THE R4 VASCULAR INC. PEGASUS CT PICC IS INDICATED FOR SHORT TERM AND LONG-TERM PERIPHERAL ACCESS TO THE CENTRAL VENOUS SYSTEM FOR INTRAVENOUS THERAPY AND POWER INJECTION OF CONTRAST MEDIA. FOR BLOOD SAMPLING, INFUSION, OR THERAPIES, USE A 4F OR LARGER CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 5F AND 6F PEGASUS CT PICC CATHETER MAY NOT EXCEED 300PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 5CC/SEC FOR 5F AND 6F CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 4F PEGASUS CT PICC CATHETER MAY NOT EXCEED 200PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 4CC/SEC FOR A 4F CATHETER.

Device Description

The Pegasus CT PICC catheters are radiopaque polyurethane.
Catheter usable length is 55 to 60 cm in length. It is available in a 4F/5F single lumen and 5F/6F dual lumen version.
The catheter has a reverse taper design.
Catheter lumen tubing is marked with depth markings for proper placement of the catheter during insertion.
Catheters are provided sterile in basic radiology and nursing PICC configurations.
The catheter has one power injectable lumen.
Purple colorant was added to the catheter materials to distinguish it from other nono power injectable catheters and recognize it as a power injectable catheter.
The catheter extension, ID rings are printed to identify the catheter as a Power Injectable Catheter to ensure proper use of the device.

AI/ML Overview

The provided text describes the 510(k) summary for the r4 Vascular Inc. Pegasus CT PICC. It states that clinical studies were not considered necessary, because the device's substantial equivalence to a predicate device (Medcomp Pro-Line CT Power Injectable CVC Catheter, K053345) was demonstrated through in vitro testing. Therefore, there is no explicit study described that proves the device meets specific acceptance criteria as would be found in a clinical trial.

However, the document does list the standards and guidelines followed for verification and validation testing, implying that these standards contain the acceptance criteria for device performance. Since no direct performance values are given from such tests in the provided text, I will describe the type of acceptance criteria implied by the cited standards and the reported device characteristics that are intended to meet these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Pegasus CT PICC are implied by the conformance to the listed international and AAMI/ANSI/ISO standards. These standards typically set requirements for:

Sterility: Ensuring the device is free from viable microorganisms.
Biocompatibility: Ensuring the materials used are safe for contact with the human body.
Physical and Chemical Properties: Requirements related to material strength, durability, patency, flow rates, and pressure limits under specified conditions.
Labeling Accuracy: Ensuring critical information like power injection limits, catheter size, and intended use is clearly marked.

Since the submission relies on substantial equivalence to a predicate device and states that "The technological characteristics such as design and materials are identical to the predicate device," the reported performance is essentially that it meets the requirements of the predicate and the general standards.

Acceptance Criteria Category (Implied by Standards)	Reported Device Performance
Sterility (AAMI/ANSI/ISO 11135:1994)	Provided sterile.
Biocompatibility (ISO 10993 Parts I)	Materials previously cleared for similar applications; permanent contact device.
Physical & Chemical Properties - Catheter Length	55 to 60 cm.
Physical & Chemical Properties - Lumen Configuration	4F/5F single lumen and 5F/6F dual lumen.
Physical & Chemical Properties - Radiopacity	Radiopaque polyurethane.
Physical & Chemical Properties - Power Injectability (General)	One power injectable lumen. Distinguished by purple colorant and ID rings.
Flow Rate & Pressure - 5F and 6F Catheter	Max recommended infusion rate: 5cc/sec. Max pressure for power injectors: 300 psi.
Flow Rate & Pressure - 4F Catheter	Max recommended infusion rate: 4cc/sec. Max pressure for power injectors: 200 psi.
Depth Markings	Catheter lumen tubing marked with depth markings for proper placement.
General Catheter Requirements (ISO 10555-1.1997, ISO 10555-3:1997)	No specific numerical performance values provided, but stated to be in accordance with these standards, implying compliance with general requirements for intravascular and central venous catheters.

No information regarding clinical study design elements like sample size, data provenance, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance is present, as no clinical studies were deemed necessary.

Here's why based on the document:

Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used for a human-centric study. In vitro testing was performed. The data provenance for the materials is that they were "previously cleared for similar applications."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established through in vitro testing against standards, not expert consensus on human data.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a medical catheter, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is compliance with international and AAMI/ANSI/ISO standards (e.g., ISO 10555, ISO 10993, AAMI/ANSI/ISO 11135), established through in vitro testing.
The sample size for the training set: Not applicable. This device is a medical catheter and was not developed using machine learning.
How the ground truth for the training set was established: Not applicable. This device is a medical catheter and was not developed using machine learning.

Summary

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AUG 2 0 2007

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Image /page/0/Picture/1 description: The image shows the text "510(k) Summary" in a large, bold font. The text is black and appears to be centered on a white background. The text is likely a title or heading for a document or presentation.

r4 Vascular Inc. Pegasus CT PICC

510(k) Summary of Safety and Effectiveness Information

Submitter Information

Submitter Name: r4 Vascular Inc.
Address: 1246 University Avenue West Suite 438 St. Paul, MN 55104

Telephone Number: (201) 394-2708

Fax Number: (651) 209-8947

Contact Person: Michael Sarajian

Date of Preparation: May 1, 2007

Device Name

Device Name: Pegasus CT PICC Trade Name: Pegasus CT PICC Common/Usual Name: Peripherally Inserted Central Catheter (PICC) Classification Panel: General hospital Classification Name: LJS - Long Term Intravascular Catheter 21 CFR 880.5970, Class II Peripherally Inserted Central Catheter (PICC)

Predicate Device Name(s)

Device Name: Medcomp Pro-Line CT Power Injectable CVC Catheter Trade Name: Medcomp Pro-Line CT Power Injectable CVC Catheter Common/Usual Name: CVC Catheter Classification Name: Long Term Intravascular Catheter (US) Premarket Notification: K053345, concurrence date-December 20, 2005

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K07/3(2)

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Device Description

o The Pegasus CT PICC catheters are radiopaque polyurethane.
o Catheter usable length is 55 to 60 cm in length. It is available in a 4F/5F single lumen and 5F/6F dual lumen version.
o The catheter has a reverse taper design.
o Catheter lumen tubing is marked with depth markings for proper placement of the catheter during insertion.
o Catheters are provided sterile in basic radiology and nursing PICC configurations.
0 The catheter has one power injectable lumen.
Purple colorant was added to the catheter materials to distinguish it from other nono power injectable catheters and recognize it as a power injectable catheter.
0 The catheter extension, ID rings are printed to identify the catheter as a Power Injectable Catheter to ensure proper use of the device.

Intended Use

The Pegasus CT PICC Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Indications for Use

The indications for use have not changed from the predicate Pro-Line Power Injectable catheter (K053345). The Pegasus CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5cc/sec. for power injection of contrast media for a 5F and 6F catheter. The maximum pressure of power injectors used with the 5F and 6F Pegasus CT PICC catheter may not exceed 300 psi. The maximum recommended infusion rate is 4cc/sec. for power injection of contrast media for a 4F catheter. The maximum pressure of power injectors used with the 4F Pegasus CT PICC catheter may not exceed 200 psi.

Characteristics of Proposed Device vs. Predicate Device

The technological characteristics such as design and materials are identical to the o predicate device.
0 The analysis did not raise any new types of safety or effectiveness questions.

Listed below are the FDA guidance documents and international standards that were followed to measure the device's performance:

o ISO 10555-1.1997, Sterile, Single-Use Intravascular Catheters, General requirements,
ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters o
AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of 0 Ethvlene Oxide Sterilization
਼ ISO 10993 Biological Evaluation of Medical Devices Part-I: Evaluation and Testing

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K071361

Sofa

All materials used in the manufacture of the proposed device were previously cleared for similar applications by predicate manufacturer per ISO 10993 requirements for a permanent contact device.

Verification and validation testing was performed in accordance with the protocols mentioned above per recommendations and standards, as well as in accordance with in-house protocols.

Clinical studies were not considered necessary since in vitro testing performed on the equivalent predicate device sufficiently demonstrated safety and effectiveness.

Conclusion

The r4 Vascular Inc. Pegasus CT PICC Power Injectable catheter is substantially equivalent to the predicate device in terms of intended use, insertion method, anatomical location, design, performance, labeling, manufacturing process and method of sterilization.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2007

Michael Sarajian Chief Executive Officer R4 Vascular, Incorporated 1246 University Avenue West, Suite 438 Saint Paul, Minnesota 55104

Re: K071361

Trade/Device Name: Pegasus CT PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 17, 2007 Received: August 17, 2007

Dear Mr. Sarajian:

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 such 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 - Mr. Sarajian

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complies with other snews not of the Act or any Federal statutes and regulations administered by other Federal sgencies. 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin 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, primits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Chiu Lin, Ph.D.

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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K071361

INDICATIONS FOR USE

510(k) Number:

Device Name: PEGASUS CT PICC

Indications for use: THE R4 VASCULAR INC. PEGASUS CT PICC IS INDICATED FOR SHORT TERM AND LONG-TERM PERIPHERAL ACCESS TO THE CENTRAL VENOUS SYSTEM FOR INTRAVENOUS THERAPY AND POWER INJECTION OF CONTRAST MEDIA. FOR BLOOD SAMPLING, INFUSION, OR THERAPIES, USE A 4F OR LARGER CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 5F AND 6F PEGASUS CT PICC CATHETER MAY NOT EXCEED 300PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 5CC/SEC FOR 5F AND 6F CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 4F PEGASUS CT PICC CATHETER MAY NOT EXCEED 200PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 4CC/SEC FOR A 4F CATHETER.

x Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles B. for ADW
(Division Sign Title)

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

510(k) Number: K071361

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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.”