(82 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Medcomp® PRO-PICC ™ CT Peripherally Inserted Central Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 10555-1, 10555-3, and internal engineering protocols) | Reported Device Performance |
|---|---|
| Air/Liquid Leakage | Within acceptable limits based on in vitro testing. |
| Force at Break | Within acceptable limits based on in vitro testing. |
| Elongation | Within acceptable limits based on in vitro testing. |
| Gravity Flow | Within acceptable limits based on in vitro testing. |
| Static Burst Pressure | Within acceptable limits based on in vitro testing. |
| High Pressure Injection Flow Rate | Within acceptable limits based on in vitro testing. |
| Chemical Testing | Within acceptable limits based on in vitro testing. |
| Biocompatibility (for permanent external communicating blood contact device) | Materials met requirements of ISO 10993 (based on predicate device testing). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "in vitro testing was performed" without specifying the number of units tested.
- Data Provenance: In vitro testing was performed. The country of origin for the testing is not specified, but the submitter is based in Harleysville, PA, USA. The testing is not retrospective or prospective in the clinical sense, as it was lab-based in vitro testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- No human experts were used to establish ground truth for this in vitro test set. The acceptance criteria are based on engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols, which are objective, measurable performance parameters.
4. Adjudication Method for the Test Set
- Not applicable. As the ground truth was established by objective engineering standards and measurements, no human adjudication was required.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. Clinical studies were explicitly not deemed necessary. The device's safety and effectiveness were demonstrated through in vitro testing and comparison to legally marketed predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical catheter, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product.
7. The Type of Ground Truth Used
- Objective Engineering Standards and Measurements: The ground truth for the device's performance was established using objective measurements against established international engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols. These standards define the acceptable range for physical and chemical properties (e.g., burst pressure, flow rate, leakage).
- Biocompatibility Standard: For biocompatibility, the ground truth was meeting the requirements of ISO 10993.
8. The Sample Size for the Training Set
- Not applicable. This refers to a physical medical device, not a machine learning algorithm. Therefore, there is no "training set." The design and materials are based on existing, cleared predicate devices and engineering principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the context of this device, this question is not relevant. The device's design is informed by established engineering principles and prior validated devices.
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A. Submitter Information: Submitteri
| Submitter: | MEDCOMP®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201Fax: (215) 256-9191 |
|---|---|
| Contact: | Jean CallowRegulatory 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-termintravascular catheter |
| C.F.R. Section: | 880.5970 Class II |
| Predicate Device: | C.R. Bard, Inc. K053501 6Fr. TLPowerPICCTM CatheterMedcomp 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.
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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.
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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
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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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§ 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.”