(153 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and equivalence to a predicate device, with no mention of AI or ML.
No.
The device is a catheter used for intravenous therapy, blood sampling, and power injection of contrast media, which are diagnostic and therapeutic delivery functions, not therapeutic actions themselves.
No
This device is a catheter for intravenous therapy and blood sampling, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly describes a physical catheter made of polyurethane, with specific dimensions, markings, and colorants. It is a hardware device for accessing the central venous system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "peripheral access to the central venous system for intravenous therapy and blood sampling" and "power injection of contrast media." These are procedures performed on the patient, not on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a catheter, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to test samples from the body to provide diagnostic information. This device is used to access the central venous system for therapeutic and diagnostic procedures performed directly on the patient.
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 Power PICC 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 Power PICC catheter may not exceed 300 psi.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
- The PowerPICC " Catheters are open-ended radiopaque polyurethane catheters. .
- . Catheter size is 5 Fr DI, with 55 cm usable length.
- . 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 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 the PowerPICC from other PICC catheters.
- The catheter extension leg, junction and clamp ID tag 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing was performed according to protocols based on FDA guidance document recommendations and standards, as well as in-house protocols. Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
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
NOV 2 3 2005
Section 6
510(k) Summary
5 Fr DL 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: | November 18, 2005 |
6.2 Device Name
| Device Name: | 5 Fr DL PowerPICC® Catheter |
|---|---|
| Trade Name: | 5 Fr DL 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 DL PowerPICC ® Catheter |
|---|---|
| Trade Name: | 6 Fr DL PowerPICC® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K050931, concurrence date-June 15, 2005 |
6.4 Device Description
- The PowerPICC " Catheters are open-ended radiopaque polyurethane catheters. .
- . Catheter size is 5 Fr DI, with 55 cm usable length.
- . 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 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 the PowerPICC from other PICC catheters.
Image /page/0/Picture/19 description: The image shows the number '000007' with a small '4' superscripted to the left of the first zero. The numbers are printed in a bold, slightly distressed font, giving them a textured appearance. The digits are closely spaced, and the overall impression is that of a numerical code or identifier.
1
- The catheter extension leg, junction and clamp ID tag were printed with markings to identify . the catheter as PowerPICC and to include information to facilitate proper use of the device.
Intended Use ર્ણને રાજ્યના સાથે સાથે છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલ
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 6 Fr DL PowerPICC catheter (K050931).
The Power PICC 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 Power PICC catheter may not exceed 300 psi.
Summary of Technological Characteristics in Relation to the Predicate Device 6.7
Does the new device have the same technological characteristics, e.g. design, material, etc.?
Not in all regards. The 5 Fr DL PowerPICC® catheter has some minor differences from the predicate 6 Fr DL PowerPICC® catheter. 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. There are no new types of issues of safety and effectiveness.
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)] Submission for Short-Term and Long-Term . Intravascular Catheters, March 16, 1995
- . ISO 10555-1:1997. Sterile, Single-Use Intravascular Catheters, General requirements
- 180 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, . Amendment I
- . ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
- AAMFANSI ISO 11135 1994 Medical Devices -- Falidation and Routine Control of Ethylene ◆ Oxide Steriliation
No new design validation was required. The design validation for the predicate device covered all issues pertaining to the subject device
Image /page/1/Picture/23 description: The image shows a sequence of numbers. The numbers are 000008. The numbers are black and the background is white. The numbers are slightly blurred.
2
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 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
Conclusion 6.8
The 5 Fr DL PowerPICC® catheter meets all the predetermined performance acceptance criteria of the testing performed and, based on FDA's decision tree, is substantially equivalent to the predicate device the 6 Fr DL PowerPICC catheter, K050931, concurrence date, June 15, 2005.
Image /page/2/Picture/8 description: The image shows the number 6 above the number 000009. The numbers are in a bold, sans-serif font. The number 6 is smaller than the number 000009. The number 000009 is centered below the number 6.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2005
Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K051672
Trade/Device Name: 5 Fr DL PowerPICC® Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 18, 2005 Received: November 21, 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 modifine and regulations and regulations administered by other Federal agencies. of the Act of any I outsal the Act's requirements, including, but not limited to: registration 1 ou intext compry will and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as betrenic 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) I rins reter notification. The FDA finding of substantial equivalence of your device to a promativer now! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you don't 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 maj overnit of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snute H. Michie Davis
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
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Section 1.2
Indications for Use Statement
510(k) Number (if known):
Device Name: 5 Fr DL 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)
Ching Veno
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എ Anesthesiology, General Hospital, lion Control, Dental Devices
Number: K451672
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