The PRO-PICC ® C 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. For blood sampling, infusions, 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

Designed for peripheral vein catherization
Comprised of a polyurethane material
The lumen is connected to the extensions by a hub with a suture wing for placement.
Clamps are provided on the extension tubes to prevent air/fluid communication.
A female luer connector provides the connection for intravenous administration.
Maximum recommended pressure limit setting 300 psi.
Maximum indicated power injection flow rate 5cc/sec.

AI/ML Overview

Let's break down the information provided about the Medcomp PRO-PICC® CT device to address your questions.

It's important to note that this document is a 510(k) summary for a medical device which is demonstrating substantial equivalence to a predicate device. This type of submission relies on showing that a new device is as safe and effective as a legally marketed device, rather than proving absolute safety and effectiveness for the first time. Therefore, the "study" described focuses on performance testing against established standards and comparison to a predicate, rather than clinical trials with human subjects in the way an AI-driven image analysis tool might.

Acceptance Criteria and Study Details for PRO-PICC® CT

1. A table of acceptance criteria and the reported device performance

For the PRO-PICC® CT, the "acceptance criteria" are implied by compliance with recognized international standards and the performance of the predicate device. The "reported device performance" is essentially that the device met these standards and performed comparably to the predicate.

Acceptance Criteria (Implied by Standards & Predicate)	Reported Device Performance
Biocompatibility: Meet ISO 10993-1 requirements for externally communicating, blood contacting, long-term devices.	All materials previously cleared for similar applications by Medcomp, Inc. Biocompatibility requirements were met.
General Intravascular Catheter Requirements: Compliance with ISO 10555-1:1997 (Sterile Single Use-Intravascular Catheters, General Requirements).	Performance testing conducted in accordance with ISO 10555-1:1997. Subject product testing yielded acceptable safety and performance outcomes.
Central Venous Catheter Requirements: Compliance with ISO 10555-3:1997 (Sterile Single Use-Intravascular Catheters, Central Venous Catheters).	Performance testing conducted in accordance with ISO 10555-3:1997. Subject product testing yielded acceptable safety and performance outcomes.
Luer Lock Fittings: Compliance with ISO 594-2 (Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings).	Performance testing conducted in accordance with ISO 594-2. Subject product testing yielded acceptable safety and performance outcomes.
Pressure Limit: Capable of withstanding a maximum recommended pressure limit of 300 psi.	Device designed for maximum recommended pressure limit setting 300 psi. (Implied successful testing to this limit).
Flow Rate: Capable of achieving a maximum indicated power injection flow rate of 5cc/sec.	Device designed for maximum indicated power injection flow rate 5cc/sec. (Implied successful testing to this rate).
Substantial Equivalence: Design, materials, sterilization, and indications for use substantially equivalent to predicate device (PRO-PICC®-CT, K081904).	Results of tests, in conjunction with substantial equivalence claims, effectively demonstrate that the PRO-PICC® CT is substantially equivalent to the cited predicate device.

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

Sample Size for Test Set: Not explicitly stated as a "sample size" in the context of clinical trials. The testing refers to objective performance testing of manufactured devices against specifications and standards, not a set of clinical data or patient samples. The number of physical units tested to ensure compliance for each standard (e.g., how many catheters were burst tested for pressure limits) is not provided.
Data Provenance: The testing was conducted by Medcomp, Inc., a US-based company, for a US FDA submission. The nature of this technical performance testing would be considered prospective, as it's performed specifically for the submission. It's not clinical data, but rather engineering/materials testing.

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)

This type of information is not applicable to this 510(k) submission.

The ground truth for this device is based on engineering specifications, material science, and compliance with recognized international standards (ISO standards) for medical devices.
The "experts" involved would be Medcomp's engineers, quality assurance personnel, and potentially external testing labs, whose qualifications would be in engineering, materials science, and medical device regulations rather than clinical expertise in establishing diagnostic ground truth. No number or specific qualifications are provided in this summary.

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

This is not applicable to this type of device submission. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology readers) where there might be disagreement in establishing ground truth from qualitative data. Here, the "truth" is determined by objective physical measurements and adherence to specified performance metrics.

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

This is not applicable. This is a physical medical device (PICC catheter), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies, AI assistance, or human reader improvement are not relevant here.

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

This is not applicable. Again, this is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for the PRO-PICC® CT's performance evaluation is:

Compliance with International Standards: Specifically ISO 10993-1, ISO 10555-1, ISO 10555-3, and ISO 594-2. The standards themselves define acceptable performance thresholds.
Engineering Specifications: Such as the 300 psi pressure limit and 5cc/sec flow rate.
Predicate Device Performance: The previous PRO-PICC®-CT (K081904) serves as the benchmark for demonstrating "substantial equivalence."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device. Training sets are used in machine learning for AI/algorithms. This submission is for a physical medical device.

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

This is not applicable for the same reasons as #8.

Summary

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K092347

SEP 16 2009

510(k) Summary PRO-PICC ® C Summary of Safety and Effectiveness Prepared June 27, 2009

General Information:

Submitter:

MEDCOMP® 1499 Delo Drive Harlevsville, PA 19438 Phone: (215) 256-4201 Fax: (215) 256-9191

Contact:

Jean Callow Regulatory Specialist

Device Trade Name: PRO-PICC ® CT Common Name: Peripherally Inserted Central Catheter (PICC) Classification Name: LJS - Catheter, Intravascular, Therapeutic, Long-Term Greater than 30 Days CFR Reference: 21 CFG 880.5970, Class II Classification Panel: General Hospital

Predicate Device:

Device Trade Name: Common Name: Classification Name:

CFR Reference: Classification Panel: Premarket Notification: PRO-PICC-%CT Peripherally Inserted Central Catheter (PICC) LJS -Catheter, Intravascular, Therapeutic, Long-Term Greater than 30 Days 21 CFR 880.5970, Class II General Hospital K081904, concurrence date September 23, 2008

Performance Standards: Performance standards have not been established by FDA under section 514 of the Federal Food, Drug, and Cosmetic Act.

Indications for Use: The PRO-PICC @ °T 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. For blood sampling, infusions, 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:

Designed for peripheral vein catherization ●
. Comprised of a polyurethane material .
The lumen is connected to the extensions by a hub with a suture wing for . placement.
Clamps are provided on the extension tubes to prevent air/fluid communication. .
. A female luer connector provides the connection for intravenous administration.

Medcomp The PRO-PICC ๑ ° ° 510(k) Summary Page 1 of 2

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Maximum recommended pressure limit setting 300 psi.
Maximum indicated power injection flow rate 5cc/sec.

Safety and Performance Tests

Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the PRO-PICC® were previously cleared for similar applications by Medcomp, Inc.

Performance testing of the PRO-PICC® was conducted in accordance with the following international standards:

ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General . Requirements
ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous . Catheters
ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and ◆ Certain Other Medical Equipment - Part 2: Lock Fittings

Subject product testing has yielded acceptable safety and performance outcomes.

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the PRO -PICC® is substantially equivalent to the cited predicate device. ,

Summary of Substantial Equivalence

Based on the indications for use and safety and performance testing, the PRO-PICC % CT meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use to the predicate device.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.

SEP 1 6 2009

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

Ms. Jean Callow Regulatory Specialist Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K092347

Trade/Device Name: PRO-PICC®" Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 30, 2009 Received: August 17, 2009

Dear Ms. Callow:

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.

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 Ms. Callow

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D., Avatar for

Susan Runher, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K092347
---------------------------	---------

PRO-PICC ® CT Device Name:

Indications for Use: -

Prescription Use X (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)

(Division Sign-Off)

(Division Sign-Q#ff Division of Anesthesiology, General Hospital infection Control, Dental Devices

Page 1 of 1

510(k) Number: K092347

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.”