(81 days)
No
The description focuses on the physical characteristics, materials, and intended use of a catheter, with no mention of AI or ML capabilities.
Yes.
The device is used for intravenous therapy, which involves administering substances to treat or manage a medical condition.
No
Explanation: The device is a catheter used for intravenous therapy, power injection of contrast media, blood sampling, infusion, or therapies. It is an access device, not a diagnostic one.
No
The device description clearly details a physical catheter made of polyurethane with lumens, hubs, clamps, and connectors. It also mentions accessories like a stylet and adaptor sideport. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media." This describes a device used for delivering substances into the body and for accessing the circulatory system, not for examining specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description details a catheter designed for insertion into the body for fluid delivery and blood sampling. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and performance of the catheter itself (leakage, strength, flow rates, etc.) and biocompatibility, which are relevant to an implanted or inserted medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, nor any reference to diagnostic purposes or obtaining information about a patient's health status through in vitro testing.
Therefore, the PRO-PICC m C catheter is a medical device used for therapeutic and access purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PRO-PICC m C catheter is indicated for short 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 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 PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.
The PRO-PICC m C catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile in two radiology versions and two nursing 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
Not Found
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)
In vitro testing was performed on the PRO-PICC ™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3 and internal engineering protocol. Testing includes air/liquid leakage, force at break, elongation, gravity flow, static burst pressure, high pressure injection flow rate and chemical testing.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices.
All materials used for the proposed device were previously cleared in the Medcomp K053345 Pro-Line™ CT Pressure Injectable CVC. Biocompatibility testing on the Pro-Line™ CT Pressure Injectable CVC demonstrated that the materials used meets the requirements of ISO 10993 for a permanent external communicating blood contact device.
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.
C.R. Bard, Inc. K053501 6Fr. TL PowerPICCTM Catheter, Medcomp K053345 Pro-Line™ CT Pressure Injectable CVC.
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
- 52
| A. | Submitter Information: | |
|---|---|---|
| Submitter: | MEDCOMP® | |
| 1499 Delp Drive | ||
| Harleysville, PA 19438 | ||
| Tel: (215) 256-4201 | ||
| Fax: (215) 256-9191 | ||
| Contact: | Jean Callow | |
| Regulatory Specialist | ||
| Date Prepared: | NOV 2 6 2007 | |
| September 7, 2007 | ||
| B. | Trade Name: | Medcomp® PRO-PICC TM CT |
| Common Name: | Peripherally Inserted Central Catheter | |
| Classification: | LJS | |
| Regulation Name: | Percutaneous, implanted, long-term | |
| intravascular catheter | ||
| C.F.R. Section: | 880.5970 Class II | |
| C. | Predicate Device: | C.R. Bard, Inc. K053501 6Fr. TL |
| PowerPICCTM Catheter | ||
| Medcomp K053345 Pro-Line™ CT Pressure | ||
| Injectable CVC. |
D. Device Description:
The PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.
The PRO-PICC m C catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.
1
E. Intended Use:
The PRO-PICC m C catheter is indicated for short 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 recommended infusion rate varies by catheter French size and is printed on the catheter.
1073500
F. Performance Data:
In vitro testing was performed on the PRO-PICC ™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3 and internal engineering protocol. Testing includes air/liquid leakage, force at break, elongation, gravity flow, static burst pressure, high pressure injection flow rate and chemical testing.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices.
All materials used for the proposed device were previously cleared in the Medcomp K053345 Pro-Line™ CT Pressure Injectable CVC. Biocompatibility testing on the Pro-Line™ CT Pressure Injectable CVC demonstrated that the materials used meets the requirements of ISO 10993 for a permanent external communicating blood contact device.
(1. Comparison to Predicate Device:
The PRO-PICC m C catheter is substantially equivalent to the predicate devices in terms of intended use, insertion method, anatomical location, design, materials, performance, labeling, packaging and method of sterilization.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2007
Ms. Jean Callow Regulatory Specialist MedComp 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K072509
Trade/Device Name: PRO-PICC таст Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 6, 2007 Received: September 17, 2007
Dear Ms. Callow:
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.
3
Page 2 - Ms. Callow
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); 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, permits 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 yours.
Chih-Lin, Ph.D.
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
4
Indications for Use
510(k) Number (if known):
Device Name: ___ PRO-PICC m CT
Indications for Use:
The PRO-PICC m C catheter is indicated for short 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 recommended infusion rate varies by catheter French size and is printed on the catheter.
Prescription Use >