(204 days)
Not Found
No
The summary describes a physical medical device (catheter) with valve technology and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is described as a Peripherally Inserted Central Vein Access Catheter designed for "intravenous therapy and blood sampling, and allows for central venous pressure monitoring," which are therapeutic and diagnostic medical purposes.
No
Explanation: The device, a peripherally inserted central catheter, is described for intravenous therapy, blood sampling, and central venous pressure monitoring. These are therapeutic and monitoring functions, not diagnostic; it does not process or analyze data to diagnose a condition.
No
The device description clearly details a physical catheter with various hardware components (lumen, extension, luer-lock connector, valve, hub, etc.) and is packaged with accessories for insertion. There is no mention of software as the primary or sole component.
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 blood sampling, and allows for central venous pressure monitoring." This describes a device used in vivo (within the body) for delivering substances, taking blood samples, and monitoring pressure.
- Device Description: The description details a catheter designed for insertion into a vein and placement in the central venous system. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test strips, analyzers, or other components used to analyze biological samples.
Therefore, the device described is a medical device used for accessing the central venous system in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Peripherally Inserted Central Vein Access Catheters with valve technology 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 (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Vascu-PICC® with Valve Technology is available in various configurations; they are a 3F & 4F single lumen and 4F & 5F double lumen. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each huer is a bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size and "Valved catheter". The transition between lumen and extension is housed within a molded hub. The hub is marked with catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter. 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.
K121094 Medcomp, Vascu-PICC® and Midline Catheters, K072230 Bard Access Systems, Inc., PowerPICC SOLO™
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
K120897
Image /page/0/Picture/1 description: The image shows a logo with the text "medcomp." in a stylized font. Above the text is an abstract geometric shape, primarily black and white. The shape appears to be a stylized letter or symbol, possibly representing the company's initials or a related concept.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax: 215-256-1787
| Section 5 | 510(k) SUMMARY | Traditional 510K | |
|---|---|---|---|
| A | Submitter Information: | ||
| Submitter: | MEDCOMP® | ||
| 1499 Delp Drive | |||
| Harleysville, PA 19438 | |||
| Tel: (215) 256-4201, x2271 | |||
| Fax: (215) 256-9191 | |||
| Contact: | Jessica Leo | ||
| Regulatory Associate | |||
| Date Prepared: | March 28, 2013 | OCT 22 2013 | |
| B. | Trade Name: | ||
| Technology | Medcomp® Vascu-PICC® with Valve | ||
| Common Name: | Catheter, Intravascular, Therapeutic, | ||
| Long-Term | |||
| Classification Name: | Long Term Intravascular Catheter (80 LJS) | ||
| Regulation Name: | |||
| intravascular | Percutaneous, implanted, long-term | ||
| C.F.R. Section: | catheter | ||
| 880.5970 | |||
| Class: | II | ||
| C. | Predicate Devices: | K121094 Medcomp, Vascu-PICC® and Midline | |
| Catheters, class II 880.5970 |
D. Device Description:
The Vascu-PICC® with Valve Technology is available in various configurations; they are a 3F & 4F single lumen and 4F & 5F double lumen. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each huer is a bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size and "Valved catheter". The transition between lumen and extension is housed within a molded hub. The hub is marked with catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
K072230 Bard Access Systems, Inc., PowerPICC SOLO™, class II 880.5970
The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.
ど。 Indications for Use:
Medcomp Vascu-PICC with Valve Technology Summary
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Image /page/1/Picture/0 description: The image shows a logo with a geometric design above the word "medcomp". The geometric design features a combination of thick, black lines forming an abstract shape, with a white circle incorporated into the design. The word "medcomp" is written in a lowercase, italicized font below the geometric shape.
F.
1499 Delp Drive
Hurleysville, PA 19438
Tel: 215-256-4201
Fax: 215-256-1787
The Peripherally Inserted Central Vein Access Catheters with valve technology 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.
Comparison to Predicate Devices:
The Vascu-PICC® with valve technology 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 difference between the Vascu-PICC® with valve technology and the predicate devices (K121094) is the addition of the valve technology to the luer.
G. 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.
ਜ਼ੁ Biocompatibility:
Testing for all materials used for the Vascu-PICC® with valve technology has been submitted in previously cleared Medcomp devices. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993.
L Technological Characteristics:
Technological similarities between the proposed device and predicate devices remain the same.
J. Summary of Substantial Equivalence:
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2013
MEDCOMP (Medical Components) Jessica Leo Regulatory Associate 1499 Delp Drive Harleysville, PA 19438
Re: K130897
Trade/Device Name: Vascu-PICC with Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Catheter, Intravascular, Therapeutic, Long-Term Regulatory Class: II Product Code: LJS Dated: September 3, 2013 Received: September 10, 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 reguirements 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,
MarySBanner-S
Kwame Ulmer M.S. Acting Division 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
K130897 510(k) Number (if known):
Vascu-PICC® with Valve Technology Device Name:
Indications for Use:
The Peripherally Inserted Central Vein Access Catheters with valve technology 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.
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)
Image /page/4/Picture/10 description: The image shows the FDA logo. The logo is a stylized version of the letters "FDA". The letters are outlined in black. The logo is simple and recognizable.
Richard C. Chapman 2013.10.22 14:06:05 -04'00'
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