ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

K082106 · Elcam Medical Acal · FMG · Oct 2, 2008 · General Hospital

Device Facts

• Record ID: K082106
• Device Name: ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
• Applicant: Elcam Medical Acal
• Product Code: FMG · General Hospital
• Decision Date: Oct 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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. Both configurations have 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

Antimicrobial stopcocks (DSS and TSS) provide fluid flow control and access ports for IV administration, pressure monitoring, and transfusion. Devices incorporate silver-based antimicrobial agent in body material to reduce contaminant growth. DSS combines antimicrobial stopcock with closed swabable luer-activated valve. TSS adds MRVLS handle design, enabling fluid flow around handle for continuous flushing of fluid path. Used in clinical settings by healthcare providers. Devices act as microbial barriers; intended to prevent contamination rather than treat existing infections.

Clinical Evidence

Bench testing only. Design verification tests confirmed all labeling claims and acceptance criteria met. Biocompatibility, chemical testing, and material characterization previously performed for patient-contact and fluid path materials with satisfactory results.

Technological Characteristics

Stopcock/manifold configuration with silver-based antimicrobial agent impregnated in body. Features closed swabable luer-activated valve and MRVLS handle design. Materials previously validated for biocompatibility. Mechanical fluid flow control. No software or electronic components.

Indications for Use

Indicated for fluid flow directional control and access for solution administration, including pressure monitoring, IV fluid administration, and transfusion in patients requiring such therapy. Not for treatment of 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 Antimicrobial Stopcock (B-Stop) (K053405)
• Elcam Closed Swabable Stopcock and MRVLS (K060231)

Submission Summary (Full Text)

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OCT 02 2008

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### SPECIAL 510(K) SUMMARY FOR ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

### DATE PREPARED: JULY 21, 2008

- 1. 510(K) OWNER NAME
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: Antimicrobial Closed Stopcocks (DSS and TSS) Proprietary/Trade name: Double Safe Stopcock (DSS) and Triple S afe Stopcock (TSS) "Stopcock = the word "Stopcock" applies also to "Manifolds"

Classification: Elcam's Antimicrobial Closed Swabable Stopcock and TSS 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 Closed Stopcocks (DSS and TSS) are substantially equivalent to Elcam's Antimicrobial Stopcock (B-Stop) cleared under 510(k) number K053405 and to Elcam's Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) cleared under 510(k) number K060231.

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Image /page/1/Picture/0 description: The image shows a logo for Elcam Medical. The logo consists of the letters 'i' and 'c' stacked on top of each other, with a circle above the 'i'. The words 'Elcam Medical' are written in a bold, sans-serif font to the left of the stacked letters. The logo is black and white.

#### 4. MODIFIED DEVICE DESCRIPTION

Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS) are a similar version of Elcam legally marketed stopcocks, cleared under 510(k) numbers K053405 and K060231, as identified in paragraph number 3 above. Our Antimicrobial DSS and TSS combine two or three features of our legally marketed devices into one product contains these two or three protection lines as following described:

The Double Safe Stopcock (DSS) consists of our antimicrobial stopcock combined with our closed swabable luer-activated valve stopcock.

The closed swabable valve functions as a microbial barrier and the antimicrobial agent, impregnated in the stopcock body acts to prevent/reduce the growth of contaminants.

This configuration presents a stopcock with two protection lines; (1) impregnated antimicrobial agent; (2) closed swabable valve.

The Triple Safe Stopcock (TSS) consists of the same platform of the antimicrobial stopcock together with our legally marketed MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) design. The two protection lines described above for the DSS exist in the TSS yet, the TSS has a third protection line which is the unique design of the MRVLS handle enables fluid flow around the handle and thus enables more thorough and continuous flushing of the entire stopcock fluid path. This configuration presents a stopcock with three protetion lines:

(1) impregnated antimicrobial agent; (2) closed swabable valve; (3) MRVLS handle unique design.

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Image /page/2/Picture/0 description: The image shows a logo for Elcam Medical. The logo is black and white and features the letters "i" and "c" stacked on top of each other. The letter "i" is a simple vertical line with a circle above it, and the letter "c" is a curved line that opens to the right. Below the letters "i" and "c" is the word "Elcam" in a bold, sans-serif font, and below that is the word "Medical" in the same font.

#### ડ. INTENDED USE

Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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.

Both configurations have 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.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Elcam's DSS and TSS are substantially equivalent to Elcam's legally marketed stopcocks cleared under 510(k) number K053405 and K060231, Elcam's new product and the predicate devices have the same indication for use, same shape, characteristics, materials, manufacturing technology and design. The modified device configurations provide even more protections than the predicates by combining all protection lines together.

There are no differences 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

Design verification 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 previously performed for all patient-contact and fluid path materials consisting Elcam's modified device with satisfactory results.

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Image /page/3/Picture/0 description: The image shows a logo for Elcam Medical. The logo consists of the letters 'ic' stacked vertically, with the word 'Elcam' above the word 'Medical' to the left of the letters. The letters and words are in a bold, sans-serif font.

#### 8. CONCLUSIONS

The evaluation of Elcam's Antimicrobial Closed Stopcocks (DSS and TSS), non-clinical tests demonstrate that the modified devices are as safe and as effective as the predicate devices. Therefore, we believe it is substantially equivalent to the Elcam's legally marketed devices identified as predicates.

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

www.elcam-medical.com 2006年2月24日 12:24 ・ 13:57 ・ 19:57 ・ 19:50 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Elcam Medical Special 510(k) July 22, 2008 Elcam Antimicrobial Closed Stopcocks – DSS and TSS

CONFIDENTIAL Page 44 of 46

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 02 2008

Ms. Tali Hazan Regulatory Affairs Specialist Elcam Medical A.C.A.L. Kibbutz Bar-AM D.N. Merom Hagalil ISRAEL 13860

Re: K082106

Trade/Device Name: Antimicrobial Closed Stopcocks (*DSS and *TSS) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: September 7, 2008 Received: September 11, 2008

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

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: _ Antimicrobial Closed Stopcocks ( DSS and TSS)__

*DSS - Double Safe Stopcock *TSS - Triple Safe Stopcock

Indications for Use: Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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.

Both configurations have 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 __ V Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _ 1_ of _1_

(Posted November 13, 2003)

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

510(k) Number: KOE210 Co

Elcam Medical Special 510(k) Elcam Antimicrobial Closed Stopcocks - DSS and TSS

CONFIDENTIAL Page 17 of 46