(173 days)
Not Found
No
The device description and performance summary focus on the physical characteristics and performance of a catheter for intravenous therapy and power injection, with no mention of AI or ML capabilities.
Yes.
The device facilitates intravenous therapy and central venous pressure monitoring, which are therapeutic interventions.
No
The device is a catheter designed for central venous access for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. While it can monitor central venous pressure, its primary function is not to diagnose medical conditions but to provide access for treatment and monitoring.
No
The device description clearly details a physical catheter and associated hardware components (lumen, hub, extension, clamp, luer connector, stylet, adaptor sideport). There is no mention of software as the primary or sole component of the device.
Based on the provided text, 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 power injection of contrast media, and allows for central venous pressure monitoring." This describes a device used in vivo (within the body) for delivering substances and monitoring physiological parameters.
- Device Description: The description details a catheter designed for insertion into the central venous system. This is a medical device used for direct patient care, not for testing samples in vitro (outside the body).
- No mention of in vitro testing: The text does not mention any use of the device for analyzing biological samples (like blood, urine, tissue) outside of the body to diagnose or monitor a condition.
IVD devices are specifically designed for testing samples in vitro to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on direct patient access and therapy delivery in vivo.
N/A
Intended Use / Indications for Use
The 3F PRO-PICC® " catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The 3F PRO-PICC of catheter is an open-ended lumen catheter designed for power injection and pressure monitoring. The 3F PRO-PICC® " catheter is comprised of a soft radiopaque probate monitorial. The lumen has a reverse taper design and is connected to the extension via a soft pliable hub with suture wing for secure placement. The clamp on the extension tube prevents air/fluid communication. The female luer connector provides the connection for intravenous administration. The power injectable extension line is purple in color to differentiate it from non-power injectable catheters. The extension is also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection.
The 3F PRO-PICC® C catheter is available with a single lumen. The catheter has a usable length of 50cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile in a variety of tray configurations 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the proposed device was conducted in accordance with applicable international standards and FDA guidance documents. Performance standards for pressure injection have not been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act. Testing is based upon internal engineering testing methods.
The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: This document is a 510(k) summary, section 5, from Medcomp. It includes the submitter information, with the address 1499 Delp Drive, Harleysville, PA 19438, and contact information for Jessica Leo, Regulatory Associate. The trade name is Medcomp 3F PRO-PICC, and the common name is Catheter, Intravascular, Therapeutic, Long-Term. The document is dated November 16, 2012, and the document was created May 15, 2013.
K091953 Medcomp, PRO-PICC® CT, class II 880.5970 K091586 Medcomp, Vascu-Picc & Midline, class II 880.5970 K102159 Bard Access Systems, Inc., PowerPICC SV Catheter, class II 880.5970
D. Device Description:
Predicate Devices:
C.
The 3F PRO-PICC of catheter is an open-ended lumen catheter designed for power injection and pressure monitoring. The 3F PRO-PICC® " catheter is comprised of a soft radiopaque probate monitorial. The lumen has a reverse taper design and is connected to the extension via a soft pliable hub with suture wing for secure placement. The clamp on the extension tube prevents air/fluid communication. The female luer connector provides the connection for intravenous administration. The power injectable extension line is purple in color to differentiate it from non-power injectable catheters. The extension is also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection.
The 3F PRO-PICC® C catheter is available with a single lumen. The catheter has a usable length of 50cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.
1
Image /page/1/Picture/0 description: The image shows a logo for a company called "medCOMP." The logo consists of a geometric design above the company name. Below the company name is the address "1499 Delp Drive." There are also the letters "E." and "F." on the right side of the image.
Harleysville. PA 19438
(".
Tel: 215-256-4201
Fax: 215-256-1787
Indications for Use:
The 3F PRO-PICC® catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Comparison to Predicate Devices:
The 3F PRO-PICC® C catheter is substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, materials, performance, labeling, manufacturing process and method of sterilization.
The differences between the 3F PRO-PICC® Et and the predicate devices is a smaller French size with a CT injectable and a shorter taper of 2 to 5 cm versus 7 to 10 cm.
Bench / Performance Data:
Performance testing of the proposed device was conducted in accordance with applicable international standards and FDA guidance documents. Performance standards for pressure injection have not been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act. Testing is based upon internal engineering testing methods.
The results of these tests in conjunction with the substantial equivalence claims effectively . demonstrate the proposed devices are equivalent to the predicate devices.
H. Biocompatibility:
Testing for all materials used for the 3F PRO-PICC of has been submitted in previously cleared Medcomp devices. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993.
Technological Characteristics: I.
Technological similarities between the proposed device and predicate devices remain the same.
Summary of Substantial Equivalence: J.
The proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and internal 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 device is substantially equivalent to the legally marketed predicate device.
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 design featuring a symbol that resembles a caduceus or a staff with a snake winding around it, but with three distinct, curved lines instead of a single staff and snake.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2013
Ms. Jessica Leo Regulatory Associate Medical Components Incorporated 1499 Delp Drive HARLEYSVILLE, Pennsylvania 19438
Re: K123617
Trade/Device Name: 3F PRO-PICC CT Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 24, 2013 Received: May 3, 2013
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
For
Tejashri S.
Purohitsheth -S
Turowat 2013.05.15
mom
10:21:35-04'00'.
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): 123617
Device Name: ____3F PRO-PICC @ CT
Indications for Use: .
The 3F PRO-PICC® " catheter is indicated for short term or long term peripheral access The or FRO-I ICC® - Cattlection in mayenous therapy and power injection of contrast to the central venous system for much vessure monitoring. The maximum recommended infusion rate varies by catherer French size and is printed on the catheter.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Image /page/4/Picture/10 description: The image shows the letters FDA in a stylized, outlined font. The letters are bold and appear to be made up of multiple parallel lines, giving them a layered effect. The overall design is simple and graphic, with a focus on the acronym itself.
Richard C. Chapman 2013.05.13 12:04:52 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hoapital Infection Control, Dental Devices
Page 1_of_1
510(k) Number: K123617