The 3F PRO-PICC® " 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. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

Device Description

The 3F PRO-PICC of catheter is an open-ended lumen catheter designed for power injection and pressure monitoring. The 3F PRO-PICC® " catheter is comprised of a soft radiopaque probate monitorial. The lumen has a reverse taper design and is connected to the extension via a soft pliable hub with suture wing for secure placement. The clamp on the extension tube prevents air/fluid communication. The female luer connector provides the connection for intravenous administration. The power injectable extension line is purple in color to differentiate it from non-power injectable catheters. The extension is also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The 3F PRO-PICC® C catheter is available with a single lumen. The catheter has a usable length of 50cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

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

AI/ML Overview

The 3F PRO-PICC® CT catheter is a medical device designed for short to long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The acceptance criteria and the study proving its performance are primarily outlined in the "Bench / Performance Data" section of the 510(k) summary (page 1).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria	Reported Device Performance
Performance Testing	Adherence to applicable international standards and FDA guidance documents. For pressure injection, internal engineering testing methods were used as no specific FDA standards exist under section 514 of the Federal Food, Drug and Cosmetic Act.	"The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices." (Implies that the device met the criteria established by these standards/guidance and internal methods, confirming equivalence.)
Biocompatibility	Meet the requirements of ISO 10993.	"All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993."
Intended Use, Anatomical Location, Basic Design, Materials, Performance, Labeling, Manufacturing Process, Sterilization	Substantially equivalent to predicate devices (K091953 Medcomp, PRO-PICC® CT; K091586 Medcomp, Vascu-Picc & Midline; K102159 Bard Access Systems, Inc., PowerPICC SV Catheter).	"The 3F PRO-PICC® CT 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."
Technological Characteristics	Remained the same compared to predicate devices.	"Technological similarities between the proposed device and predicate devices remain the same."
Safety and Effectiveness	No new issues of safety and effectiveness raised by any differences from predicate devices.	"There are no differences that raise new issues of safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are referred to as "internal engineering testing methods" and "performance testing... in accordance with applicable international standards and FDA guidance documents."

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)

The document does not mention the use of experts to establish ground truth for any test set. The evaluation relies on "internal engineering testing methods" and adherence to "international standards and FDA guidance documents," which typically involve engineering and quality control personnel, not clinical experts for ground truthing in this context.

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

The document does not describe any adjudication method. This type of method is typically used in clinical trials involving human readers assessing medical images or outcomes, which is not the nature of the "Bench / Performance Data" presented here for a catheter.

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

No MRMC comparative effectiveness study was done. This is a physical medical device (catheter), not an AI-powered diagnostic tool, so such a study would not be applicable.

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

No standalone algorithm performance was done. This is a physical medical device, not an algorithm. The performance evaluation focuses on its physical and material properties (e.g., pressure injection, biocompatibility, substantial equivalence to predicate devices).

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

For the performance tests, the "ground truth" is established by the specified international standards, FDA guidance documents, and internal engineering testing methods. For biocompatibility, it's defined by the requirements of ISO 10993. For substantial equivalence, it's a direct comparison against the characteristics and performance of the identified predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used for ground truth.

8. The sample size for the training set

The document does not mention a training set sample size. This is a physical device, and the testing methods described are typically verification and validation tests against established specifications rather than machine learning model training.

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

Not applicable, as there is no mention of a training set or machine learning components for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: This document is a 510(k) summary, section 5, from Medcomp. It includes the submitter information, with the address 1499 Delp Drive, Harleysville, PA 19438, and contact information for Jessica Leo, Regulatory Associate. The trade name is Medcomp 3F PRO-PICC, and the common name is Catheter, Intravascular, Therapeutic, Long-Term. The document is dated November 16, 2012, and the document was created May 15, 2013.

K091953 Medcomp, PRO-PICC® CT, class II 880.5970 K091586 Medcomp, Vascu-Picc & Midline, class II 880.5970 K102159 Bard Access Systems, Inc., PowerPICC SV Catheter, class II 880.5970

D. Device Description:

Predicate Devices:

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

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo for a company called "medCOMP." The logo consists of a geometric design above the company name. Below the company name is the address "1499 Delp Drive." There are also the letters "E." and "F." on the right side of the image.

Harleysville. PA 19438

(".

Tel: 215-256-4201

Fax: 215-256-1787

www.medcompnet.com

Indications for Use:

The 3F PRO-PICC® 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. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

Comparison to Predicate Devices:

The 3F PRO-PICC® C 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 differences between the 3F PRO-PICC® Et and the predicate devices is a smaller French size with a CT injectable and a shorter taper of 2 to 5 cm versus 7 to 10 cm.

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 3F PRO-PICC of has been submitted in previously cleared Medcomp devices. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993.

Technological Characteristics: I.

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

Summary of Substantial Equivalence: J.

The proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and internal 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 legally marketed predicate device.

Page 2 of 2

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a caduceus or a staff with a snake winding around it, but with three distinct, curved lines instead of a single staff and snake.

Public Health Service

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

May 15, 2013

Ms. Jessica Leo Regulatory Associate Medical Components Incorporated 1499 Delp Drive HARLEYSVILLE, Pennsylvania 19438

Re: K123617

Trade/Device Name: 3F PRO-PICC CT Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 24, 2013 Received: May 3, 2013

Dear Ms. Leo:

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.

{3}------------------------------------------------

Page 2 - Ms. Leo

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

For

Tejashri S.
Purohitsheth -S

Turowat 2013.05.15

mom

10:21:35-04'00'.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): 123617

Device Name: ____3F PRO-PICC @ CT

Indications for Use: .

The 3F PRO-PICC® " catheter is indicated for short term or long term peripheral access The or FRO-I ICC® - Cattlection in mayenous therapy and power injection of contrast to the central venous system for much vessure monitoring. The maximum recommended infusion rate varies by catherer French size and is printed on the catheter.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/10 description: The image shows the letters FDA in a stylized, outlined font. The letters are bold and appear to be made up of multiple parallel lines, giving them a layered effect. The overall design is simple and graphic, with a focus on the acronym itself.

Richard C. Chapman 2013.05.13 12:04:52 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hoapital Infection Control, Dental Devices

Page 1_of_1

510(k) Number: K123617

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.”