(28 days)
Not Found
No
The document describes a physical medical device (a catheter) and its intended use and physical characteristics. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on physical properties and equivalence to predicate devices.
No.
Explanation: The device is a catheter used for intravenous therapy and blood sampling, providing access to the central venous system. It does not actively treat or mitigate a disease or condition itself, but rather facilitates the delivery of therapeutic agents or removal of blood.
No
Explanation: The device is a catheter used for intravenous therapy, blood sampling, and power injection of contrast media into the central venous system. It is a therapy delivery and access device, not one that diagnoses a condition.
No
The device description clearly describes a physical catheter made of polyurethane with specific dimensions and features, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The PowerPICC® Catheter is a medical device used for accessing the central venous system for intravenous therapy, blood sampling, and power injection of contrast media. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a procedure involving direct access to the central venous system for delivering substances or withdrawing blood, not analyzing a sample in a lab.
- Device Description: The description details the physical characteristics of the catheter, its materials, and markings, which are typical for an invasive medical device, not an IVD.
Therefore, the PowerPICC® Catheter falls under the category of an invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
Product codes
LJS
Device Description
- The 6 FR TL PowerPICC® Catheters are open-ended radiopaque polyurethanc. .
- . Catheter usable length is 55 cm.
- . The catheter has a reverse taper design
- Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference ◆ for the catheter insertion point.
- . Catheters are provided sterile in basic radiology and nursing PICC configurations.
- Purple colorants were added to the catheter materials to provide the catheter with an appearance . that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters.
- . The catheter has one power injectable lumen.
- The product labeling warns against power injection procedures through the two small lumens. .
- The catheter extension legs, junction and clamp ID tags were printed with markings to identify the catheter as PowerPICC® and to include information to facilitate proper use of the device.
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
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Summary of Performance Studies
Verification and validation testing was performed according to protocols based on the above referenced guidance document recommendations and standards, as well as in accordance with inhouse protocols. Performance data gathered in design verification testing demonstrated that the 6 Fr TL PowerPICC® catheter is substantially equivalent to the predicate devices, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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6 Fr TL PowerPICC®
53501 1 of 3
Section 6
510(k) Summary
6 Fr TL PowerPICC® Catheter
510(k) Summary of Safety and Effectiveness Information 21CFR 807.92
6.1 Submitter Information
| Submitter Name: | Bard Access Systems, Inc. (BAS)
[Subsidiary of C.R. Bard, Inc.] |
|----------------------|--------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700, Ext. 7136 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Lynn M. Kirchoff |
| Date of Preparation: | December 15, 2005 |
6.2 Device Name
| Device Name: | 6 Fr TL PowerPICC ® Catheter |
|---|---|
| Trade Name: | 6 Fr TL PowerPICC ® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Panel: | General Hospital |
| Classification Name: | 80LJS - Long Term Intravascular Catheter |
| 21 CFR 880.5970, Class II | |
| Peripherally Inserted Central Catheter (PICC) |
6.3 Predicate Device Name(s)
| Device Name: | 6 Fr TL Poly Per-Q-Cath ® PICC Catheter |
|---|---|
| Trade Name: | 6 Fr TL Poly Per-Q-Cath ® PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K043502, concurrence date-January 14, 2005 |
| Device Name: | 5 Fr DL PowerPICC® Catheter |
| Trade Name: | 5 Fr DL PowerPICC® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K051672, concurrence date-November 23, 2005 |
6.4 Device Description
- The 6 FR TL PowerPICC® Catheters are open-ended radiopaque polyurethanc. .
- . Catheter usable length is 55 cm.
- . The catheter has a reverse taper design
- Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference ◆ for the catheter insertion point.
- . Catheters are provided sterile in basic radiology and nursing PICC configurations.
Image /page/0/Picture/19 description: The image shows the number 00046. The numbers are in a bold, sans-serif font. The number 46 is also written above the last two digits, but it is smaller in size.
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KOS350)
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- Purple colorants were added to the catheter materials to provide the catheter with an appearance . that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters.
- . The catheter has one power injectable lumen.
- The product labeling warns against power injection procedures through the two small lumens. .
- The catheter extension legs, junction and clamp ID tags were printed with markings to identify the � catheter as PowerPICC® and to include information to facilitate proper use of the device.
6.5 Intended Use
The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The intended use has not changed.
6.6 Indications for Use
The indications for use have not changed from the predicate 5 Fr DL PowerPICC® catheter (K051672).
The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
6.7 Summary of Technological Characteristics in Relation to the Predicate Device
Does the new device have the same technological characteristics, e.g. design, material, etc.?
Not in all regards. The 6 Fr TL PowerPICC® catheter has some minor differences from the predicate devices. However, the basic fundamental scientific technology of the catheter has not changed.
Could the new characteristics affect safety or effectiveness?
Yes. The new characteristics could affect safety or effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions?
No. A failure modes and effects analysis (FMEA) of the subject device was conducted in accordance with an internal protocol based on ISO 14971:2000, Medical Devices - Rich Management for Medical Devices, to assure that risks posed by the subject device are acceptable. The analysis did not raise any new types of safety or effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. The following FDA guidance documents and international standards were used to evaluate the device's performance:
- Guidance on Premarket Notification [510(k)] Suhmission for Short-Term and Long-Term . Intravascular Catheters, March 16, 1995
- . ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements
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053051 3 of 3
- ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, . Amendment I
- ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters .
- . AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1 : Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the subject device were previously cleared for similar applications by Bard Access Systems.
Are performance data available to assess effects of new characteristics?
Yes. Verification and validation testing was performed according to protocols based on the above referenced guidance document recommendations and standards, as well as in accordance with inhouse protocols.
Do performance data demonstrate equivalence?
Yes. Performance data gathered in design verification testing demonstrated that the 6 Fr TL PowerPICC® catheter is substantially equivalent to the predicate devices, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
6.8 Conclusion
The 6 Fr TL PowerPICC* catheter meets all the prodetermined performance acceptance criteria of the testing performed and, based on FDA's decision tree, is substantially equivalent to the predicate devices the 6 Fr TL Poly Per-Q-Cath" PICC catheter, K043502, concurrence date, November 23, 2005.
Image /page/2/Picture/13 description: The image shows the number 48 at the top and the number 000048 below it. The number 000048 is written in a bold font. The number 48 at the top is smaller than the number 000048 below it.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2006
Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K053501
Trade/Device Name: 6 Fr TL PowerPICC Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Cathcter Regulatory Class: II Product Code: LJS Dated: December 15, 2005 Received: December 16, 2005
Dear Ms. Kirchoff:
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. Kirchoff
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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
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
5
6 Fr TL PowerPICC®
K053501 1 of 1
Section 1.2
Indications for Use Statement
510(k) Number (if known):
Device Name: 6 Fr TL PowerPICC® Catheter
Indications For Use:
The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mVsec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthen D. Anz
Schooly, Correstal I Dirist Liarter