The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

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.
A clamp is provided on the extension tube to prevent air/fluid communication. .
A female luer connector provides the connection for intravenous administration. .

AI/ML Overview

Here's an analysis of the provided text regarding the 1.9F Vascu-PICC® device, focusing on acceptance criteria and supporting studies:

It is important to note that the provided document is a 510(k) summary for a medical device (1.9F Vascu-PICC®). This type of submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against novel acceptance criteria through extensive clinical studies. Therefore, the information typically found in an AI/ML device study, such as specific performance metrics like sensitivity, specificity, F1-score, or ROC AUC, and detailed descriptions of ground truth establishment, reader studies, and training/test set specifics, will not be present.

Instead, the acceptance criteria here relate to demonstrating compliance with recognized standards and substantial equivalence in design, materials, and intended use.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biocompatibility	ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices	Met. All materials used were previously cleared for similar applications by Medcomp, Inc.
Performance Testing (General)	ISO 10555-1: 1997: Sterile Single Use-Intravascular Catheters, General Requirements	Acceptable safety and performance outcomes.
Performance Testing (Central Venous Catheters)	ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous Catheters	Acceptable safety and performance outcomes.
Performance Testing (Conical Fittings)	ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings	Acceptable safety and performance outcomes.
Substantial Equivalence	Equivalence in design, materials, sterilization, and indications for use to the predicate device (1.9F Vascu-PICC™ K061986).	Meets requirements for intended use and is substantially equivalent to the cited predicate device.

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

This information is not provided in the 510(k) summary. The "test set" in this context refers to the physical samples of the device undergoing laboratory testing against ISO standards, not a data set for an AI/ML algorithm. The document doesn't specify the number of units tested.

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 information is not applicable/provided. The ground truth for this type of device (a physical medical catheter) is established by adherence to engineering performance standards (e.g., tensile strength, flow rates, leak testing, biocompatibility) and regulatory guidelines, rather than expert consensus on diagnostic images. The assessment is based on the device's physical properties and material safety.

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

This information is not applicable/provided. Adjudication methods are typically relevant for subjective assessments, such as interpreting medical images where multiple experts might disagree. For mechanical and material performance testing, the results are typically quantitative and objective, measured against predefined thresholds in the standards.

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

There was no MRMC comparative effectiveness study done. This type of study is specific to AI-powered diagnostic or assistive devices, which the 1.9F Vascu-PICC® (a physical catheter) is not.

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

There was no standalone algorithm performance study done. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established by objective measurements and assessments against internationally recognized performance standards (ISO 10993-1, ISO 10555-1, ISO 10555-3, ISO 594-2) and the material properties of components previously cleared for similar applications.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable/provided. There is no "training set." For the safety and performance studies mentioned, the "ground truth" (i.e., acceptable performance) is defined by the requirements outlined in the specified ISO standards.

Summary

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510(k) Summary

1.9F Vascu-PICC® Summary of Safety and Effectiveness Prepared May 15, 2009

General Information

Submitter:

JUN 17 2009

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

Contact:	Susan Pileggi
	Regulatory Specialist

Device Trade Name:	1.9F Vascu-PICC®
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	LJS - Catheter, Intravascular, Therapeutic, Long-TermGreater then 30 Days
CFR Reference:	21 CFG 880.5970, Class II
Classification Panel:	General Hospital

Predicate Device:

Device Trade Name:	1.9F Vascu-PICC™
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	LJS-Catheter, Intravascular, Therapeutic, Long-Term Greater then 30 Days
CFR Reference:	21 CFR 880.5970, Class II
Classification Panel:	General Hospital
Premarket Notification:	K061986, concurrence date August 15, 2006

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 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.

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.
A clamp is provided on the extension tube to prevent air/fluid communication. .
A female luer connector provides the connection for intravenous administration. .

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1091464

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 1.9F Vascu-PICC® were previously cleared for similar applications by Medcomp, Inc.

Performance testing of the 1.9F Vascu-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 vielded acceptable safety and performance outcomes.

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the 1.9F Vascu-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 1.9F Vascu-PICC® 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.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

JUN 1 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Pileggi Regulatory Specialist MedCOMP 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K091466

Trade/Device Name: 1.9F Vascu-PICC® Regulation Number: 21 CFR 880.5970 . Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 15, 2009 Received: May 18, 2009

Dear Ms. Pileggi:

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. Pileggi

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/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Anthony O. Arthur for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, 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):

Device Name: 1.9F Vascu-PICC®

Indications for Use:

Prescription Use X Over-The-Counter Use Prescription Ose (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 of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K091466

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.”