(125 days)
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.
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.
Acceptance Criteria and Study for Vascu-PICC® Catheters
The provided document describes the Vascu-PICC® catheter, intended for peripheral vein catheterization, and a 510(k) submission (K122423) demonstrating its substantial equivalence to predicate devices. The "study" described is a series of in-vitro bench and performance tests, along with biocompatibility testing, rather than a clinical study with human subjects.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria with specific numerical thresholds for each test, as might be found in a later-stage clinical trial. Instead, it refers to ensuring "reliable design and performance in accordance with ISO standards" and meeting "the requirements of ISO 10993" for biocompatibility. The reported device performance is a general statement of compliance rather than discrete data points.
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Bench / Performance Data: (Assure reliable design and performance in accordance with ISO standards) | "The following in-vitro testing was performed on the Vascu-PICC® Catheter to assure reliable design and performance in accordance with ISO standards." Specific tests performed: - Air Leakage - Liquid Leakage - Force at Break - Elongation - Gravity Flow Rate - Infusion Simulation - Priming Volume - Catheter Collapse - Aging - Chemical Testing Conclusion: "The proposed devices meet the performance criteria of design verification as specified throughout test protocols." |
| Biocompatibility: (Meet the requirements of ISO 10993) | "All materials used for the Vascu-PICC are identical to the predicate Vascu-PICC (...) and have been submitted in (K12 1094 and R00 1000) and = Satir 100 (sic)." "All biocompatibility testing demonstrated the materials used meet the requirements of ISO 10993." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of catheters tested) for each in-vitro bench test. It generically states that "in-vitro testing was performed."
- Sample Size: Not specified.
- Data Provenance: The testing was in-vitro (bench testing). The origin is the manufacturer, MEDCOMP®, located in Harleysville, PA, USA. This is not patient data, so "retrospective or prospective" does not apply in the traditional sense, but the testing was conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The "test set" in this context refers to physical devices, and "ground truth" is established by direct measurement of physical properties and material characteristics against documented ISO standards and internal test protocols. No human expert interpretation of images or clinical data was involved in this type of testing.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 typically apply to the interpretation of clinical data (e.g., medical images) by multiple human readers to establish a definitive "ground truth." For in-vitro bench testing, the results are derived directly from scientific measurements and comparisons to established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. This type of study is relevant for diagnostic or screening devices where human readers interpret medical data (e.g., images), and the AI's impact on their performance is being evaluated. The Vascu-PICC® is an intravascular catheter, and its performance is evaluated through physical and material properties, not through interpretation of medical images or data by human readers.
6. Standalone (Algorithm Only) Performance
This section is not applicable. The Vascu-PICC® is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission.
7. Type of Ground Truth Used
The "ground truth" for this catheter's performance is based on engineering specifications, established ISO standards (e.g., for safety, performance, and biocompatibility), and internal test protocols defined by the manufacturer. For biocompatibility, the ground truth is whether materials meet the requirements of ISO 10993. For performance tests, the ground truth is whether physical properties (e.g., air leakage, force at break, flow rate) fall within acceptable ranges defined by these standards and protocols.
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a physical medical device and its in-vitro performance testing. Training sets are relevant for AI/machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable, as there is no training set for this device.
{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 DriveHarleysville, PA 19438Telephone: (215) 256-4201, ext. 2271Fax: (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 PICCK121094 Vascu-PICC and Midline CathetersK091586 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:
Page 1 of 1
§ 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.”