The Pro-PICC catheter with valve technology is indicated for short and long peripheral access to the central venous system for intravenous therapy and power injection media, and allow for central venous pressure monitoring. 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.

Device Description

The Pro-PICC®07 with Valve Technology is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® Pro-PICC®CT (K091953 and K092347). The Pro-PICC®67 with Valve Technology 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. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each luer is a Bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size, "Valved CT Catheter" or "Do Not Power Inject", and the maximum flow rates. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.

The Pro-PICC® with Valve Technology catheter is available in additional French sizes and either a single, double, or triple lumen. The catheter has a usable length of 50cm to 60cm depending on French size with depth markings in 5cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of trav configurations with the necessary accessories to facilitate catheter insertion.

AI/ML Overview

The provided text appears to be a 510(k) summary for a medical device (Medcomp® Pro-PICC® with Valve Technology), rather than a study report detailing acceptance criteria and performance data for an AI/algorithm-based device.

Therefore, many of the requested categories for AI device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and how ground truth was established for training and test sets) are not applicable or cannot be extracted from this document.

However, I can extract information related to the performance data (bench/performance data) as described in the document, which pertains to the physical device rather than an AI algorithm.

Here's the information that can be extracted, with notes on where the requested AI-specific information is not available:

Acceptance Criteria and Study for Medcomp® Pro-PICC® with Valve Technology

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance
Bench/Performance Data	Performance testing in accordance with applicable international standards and FDA guidance documents.	"The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices."
	Performance standards for pressure injection (internal engineering testing methods).	Tested based on internal engineering methods.
Biocompatibility	Meet requirements of ISO 10993.	All biocompatibility testing demonstrates materials meet ISO 10993 requirements.
Substantial Equivalence	Same intended use, operation, function as predicates. No new issues of safety and effectiveness.	"The proposed device is substantially equivalent to the legally marketed predicate device."

Notes on AI-Specific Information (Not Applicable/Available from this document):

This document describes a physical medical device (catheter), not an AI algorithm. Therefore, there are no specific AI-driven acceptance criteria for metrics like sensitivity, specificity, AUC, or F1-score that would be relevant for an AI system.
The "performance" referred to in the document relates to the physical and functional characteristics of the catheter (e.g., pressure injection capabilities, material properties), not algorithmic performance.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This document is for a physical medical device, not an AI algorithm. There is no mention of a "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to bench testing of the physical catheter.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This document is for a physical medical device. "Ground truth" in the context of expert consensus for image or data interpretation is not relevant here.

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

Not Applicable. This document is for a physical medical device. Adjudication methods are relevant for expert review in AI studies, not for physical device testing.

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

Not Applicable. This document is for a physical medical device. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant here.

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

Not Applicable. This document is for a physical medical device. There is no "algorithm only" performance reported, as there is no AI algorithm.

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

Not Applicable. For the bench and biocompatibility testing, the "ground truth" would be established by validated measurement techniques, chemical analyses, and adherence to relevant ISO standards, rather than expert consensus on image interpretation or pathology.

8. The sample size for the training set

Not Applicable. This document describes a physical medical device, not an AI algorithm. There is no concept of a "training set" for this type of device submission.

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

Not Applicable. As there is no training set for an AI algorithm, this question does not apply.

Summary of Relevant Information from the Document:

The document is a 510(k) premarket notification for a physical medical device, the Medcomp® Pro-PICC® with Valve Technology, a catheter. The core of the submission is to demonstrate substantial equivalence to existing predicate devices.

Study Objective: To demonstrate that the Medcomp® Pro-PICC® with Valve Technology is substantially equivalent to legally marketed predicate devices.
Study Types:
- Bench/Performance Testing: Conducted in accordance with applicable international standards and FDA guidance documents, and internal engineering testing methods (specifically for pressure injection, where no FDA standard exists). The document states these tests "effectively demonstrate the proposed devices are equivalent to the predicate devices."
- Biocompatibility Testing: All materials used were tested on the complete, finished device, demonstrating they meet the requirements of ISO 10993.
Conclusion: The device meets performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols. It has the same intended use, operation, and function as the predicates, with no differences raising new safety or effectiveness issues, thus demonstrating substantial equivalence.

Summary

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

September 29, 2014

MEDCOMP® Mr. Jonathan Schell Regulatory Associate 1499 Delp Drive Harleysville, PA 19438

Re: K141633

Trade/Device Name: Medcomp® Pro-PICC® with Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Catheter, Intravascular, Therapeutic, Long-Term Regulatory Class: II Product Code: LJS Dated: June 19, 2014 Received: June 20, 2014

Dear Mr. Schell:

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.

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Page 2 - Mr. Schell

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (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

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Indications for Use

510(k) Number (if known) K141633

Device Name

Pro-PICC with Valve Technology

Indications for Use (Describe)

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)

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:

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"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."

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Sectio

1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax: 215-256-1787

www.medcompnet.com

	5		510(k) SUMMARY		Traditional 510K
	Submitter Information:
	Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201, x2271Fax: (215) 256-9191
	Contact:	Jonathan SchellRegulatory Associate
	Date Prepared:	06/16/2014
	Trade Name:	Medcomp® Pro-PICC® CT with Valve Technology
	Common Name:	Catheter, Intravascular, Therapeutic,Long-Term
	Classification Name:	Long Term Intravascular Catheter (80 LJS)
	Regulation Name:	Percutaneous, implanted, long-term intravascularcatheter
	C.F.R. Section:	880.5970
	Class:	II
	Predicate Devices:	K091953 Medcomp, Pro-PICC® CT, class II880.5970K092347 Medcomp, Pro-PICC® CT, class II880.5970K072230 Bard Access Systems, Inc., PowerPICC

D. Device Description:

SOLOTM. class II 880.5970

The Pro-PICC® with Valve Technology catheter is available in additional French sizes and either a single, double, or triple lumen. The catheter has a usable length of

Medcomp Pro-PICC®CT with Valve Technology Summary Page 1 of 2

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1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax: 215-256-1787

www.medcompnet.com

50cm to 60cm depending on French size with depth markings in 5cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of trav configurations with the necessary accessories to facilitate catheter insertion.

Indications for Use:

The PRO-PICC®OT catheter with valve technology is indicated for short 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. 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.

Comparison to Predicate Devices:

The PRO-PICC® T with valve technology catheter 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,

The difference between the PRO-PICC®CT with valve technology and the Medcomp Pro-PICC® (K091953 and K092347) predicate devices is the addition of the valve technology to the luer.

() Bench / Performance Data:

Performance testing of the proposed device was conducted in accordance with applicable international standards and FDA guidance documents. Performance standards for pressure injection have not been established by FDA under section 514 of the Federal Food. Drug and Cosmetic Act. Testing is based upon internal engineering testing methods.

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

H. Biocompatibility:

Testing for all materials used for the PRO-PICC®CT with valve technology has been done on the complete, finished PRO-PICC®CT device. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993, and is contained in section 15.

past Technological Characteristics:

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

J. 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

Medcomp Pro-PICC®CT with Valve Technology Summary Page 2 of 2

5-2

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1499 Delp Drive

Harleysville, PA 19438

Tel: 215-256-4201

Fax: 215-256-1787

www.medcompnet.com

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.

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.”