(125 days)
No
The device description and performance studies focus on the physical characteristics and fluid dynamics of a catheter, with no mention of AI/ML or related concepts.
Yes
The device is a peripherally inserted central catheter used for intravenous therapy and blood sampling, which are therapeutic functions.
No
Explanation: The device is described as a catheter for intravenous therapy, blood sampling, and central venous pressure monitoring, which are functions related to treatment and monitoring, not diagnosis. It facilitates access to the central venous system but does not itself provide diagnostic information or interpretation.
No
The device description clearly details a physical catheter made of polyurethane with lumens, extension tubes, clamps, and luer connectors. 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 is for "peripheral access to the central venous system for intravenous therapy and blood sampling and allows for central venous pressure monitoring." This describes a device used in vivo (within the body) for delivering substances, collecting blood, and monitoring pressure.
- Device Description: The description details a catheter designed for insertion into a vein. This is a medical device used for direct patient care, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. There are no reagents, test strips, or analytical components described.
Therefore, this device falls under the category of a general medical device used for patient treatment and monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vascu-PICC 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, it is recommended that catheter lumen of 20 gauge or larger be used.
The Peripherally Inserted Central Vein Access Catheters are designed for long or short-term peripheral access to the central venous system for intravenous therapy and blood sampling and allows for central venous pressure monitoring.
Product codes
LJS
Device Description
The Vascu-PICC taperless catheters are designed for peripheral vein catheterization. The Vascu-i TOO taponoos cansion comprised of a soft radiopaque polyurethane The lument is an open oncediopacity. The lumen is connected to the extensions material with bandin suitate for facts passement. 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 The Cathelers are available in a fange on a fange on throughout the length of the lument "The outside diameter of the lamon to sculature consistent luminal sizing. The Catherer, providing patiente with capseter and numerical marks every 5" centimeter and lumen has depth mants overy continues have in-line clamps to control fluid are available in a thin uble of am. I the gauge size and French size and French size.
The Vascu-PICC® catheter product line is packaged sterile with the necessary accessories to facilitate catheter insertion.
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
The following in-vitro testing was performed on the Vascu-PICC® Catheter to assure reliable design and performance in accordance with ISO standards.
Air Leakage Liquid Leakage Force at Break Elongation Gravity Flow Rate Infusion Simulation Priming Volume Catheter Collapse Aging Chemical Testing
All materials used for the Vascu-PICC are identical to the predicate Vascu-PICC (K12 1094 and R00 1000) and have been submitted in (K003682) and = Satir 100 (All biocompatibility testing demonstrated thematerials used meet the requirements of ISO 10993.
Key Metrics
Not Found
Predicate Device(s)
K003682 Z-Cath PICC, K121094 Vascu-PICC and Midline Catheters, K091586 Vascu-PICC and Midline Catheters
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.”
0
DEC 1 2 2012
Image /page/0/Picture/1 description: The image shows a logo with the text "medCOMP." The logo consists of a geometric shape above the text. The geometric shape is made up of black and white stripes, forming an abstract design. The text "medCOMP" is in a lowercase, italicized font.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax: 215-256-1787
| Section 5 | 510(k) SUMMARY | K12242 |
|---|---|---|
| Submitter Information: | ||
| Submitter: | MEDCOMP® | |
| 1499 Delp Drive | ||
| Harleysville, PA 19438 | ||
| Telephone: (215) 256-4201, ext. 2271 | ||
| Fax: (215) 256-9191 | ||
| Contact: | Jessica Leo | |
| Date Prepared: | October 1, 2012 | |
| Device Name: | Vascu-PICC® | |
| Common Name: | Catheter, Intravascular, Therapeutic, Long-Term | |
| Classification Name: | Long Term Intravascular Catheter (LJS 78) | |
| C.F.R. Section: | 880.5970 | |
| Class: | II | |
| Predicate Devices: | K003682 Z-Cath PICC | |
| K121094 Vascu-PICC and Midline Catheters | ||
| K091586 Vascu-PICC and Midline Catheters |
Device Description:
The Vascu-PICC taperless catheters are designed for peripheral vein catheterization. The Vascu-i TOO taponoos cansion comprised of a soft radiopaque polyurethane The lument is an open oncediopacity. The lumen is connected to the extensions material with bandin suitate for facts passement. 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 The Cathelers are available in a fange on a fange on throughout the length of the lument "The outside diameter of the lamon to sculature consistent luminal sizing. The Catherer, providing patiente with capseter and numerical marks every 5" centimeter and lumen has depth mants overy continues have in-line clamps to control fluid are available in a thin uble of am. I the gauge size and French size and French size.
The Vascu-PICC® catheter product line is packaged sterile with the necessary accessories to facilitate catheter insertion.
Intended Use:
The Vascu-PICC catheters are designed for short or long term peripheral access to the The Vasual TOO catherors are associations therapy and blood sampling. For central venous central venous system for intraverled that catheter lumen of 20 gauge or larger be used.
1
Image /page/1/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a geometric shape that is black and white. The word "medCOMP" is written in a lowercase, italicized font below the geometric shape.
- 1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax: 215-256-1787
Indications for Use:
The Peripherally Inserted Central Vein Access Catheters are designed for long or r he r enpherally insertou ookly in exentral venous system for intravenous therapy and blood sampling and allows for central venous pressure monitoring.
Comparison to Predicate Devices:
The Vascu-PICC® catheters are substantially equivalent to the predicate devices in The vasou 1 1000 battlers area location, basic design, performance, labeling, manufacturing process, method of sterilization and materials.
The difference between the Vascu-PICC® and the predicate Vascu-PICC® device is the taperless lumen design which is based on the original Z-Cath.
Bench / Performance Data:
The following in-vitro testing was performed on the Vascu-PICC® Catheter to assure reliable design and performance in accordance with ISO standards.
Air Leakage Liquid Leakage Force at Break Elongation Gravity Flow Rate Infusion Simulation Priming Volume Catheter Collapse Aging Chemical Testing
Biocompatibility:
All materials used for the Vascu-PICC are identical to the predicate Vascu-PICC All matenals used for the Vacca Price (K003682) and have been submitted in (K12 1094 and R00 1000) and = Satir 100 (All biocompatibility testing demonstrated thematerials used meet the requirements of ISO 10993.
Technological characteristics:
The principles of operation are the same as the predicate devices. The lumen design change does not affect the safety or effectiveness of the device.
Conclusion:
The proposed devices meet the performance criteria of design verification as specified The proposed as not test protocols. The proposed devices are substantially equivalent to the legally marketed predicate devices.
Page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-002
December 12, 2012
Ms. Jessica Leo Regulatory Associate Medical Components Incorporated 1499 Delp Drive Harleysville, PA 19438
Re: K122423
Trade/Device Name: Vascu-PICC® Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 27, 2012 Received: November 27, 2012
Dear Ms. Leo:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Ms. Leo
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Cinthorn Lo m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _k|22423
Vascu-PICC® Device Name:
Indications for Use:
The Peripherally Inserted Central Vein Access Catheters are designed for long or shortterm peripheral access to the central venous system for intravenous therapy and blood sampling and allows for central venous pressure monitoring.
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)
Digitally signed by Richard C. Chapman Date: 2012.12.10 12:16:00 -05'00'
(Division Sign-Off) (Division Sign-off)
Division of Anesthesiology, General Hospital Division of Antsoulocion.org/ Divises
1122423
510(k) Number:
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