THE MEDCOMP SILICONE Vascu-PICC™ CATHETERS ARE DESIGNED FOR LONG-TERM CENTRAL VENOUS CATHETERIZATION OR PROLONGED INTRAVENOUS ADMINISTRATION OF FLUIDS, MEDICATION, AND /OR WHEN NUTRITIONAL THERAPY IS PRESCRIBED.

THIS CATHETER MAY BE INSERTED VIA THE BASILIC OR CEPHALIC VEIN.

Device Description

The Medcomp Silicone Vascu-PICC™ Catheters are designed for peripheral vein catheterization. The Silicone Vascu-PICC™ lumen is comprised of a soft radiopaque silicone material. 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 communication. Female luer connectors provide the connection for intravenous administration.

The catheters are available in 3F, 4F, and 5F single lumen versions, and 4F, 5F, and 6F double lumen versions. All versions are 60 cm long with depth markings in 5cm increments.

The Silicone Vascu-PICC™ Catheter product line is packaged with the necessary accessories to facilitate catheter insertion.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medcomp Silicone Vascu-PICC™ Catheter, based on the provided 510(k) summary:

This device is not an AI/ML device. Therefore, the specific questions related to AI/ML device evaluations (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable. The provided document concerns a traditional medical device (intravascular catheter) and its clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: To demonstrate substantial equivalence to the predicate device and assure reliable design and performance.
The 510(k) summary implicitly defines the acceptance criteria as meeting relevant international standards for medical devices and demonstrating biocompatibility.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Performance Testing	Reliable design and performance in accordance with ISO 10555-1 and 10555-3	"In vitro testing was performed on the Medcomp Silicone Vascu-PICC™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3."
Biocompatibility	Meet requirements of ISO 10993 for a permanent contact device	"Biocompatibility testing on the Medcomp Silicone Vascu-PICC™ Catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device."
Substantial Equivalence	Equivalent to predicate device in terms of: intended use, insertion method, anatomical location, design, material type, performance, labeling, manufacturing process, and method of sterilization.	"The Medcomp Silicone Vascu-PICC™ Catheter is substantially equivalent to the predicate device in terms of intended use, insertion method, anatomical location, design, material type, performance, labeling, manufacturing process, and method of sterilization."

2. Sample Size for the Test Set and Data Provenance

Not applicable as this is not an AI/ML device and does not involve a "test set" in the context of algorithm evaluation. The performance data cited refers to in vitro testing and biocompatibility testing of the physical device components.

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

Not applicable as this is not an AI/ML device. Ground truth for a physical medical device typically comes from established international standards and validated testing methodologies, not expert consensus on data interpretation.

4. Adjudication Method for the Test Set

Not applicable as this is not an AI/ML device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Not applicable as this is not an AI/ML device. MRMC studies are specific to evaluating the impact of AI/ML on human reader performance.

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

Not applicable as this is not an AI/ML device. "Standalone performance" in this context would refer to the physical device's performance characteristics (e.g., flow rates, tensile strength) as measured in in vitro tests, which were stated as being conducted.

7. The type of ground truth used

For the performance data mentioned:

Performance Testing (ISO 10555-1 and 10555-3): The "ground truth" is defined by the technical specifications and requirements outlined in these international standards for sterile, single-use intravascular catheters. Meeting these standards confirms the device's functional integrity.
Biocompatibility Testing (ISO 10993): The "ground truth" is defined by the biological safety requirements of the ISO 10993 series of standards, which assess the potential for adverse biological reactions.

For the substantial equivalence claim:

The "ground truth" for substantial equivalence is the existence and characteristics of the legally marketed predicate device (A137605 Cook PICC Catheters) and the established regulatory framework for comparing new devices to predicates.

8. The Sample Size for the Training Set

Not applicable as this is not an AI/ML device. "Training set" is a concept specific to machine learning model development.

9. How the Ground Truth for the Training Set was Established

Not applicable as this is not an AI/ML device.

Summary

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510(k) SUMMARY

A. Submitter Information:

Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA 19438(215) 256-4201 Telephone(215) 256-0818 Fax
Contact:	Meghan J. TintleRegulatory Affairs Assistant
Date Prepared:	January 23, 2003
Trade Name:	Medcomp Silicone Vascu-PICC™
Common Name:	Catheter, Intravascular, Therapeutic,Long-Term
Classification:	LJS
C.F.R. Section:	880.5970

C. Predicate Device:

A137605 Cook PICC Catheters

D. Device Description:

The catheters are available in 3F, 4F, and 5F single lumen versions, and 4F, 5F, and 6F double lumen versions. All versions are 60 cm long with depth markings in 5cm increments.

The Silicone Vascu-PICC™ Catheter product line is packaged with the necessary accessories to facilitate catheter insertion.

ட். Intended Use:

The Medcomp Silicone Vascu-PICC™ Catheters are designed for long-term central venous catheterization or prolonged intravenous administration of fluids, medications, and/or when nutritional therapy is prescribed.

This catheter may be inserted via the basilic or cephalic vein.

F. Comparison to Predicate Device:

The Medcomp Silicone Vascu-PICC™ Catheter is substantially equivalent to the predicate device in terms of intended use, insertion method, anatomical location,

Medcomp Silicone Vascu-PICC™ Catheter Summary Page 1 of 2 APR 1 1 2003

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design, material type, performance, labeling, manufacturing process, and method of sterilization.

G. Performance Data:

In vitro testing was performed on the Medcomp Silicone Vascu-PICC™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3.

Biocompatibility testing on the Medcomp Silicone Vascu-PICC™ Catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.

02 1

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2003

Ms. Meghan J. Tintle Regulatory Affairs Assistant MEDCOMP® 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K030270

Trade/Device Name: MEDCOMP SILICONE Vascu-PICC™ CATHETER Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: January 23, 2003 Received: January 27, 2003

Dear Ms. Tintle:

This letter corrects our substantially equivalent letter of January 23, 2003 regarding the contact name.

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 (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. Tintle

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); 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 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Susan Runser

Susan Runner, DDS, MA Interim 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

KO30270 510(k) Number:

Device Name: MEDCOMP SILICONE Vascu-PICC™CATHETER

Indications for use:

THIS CATHETER MAY BE INSERTED VIA THE BASILIC OR CEPHALIC VEIN.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR --

Over-The-Counter

(Optional Format 1-2-96)

Patricia Lucente

y. General Hospital

510(k) Number.__

1 03

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.”