(29 days)
Not Found
No
The summary describes a physical medical device (catheter) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a catheter used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, all of which are therapeutic or diagnostic procedures.
No
Explanation: The provided text describes the PowerPICC® Catheters as devices for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring, which are all therapeutic or monitoring functions, not diagnostic.
No
The device description clearly details a physical catheter made of polyurethane with specific dimensions and features, indicating it is a hardware medical device. The performance studies also focus on testing related to physical catheter properties and sterilization.
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." This describes a device used in vivo (within the body) for direct patient treatment and sample collection.
- Device Description: The description details a catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits used on biological samples.
Therefore, the PowerPICC® Catheter is a medical device used for direct patient care, not an in vitro diagnostic device.
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, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The 4 Fr SL PowerPICC® Catheters are open-ended radiopaque polyurethane. 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 and full PICC configurations with legally marketed kit components. 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 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)
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. Performance testing of the 4 Fr SL PowerPICC® catheter was conducted in accordance with the following FDA guidance documents and international standards: 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 1; 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; AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile; IEC 60601-2-34: 2000-10, Medical electrical equipment Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment; AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring; ANSI/AAMI BP22: 1994, Blood Pressure Transducers. Subject product testing has yielded acceptable safety & performance outcomes. In addition, EO sterilization adoption tests also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the 4 Fr SL PowerPICC® catheters' substantial equivalence to the cited 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
4 Fr SL PowerPICC®
Special 510(k)
Section 6
510(k) Summary
4 Fr Single Lumen (SL) PowerPICC® Catheter
MAY - 8 2007
Summary of Safety & Effectiveness Prepared April 23, 2007
| | Submitter of 510(k)
Premarket Notification: | Bard Access Systems, Inc. (BAS)
[Subsidiary of C.R. Bard, Inc.]
Salt Lake City, Utah 84116
Phone: (801) 595-0700, Ext. 7136
Fax: (801) 595-5425 |
|-----------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Provisions | Contact Person: | Lynn M. Kirchoff
Regulatory Affairs Specialist |
| | Device Trade Name: | 4 Fr SL PowerPICC® Catheter |
| | Device Generic Name: | Peripherally Inserted Central Catheter (PICC) |
| | The predicate devices are listed below. | |
| Predicate
Devices | Device Name:
Trade Name:
Common/Usual Name:
Classification Name:
Premarket Notification: | 6 Fr TL PowerPICC® Catheter
PowerPICC® Catheter
Peripherally Inserted Central Catheter (PICC)
Long Term Intravascular Catheter (80 LJS)
K053501, concurrence date-January 13, 2006 |
| | Device Name:
Trade Name: | 5 Fr SL PowerPICC® Catheter
PowerPICC® Catheter |
PowerPICC® Catheter Common/Usual Name: Peripherally Inserted Central Catheter (PICC) Long Term Intravascular Catheter (80 LJS) Premarket Notification: K033389, concurrence date March 14, 2004 K051991, concurrence date October 20, 2005
Classification 21 CFR 880.5970, Class II, 80LJS - Long Term Intravascular Catheter Performance Performance standards have not been established by FDA under section 514 of the Standards Federal Food, Drug and Cosmetic Act. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Classification Name:
000003
1
10000000 2005 4 Fr SL PowerPICC®
Special 510(k)
| 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. | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for
Use | The PowerPICC® catheter is indicated for short or long term peripheral access to the
central venous system for intravenous therapy, power injection of contrast media and
allows for central venous pressure monitoring. For blood sampling, infusion or therapy,
use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec.
For central venous pressure monitoring, it is recommended that catheter lumen of 20
gauge or larger be used. | |
| Device
Description | The 4 Fr SL PowerPICC® Catheters are open-ended radiopaque polyurethane. 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 and full PICC configurations with
legally marketed kit components. 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 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. | |
| Technological
Characteristics | Technological similarities between the subject 4 Fr SL PowerPICC® catheter and the
predicate devices remain identical. There are no new questions raised regarding safety
or efficacy of the 4 Fr SL PowerPICC®. | |
| Safety and
Performance
Tests | 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.
Performance testing of the 4 Fr SL PowerPICC® catheter was conducted in accordance
with the following FDA guidance documents and international standards: 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 1 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/2 description: The image shows the number 4 in two different formats. The first format is "4]", which is likely a section or item number. The second format is "000004", which is a numerical representation of the number 4 with leading zeros. The number is written in a bold, sans-serif font.
.
2
4 Fr SL PowerPIC Special 510(k)
- AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical . Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- IEC 60601-2-34: 2000-10, Medical electrical equipment Particular . requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
- . AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
- . ANSI/AAMI BP22: 1994, Blood Pressure Transducers
Subject product testing has yielded acceptable safety & performance outcomes.
In addition, EO sterilization adoption tests also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the 4 Fr SL PowerPICC® catheters' substantial equivalence to the cited predicate devices.
Summary of Substantial Equivalence
Safety and
Performance
Tests Continued
Based on the indications for use, technological characteristics, and safety and performance testing, the subject 4 Fr SL PowerPICC® catheter meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is a symbol of medicine and healing. The seal is used to represent the HHS and its mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 8 2007
Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K070996
Trade/Device Name: 4 Fr Single Lumen (SL) PowerPICC® Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 6, 2007 Received: April 9, 2007
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.
4
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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
K570YY6
4 Fr SL PowerPICC®
Special 510(k)
Section 1.2
Indications for Use Statement
5 10(k) Number (if known):
Device Name: 4 Fr Single Lumen (SL) 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, power injection of contrast media and allows for central venous pressure monitoring. 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. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
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)
Aitken V. Vartan
of Anesthesiology, General Hospital, Jon Control, Dental Dovices
Number: K970496
00002