PICC

K042126 · Arrow Intl., Inc. · LJS · Aug 27, 2004 · General Hospital

Device Facts

• Record ID: K042126
• Device Name: PICC
• Applicant: Arrow Intl., Inc.
• Product Code: LJS · General Hospital
• Decision Date: Aug 27, 2004
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Arrow International Peripherally Inserted Central Catheter is intended for short-term peripheral venous access to the central circulation. It offers an alternative method of intravenous therapy for select adult and pediatric patients.

Device Story

Peripherally Inserted Central Catheter (PICC) provides venous access to central circulation; intended for short-term intravenous therapy in adult and pediatric patients. Device consists of trimmable catheter (40-60 cm) with modified juncture for increased strength; available in single and double lumen configurations. Operated by healthcare professionals in clinical settings. Output is established venous access for infusion therapy. Benefits include alternative route for central venous access. Safety for power injection/high-pressure infusion systems not established.

Clinical Evidence

Bench testing only. Performance evaluation included tensile strength, flex test, burst, fatigue, and leakage testing. Results demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Trimmable intravascular catheter; single or double lumen; lengths 40-60 cm. Features modified catheter juncture for increased strength. Materials and design characteristics are identical to predicate devices. No software or electronic components.

Indications for Use

Indicated for adult and pediatric patients requiring venous access to the central circulation via a peripheral vein for intravenous 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

• Arrow International's Peripherally Inserted Central Catheter (K930129)
• Two Lumen PICC with Blue FlexTip® Catheter with Integral Needle Protection (K003006)

Submission Summary (Full Text)

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K042126

## AUG 27 2004

## ATTACHMENT 1: 510 (K) SUMMARY

| Submitter | ARROW International Inc<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Suzanne Schorle<br>Regulatory Affairs Associate<br>Phone: [phone], ext. 3443<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary prepared: | August 4, 2004 |
| Device trade name: | Peripherally Inserted Central Catheters |
| Device common name: | PICC |
| Device classification name: | Catheter, intravascular, therapeutic, long-term greater than<br>30 days |
| Legally marketed devices to<br>which the device is<br>substantially equivalent: | Arrow International's Peripherally Inserted Central<br>Catheter (K930129) and Two Lumen PICC with Blue<br>FlexTip® Catheter with Integral Needle Protection<br>(K003006) |
| Description of the device: | The Arrow International Peripherally Inserted Central<br>Catheters are similar to the currently marketed Arrow<br>Trimmable and Blue FlexTip® single and double lumen<br>catheters. The catheter juncture has been modified to<br>improve overall catheter strength. The hub colors and<br>catheter labeling have changed to distinguish the new<br>Arrow catheters. The catheter is available in lengths of 40<br>cm - 60 cm. |
| Intended use of the device: | The Arrow International Peripherally Inserted Central<br>Catheter is intended for short-term peripheral venous<br>access to the central circulation. It offers an alternative<br>method of intravenous therapy for select adult and<br>pediatric patients. |
| Technological<br>characteristics: | The proposed peripherally inserted central catheters have<br>the same technological design characteristics as the<br>predicate devices. |
| Performance tests: | The following tests were performed to demonstrate<br>substantial equivalence:<br>• Tensile Strength<br>• Flex Test<br>• Burst<br>• Fatigue<br>• Leakage |
| Assessment of non-clinical<br>performance data: | The results of the laboratory tests demonstrate that the<br>Arrow peripherally inserted central catheter are<br>substantially equivalent to the legally marketed predicate<br>devices. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 7 2004

Ms. Suzanne Schorle Regulatory Affairs Associate Arrow International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605

Re: K042126

Trade/Device Name: Peripherally Inserted Central Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter. Regulatory Class: II Product Code: LJS Dated: August 5, 2004 Received: August 6, 2004

Dear Ms. Schorle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller by 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 Interstate conninetee prior to ria, 20, 1778, as a see and the provisions of Amendments, of to devices that ha 70 Act (Act). You may, therefore, market the device, the rederal rood, Drag, and Cosmonions of the Act and the limitations described below. subject to the general controls provisions of the Act include requirements for annual registration, I he general controls provisions turing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that The Office of Device Draiaator inded use not identified in your Indications For Use this device will be used for an menava sharm. Therefore, in accordance with Section Statement and that such as ecure can in the Warnings of device's labeling:

- The safety and effectiveness of this device for the use with power injection and high t power infusion systems has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the I icase not that the above laboring mirred before these limitations are modified in any way or removed from the device's labeling.

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Page-2 Mr. Schorle

The FDA finding of substantial equivalence of your device to a legally marketed predicate I he FDA Inding of substantial equivalence or your device and permits your device to proceed to the device results in a classification for your de rice as described in your market. This letter will anow you to begin marteeining your marketing on and ed to vour labeling.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into cols. Existing major regulations affecting your (PMA), It may be subject to adultions, Title 21, Parts 800 to 898. In device can be louind in the Code of Peachards, rought in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 ISSuance of a bases on a base on plies with other requirements mean that IDA has made a decommanen in administered by other Federal agencies. of the Act of ally rederal statues and regaranents, including, but not limited to: registration You must continue with an the Free 5 rog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), idooling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to II you desire specific information as our art appear and compliance at [phone]. your device (21 CFR Part 607), presided, "Misbranding by reference to premarket Also, please note the regulation entitled, "You may obtain other general information on your notification (21 CFR Part 007.77): Touring Schall Manufacturers, International, and responsibilities under the Net Hom and Division of [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

[signature]

Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K043126

## ATTACHMENT 2: INDICATIONS FOR USE STATEMENT

| 510(k) Number: | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Peripherally Inserted Central Catheter |
| Indications for Use: | A Peripherally inserted Central Catheter permits venous access to the<br>central circulation through a peripheral vein. It offers an alternative<br>method of intravenous therapy for select adult and pediatric patients. |

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

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

- Use
(part C)

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

Antin Dint

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________