(82 days)
No
The summary describes a physical medical device (a catheter) and its performance testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a catheter indicated for intravenous therapy and power injection of contrast media, both of which are therapeutic medical interventions.
No
The device is a catheter for intravenous therapy, not for diagnosing conditions. Its function is to provide access to the central venous system for infusions, injections, and blood sampling.
No
The device description clearly details a physical catheter made of polyurethane with lumens, hubs, clamps, and connectors. It also mentions accessories for insertion. There is no mention of software as the primary component or function.
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," "blood sampling, infusion, or therapies." This describes a device used in vivo (within the body) for direct patient treatment and access, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into the body, with features like lumens, hubs, clamps, and connectors for intravenous administration. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The focus is on delivering substances or drawing blood directly from the patient's circulatory system.
Therefore, the PRO-PICC m C catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The PRO-PICC ™ C 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. 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. Injectable CVC. The PRO-PICC m ™ 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
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)
In vitro testing was performed on the PRO-PICC m C 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 effectivencss by way of comparison to legally marketed 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
A. Submitter Information: Submitteri
| Submitter: | MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
Tel: (215) 256-4201
Fax: (215) 256-9191 |
|-------------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Jean Callow
Regulatory Specialist |
| Date Prepared: | September 7, 2007 |
| 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 |
| Predicate Device: | C.R. Bard, Inc. K053501 6Fr. TL
PowerPICCTM Catheter
Medcomp K053345 Pro-LineTM CT Press |
D. Device Description:
B.
ﺰ
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.
Injectable CVC.
The PRO-PICC m ™ 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.
Medcomp PRO-PICC ru CT catheter Summary Page 1 of 2
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E. Intended Use:
'The PRO-PICC ™ C 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. For blood sampling, infusion, or therapics, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
મું. Performance Data:
In vitro testing was performed on the PRO-PICC m C 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 effectivencss 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.
G. 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
SEP 2 3 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jean Callow Regulatory Specialist Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K081904
Trade/Device Name: PRO-PICCru CT Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 2, 2008 Received: July 8, 2008
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 docs 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
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 7m CT
Indications for Use:
The PRO-PICC m C 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. 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 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)
Anthony Di nome
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
Page 1_of 1
510(k) Number: _ Ka81944
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