KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311

K061936 · The Kendall Company · LJS · Aug 9, 2006 · General Hospital

Device Facts

• Record ID: K061936
• Device Name: KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
• Applicant: The Kendall Company
• Product Code: LJS · General Hospital
• Decision Date: Aug 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved by a peripheral or poundine patient theter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.

Device Story

Dual lumen polyurethane PICC; 1.9 Fr diameter; bifurcates into two 5.0 Fr pigtails. Primary lumen clear; secondary lumen lavender-tinted for differentiation. Insert-molded hubs. Used in clinical settings for neonates/pediatrics requiring long-term venous access. Facilitates simultaneous administration of hydration fluids, parenteral nutrition, and medications. Placed via peripheral vein or subclavian cutdown by healthcare professionals. Benefits include reliable long-term vascular access for fragile patient populations.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO-10993 standards confirmed materials are biocompatible.

Technological Characteristics

Dual lumen polyurethane tube; 1.9 Fr diameter; bifurcates into two 5.0 Fr pigtails. Biocompatible materials per ISO-10993. Non-electronic, mechanical device.

Indications for Use

Indicated for neonate and pediatric patients requiring venous catheterization or long-term I.V. administration of fluids for hydration, parenteral nutrition, and other intravenous medications. Placement via peripheral venous site or subclavian cutdown.

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

• Kendall Argyle 2.0 Fr. Single Lumen PICC (K974015)
• Kendall Argyle 1.9 Fr. Dual Lumen PICC (K42461)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness

AUG - 9 2006

| Submitted by: | The Kendall Company<br>15 Hampshire Street<br>Mansfield, MA 02048 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul W. Evans<br>[phone] |
| Date Prepared: | July 7, 2006 |
| Proprietary Name: | Kendall Argyle® 1.9 Fr Dual Lumen<br>Neonatal/Pediatric Peripherally Inserted<br>Central Catheter |
| Common Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long-term catheters (30 days or more) |
| Predicate Devices: | Kendall Argyle 2.0 Fr. Single Lumen PICC<br>(K974015)<br>Kendall Argyle 1.9 Fr. Dual Lumen PICC<br>(K42461) |

Description of the Device:

The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen.

## Intended Use of the Device:

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The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved by a peripheral or poundine patient theter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.

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## Technological Characteristics:

The Argyle Neonatal / Pediatric PICC is equivalent to the referenced from signed devices in that they are fabricated from similar materials, have the same function, equivalent indications for use, and similar overall design. ! ※ 2

Nonclinical testing:

Biocompatibility testing was performed on the Argyle PICC catheter, following ISO-10993 Biological Evaluation of Medical Devices. The testing found that the materials used in the Kendall Argyle PICC catheter are biocompatible.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2006

The Kendall Company Mr. Paul W. Evans Director, Regulatory Affairs Division of Tyco Healthcare Group LP 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K061936

Trade/Device Name: Kendall Argyle® 1.9 Fr Dual Lumen Neonatal/Pediatric Peripherally Inserted Central Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 7 2006 Received: July 10, 2006

Dear Mr. Evans:

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. Evans

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 mamifacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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,

Smith J. Michie DMD.

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

K061936 510(k) Number:

Device Name:

Kendall / Argyle 1.9 Fr Neonatal / Pediatric Peripherally Inserted Central Catheter (PICC)

## Indications for Use:

The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.

Over-The Counter Use OR Prescription Use (Per 21 CFR §801.109) ... . 19:00 - 11:00 : 1 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 1998 - 1999 - 1999 Concurrence of CDRH, Office of Device Evaluation (ODE)

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