibility assessment was performed on the patient-contact and fluid path materials of Elcam I&S Manifold with satisfactory results.

Image /page/2/Picture/7 description: The image shows a CE marking with the number 0483 below it. To the right of the CE marking are the text "ISO 13485" and "ISO 9001", stacked on top of each other. The entire image is surrounded by a square bracket.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2003

Elcam Medical ACAL C/O Ms. Shachar Regev Quality Assurance Manager Elcam Medical, Incorporated 7600 North 15th Street Suite 217 Phoenix, Arizona 85020

Re: K032393

Trade/Device Name: Induction and Sampling Manifold (or Stopcock) Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: July 22, 2003 Received: August 8, 2003

Dear Ms. Regev:

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.

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Page 2 -Ms. Regev

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Purser

Susan Runner, DDS, MA Interim 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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K032393

#### Device Name: Induction & Sampling Manifold [or Stopcock]

## Indication for use:

Elcan Induction & Sampling Manifold for Stopcock] is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.

Pulitan Lucente

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

510(k) Number: K032392

...

### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY

(Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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CONFIDENTIAL Page iv