EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER

K043446 · Emmebi Srl · FOZ · Feb 4, 2005 · General Hospital

Device Facts

• Record ID: K043446
• Device Name: EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
• Applicant: Emmebi Srl
• Product Code: FOZ · General Hospital
• Decision Date: Feb 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The EmmeBi Lepstep Central Venous Catheter Kit is intended for short term use as an aid for catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw blood samples where the peripheral venous system is not practicable. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a Physician.

Device Story

Emmebi Central Venous Catheter Kit facilitates short-term central venous access; used for parenteral therapy or blood sampling when peripheral access is impractical. Kit includes syringe/inserter, guidewire (J-Wire), and central venous catheter. Physician performs catheterization using syringe/inserter to simplify insertion; guidewire directs catheter placement into superior vena cava. Catheters feature radiopaque markings, depth indicators, and flexible tapered tips; available in 14-22 gauge and 4-7 Fr sizes with single, double, or triple lumens. Device aids clinical decision-making by providing reliable venous access for critical therapies. Benefits include improved patient management for nutritional or infusional needs.

Clinical Evidence

Bench testing only. Performance data provided includes tensile strength, bond strength, bend test, and air/liquid leakage testing to demonstrate substantial equivalence.

Technological Characteristics

Intravascular catheter kit; 14-22 gauge, 4-7 Fr; single/double/triple lumen configurations. Features radiopaque markings, depth indicators, and soft flexible tapered tips. Materials and manufacturing processes are consistent with predicate devices. Sterilization method utilized.

Indications for Use

Indicated for short-term catheterization of the superior vena cava in patients requiring parenteral infusional or nutritional therapy or blood sampling when peripheral venous access is not practicable. Restricted to prescription use by physicians.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Arrowg⁺ard Blue Plus Multi-Lumen Central Venous Catheter (Arrow International)
• Triple Lumen Central Venous Catheter (Cook Critical Care)
• Quad Lumen Central Venous Catheter (Medcomp)
• Guidewire (Lake Region Mfg., Inc. K963320)
• One Step Guidewire Insertion Bulb Needle (Raulerson Syringe K971281)
• Micro Stick Introducer (Unknown)

Submission Summary (Full Text)

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FEB - 4 2005

## PREMARKET NOTIFICATION 510(K) SUMMARY

T043446
P. 1 of 2

## SUMMARY OF SAFETY AND EFFICACY

A. The submitter's name, address, telephone number, contact person and date of preparation.

| Submitter's Name: | Emmebi, srl |
|--------------------------------|---------------------------------------------------|
| Submitter's Address: | Via Albettoniera, 50/E<br>35030 Bastia Di Rovolon |
| Submitter's Phone Number | [phone]<br>[phone] |
| Contact Person: | Marjorie Bush |
| Contact Person's Phone Number: | [phone] |
| Date of Preparation: | 11/01/04 |

B. The name of the device including trade or proprietary name if applicable, the common or usual name and the classification name.

| Name: | Central Venous Catheter with<br>Lestep® Introducer |
|----------------------|-----------------------------------------------------------|
| Brand: | EmmeBi Central Venous Catheter with<br>Lestep® Introducer |
| 1. Common Name: | Emmebi Central Venous Catheter |
| Classification Name: | Intravascular Catheter |
| 2. Common Name: | Guidewire |
| Classification Name: | Catheter guidewire |
| 3. Common Name: | Lestep® Introducer |
| Classification Name: | Intrroducer, Catheter |

C. An identification of the predicate or legally marketed device(s) to which substantial equivalence is claimed:

| Predicate Device: Arrow International | Arrowg⁺ard Blue Plus Multi-Lumen<br>Central Venous Catheter |
|------------------------------------------------|-------------------------------------------------------------|
| Predicate Device: Cook Critical Care | Triple Lumen Central Venous<br>Catheter |
| Predicate Device: Medcomp | Quad Lumen Central Venous<br>Catheter |
| Predicate Guidewire: Lake Region<br>Mfg., Inc. | K963320 |
| Predicate Introducer Raulerson<br>Syringe | K971281 – One Step Guidewire<br>Insertion Bulb Needle |
| Predicate Introducer Micro Stick | Unknown |

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D. A description of the device that is the subject of the Premarket Notification submission:

The Emmebi Central Venous Catheter Kit is comprised of three main components; 1. Syringe/inserter 2. guidewire (J-Wire) and 3. central venous catheter. The catheter kit is intended for short term use as an aid to access the central venous system.

The Syringe/inserter simplifies the technique used by physicians to perform catheterization.

The guidewire (J-Wire) is designed to fit inside a percutaneous catheter for the purpose of directing the catheter being introduced.

The catheters are available in 14-> 22 gauge sizes with 4, 5, 6 and 7 Fr. diameter sizes in either a single, double or triple lumen. Circular lumen passages have soft flexible tapered tips. Lumens are connected to extensions containing hubs and catheter fixing wings. The lumens are printed with depth markings. Catheter markings are radiopaque.

- E. Statement of intended use of the device: The EmmeBi Central Venous Catheter with Lestep® Introducer is intended for short term use as an aid for the catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw
- F. Statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in 510K submission:

blood samples where the peripheral venous system is not practicable.

The technological characteristics of Emmebi's Central Venous Catheter Kit with Lestep® Introducer are substantially equivalent to the predicate devices in terms of intended use, insertion method, anatomical location, design, materials, performance, manufacturing process and sterilization method.

- G. Performance data for the Emmebi Central Venous Catheter Kit with Lestep® Introducer including tensile strength, bond strength test, bend test, air and liquid leakage, performance demonstrate that this device is substantially equivalent to legally marketed devices intended for central venous catheterization.
Andy Yaden

David L. Yoder Statutory Agent/EmmeBi, srl

1/18/05 Date

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2005

Emmebi SRL C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K043446

Trade/Device Name: Emmebi Central Venous Catheter Kit with Lestep® Introducer Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 18, 2005 Received: January 21, 2005

Dear Mr. Devine:

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 - Mr. Devine

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 and iboms (s 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), rt you dontact 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 yours,

Chris Liu, Ph.D.

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 STATEMENT

510(K) Number: K043446

Device Name: Emmebi Central Venous Catheter Kit with Lestep® Introducer

Indications for Use:

The EmmeBi Lepstep Central Venous Catheter Kit is intended for short term use as an aid for catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw blood samples where the peripheral venous system is not practicable.

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a Physician.

(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-the-Counter Use:

Cinton V. King

Insion Sign-Off) Offision of Anesthesiology, General Hospital, Intection Control, Dental Devices

2(k) Number K1943446