(62 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a catheter for intravenous therapy, blood sampling, and power injection of contrast media, which are diagnostic and delivery functions, not therapeutic.
No
The device is a PowerPICC™ Catheter, which is indicated for intravenous therapy, power injection of contrast media, and blood sampling. These are therapeutic and sample collection functions, not diagnostic ones.
No
The device description clearly outlines a physical catheter made of polyurethane with specific dimensions and features, indicating it is a hardware medical device.
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's body, not on samples from the patient's body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a medical device used for therapeutic and procedural purposes within the body.
N/A
Intended Use / 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 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
Product codes
LJS
Device Description
- The PowerPICC™ Catheters are open-ended radiopaque polyurethane catheters. .
- Catheter size is 6 Fr DL with 50 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 basic radiology 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 accordance with inhouse protocols. Performance data gathered in design verification testing demonstrated that the 6 Fr DL PowerPICC™ catheter is substantially equivalent to the predicate 5 Fr SL 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)
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.”
0
6 Fr DL PowerPICC™ Special 510(k)
Section 6
JUN 1 5 2005
510(k) Summary
6 Fr DL PowerPICC™ Catheter
510(k) Summary of Safety and Effectiveness Information 21CFR 807.92
Submitter Information 6. I
| 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. 4903 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Peggy Keiffer |
| Date of Preparation: | April 13, 2005 |
Device Name 6.2
| Device Name: | 6 Fr DL PowerPICC™ Catheter |
|---|---|
| Trade Name: | 6 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) |
Predicate Device Name(s) 6.3
| Device Name: | 5 Fr SL PowerPICC™ Catheter |
|---|---|
| Trade Name: | 5 Fr SL PowerPICC™ Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K033389, concurrence date - March 19, 2004 |
| Device Name: | Poly Per-Q-Cath PICC Catheter |
| Trade Name: | Poly Per-Q-Cath PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K034019, concurrence date - January 21, 2004 |
Device Description 6.4
- The PowerPICC™ Catheters are open-ended radiopaque polyurethane catheters. .
- Catheter size is 6 Fr DL with 50 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 basic radiology PICC configurations. .
1
6 Fr DL PowerPICC TM Special 510(k)
- 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.
Intended Use 6.5
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.
Indications for Use 6.6
The indications for use have not changed from the predicate 5 Fr SL PowerPICC™ catheter (K033389).
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 samoling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerPICC 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 6 Fr DL PowerPICC™ catheter has some minor differences from the predicate 5 Fr SL 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 ●
- 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
Image /page/1/Picture/24 description: The image shows the number 000037 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.
2
6 Fr DL PowerPICC™ Special 510(k)
No new design validation was required. The design validation for the predicate device covered all issues pertaining to the subject device
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 DL PowerPICC™ catheter is substantially equivalent to the predicate 5 Fr SL PowerPICC™ catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
6.8 Conclusion
The 6 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 5 Fr SL PowerPICC™ catheter, K033389, cleared March, 2004 and the Poly Per-Q-Cath PICC Catheters, cleared under K034019.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2005
Ms. Peggy Keiffer Senior Regulatory Affairs Manager Bard Access System, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K050931
Trade/Device Name: 6 Fr DL PowerPICCTM Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 28, 2005 Received: May 17, 2005
Dear Ms. Keiffer:
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.
4
Page 2 - Ms. Keiffer
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sustie y. Mchale Dus.
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
K 050431
6 Fr DL PowerPICC™M Special 510(k)
Section 1.2
Indications for Use Statement
510(k) Number (if known):
Device Name: 6 Fr DL PowerPICCTN 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 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Chr. V. Amm
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: k45993i