Who is the manufacturer of CT MIDLINE?

Medcomp (Medical Components, Inc.) filed the 510(k) submission for CT MIDLINE (K141151).

What is the FDA product code for CT MIDLINE?

LJS. It is classified under 21 CFR 880.5970 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for CT MIDLINE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CT MIDLINE?

Midline (K121094); Pro-PICC CT (K091953).

Who can help prepare an FDA 510(k) submission like CT MIDLINE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CT MIDLINE

K141151 · Medcomp (Medical Components, Inc.) · LJS · Jul 8, 2014 · General Hospital

Device Facts

Record ID	K141151
Device Name	CT MIDLINE
Applicant	Medcomp (Medical Components, Inc.)
Product Code	LJS · General Hospital
Decision Date	Jul 8, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5970
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

CT Midline is a peripheral venous catheter designed for short-term vascular access. It facilitates intravenous therapy, blood sampling, and power injection of contrast media. The device is used in hospital settings by healthcare professionals. It consists of a catheter lumen (Tecothane), hub/suture wing (Pellethane), and purple-colored acetal clamps to signify power injection capability. The device is inserted into the peripheral venous system; clinicians monitor infusion rates printed on the catheter hub. Power injection allows for rapid delivery of contrast media during diagnostic imaging. The device benefits patients by providing a reliable, multi-purpose venous access point that supports both standard therapies and high-pressure contrast administration.

Clinical Evidence

Bench testing only. Performance verified via power injection flow rate testing and maximum static burst pressure testing in accordance with ISO 10555-1. Biocompatibility testing confirms materials meet ISO 10993 requirements.

Technological Characteristics

Materials: Tecothane TT2095A (lumen), Pellethane 2363-80A (hub/suture wing/extensions), Isoplast 2510 (luers), Acetal copolymer (clamps), ABS (ID ring). Sterilization: 100% Ethylene Oxide. Design: Single-lumen (4F) and double-lumen (5F) configurations. Connectivity: None. Software: None.

Indications for Use

Indicated for short-term peripheral venous access in patients requiring intravenous therapy, blood sampling, or power injection of contrast media. Contraindications not specified.

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

Midline (K121094)
Pro-PICC CT (K091953)

Related Devices

K092347 — PRO-PICC CT · Medcomp · Sep 16, 2009
K162900 — PowerMidline Catheter · C.R. Bard, Inc. · Dec 14, 2016
K111244 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) · Cook, Inc. · Jun 14, 2011
K192802 — primeMidline Catheters · Pfm Medical, Inc. · Oct 28, 2019
K213203 — Provena(TM) Midline Catheter · C.R. Bard, Inc. · May 13, 2022

Submission Summary (Full Text)

{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 (Proposed) | Midline (Predicate) K121094 | Pro-PICCCT (Predicate) K091953 | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | The Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. (see Contraindications) For blood therapy it is recommended that a 4French or larger catheter is used. | The PRO-PICCCT 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. | | WHERE USED: | Hospital | Hospital | Hospital | | STERILITY: | 100% Ethylene Oxide | 100% Ethylene Oxide | 100% Ethylene Oxide | | BIOCOMPATIBILITY: | Materials are identical to legally marketed | Legally Marketed 510(k) K121094 | Legally Marketed 510(k) K091953 | | Attribute | CT Midline (Proposed) | Midline (Predicate) | Pro-PICC CT (Predicate) K091953 | | | K121094 with the exception of the Acetal clamp which was cleared in legally marketed K091953. Biocompatibility summaries located in Section 15 page 1. | K121094 | | | MATERIALS AND ADDITIVES: | LUMEN: Thermedics Tecothane TT2095A (30% Barium Sulfate) | LUMEN: Thermedics Tecothane TT2095A (30% Barium Sulfate) | | | | PRINTING: Markem, Black | PRINTING: Markem, Black | | | | HUB and SUTURE WING: Dow Pellethane 2363-80A | HUB and SUTURE WING: Dow Pellethane 2363-80A | | | | LUERS: Isoplast 2510. Natural White additives: Titanium Dioxide. | LUERS: Isoplast 2510. Natural White additives: Titanium Dioxide. | CLAMPS: Halkey Roberts Acetal, Purple | | | EXTENSIONS: Dow Pellethane 2363-80A | EXTENSIONS: Dow Pellethane 2363-80A | | | | CLAMPS: Halkey Roberts Acetal Copolymer- Purple - single lumen Purple- double lumen | CLAMPS: Halkey Roberts Acetal Copolymer- Natural - single lumen Natural- double lumen | | | | I.D. RING: ABS Lustran 348 | I.D. RING: ABS Lustran 348 | | | | Drawings in Section 11. | Drawings in Section 11. | | | Design Specifications | LUMEN and TAPER LENGTH AVG.: Single lumen 4F - | LUMEN and TAPER LENGTH AVG.: Single lumen 4F - | N/A | Medcomp CT Midline Summary 5-2 {2}------------------------------------------------ {3}------------------------------------------------ | Attribute | CT Midline (Proposed) | Midline (Predicate) K121094 | Pro-PICC CT (Predicate) K091953 | |-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | | short taper 2.756 inch (7cm) (Midline) | short taper 2.756 inch (7cm) (Midline) | | | | Double 5F – long taper 3.44 to 5.44 inch. | Double 5F – long taper 3.44 to 5.44 inch. | | | | LUMEN I.D./O.D. AVG.: Proximal to taper (applies to both short and long taper) 4F Single: I.D. .045 inch (1.14mm) O.D. .082 inch (2.08mm) 5F Double*: I.D. .039 inch (.99mm) O.D. .092 inch (2.24mm) * Equivalent diameter of each lumen based on D- lumen cross-section area. | LUMEN I.D./O.D. AVG.: Proximal to taper (applies to both short and long taper) 4F Single: I.D. .045 inch (1.14mm) O.D. .082 inch (2.08mm) 5F Double*: I.D. .039 inch (.99mm) O.D. .092 inch (2.24mm) * Equivalent diameter of each lumen based on D-lumen cross-section area. | | | | TIP LUMEN I.D./O.D. AVG.: 4F Single: I.D. .032 inch (.81mm) O.D. .052 inch (1.32mm) 5F Double*: I.D. .031 inch (.79mm) O.D. .068 inch (1.73mm) * Equivalent diameter of each lumen based on D- lumen cross-section area. | TIP LUMEN I.D./O.D. AVG.: 4F Single: I.D. .032 inch (.81mm) O.D. .052 inch (1.32mm) 5F Double*: I.D. .031 inch (.79mm) O.D. .068 inch (1.73mm) * Equivalent diameter of each lumen based on D-lumen cross-section area. | | | | LUMEN LENGTH: 20cm (midline). Open ended design. DEPTH | LUMEN LENGTH: 20cm (midline). Open ended design. DEPTH | | P Medcomp CT Midline Summary 5-4 {4}------------------------------------------------ | | | CT Midline 15 (Proposed) | Midline (Predicate); 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 on hub. | Contains French size on hub. | | | 1499 Delp Drive | | | | | | Harleysville, PA 19438 | | LUER: Easy Grip design. | LUER: Easy Grip™ 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/ 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 (Proposed) | Midline (Predicate) K121094 | Pro-PICC CT (Predicate) K09195- | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | All versions passed in accordance with ISO 10555- 1, Annex C. Reference testing summaries and protocols in Section 18. | | | | Power Injection Capability Testing | POWER INJECTION FLOW RATE: | | POWER INJECTION FLOW RATE: | | | 4F: V-9131: Power Injection Flow Rate / Injection Pressure (Avg.) Flow Rate (cc/sec)- 4.9 Machine Pressure (psi)- 213 HYDAC Pressure (psi)- 168 | | 4F: 4Fx50cm Single Power Injection Flow Rate / Injection Pressure (Avg.) Flow Rate (cc/sec)- 3.9 Machine Pressure (psi)- 183 | | | 5F: V-9077: Power Injection Flow Rate / Injection Pressure (Avg.) Flow Rate (cc/sec)- 6.9 Catheter Pressure (psi)- 244 HYDAC Pressure (psi)- 181 | | 5F: 5Fx55cm Double Power Injection Flow Rate / Injection Pressure (Avg.) Flow Rate (cc/sec)- 4.9 Machine Pressure (psi)- 212 | | | MAX STATIC BURST: | | MAX STATIC BURST: | | | 4F: V-9043: The average maximum burst pressure was 302±5psi. The range of burst pressures was 292- 312 psi. | | 4F: The average maximum burst pressure was 288±4psi. The range of burst pressures was 279-293 psi. All samples burst along the lumen. | | | 5F: V-9073: The average maximum burst pressure was 249±8psi. The range of burst pressures was 241- 262 psi. | | 5F: The average maximum burst pressure was 269±4psi. The range of burst pressures was 262-278 psi. All samples failed by 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."

CT MIDLINE

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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CT MIDLINE

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

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