(56 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and standard performance testing of a catheter, with no mention of AI or ML.
Yes
The device is described as being for "intravenous therapy," indicating that it is used for treatment. Therapy is a form of treatment, making the device therapeutic.
No
The text describes the PowerPICC SOLO™ catheter as being used for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. While blood sampling and central venous pressure monitoring can provide data that is used for diagnosis, the device itself is not performing the diagnostic function; it is merely facilitating the collection of information. The primary intended uses are therapeutic (intravenous therapy, contrast media injection).
No
The device description clearly details a physical catheter made of polyurethane with various lumen configurations and physical markings. The performance studies also focus on testing of the physical catheter according to standards for intravascular catheters. There is no mention of software as the primary component or function of the device.
Based on the provided text, 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," "power injection of contrast media," and "central venous pressure monitoring." These are all procedures performed in vivo (within the body) for therapeutic or diagnostic purposes related to the patient's circulatory system.
- Device Description: The description details a catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the body, not for direct access to the circulatory system for therapy or monitoring.
N/A
Intended Use / Indications for Use
Intended Use: The PowerPICC SOLO™ 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 from the predicate PowerPICC® catheters.
Indications for Use: The PowerPICC SOLO™ 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. The indications for use have not changed from the predicate PowerPICC® catheters.
Product codes
LJS
Device Description
The PowerPICC SOLO™ catheter is a clampless proximally valved catheter. The PowerPICC SOLO™ catheters are open-ended radiopaque polyurethane. The PowerPICC SOLO™ catheters are offered in 4 Fr Single Lumen (SL), 5 Fr Single Lumen (SL), 5 Fr Dual Lumen (DL), 6 Fr Dual Lumen (DL), and 6 Fr Triple Lumen (TL) configurations. 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' catheters. Lower portion of luer hub is blue to identify the catheter as PowerPICC SOLO™ catheter. The catheter extension leg, luer hub and junction were printed with markings to identify the catheter as PowerPICC SOLO™ 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)
Performance testing of the PowerPICC SOLO™ catheters were 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 BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General requirements ISO 10555-1:2004, Sterile, single-use intravascular catheters, Part 1. General requirements, Amendment 2 ASTM F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics for Medical Use BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings 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.
The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PowerPICC SOLO™ catheters' substantial equivalence to the cited predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033389, K050931, K051672, K053501, K070996, K051991, K063848, K021704
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
Page 20 of 112
510(k) Summary 21 CFR 807.92(a)
| OCT 5 | 2007
PowerPICC SOLOTM Catheter Family
Prepared August 9, 2007 | | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|
| General
Provisions | 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
(801) 595-5425
Fax: | | |
| | Contact Person: | Lynn M. Kirchoff
Regulatory Affairs Specialist | | |
| | Device Trade Name:
Device Generic Name: | PowerPICC SOLO™ Catheter
Peripherally Inserted Central Catheter (PICC) | | |
| | Trade Name:
Common/Usual Name: Peripherally Inserted Central Catheter (PICC)
Classification Name:
CFR Reference:
Classification Panel:
Premarket Notification: See below | PowerPICC® Catheter
21 CFR §880.5970, Class II
General Hospital | 80 LJS- Long Term Intravascular Catheter | |
| | Predicate Device Name | 510(k) | Concurrence Date | |
| | 5 Fr Single Lumen (SL)
PowerPICC® catheter | K033389 | March 14, 2004 | |
| Predicate
Devices | 6 Fr Dual Lumen (DL)
PowerPICC® catheter | K050931 | June 15, 2005 | |
| | 5 Fr Dual Lumen (DL)
PowerPICC® catheter | K051672 | November 23, 2005 | |
| | 6 Fr Triple Lumen (TL)
PowerPICC® catheter | K053501 | January 13, 2006 | |
| | 4 Fr Single Lumen (SL)
PowerPICC® catheter | K070996 | May 8, 2007 | |
| | PowerPICC®, Poly Per-Q-Cath,
6 Fr TL Poly Per-Q-Cath,
PowerHohn and PowerLines | K051991 | October 20, 2005 | |
| | Trade Name:
Common/Usual Name: Peripherally Inserted Central Catheter (PICC)
Classification Name:
CFR Reference:
Classification Panel:
Premarket Notification: See below | PowerGroshong™ PICC Catheter
21 CFR §880.5970, Class II
General Hospital | 80 LJS- Long Term Intravascular Catheter | |
| | Predicate Device Name | 510(k) | Concurrence Date | |
| | 5 Fr SL PowerGroshong™
PICC Catheter | K063848 | April 4, 2007 | |
1
Page 21 of 112
| Predicate
Devices
Continued | Trade Name: Vaxcel® PICC with PASV® Valve Technology
Common/Usual Name: Peripherally Inserted Central Catheter (PICC)
Classification Name: 80 LJS-Long Term Intravascular Catheter
CFR Reference: 21 CFR §880.5970, Class II
Classification Panel: General Hospital
Premarket Notification: See below | K072230
Pg2 | | | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--|--|--|--|--|--|
| | Predicate Device Name 510(k) Concurrence Date Vaxcel® PICC with PASV®
Valve Technology K021704 June 6, 2002 | | | | | | | |
| Classification | 21 CFR 880.5970, Class II, 80LJS - Long Term Intravascular Catheter | | | | | | | |
| Performance
Standards | Performance standards have not been established by FDA under section 514
of the Federal Food, Drug and Cosmetic Act. | | | | | | | |
| Intended Use | The PowerPICC SOLO™ 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 from the predicate PowerPICC® catheters. | | | | | | | |
| Indications for
Use | The PowerPICC SOLO™ 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.
The indications for use have not changed from the predicate PowerPICC®
catheters. | | | | | | | |
| Device
Description | The PowerPICC SOLO™ catheter is a clampless proximally valved catheter. The PowerPICC SOLO™ catheters are open-ended radiopaque polyurethane. The PowerPICC SOLO™ catheters are offered in 4 Fr Single Lumen (SL), 5 Fr Single Lumen (SL), 5 Fr Dual Lumen (DL), 6 Fr Dual Lumen (DL), and 6 Fr Triple Lumen (TL) configurations. 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 | | | | | | | |
2
Bard Access Systems
PowerPICC SOLO™ Catheter
Special 510(k) Premarket Notification
Section 5 – 510(k) Summary
Page 22 of 112
K072230
Pg3
| Device
Description
Continued | Bard's power injectable catheters from other manufacturers' catheters.
Lower portion of luer hub is blue to identify the catheter as PowerPICC
SOLO™ catheter.
The catheter extension leg, luer hub and junction were printed with
markings to identify the catheter as PowerPICC SOLO™ and to
include information to facilitate proper use of the device. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | Technological similarities between the subject PowerPICC SOLO™ catheters
and the predicate devices remain identical. There are no new questions raised
regarding safety or efficacy of the PowerPICC SOLO™ catheters. |
| 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 have
been met. |
| | Performance testing of the PowerPICC SOLO™ catheters were 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 BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular
catheters, Part 1. General requirements ISO 10555-1:2004, Sterile, single-use intravascular catheters, Part
- General requirements, Amendment 2 ASTM F640-79 (reapproved 2000), Standard Test Methods for
Radiopacity of Plastics for Medical Use BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular
catheters, Part 3. Central venous catheters ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper for
syringes, needles and certain other medical equipment - Part 2:
Lock Fittings 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. |
| | The results of these tests, in conjunction with the substantial equivalence
claims as outlined in the premarket notification, effectively demonstrate the
PowerPICC SOLO™ catheters' substantial equivalence to the cited predicate
devices. |
3
Bard Access Systems PowerPICC SOLO™ Catheter
Special 510(k) Premarket Notification Section 5 - 510(k) Summary
Page 23 of 112
K072230
Pg4
Summary of Substantial Equivalence
Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerPICC SOLO™ catheters met 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.
4
Image /page/4/Picture/2 description: The image shows the seal for the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
NOV 18 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynn M. Kirchoff Regulatory Affairs Specialist C.R. Bard, Incorporated Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116
Re: K072230 Trade/Device Name: PowerPICC SOLO™ Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 6, 2007 Received: September 7, 2007
Dear Ms. Kirchoff:
This letter corrects our substantially equivalent letter of October 5, 2007. 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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 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.
5
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.
In addition, we have determined that your device kit contains chloraprep applicator, alcohol wipes, and lidocaine 1% which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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, please contact the Office of Compliance at (240) 276-0141. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
6
Bard Access Systems PowerPICC SOLO™ Catheter Special 510(k) Premarket Notification Section 4 - Indications for Use Statement
Page 18 of 112
510(k) Number (if known):
Device Name:
长072230 PowerPICC SOLO™ Catheter Familv
Indications for Use:
The PowerPICC SOLO™ 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 V (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)
Signature
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: