1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50

K061986 · Medcomp · LJS · Aug 3, 2006 · General Hospital

Device Facts

• Record ID: K061986
• Device Name: 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50
• Applicant: Medcomp
• Product Code: LJS · General Hospital
• Decision Date: Aug 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 1.9F Vascu-PICC™ is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Device Story

1.9F Vascu-PICC™ is a polyurethane peripheral vein catheter for long-term central venous access; used in neonates, infants, and children. Device includes catheter lumen, hub with suture wing, extension tube with clamp, and female luer connector for IV administration. Stainless steel twisted wire stylet with nylon/HDPE handle aids insertion. Device facilitates delivery of fluids, medications, and nutritional therapy. Operated by clinicians in clinical settings. No electronic or software components.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via in vitro bench testing (gravity flow, air/liquid leakage, tensile strength, elongation, air priming volume) and biocompatibility testing per ISO 10993.

Technological Characteristics

Polyurethane catheter; stainless steel stylet with nylon/HDPE handle. Dimensions: 1.9F. Sterilization method not specified. Testing performed per ISO 10555-1 and 10555-3. Biocompatibility per ISO 10993.

Indications for Use

Indicated for central venous access in neonates, infants, and children for administration of fluids, medication, and nutritional therapy.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Vygon 2F Epicutaneo Catheter (K993052)

Reference Devices

• Medcomp Duo-Flow Soft Line Catheter (K974236)
• Medcomp Z Cath (K003682)

Submission Summary (Full Text)

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# 510(k) SUMMARY

#### A. Submitter Information:

Submitter:

AUG - 3 2006

MEDCOMP® 1499 Delo Drive Harleysville, PA 19438 [phone] Telephone [phone] Fax Susan Motzer July 12, 2006

1.9F Vascu-PICC™

Than 30 Days

ાજરી

Catheter, Intravascular,

Contact: Date Prepared:

- B. Trade Name: Common Name:
Classification: C.F.R. Section:

C. Predicate Device: 880.5970 K993052 Vygon 2F Epicutaneo

Therapeutic, Long-Term Greater

PUR Catheter

#### D. Device Description:

The Medcomp 1.9F Vascu-PICC™ catheter is designed for peripheral vein catheterization. The 1.9F Vascu-PICC™is comprised of a polyurethane material. The lumen is connected to the extensions by a hub with a suture wing for placement. A clamp is provided on the extension tube to prevent air/fluid communication. A female luer connector provides the connection for intravenous administration. The twisted wire stylet is made of stainless steel with a nylon and high density polyethylene handle. The stylet aids in insertion of the catheter.

#### E. Intended Use:

The 1.9F Vascu-PICC™ is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

#### F. Comparison to Predicate Device:

The Medcomp 1.9F Vascu-PICC™ is substantially equivalent to the Vygon 2F Epicutaneo Catheter in terms of intended use, insertion method, anatomical location, performance and method of sterilization.

> Medcomp 1.9F Vascu-PICC™ 510(k) Summary Page 1 of 2

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#### G. Performance Data:

In vitro testing was performed on the Medcomp 1.9F Vascu-PICC™ to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3. Testing includes gravity flow, air leakage, liquid leakage, tensile strength, elongation, air priming volume.

Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.

Biocompatibility testing on the same materials that are included in the 1.9F Vascu-PICC™ were completed on K974236, Medcomp Duo-Flow Soft Line Catheter and K003682, Medcomp Z Cath. These tests demonstrate that the materials used in the 1.9F Vascu-PICC™ meet the requirements of ISO 10993 for a permanent contact device. Biocompatibility testing on the stainless steel with silicone coating of the stylet was completed by the vendor and is enclosed in this submission. These tests demonstrate that the stylet meets requirements of ISO 10993 for a limited externally communicating device with indirect blood path. The handle of the stylet has no patient contact and therefore biocompatibility testing is unnecessary.

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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 depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2006

Ms. Susan Motzer Regulatory Specialist Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K061986

Trade/Device Name: 1.9F Vasu-PICCTM Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 13, 2006 Received: July 13, 2006

Dcar Ms. Motzer:

We have reviewed your Section 510(k) premarket notification of intent to market the device rcferenced 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 Eederal Register.

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### Page 2 - Ms. Motzer

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 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

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## Indications for Use

510(k) Number (if known):

Device Name: 1.9F Vascu-PICCTM

Indications for Use:

The 1.9F Vascu-PICC™ is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clues

ംസ Sign-Off) ്ഥാ of Anesthesiology, General Hospital, I. Haction Control, Dental Devices 540(k) Number:

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