6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET

K131687 · Medical Components, Inc. · LJS · Aug 16, 2013 · General Hospital

Device Facts

• Record ID: K131687
• Device Name: 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
• Applicant: Medical Components, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Aug 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medcomp® 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal, allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec.

Device Story

Pro-Line CT Power Injectable CVC is an open-ended triple lumen catheter; constructed of radiopaque polyurethane. Features reverse taper design; soft pliable hub with suture wing; clamps on extension tubes; female luer connectors. Purple-colored 17ga extension line/clamp identifies power-injectable lumen; clear 19ga extensions are non-power injectable. Includes stylet and adaptor sideport for insertion. Used in clinical settings for central venous access; operated by healthcare professionals. Provides pathway for fluid/drug administration, blood withdrawal, pressure monitoring, and contrast media power injection. Benefits patient by enabling reliable central venous access for various therapies and diagnostic imaging.

Clinical Evidence

No clinical data. Bench testing only. Performance testing conducted per international standards and internal engineering protocols demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Radiopaque polyurethane catheter; triple lumen; reverse taper design; 60 cm usable length; numerical/depth markings. Purple color-coding for power-injectable lumen. Sterile, single-use. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring short or long-term central venous access for administration of IV fluids, blood products, drugs, parenteral nutrition, blood withdrawal, central venous pressure monitoring, and power injection of contrast media at rates up to 5cc/sec.

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-PICC CT (K092347)
• Medcomp® Vascu-PICC and Midline Catheters (K121094)
• Medcomp® Pro-Line™ CT Power Injectable CVC (K093309)
• Medcomp® Pro-PICC CT (K123617)

Submission Summary (Full Text)

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| Section 5 | 510(k) SUMMARY | Traditional 510K |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Submitter Information: | | |
| Submitter: | MEDCOMP®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Tel: [phone], x2271<br>Fax: [phone] | |
| Contact: | Jessica Leo | |
| | Regulatory Associate | |
| Date Prepared: | June 7, 2013 | |
| Trade Name: | Medcomp® Pro-Line ^CT Power Injectable CVC | |
| Common Name: | power injectable central venous catheter | |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) | |
| Regulation Name: | Percutaneous, implanted, long-term intravascular catheter | |
| C.F.R. Section: | 880.5970 | |
| Class: | II | |
| Predicate Devices: | K092347, Medcomp® Pro-PICC ^CT<br>K121094, Medcomp® Vascu-PICC and Midline Catheters<br>K093309, Medcomp® Pro-Line™ CT Power Injectable CVC<br>K123617, Medcomp® Pro-PICC ^CT | |
| | | |
| AUG 16 2013 | | |

KI31687

#### D. Device Description:

The Pro-Line of Power Injectable CVC triple lumen is an open-ended triple lumen catheter designed for power injection through one designated lumen. The power injectable central venous 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 17ga. power injectable extension line and clamp material are purple in color to differentiate it from the clear 19ga. non-power injectable extensions. The purple lumen identifies it as a power injectable catheter. The center extension is also 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 catheter has a usable length of 60 cm with numerical markings every 5 cm and depth markings in 1 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

Medcomp Pro-Line OCT Power Injectable CVC Triple Lumen Summary Page 1 of 3

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1499 Delp Drive

Harleysville, PA 19438

Tel: [phone]

Fax: [phone]

www.medcompnet.com

The catheter is packaged sterile with the necessary accessories to facilitate catheter insertion.

# Indications for Use:

ដើ

The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering L.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal. allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is Scc/sec.

F. Comparison to Predicate Devices:

> The Pro-Line on Power Injectable CVC is substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, materials, performance, labeling, manufacturing process and method of sterilization.

## () Bench / Performance Data:

Performance data for the Pro-Line CT Power Injectable CVC demonstrates that this device is substantially equivalent to the legally marketed device.

Performance testing of the proposed device was conducted in accordance with applicable international standards and along with internal engineering protocols.

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

# ਜ਼. Biocompatibility:

Testing for all materials used for the Pro-Line of Power Injectable CVC has been submitted in previously cleared Medcomp devices. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993.

### Technological Characteristics: I.

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

### ... Summary of Substantial Equivalence:

The proposed device meets 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 device is substantially equivalent to the legally marketed predicate device.

Medcomp Pro-Line T Power Injectable CVC Triple Lumen Summary Page 2 of 3

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Image /page/2/Picture/0 description: The image shows a logo with a geometric design above the word "medCOMP." The geometric design consists of a combination of curved and straight lines, creating an abstract shape. The word "medCOMP" is written in a stylized font, with the letters appearing to be italicized. The logo has a professional and modern look.

1 499 Delp Drive

Harleysville, PA 19438

Tel: [phone]

Fax: [phone]

www.medcompnet.com

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

Medcomp Pro-Line Power Injectable CVC Triple Lumen Summary Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

Agust 16, 2013

Medical Components, Incorporated Ms. Jessica Leo Regulatory Associate 1499 Delp Drive HARLEYSVILLE PA 19438

Re: K131687

Trade/Device Name: Pro-Line™CT Power Injectable CVC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 7, 2013 Received: June 11, 2013

Dear Ms. Leo:

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 for association to May 28, 1976. the enactment date of the Medical Device Amendments, or to eonimers 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Leo

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): _ K131687

Pro-Line @CT Power Injectable CVC_____________________________________________________________________________________________________________________________________________ Device Name:

Indications for Use:

The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal, allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec.

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

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)

| Richard C. Chapman |
|---------------------|
| 2013.08.15 13:26:29 |
| -04'00' |

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(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510 (k) Number: ___K131687____________________________________________________________________________________________________________________________________________________