PRO-PICC

K091953 · Medcomp · LJS · Sep 16, 2009 · General Hospital

Device Facts

• Record ID: K091953
• Device Name: PRO-PICC
• Applicant: Medcomp
• Product Code: LJS · General Hospital
• Decision Date: Sep 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PRO-PICC® catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. 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 an open-ended, radiopaque polyurethane catheter for peripheral access to the central venous system. Features include reverse taper lumen design, soft pliable hub with suture wings, and extension tubes with clamps. Purple-colored extension lines and specific labeling identify power-injectable capability. Device facilitates intravenous therapy, contrast media power injection, and central venous pressure monitoring. Used in clinical settings by healthcare professionals for catheter insertion and management. Stylet and adaptor sideport assist in placement. Output is the established venous access path; healthcare providers use the device to deliver fluids/contrast or monitor pressure, directly impacting patient treatment and diagnostic imaging capabilities.

Clinical Evidence

Bench testing only. Performance testing conducted per international standards and FDA guidance. Biocompatibility testing confirms materials meet ISO 10993 requirements. No clinical data presented.

Technological Characteristics

Radiopaque polyurethane catheter; reverse taper lumen design; soft pliable hub with suture wings; purple-colored extension lines for power injection identification. Available in single/double lumen configurations. Sterilized. Materials meet ISO 10993 biocompatibility standards.

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for IV therapy, power injection of contrast media, and central venous pressure monitoring (if 20G+ lumen). Blood sampling/infusion requires 4F+ catheter.

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

• Medcomp, PRO-LINE® CT Pressure Injectable CVC (K053345)
• Medcomp, PRO-PICC® CT (K081904)
• Bard Access Systems, Inc., 4Fr SL PowerPICC® (K070996)

Submission Summary (Full Text)

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# SEP 1 6 2009

| Section 5 | | 510(k) SUMMARY | Traditional 510K |
|-----------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 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: | June 30, 2009 | |
| B. | Trade Name: | Medcomp® PRO-PICCCT | |
| | Common Name: | Catheter, Intravascular, Therapeutic,<br>Long-Term | |
| | Classification Name: | Long Term Intravascular Catheter (80 LJS) | |
| | Regulation Name: | Percutaneous, implanted, long-term intravascular<br>catheter | |
| | C.F.R. Section: | 880.5970 | |
| | Class: | II | |
| C. | Predicate Devices: | K053345 Medcomp, PRO-LINE® CT Pressure<br>Injectable CVC, class II 880.5970<br>K081904 Medcomp, PRO-PICC® CT, class II 880.5970<br>K070996 Bard Access Systems, Inc., 4Fr SL PowerPICC®, class II 880.5970 | |

## Device Description:

The PRO-PICC catheter is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® PRO-LINE® CT Power Injectable CVC (K053345) and PRO-PICC® CT (K081904) catheter line. The PRO-PICCo CT 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 and fluid communication. Female luer connectors provide the connection for intravenous administration. The power iniectable extension lines are purple in color to differentiate it from non-power injectable catheters. The extensions are also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection. The dual lumen catheter has one purple colored clamp and one natural colored clamp allowing units to designate power injection on one side and infusion; blood withdraw and pressure monitoring on the other although both lumens are capable of power injection.

The PRO-PICC catheter is available in additional French sizes and either a single or double lumen. The catheter has a usable length of 50cm to 60 cm depending on French size with depth

Medcomp PRO-PICC o catheter Summary

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markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

Kos 1983

The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.

## Indications for Use:

The PRO-PICC catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. 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.

#### Comparison to Predicate Devices:

The PRO-PICC catheters are substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, most materials, performance, labeling, manufacturing process and method of sterilization.

The differences between the PRO-PICC and the predicate devices are one material change and expansion of product line with additional French sizes and the addition of single and double lumens.

## Bench / Performance Data:

Performance testing of the proposed devices was conducted in accordance with applicable international standards and FDA guidance documents. Performance standards for pressure injection have not been established by FDA under section 514 of the Federal Food, Drug and. Cosmetic Act. Testing is based upon internal engineering testing methods.

The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices.

## Biocompatibility:

Testing for all materials used for the PRO-PICC o has been submitted in previously cleared Medcomp devices. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993.

#### Technological Characteristics:

Technological similarities between the proposed devices and predicate devices remain the same.

## Summary of Substantial Equivalence:

The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed devices are substantially equivalent to the legally marketed predicate devices.

Medcomp PRO-PICC o catheter Summary

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has a staff with a snake winding around it, and a pair of wings at the top.

Food and Drug Administration 10903 New Hampshire Avenne Document Mail Conter - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K091953

Trade/Device Name: PRO-PICCo CT Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 29, 2009 Received: July 13, 2009

SEP 1 6 2009

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 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH

/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony V. Watson br

Susan Runner, D.D.S., M.A. Acting Division 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

510(k) Number (if known):

PRO-PICC ® CT Device Name: ------------

Indications for Use:

The PRO-PICC® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. 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 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),

Charles Zeller
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K091953