MULTICATH EXPERT

K061250 · Vygon Corp. · FOZ · Sep 29, 2006 · General Hospital

Device Facts

• Record ID: K061250
• Device Name: MULTICATH EXPERT
• Applicant: Vygon Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vygon Multicath Expert Catheter is intended for use in patients who require short-term (less than 30 days) I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters incorporate a silver based antimicrobial agent.

Device Story

Multilumen intravascular catheter; polyurethane construction impregnated with AgION™ silver ion-based antimicrobial agent. Designed for short-term (less than 30 days) I.V. therapy; administers hyperalimentation, antibiotics, chemotherapy, pain management drugs, or fluids. Silver ions released gradually from internal/external surfaces to provide broad-spectrum antimicrobial activity against bacteria and fungi. Used in clinical settings for patients requiring venous access. Healthcare providers insert and manage the catheter to deliver therapy; antimicrobial properties intended to reduce infection risk. Biocompatible and bio-inert material.

Clinical Evidence

No clinical data. Safety and efficacy established via biocompatibility testing (non-irritant, non-toxic) and performance testing.

Technological Characteristics

Multilumen intravascular catheter; polyurethane material; AgION™ silver ion-based antimicrobial agent. Available in 2, 3, 4, or 5-lumen configurations. Antimicrobial mechanism involves gradual release of silver ions from internal and external surfaces. Compliant with ISO 14971 risk assessment standards.

Indications for Use

Indicated for patients requiring short-term (less than 30 days) I.V. therapy, including administration of hyperalimentation, antibiotics, chemotherapy, pain management drugs, or intravenous fluids.

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

• Multicath (K870067)
• Vantex (K992532)
• Vantex (K033250)

Submission Summary (Full Text)

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K061250

12

SEP 2 9 2006

## 510K Premarket Notification Submission Summary of Safety and Efficacy

Date of Preparation: September 12, 2006

| Applicant: | Vygon Corporation<br>2495 General Amistead Ave.<br>Norristown, PA 19403 |
|------------------------|-------------------------------------------------------------------------|
| Contact Individual: | Courtney Smith, Regulatory Affairs Manager<br>610-539-9300 Ext. 110 |
| Trade Name: | Multicath Expert |
| Common Name: | Intravascular Catheter |
| Regulation Number: | 880.5200 |
| Product Code: | FOZ |
| Classification Name: | Intravascular Catheter |
| Classification: | Class II |
| Predicate Device Name: | Multicath (K870067), Vantex (K992532 / K033250) |

Device Description: The Multicath Expert catheters are a line of multilumen catheters which have an antimicrobial function. The polyurethane catheters are impregnated with the silver ion-based antimicrobial agent AgION™ and are available in 2-, 3-, 4-, or 5-lumen catheters. Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antise>tic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices.

The Multicath Expert catheters are as follows:

| Description | Reference |
|----------------------------|----------------------------------------|
| Multicath Expert Catheters | 8159.xxx, 8158.xxx, 8157.xxx, 8155.xxx |

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The Vygon Multicath Expert Catheter is intended for use in patients who Intended Use: require short-term (less than 30 days) I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters incorporate a silver based antimicrobial agent.

Technology Characteristics: Silver has becn shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antiseptic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released verv gradually over an extended period of time, ensuring longterm efficacy.

## Summary of Design Control Activities:

Biocompatibility testing of the material demonstrate that it is non-irritant and non-toxic. ! erformance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971.

Kdollast

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The only change between the predicate device (Multicath K870067) and the Conclusion: Multicath Expert is the addition of the Agion techniology. Biocompatibility testing, performance testing and risk assessment demonstrate that the Multicath Expert is safe and effective to use, when used in accordance with the supplied instructions for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

tilliUlt to the 2000

Ms. Courtney Smith Regulatory Affairs Manager Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403

Re: K061250

Trade/Device Name: Vygon Multicath Expert Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 15, 2006 Received: September 18, 2006

Dear Ms. Smith:

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. Smith

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/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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K06 1250

## Indications for Use

510(k) Number (if known):

Device Name: Vygon Multicath Expert Catheters

Indications For Use:

The Vygon Multicath Expert Catheter is intended for use in patients who require Short-term (less than 30 days) I.V. iherapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters are manufactured with a Pellethane-based AgION™ antimicrobial. The AglON™ uses silver as the antimicrobial agent.

Prescription Use × (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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