CT MIDLINE

{0}------------------------------------------------ Image /page/0/Picture/0 description: This document is a 510(k) summary for a CT Midline device by MEDCOMP®, dated July 8, 2014. It includes the submitter's information, device name, common name, classification details, and predicate devices. The device is designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations. The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for medCoMP. The logo consists of a stylized geometric shape above the text "medCoMP". The geometric shape is made up of black lines and white space, forming an abstract design. The text "medCoMP" is in a serif font and is positioned below the geometric shape. l 499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax: 215-256-1787 www.medcompnet.com Indications for Use: The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter. # Comparison to Predicate Devices: The CT Midline is substantially equivalent to the predicate devices in terms of intended use. materials, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization. | Attribute | CT Midline<br>(Proposed) | Midline (Predicate)<br>K121094 | Pro-PICCCT<br>(Predicate) K091953 | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | INDICATIONS<br>FOR USE: | The CT Midlines are<br>indicated for Short-<br>Term peripheral<br>access to the<br>peripheral venous<br>system for selected<br>intravenous therapies,<br>blood sampling, and<br>power injection of<br>contrast media. The<br>maximum<br>recommended<br>infusion rate varies<br>by catheter French<br>size and is printed on<br>the catheter. | The Midline<br>catheters are<br>indicated for short or<br>long term peripheral<br>access to the<br>peripheral venous<br>system for selected<br>intravenous therapies<br>and blood sampling.<br>(see<br>Contraindications)<br>For blood therapy it<br>is recommended that<br>a 4French or larger<br>catheter is used. | The PRO-PICCCT<br>catheter is indicated<br>for short term or<br>long term peripheral<br>access to the central<br>venous system for<br>intravenous therapy<br>and power injection<br>of contrast media<br>and allows for<br>central venous<br>pressure monitoring<br>when a 20gauge or<br>larger lumen is<br>used. For blood<br>sampling, infusion<br>or therapies use a<br>4F or larger<br>catheter. The<br>maximum<br>recommended<br>infusion rate varies<br>by catheter French<br>size and is printed<br>on the catheter. | | WHERE USED: | Hospital | Hospital | Hospital | | STERILITY: | 100% Ethylene Oxide | 100% Ethylene Oxide | 100% Ethylene Oxide | | BIOCOMPATIBILITY: | Materials are identical to<br>legally marketed | Legally Marketed<br>510(k) K121094 | Legally Marketed<br>510(k) K091953 | | Attribute | CT Midline<br>(Proposed) | Midline (Predicate) | Pro-PICC CT<br>(Predicate) K091953 | | | K121094 with the<br>exception of the Acetal<br>clamp which was cleared<br>in legally marketed<br>K091953.<br><br>Biocompatibility<br>summaries located in<br>Section 15 page 1. | K121094 | | | MATERIALS<br>AND<br>ADDITIVES: | LUMEN:<br>Thermedics<br>Tecothane TT2095A<br>(30% Barium Sulfate) | LUMEN:<br>Thermedics<br>Tecothane TT2095A<br>(30% Barium<br>Sulfate) | | | | PRINTING:<br>Markem, Black | PRINTING:<br>Markem, Black | | | | HUB and SUTURE<br>WING: Dow<br>Pellethane 2363-80A | HUB and SUTURE<br>WING: Dow<br>Pellethane 2363-80A | | | | LUERS: Isoplast<br>2510. Natural White<br>additives: Titanium<br>Dioxide. | LUERS: Isoplast<br>2510. Natural White<br>additives: Titanium<br>Dioxide. | CLAMPS: Halkey<br>Roberts Acetal,<br>Purple | | | EXTENSIONS:<br>Dow Pellethane<br>2363-80A | EXTENSIONS:<br>Dow Pellethane<br>2363-80A | | | | CLAMPS: Halkey<br>Roberts Acetal<br>Copolymer-<br>Purple - single lumen<br>Purple- double lumen | CLAMPS: Halkey<br>Roberts Acetal<br>Copolymer-<br>Natural - single<br>lumen<br>Natural- double<br>lumen | | | | I.D. RING: ABS<br>Lustran 348 | I.D. RING: ABS<br>Lustran 348 | | | | Drawings in Section<br>11. | Drawings in Section<br>11. | | | Design<br>Specifications | LUMEN and<br>TAPER LENGTH<br>AVG.:<br>Single lumen 4F - | LUMEN and<br>TAPER LENGTH<br>AVG.:<br>Single lumen 4F - | N/A | Medcomp CT Midline Summary 5-2 {2}------------------------------------------------ {3}------------------------------------------------ | Attribute | CT Midline<br>(Proposed) | Midline (Predicate)<br>K121094 | Pro-PICC CT<br>(Predicate) K091953 | |-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | | short taper 2.756 inch<br>(7cm) (Midline) | short taper 2.756 inch<br>(7cm) (Midline) | | | | Double 5F – long<br>taper 3.44 to 5.44<br>inch. | Double 5F – long<br>taper 3.44 to 5.44<br>inch. | | | | LUMEN I.D./O.D.<br>AVG.: Proximal to<br>taper (applies to both<br>short and long taper)<br>4F Single: I.D. .045<br>inch (1.14mm)<br>O.D. .082<br>inch (2.08mm)<br>5F Double*: I.D.<br>.039 inch (.99mm)<br>O.D. .092<br>inch (2.24mm)<br>* Equivalent<br>diameter of each<br>lumen based on D-<br>lumen cross-section<br>area. | LUMEN I.D./O.D.<br>AVG.: Proximal to<br>taper (applies to both<br>short and long taper)<br>4F Single: I.D. .045<br>inch (1.14mm)<br>O.D. .082<br>inch (2.08mm)<br>5F Double*: I.D.<br>.039 inch (.99mm)<br>O.D. .092<br>inch (2.24mm)<br>* Equivalent diameter<br>of each lumen based on<br>D-lumen cross-section<br>area. | | | | TIP LUMEN<br>I.D./O.D. AVG.:<br>4F Single: I.D. .032<br>inch (.81mm)<br>O.D. .052<br>inch (1.32mm)<br>5F Double*: I.D.<br>.031 inch (.79mm)<br>O.D. .068<br>inch (1.73mm)<br>* Equivalent<br>diameter of each<br>lumen based on D-<br>lumen cross-section<br>area. | TIP LUMEN<br>I.D./O.D. AVG.:<br>4F Single: I.D. .032<br>inch (.81mm)<br>O.D. .052<br>inch (1.32mm)<br>5F Double*: I.D.<br>.031 inch (.79mm)<br>O.D. .068<br>inch (1.73mm)<br>* Equivalent diameter<br>of each lumen based on<br>D-lumen cross-section<br>area. | | | | LUMEN LENGTH:<br>20cm (midline).<br>Open ended design.<br>DEPTH | LUMEN LENGTH:<br>20cm (midline).<br>Open ended design.<br>DEPTH | | P Medcomp CT Midline Summary 5-4 {4}------------------------------------------------ | | | CT Midline 15<br>(Proposed) | Midline (Predicate);<br>K121094 .; I | | |------------------------|----------------------------|--------------------------------------------|--------------------------------------|--| | | | MARKING: | MARKING: | | | | | Number every Scim | Number every Scm | | | | | and depth mark every | and depth mark every | | | | | cm. | cm. | | | | | HUB: With suture | HUB: With suture | | | | | wing, all models. | wing, all models. | | | medCoMP | | Contains French size<br>on hub. | Contains French size<br>on hub. | | | 1499 Delp Drive | | | | | | Harleysville, PA 19438 | | LUER: Easy Grip<br>design. | LUER: Easy Grip™<br>design. | | | | | | | | | Tel: 215-256-4201 | | EXTENSION | EXTENSION | | | Fax: 215-256-1787 | | AVG.: Clear with | AVG .: Clear with | | | | | clamp. | clamp. | | | www.medcompnet.com | | 4F Single - 19 gauge | 4F Single - 19 gauge | | | | | 5F Double - 18 | 5F Double - 18 | | | | | gauge | gauge | | | | | ALL SINGLE, AND | ALL SINGLE, AND | | | | | DOUBLE | DOUBLE | | | | | EXTENSIONS: | EXTENSIONS: | | | | | I.D .: . 070 inches | I.D . 070 inches | | | | | O.D .: . 106 inches | O.D .: 106 inches | | | | | I.D. RING WITHIN | I.D. RING WITHIN | | | | | CLAMP: On CT | CLAMP: On | | | | | Midline contains | Midline contains | | | | | product name and | extension gauge and | | | | | Max rate of 7cc/sec. | French size with | | | | | | lumen length. | | | | | Drawings in Section | Drawings in Section | | | | | ] l . | l 2. | | | | MECHANICAL/<br>PERFORMANCE | AIR LEAKAGE: | | | | | TESTING: | 4F | | | | | | All versions passed in accordance with ISO | | | | | | 10555-1. Annex D. Reference testing | | | | | | summaries and protocols in Section 18. | | | | | | SF | | | | | | All versions passed in accordance with ISO | | | | | | 10555-1. Annex D. Reference testing | | | | | | summaries and protocols in Section 18. | | | | | | LIQUID LEAKAGE: | | | ﺴﺴ {5}------------------------------------------------ | Attribute | CT Midline<br>(Proposed) | Midline (Predicate)<br>K121094 | Pro-PICC CT<br>(Predicate) K09195- | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | All versions passed in accordance with ISO 10555-<br>1, Annex C. Reference testing summaries and<br>protocols in Section 18. | | | | Power Injection<br>Capability<br>Testing | POWER INJECTION<br>FLOW RATE: | | POWER INJECTION<br>FLOW RATE: | | | 4F:<br>V-9131:<br>Power Injection Flow<br>Rate / Injection<br>Pressure (Avg.)<br>Flow Rate (cc/sec)- 4.9<br>Machine Pressure (psi)-<br>213<br>HYDAC Pressure (psi)-<br>168 | | 4F:<br>4Fx50cm Single<br>Power Injection Flow<br>Rate / Injection<br>Pressure (Avg.)<br>Flow Rate (cc/sec)-<br>3.9<br>Machine Pressure<br>(psi)- 183 | | | 5F:<br>V-9077:<br>Power Injection Flow<br>Rate / Injection<br>Pressure (Avg.)<br>Flow Rate (cc/sec)- 6.9<br>Catheter Pressure (psi)-<br>244<br>HYDAC Pressure (psi)-<br>181 | | 5F:<br>5Fx55cm Double<br>Power Injection<br>Flow Rate / Injection<br>Pressure (Avg.)<br>Flow Rate (cc/sec)-<br>4.9<br>Machine Pressure<br>(psi)- 212 | | | MAX STATIC BURST: | | MAX STATIC<br>BURST: | | | 4F:<br>V-9043:<br>The average maximum<br>burst pressure was<br>302±5psi. The range of<br>burst pressures was 292-<br>312 psi. | | 4F:<br>The average maximum<br>burst pressure was<br>288±4psi. The range<br>of burst pressures was<br>279-293 psi. All<br>samples burst along<br>the lumen. | | | 5F:<br>V-9073:<br>The average maximum<br>burst pressure was<br>249±8psi. The range of<br>burst pressures was 241-<br>262 psi. | | 5F:<br>The average maximum<br>burst pressure was<br>269±4psi. The range<br>of burst pressures was<br>262-278 psi. All<br>samples failed by<br>rupture of the lumen. | Comparison to Predicate Devices (cont.): {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with a geometric design above the word "medCOMP." The geometric design consists of a stylized shape, possibly representing a stylized letter or symbol, with a combination of black and white areas creating a sense of depth. The word "medCOMP" is written in a serif font, with the letters in lowercase except for the "COMP" part, which is in uppercase. There is a period at the end of the word. 1499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4207 Fax: 215-256-1787 www.medcompnet.com The proposed device is substantially equivalent to the predicate devices because the data demonstrates the proposed device matches the power injection indication and performance of the predicate K091953 while being otherwise identical to the K121094 predicate device. ## Performance Standards: Performance standards have not been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act. # Nonclinical Performance Tests: The following tests were performed to establish the device's equivalence to the relevant predicate device: - o Power Injection Flow Rate - � Max Static Burst These tests highlight the relevant difference between the proposed device and predicate K121094 by testing for the safety and effectiveness of the proposed device with regard to the expanded indication for use of power injection. As the predicate K121094 was not indicated for power injection, the K091953 performance data is discussed in this submission to establish that the proposed device is substantially equivalent in terms of power injection performance. # Biocompatibility: Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993. ## Technological Characteristics: The principles of operation are the same as the predicate devices, with the exception that the proposed device is indicated for power injection of contrast media. Fundamentally, the proposed device is physically identical to the predicate K 121094 aside from the clamp, which is now colored purple to indicate power injection. The purpose of this submission is to establish that the proposed device can be properly indicated for power injection as supported by the provided data. There are no new questions raised regarding the safety or effectiveness of the device. ### Summary of Substantial Equivalence: The proposed device meets the performance criteria of design verification as specified by ISOstandards, guidance documents and 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 logally marketed predicate devices. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 # July 8, 2014 Medical Components, Inc. Timothy Holwick International Principal Regulatory Associate 1499 Delo Drive Harleysville, PA 19438 Re: K141151 Trade/Device Name: CT Midline Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: May 5, 2014 Reccived: May 6, 2014 Dear Mr. Holwick: 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 10 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. 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. {8}------------------------------------------------ Page 2 - Mr. Holwick 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Mary S. Runner -S Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K141151 Device Name Medcomp CT Midline Indications for Use (Describe) The CT Midlines are indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) . Digitally signed by Richard C. Chapman -S Date: 2014.07.08 11:11:27 -04'00' This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."