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 Description

The CT Midlines are designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations. 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.

AI/ML Overview

The provided document is a 510(k) summary for the Medcomp CT Midline device, indicating that it is being submitted for substantial equivalence to existing predicate devices, K121094 (Midline) and K091953 (Pro-PICC CT). The primary focus of the submission is to demonstrate that the CT Midline, while otherwise identical to predicate K121094, is also safe and effective for power injection, an indication shared with predicate K091953.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly labeled as such but are derived from the performance data presented for the proposed CT Midline and compared against the predicate devices, particularly the Pro-PICC CT (K091953) for power injection capabilities. The document asserts that the proposed device is "substantially equivalent" to predicate devices. For mechanical performance, specifically power injection, the CT Midline is compared to the Pro-PICC CT.

Attribute	Acceptance Criteria (Predicate K091953)	Reported Device Performance (CT Midline - Proposed)
Power Injection Flow Rate	4F: Flow Rate (cc/sec)- 3.9; Machine Pressure (psi)- 183 5F: Flow Rate (cc/sec)- 4.9; Machine Pressure (psi)- 212	4F (V-9131): Flow Rate (cc/sec)- 4.9; Machine Pressure (psi)- 213; HYDAC Pressure (psi)- 168 5F (V-9077): Flow Rate (cc/sec)- 6.9; Catheter Pressure (psi)- 244; HYDAC Pressure (psi)- 181
Max Static Burst	4F: Average max burst pressure 288±4 psi; Range 279-293 psi 5F: Average max burst pressure 269±4 psi; Range 262-278 psi	4F (V-9043): Average max burst pressure 302±5 psi; Range 292-312 psi 5F (V-9073): Average max burst pressure 249±8 psi; Range 241-262 psi
Air Leakage	Passed in accordance with ISO 10555-1, Annex D (Predicate K121094)	All versions passed in accordance with ISO 10555-1, Annex D.
Liquid Leakage	Passed in accordance with ISO 10555-1, Annex C (Predicate K121094)	All versions passed in accordance with ISO 10555-1, Annex C.
Biocompatibility	Materials are identical to legally marketed K121094 with the exception of the Acetal clamp which was cleared in legally marketed K091953. Biocompatibility summaries located in Section 15 page 1. (This implies predicate devices met ISO 10993 requirements.)	Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.
Sterility	100% Ethylene Oxide (Predicate K121094 and K091953)	100% Ethylene Oxide
Intended Use	Short-Term peripheral access for IV therapies, blood sampling, and power injection of contrast media (Predicate K091953 for power injection)	Short-Term peripheral access for IV therapies, blood sampling, and power injection of contrast media.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a nonclinical performance test study. It specifically focused on the power injection capabilities, as this was the key performance difference between the proposed CT Midline and the primary predicate (K121094).

The document states: "The following tests were performed to establish the device's equivalence to the relevant predicate device: o Power Injection Flow Rate o 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."

The reported performance data for the CT Midline in the table above demonstrates that for both 4F and 5F configurations, the proposed device achieved equal or higher flow rates and burst pressures compared to the predicate Pro-PICC CT (K091953) for power injection. This indicates that the CT Midline meets or exceeds the power injection performance of the predicate device with that indication.

For air leakage, liquid leakage, biocompatibility, and sterility, the claims of substantial equivalence are based on either being identical in materials to a cleared predicate or passing relevant ISO standards, which implies meeting the acceptance criteria set by those standards.

The remaining information requested is largely not applicable (NA) or not explicitly provided in the given excerpts, as this is a 510(k) summary for a medical device (catheter), not an AI/software device or a clinical study in the typical sense that would involve human readers, ground truth consensus, or training data for an algorithm.

2. Sample size used for the test set and the data provenance:

Sample Size: The exact sample sizes for the power injection and static burst tests are not explicitly stated as "n=X". However, for the Max Static Burst, the standard deviation and range are provided (e.g., "302±5psi," "range of burst pressures was 292-312 psi"), which implies multiple tests were performed on multiple units to generate an average and range. Without the full Section 18 (reference testing summaries and protocols), the specific number of units tested is unknown.
Data Provenance: This is an in-vitro nonclinical performance test, conducted by the manufacturer (Medcomp). Therefore, it is a prospective test conducted on manufactured devices, likely in a laboratory setting. Country of origin of the data is the US, where Medcomp is located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

NA. This is a hardware device performance test. There are no human experts establishing ground truth for image interpretation or diagnosis. The "ground truth" is defined by the physical properties of the device and its performance under specified testing conditions as measured by instruments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

NA. There is no adjudication method as this is a physical performance test, not a subjective judgment task.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

NA. This is not an AI or imaging device subject to MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

NA. This is not an algorithm. Standalone performance refers to the device's functional attributes (e.g., flow rate, burst pressure) under test conditions as measured by equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the nonclinical performance tests (power injection, static burst, leakage, biocompatibility), the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, verified against established ISO standards and the performance of legally marketed predicate devices.

8. The sample size for the training set:

NA. This is a physical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

NA. This is a physical device, not an algorithm that requires a training set and its associated ground truth establishment.

Summary

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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.

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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:

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
INDICATIONSFOR USE:	The CT Midlines areindicated for Short-Term peripheralaccess to theperipheral venoussystem for selectedintravenous therapies,blood sampling, andpower injection ofcontrast media. Themaximumrecommendedinfusion rate variesby catheter Frenchsize and is printed onthe catheter.	The Midlinecatheters areindicated for short orlong term peripheralaccess to theperipheral venoussystem for selectedintravenous therapiesand blood sampling.(seeContraindications)For blood therapy itis recommended thata 4French or largercatheter is used.	The PRO-PICCCTcatheter is indicatedfor short term orlong term peripheralaccess to the centralvenous system forintravenous therapyand power injectionof contrast mediaand allows forcentral venouspressure monitoringwhen a 20gauge orlarger lumen isused. For bloodsampling, infusionor therapies use a4F or largercatheter. Themaximumrecommendedinfusion rate variesby catheter Frenchsize and is printedon the catheter.
WHERE USED:	Hospital	Hospital	Hospital
STERILITY:	100% Ethylene Oxide	100% Ethylene Oxide	100% Ethylene Oxide
BIOCOMPATIBILITY:	Materials are identical tolegally marketed	Legally Marketed510(k) K121094	Legally Marketed510(k) K091953
Attribute	CT Midline(Proposed)	Midline (Predicate)	Pro-PICC CT(Predicate) K091953
	K121094 with theexception of the Acetalclamp which was clearedin legally marketedK091953.Biocompatibilitysummaries located inSection 15 page 1.	K121094
MATERIALSANDADDITIVES:	LUMEN:ThermedicsTecothane TT2095A(30% Barium Sulfate)	LUMEN:ThermedicsTecothane TT2095A(30% BariumSulfate)
	PRINTING:Markem, Black	PRINTING:Markem, Black
	HUB and SUTUREWING: DowPellethane 2363-80A	HUB and SUTUREWING: DowPellethane 2363-80A
	LUERS: Isoplast2510. Natural Whiteadditives: TitaniumDioxide.	LUERS: Isoplast2510. Natural Whiteadditives: TitaniumDioxide.	CLAMPS: HalkeyRoberts Acetal,Purple
	EXTENSIONS:Dow Pellethane2363-80A	EXTENSIONS:Dow Pellethane2363-80A
	CLAMPS: HalkeyRoberts AcetalCopolymer-Purple - single lumenPurple- double lumen	CLAMPS: HalkeyRoberts AcetalCopolymer-Natural - singlelumenNatural- doublelumen
	I.D. RING: ABSLustran 348	I.D. RING: ABSLustran 348
	Drawings in Section11.	Drawings in Section11.
DesignSpecifications	LUMEN andTAPER LENGTHAVG.:Single lumen 4F -	LUMEN andTAPER LENGTHAVG.:Single lumen 4F -	N/A

Medcomp CT Midline Summary 5-2

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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 – longtaper 3.44 to 5.44inch.	Double 5F – longtaper 3.44 to 5.44inch.
	LUMEN I.D./O.D.AVG.: Proximal totaper (applies to bothshort and long taper)4F Single: I.D. .045inch (1.14mm)O.D. .082inch (2.08mm)5F Double: I.D..039 inch (.99mm)O.D. .092inch (2.24mm) Equivalentdiameter of eachlumen based on D-lumen cross-sectionarea.	LUMEN I.D./O.D.AVG.: Proximal totaper (applies to bothshort and long taper)4F Single: I.D. .045inch (1.14mm)O.D. .082inch (2.08mm)5F Double: I.D..039 inch (.99mm)O.D. .092inch (2.24mm) Equivalent diameterof each lumen based onD-lumen cross-sectionarea.
	TIP LUMENI.D./O.D. AVG.:4F Single: I.D. .032inch (.81mm)O.D. .052inch (1.32mm)5F Double: I.D..031 inch (.79mm)O.D. .068inch (1.73mm) Equivalentdiameter of eachlumen based on D-lumen cross-sectionarea.	TIP LUMENI.D./O.D. AVG.:4F Single: I.D. .032inch (.81mm)O.D. .052inch (1.32mm)5F Double: I.D..031 inch (.79mm)O.D. .068inch (1.73mm) Equivalent diameterof each lumen based onD-lumen cross-sectionarea.
	LUMEN LENGTH:20cm (midline).Open ended design.DEPTH	LUMEN LENGTH:20cm (midline).Open ended design.DEPTH

Medcomp CT Midline Summary 5-4

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		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 sizeon hub.	Contains French sizeon hub.
1499 Delp Drive
Harleysville, PA 19438		LUER: Easy Gripdesign.	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

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Attribute	CT Midline(Proposed)	Pro-PICC CT(Predicate) K09195-
	All versions passed in accordance with ISO 10555-1, Annex C. Reference testing summaries andprotocols in Section 18.
Power InjectionCapabilityTesting	POWER INJECTIONFLOW RATE:	POWER INJECTIONFLOW RATE:
	4F:V-9131:Power Injection FlowRate / InjectionPressure (Avg.)Flow Rate (cc/sec)- 4.9Machine Pressure (psi)-213HYDAC Pressure (psi)-168	4F:4Fx50cm SinglePower Injection FlowRate / InjectionPressure (Avg.)Flow Rate (cc/sec)-3.9Machine Pressure(psi)- 183
	5F:V-9077:Power Injection FlowRate / InjectionPressure (Avg.)Flow Rate (cc/sec)- 6.9Catheter Pressure (psi)-244HYDAC Pressure (psi)-181	5F:5Fx55cm DoublePower InjectionFlow Rate / InjectionPressure (Avg.)Flow Rate (cc/sec)-4.9Machine Pressure(psi)- 212
	MAX STATIC BURST:	MAX STATICBURST:
	4F:V-9043:The average maximumburst pressure was302±5psi. The range ofburst pressures was 292-312 psi.	4F:The average maximumburst pressure was288±4psi. The rangeof burst pressures was279-293 psi. Allsamples burst alongthe lumen.
	5F:V-9073:The average maximumburst pressure was249±8psi. The range ofburst pressures was 241-262 psi.	5F:The average maximumburst pressure was269±4psi. The rangeof burst pressures was262-278 psi. Allsamples failed byrupture of the lumen.

Comparison to Predicate Devices (cont.):

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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.

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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.

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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

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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."

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
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.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”