The Peripherally Inserted Central Vein Access catheters are designed for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For central venous pressure monitoring (CVP), it is recommended that catheter lumen of 20 gauge or larger be used.

The Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. (See Contraindications). For blood therapy it is recommended that a 4French or larger catheter be used.

Device Description

The Vascu-PICC® and Midline Catheters are designed for peripheral vein catheterization. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. 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 a range of French sizes in single, double and triple lumen. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every 5th centimeter and are available in 20cm for Midline placement and a trimmable 60cm for PICC's.

The Vascu-PICC® and Midline Catheters product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

AI/ML Overview

This document describes the design and performance of the Vascu-PICC® and Midline Catheters by MEDCOMP. The information provided is for a 510(k) premarket notification to the FDA.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to predicate devices rather than defining novel acceptance criteria for absolute performance. The acceptance criteria for the Vascu-PICC® and Midline Catheters are implicitly tied to meeting the performance of existing, legally marketed predicate devices and conformity with relevant ISO standards through in-vitro testing.

Acceptance Criteria Category	Specific Criteria (from text)	Reported Device Performance (from text)
Material Properties	Biocompatibility ISO 10993	"Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993."
Functional Performance	Air Leakage (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
	Liquid Leakage (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
	Elongation (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
	Tensile (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
	Gravity Flow Rate (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
	Priming Volume (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
Durability	Aging (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
Chemical Resistance	Chemical Testing (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
Mechanical Integrity	Stress Testing (ISO standards compliance)	In-vitro testing performed to assure reliable design and performance in accordance with ISO standards. (Specific results not detailed)
Equivalence	Intended Use, Anatomical Location, Basic Design, Performance, Labeling, Manufacturing Process, Method of Sterilization similar to predicate devices	"The Vascu-PICC® and Midline Catheters are substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization."

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of in-vitro (bench/performance) tests and biocompatibility testing.

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each in-vitro test (e.g., how many catheters were tested for air leakage, tensile strength, etc.). It only states that "The following in-vitro testing was performed on the Vascu-PICC® and Midline Catheters."
- Data Provenance: The tests are in-vitro (bench tests) conducted by the manufacturer, MEDCOMP, as part of their design verification process. The country of origin for the data is implicitly the USA, where MEDCOMP is located. It is retrospective in the sense that the testing was completed before the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the type of safety and performance testing described. The "ground truth" for these tests are technical specifications and ISO standards, which are objective measurements rather than subjective expert interpretations. For example, air leakage isn't adjudicated by an expert; it's measured according to a standard protocol.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. The tests are objective measurements against predefined ISO standards and internal specifications, not subjective assessments requiring expert adjudication.
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 document is for a medical device (catheter), not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies involving human readers or AI assistance are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As stated above, this is a physical medical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the in-vitro performance tests are established ISO standards and test protocols. For biocompatibility, it's the criteria set forth in ISO 10993. For substantial equivalence, the "ground truth" is the performance, design, and intended use characteristics of the cited predicate devices.
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above.

Summary

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Ko91/586

JUL 2 3 2009

510(k) SUMMARY

Submitter Information: A.

Submitter:

MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 (215) 256-4201 Telephone (215) 256-9191 Fax Jean Callow May 26, 2009

Contact: Date Prepared:

Device Name:

Vascu-PICC® and Midline Catheters, Single, Double and Triple Lumen

Catheter, Intravascular, Therapeutic,

Common Name: Classification Name: C.F.R. Section:

C. Predicate Devices:

Class:

Lona-Term Long Term Intravascular Catheter (80 LJS) 880.5970 ll

K003682 Medcomp, Z-Cath PICC K001901 Bard Access, Poly-Q-Cath® Midline K043502 Bard Access, Poly Per-Q-Cath® Triple Lumen PICC Catheter K051991 Bard Access, Poly-Q-Cath PICC

Device Description: D.

Medcomp Vascu-PICC® and Midline Catheters Summary Page 1 of 2

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The Vascu-PICC® and Midline Catheters product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

E. Intended Use:

F. Comparison to Predicate Devices:

The Vascu-PICC® and Midline Catheters are substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization.

The differences between the Vascu-PICC® and Midline Catheters and the predicate Z-Cath device are material change/ formulation, modified design and expansion of product line with additional French sizes and the addition of a triple lumen and midline design.

Indications have been expanded to match the predicate devices.

G. Bench / Performance Data:

The following in-vitro testing was performed on the Vascu-PICC® and Midline Catheters to assure reliable design and performance in accordance with ISO standards.

Air Leakage �
Liquid Leakage 0
Elongation g
Tensile .
Gravity Flow Rate �
Priming Volume �
Aging �
Chemical Testing �
Stress Testing ●

H. Biocompatibility:

Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.

Medcomp Vascu-PICC® and Midline Catheters Summary Page 2 of 2

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Technological characteristics: ﺘﮯ

The principles of operation are the same as the predicate devices. There are no new design changes that could affect the safety or effectiveness of the device.

J. Conclusion:

The proposed devices meet the performance criteria of design verification as specified by ISO standards and 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 devices are substantially equivalent to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles three human figures connected at the base, with their arms raised upwards.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

TUL 2 3 2009

Re: K091586

Trade/Device Name: Vascu-PICC® and Midline Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 29, 2009 Received: July 02, 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/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 yours,

Antrim 29. Martin for

Susan Runner, 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):

Vascu-PICC® and Midline catheters 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)

Arimid.

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

Page 1

510(k) Number.

4-1

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.”