PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY

K072509 · Medcomp · LJS · Nov 26, 2007 · General Hospital

Device Facts

• Record ID: K072509
• Device Name: PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY
• Applicant: Medcomp
• Product Code: LJS · General Hospital
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PRO-PICC m C catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

Device Story

PRO-PICC CT is a triple-lumen, open-ended, peripherally inserted central catheter (PICC) designed for intravenous therapy and power injection of contrast media. Constructed from radiopaque polyurethane; features reverse taper design; includes soft pliable hub with suture wings for securement. Purple-colored extension line and lumen identify power-injectable capability; I.D. ring on clamp provides infusion rate and flushing instructions. Device is inserted by clinicians to provide central venous access. Output is the delivery of fluids or contrast media; enables diagnostic imaging via power injection and therapeutic administration. Benefits include reliable central venous access and compatibility with high-pressure contrast injection protocols.

Clinical Evidence

Bench testing only. In vitro testing performed per ISO 10555-1 and 10555-3, including air/liquid leakage, force at break, elongation, gravity flow, static burst pressure, high-pressure injection flow rate, and chemical testing. Biocompatibility data leveraged from predicate K053345.

Technological Characteristics

Triple-lumen, open-ended PICC; radiopaque polyurethane construction; 6F size; 60 cm length. Features reverse taper lumen design, suture wings, and luer connectors. Sterilized; intended for permanent external communicating blood contact. No software or electronic components.

Indications for Use

Indicated for short-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media in patients requiring such access.

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

• C.R. Bard, Inc. 6Fr. TL PowerPICC Catheter (K053501)
• Medcomp Pro-Line CT Pressure Injectable CVC (K053345)

Reference Devices

• Medcomp Power Injectable Implantable Port (K070003)

Submission Summary (Full Text)

{0}------------------------------------------------

K072509

1. 52

| A. | Submitter Information: | |
|----|------------------------|---------------------------------------------------------------------------------------------------------------------|
| | Submitter: | MEDCOMP®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Tel: [phone]<br>Fax: [phone] |
| | Contact: | Jean Callow<br>Regulatory Specialist |
| | Date Prepared: | NOV 2 6 2007<br>September 7, 2007 |
| B. | Trade Name: | Medcomp® PRO-PICC TM CT |
| | Common Name: | Peripherally Inserted Central Catheter |
| | Classification: | LJS |
| | Regulation Name: | Percutaneous, implanted, long-term<br>intravascular catheter |
| | C.F.R. Section: | 880.5970 Class II |
| C. | Predicate Device: | C.R. Bard, Inc. K053501 6Fr. TL<br>PowerPICCTM Catheter<br>Medcomp K053345 Pro-Line™ CT Pressure<br>Injectable CVC. |

## D. Device Description:

The PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The PRO-PICC m C catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

{1}------------------------------------------------

### E. Intended Use:

The PRO-PICC m C catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

1073500

### F. Performance Data:

In vitro testing was performed on the PRO-PICC ™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3 and internal engineering protocol. Testing includes air/liquid leakage, force at break, elongation, gravity flow, static burst pressure, high pressure injection flow rate and chemical testing.

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 devices.

All materials used for the proposed device were previously cleared in the Medcomp K053345 Pro-Line™ CT Pressure Injectable CVC. Biocompatibility testing on the Pro-Line™ CT Pressure Injectable CVC demonstrated that the materials used meets the requirements of ISO 10993 for a permanent external communicating blood contact device.

### (1. Comparison to Predicate Device:

The PRO-PICC m C catheter is substantially equivalent to the predicate devices in terms of intended use, insertion method, anatomical location, design, materials, performance, labeling, packaging and method of sterilization.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2007

Ms. Jean Callow Regulatory Specialist MedComp 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K072509

Trade/Device Name: PRO-PICC таст Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 6, 2007 Received: September 17, 2007

Dear Ms. Callow:

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.

{3}------------------------------------------------

Page 2 - Ms. Callow

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.

Chih-Lin, 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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: ___ PRO-PICC m CT

Indications for Use:

The PRO-PICC m C catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

Prescription Use >< (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)

Anthon 29, a

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

Page 1 of 1

Kona509

181

510(k) Number: Kun2549