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 Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen 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 contamination. Female luer connectors provide the connection for intravenous administration.

The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (CT Midline) and primarily discusses its substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific acceptance criteria.

The submission states that the purpose of this particular 510(k) is to "remove a contraindication that was once cited in the Journal of Infusion Nursing but has since been revised." This is a change to the labeling, not a new performance claim or a new device design that would necessitate a comprehensive performance study with acceptance criteria and reported results.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of why each point cannot be thoroughly answered from the provided text:

A table of acceptance criteria and the reported device performance:
- The document implies that the device's performance (e.g., flow rates for power injection) is identical to the predicate device K141151.
- Table 5.1 "Design Comparison Matrix" lists "Performance Testing" with "Power Injection: 5cc/sec (4F), 7cc/sec (5F)" for both the proposed and predicate devices, stating "Identical, no change." This indicates the expected performance, but not explicit acceptance criteria, nor the results of a new study designed to meet those criteria for this specific submission. It's a statement of equivalence.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set is described for evaluating new performance. The comparison is based on the predicate device's existing performance data.
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):
- Not applicable as no new performance test set requiring expert ground truth is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is an intravascular catheter, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" here is the established performance of the predicate device, against which the proposed device is declared equivalent.
The sample size for the training set:
- Not applicable as this is a physical medical device, not an algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary from the document:

The submission explicitly states under "Bench / Performance Data / Non-Clinical Testing":
"No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151)."

The basis for equivalence is that the "Proposed CT Midline is substantially equivalent to the predicate device. CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization." The only difference is a "revision to the instructions for use (labeling)" to remove a contraindication.

Therefore, for this specific 510(k) submission (K170770), no new study was conducted to prove the device meets performance acceptance criteria, because the device itself and its performance characteristics are deemed identical to a previously cleared predicate device. The change is solely in the labeling information, specifically removing a contraindication.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2017

Medical Components, Inc. (dba Medcomp) Courtney Nix Regulatory Affairs Manager. North America and Europe 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K170770

Trade/Device Name: CT Midline Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: July 5, 2017 Received: July 6, 2017

Dear Courtney Nix:

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. 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (21 CFR 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.

Tara A. Ryan -S

for Lori Wiggins Acting 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

510(k) Number (if known) N/A - Unknown

K170770

Device Name 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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Section 6		510(k) SUMMARY
A.	Submitter Information:
	Submitter:	Medcomp®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201, x 2285Fax: (215) 256-9191
	Registration Number:	2518902
	Contact:	Courtney NixCnix@Medcompnet.comRegulatory Affairs Manager: North America and EU
	Date Prepared:	03/13/2017
в.	Proposed or Subject Device Information:
	Trade Name:	CT Midline
	Device:	Midline Catheter
	Product Code:	PND
	Regulation Description	Intravascular Catheter
	C.F.R. Section:	880.5200
	Class:	ll
	Regulation MedicalSpecialty and ReviewPanel:	General Hospital
B.	Predicate Device Information:
	510(k) Number:	K141151
	510(k) Holder:	Medcomp®
	Trade Name:	CT Midline
	Device:	Catheter, Intravascular, Therapeutic, Long-TermGreater Than 30 Days
	Product Code:	LJS
	Medcomp®: CT MidlineSection 6: 510(k) Site Summary		6-1

K170770

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Image /page/4/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a stylized geometric shape in pink, resembling a house or an arrow pointing upwards. Below the shape, the word "med" is written in pink, lowercase letters, followed by "COMP" in gray, uppercase letters. The overall design is clean and modern.

1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Requlation Description:

Percutaneous, implanted, long-term intravascular catheter

880.5970 C.F.R Section:

Class:

Requlation Medical Specialty and Review Panel: General Hospital

Purpose for Submission:

The purpose of this submission is to remove a contraindication that was once cited in the Journal of Infusion Nursing but has since been revised.

Device Description:

G. Indications for Use:

H. 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.

-Comparison to Predicate Devices:
Medcomp®: CT Midline Section 6: 510(k) Site Summary

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Image /page/5/Picture/0 description: The image shows the MedComp logo. The logo features a stylized, geometric shape in pink, resembling a simplified house or building outline. Below the shape, the word "med" is written in pink, followed by "COMP" in gray, indicating the company name.

1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

The proposed CT Midline is substantially equivalent to the predicate device. CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization. All technology, including features, materials, and principles of operation are identical to what was cleared in K141151, CT Midline. The only difference between the predicate and the proposed device is a revision to the instructions for use (labeling). This revision is to remove a contraindication. The revision to the labeling does not change the intended use of the device, both revisions are in are in alight with the Journal of Infusion Nursing.

The difference or changes between the proposed CT Midline and the predicate, CT Midline (K141151), is that the revision to the instructions for use, below is a comparison matrix demonstrating substantial equivalence.

Table 5.1: 510(K) Summary: Design Comparison Matrix

Device	Proposed Device:CT Midline	Predicate Device:CT Midline (K141151)	SubstantiallyEquivalentComparison
Dimensionsor Lengths	Lumen: 4F Single and 5FDoubleLumen Length: 20cm	Lumen: 4F Single and 5FDoubleLumen Length: 20cm	Identical, nochange
Indicationsfor Use	The CT Midlines areindicated for Short-Termperipheral access to theperipheral venous systemfor selected intravenoustherapies, blood sampling,and power injection ofcontrast media. Themaximum recommendedinfusion rate varies bycatheter French size andis printed on the catheter.	The CT Midlines areindicated for Short-Termperipheral access to theperipheral venous systemfor selected intravenoustherapies, blood sampling,and power injection ofcontrast media. Themaximum recommendedinfusion rate varies bycatheter French size andis printed on the catheter.	Identical, nochange
SterilizationMethod	ETO	ETO	Identical, nochange
MaterialsandProcesses	LUMEN: TecothaneHUB and SUTURE WING:PellethaneLUERS: IsoplastEXTENSIONS: PellethaneCLAMPS: AcetalPurple: single lumenPurple: double lumenI.D. RING: Lustran	LUMEN: TecothaneHUB and SUTURE WING:PellethaneLUERS: IsoplastEXTENSIONS: PellethaneCLAMPS: AcetalPurple: single lumenPurple: double lumenI.D. RING: Lustran	Identical, nochange
PerformanceTesting	Power Injection:5cc/sec (4F)	Power Injection:5cc/sec (4F)	Identical, nochange

Medcomp®: CT Midline Section 6: 510(k) Site Summary 6-3

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Image /page/6/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a pink geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in pink, while "COMP" is written in gray. The logo appears to be for a medical company.

1499 Delp Drive
Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

7cc/sec (5F)

Bench / Performance Data / Non-Clinical Testing:

No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151).

Biocompatibility:

Biocompatibility was performed on the CT Midline in accordance with ISO 10993-1. According to ISO 10993-1 the final, finished 5F Double lumen CT midline was tested as an implant device with blood contact and prolonged contact duration (greater than 24 hours less than 30 days). Biocompatibility was performed on the finished and sterilized device in accordance with ISO 10993-12:2012. Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials, and 21CFR. Part 58 - Good Laboratory Practices for Nonclinical Laboratory Studies by a contracted laboratory that is ISO 17025 certified.

Summary of Substantial Equivalence:
The proposed CT Midline is substantially equivalent to the predicate device, CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization. The only difference between the predicate and the proposed device is a revision to the instructions for use (labeling). This revision is to remove a contraindication.

The proposed device, CT Midline, meets the performance criteria of design verification as specified by ISO standards, quidance documents and internal test protocols. The proposed device is substantially equivalent to the indicated legally marketed predicate as defined in paragraph above.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).