(97 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a PICC catheter, with no mention of AI or ML capabilities.
Yes
The device is a peripherally inserted central catheter (PICC) indicated for intravenous therapy and power injection of contrast media, both of which are therapeutic interventions.
No
This device is a peripheral access catheter designed for intravenous therapy and power injection of contrast media, not for diagnosing medical conditions. It functions as a delivery system rather than a diagnostic tool.
No
The device description clearly details a physical catheter made of polyurethane with specific dimensions, lumens, and markings. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "peripheral access to the central venous system for intravenous therapy and power injection of contrast media." This describes a device used in vivo (within the body) for delivering substances and accessing the circulatory system.
- Device Description: The description details a catheter, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body for therapeutic or diagnostic imaging purposes like this catheter does.
N/A
Intended Use / Indications for 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.
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.
Product codes
LJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical studies were not considered necessary since in vitro testing performed on the equivalent predicate device sufficiently demonstrated safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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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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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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)
OR
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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