BACSTOP

K053405 · Elcam Medical Acal · FMG · May 11, 2006 · General Hospital

Device Facts

• Record ID: K053405
• Device Name: BACSTOP
• Applicant: Elcam Medical Acal
• Product Code: FMG · General Hospital
• Decision Date: May 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Elcam Antimicrobial Stopcock [or Manifold] 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. Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver. The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device. The device is NOT intended to be used as a treatment for patient infections.

Device Story

Stopcock/manifold device provides access ports for medication injection, IV administration, and blood sampling; features handle to direct fluid flow. Incorporates silver-based antimicrobial agent into raw material to reduce bacterial colonization on device surfaces. Used in clinical settings for fluid management; operated by healthcare professionals. Device functions as passive fluid path component; antimicrobial feature acts to prevent/reduce microbial growth on device. Benefits patient by reducing potential for device-related infections.

Clinical Evidence

Bench testing only. Microbiological testing demonstrated at least 2-log reduction of bacteria. Mechanical testing performed per conventional stopcock specifications. Biocompatibility and chemical testing conducted per ISO 10993-1:2003 and FDA Memorandum #G95-1.

Technological Characteristics

Stopcock/manifold with silver-ion antimicrobial agent incorporated into body/fluid contact materials. Mechanical design includes ports and flow-directing handle. Materials tested for biocompatibility per ISO 10993-1:2003.

Indications for Use

Indicated for fluid flow directional control and access for solution administration, including pressure monitoring, IV administration, and transfusion. Not intended for treatment of patient infections.

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 Manifolds (K022895)
• Medex MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug (K954970)

Submission Summary (Full Text)

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K05 3405

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SarAm 13860 11736 1-377-4499-8120112 [e-mail].i eicam-medical.com

MAY 11 2006

## 510(K) SUMMARY FOR ELCAM ANTIMICROBIAL STOPCOCK [OR MANIFOLD]

## DATE PREPARED: APRIL 3, 2006

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

Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 13860, Israel

Submitter & Contact person name: Ms. Tali Hazan - R.A Specialist Telephone: [phone], Fax: [phone], E-mail: tali(@elcam.co.il

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: Antimicrobial Stopcock for Manifold] Proprietary/Trade name: Elcam B-Stop Classification: Elcam Antimicrobial Stopcock 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 Antimicrobial Stopcock for Manifold] is substantially equivalent to Elcam's Stopcocks and Manifolds cleared under 510(k) number K022895.

For the antimicrobial feature, it is substantially equivalent to Medex's MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug cleared under 510(k) number K954970.

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#### 4. DEVICE DESCRIPTION

Elcam Antimicrobial Stopcock [or Manifold] is identical to Elcam conventional legally marketed Stopcocks. A model of typical Stopcock is illustrated in Figure 1, section 11, page 33 of this submission.

1053405

Stopcocks and Manifolds have port(s) that provide access for medications injection, IV administration and blood sampling. The Stopcock usually has three ports and a handle that directs the fluid flow. It has one female side port that is used for medication injection or blood sampling. Both opposite ports (female/male) are connected to the IV line. The Manifold is assembled from two to five stopcocks bonded to each other to create a "stopcocks line" so the Manifold can have between two to five side ports for injection or sampling. Naturally, when the port is open, it can be a potential portal of entry for microorganisms into the device fluid path.

Elcam's Antimicrobial Stopcock [or Manifolds] provides an effective solution in preventing/reducing bacterial colonization in the device.

The antimicrobial agent is based on silver like in Medex's antimicrobial stopcock legally marketed device, cleared by 510(k) number K954970.

All body/fluid contact materials that composed the Antimicrobial Stopcock were tested widely for chemical and 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.

#### ട. INTENDED USE

Elcam Antimicrobial Stopcock [or Manifold] 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.

Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver.

The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.

The device is NOT intended to be used as a treatment for patient infections.

- 5.1 The indications for Antimicrobial Stopcock [or Manifold] and its predicate devices are the same except for the following:

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K053405 page 3 of 4

- 5.1.1 Elcam's legally marketed Stopcocks indication for use does not include the antimicrobial feature as no antimicrobial agent exists in these devices.
- 5.1.2 Medex's Antimicrobial IV set Stopcock and Antimicrobial luer lock plug indication for use has additional reference to the luer lock plug component. Elcam does not refer to the plug separately but as possible device variation.

· Elcam plugs do not include the antimicrobial agent and continue to function traditionally.

These two exceptions are not critical to the intended therapeutic use of the device and do not affect the safety and effectiveness of the device.

Note: Due to the similarity between Elcam's Stopcocks and Manifolds, henceforth the word Stopcock is referring also to Manifolds and may be used interchangeably unless specifically mentioned otherwise.

#### Q. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Elcam's Antimicrobial Stopcock is substantially equivalent to Elcam's conventional legally marketed Stopcock cleared by 510(k) number K022895 and to Medex's legally marketed Antimicrobial Stopcock cleared by 510(k) number K954970. Elcam conventional stopcock does not have the antimicrobial feature. Medex's Antimicrobial Stopcock completes the new device substantial equivalency. Elcam's new product and the predicate devices have the same indication for use, same basic shape, design, characteristics, materials, manufacturing technology and same antimicrobial agent (silver ions) mechanism. Elcam's Antimicrobial Stopcock combines the two predicate devices into one device that has an added value to the product therapeutic use and helping to protect the patient from device-related infections.

In both, the antimicrobial new device and Medex predicate device, the antimicrobial agent is incorporated into the stopcock raw material and the devices were tested widely for their intended use.

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K053405 Page 4 of 4

#### NONE CLINICAL PERFORMANCE DATA 7.

Standard testing related to functionality (mechanically and microbiologically) of the new device has been conducted on Elcam Antimicrobial Stopcock. Extensive tests were performed with a variety of organisms in order to establish the new device effectiveness by demonstrating significant reduction of bacteria levels (at least 2 log). Mechanical tests were performed according to Elcam conventional stopcock specification with acceptable results.

Tests results are supporting all labeling claims and substantial equivalency. Biocompatibility and chemical tests, material characterization and risk assessment were performed on the patient-contact and fluid path materials of Elcam's Antimicrobial Stopcock with satisfactory results.

#### 8. CONCLUSIONS

The evaluation of Elcam Antimicrobial Stopcock non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2006

Ms. Tali Hazan Regulatory Affairs Specialist Elcam Medical, A.C.A.L. Kibbutz BarAm Merom HaGalil 13860 ISRAEL

Re: K053405

Trade/Device Name: Antimicrobial Stopcock [or Manifold], B-Stop Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: March 9, 2006 Received: March 14, 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 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. 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 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 vour 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/industry/support/index.html.

Sincerely vours.

Clus

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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# Elcam Medical

BarAm 13860 Israel Tel: [phone] Fax: [phone] [e-mail] eicam-medical.com

## Indications for Use

510(k) Number (if known): _K053405

Device Name: Antimicrobial Stopcock [or Manifold]

Indications for Use: Elcam Antimicrobial Stopcock [or Manifold] 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.

Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver.

The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.

The device is NOT intended to be used as a treatment for patient infections.

| Prescription Use | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Elcam Medical 510(k) Elcam Antimicrobial Stopcock [or Manifold]

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