(56 days)
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 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 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.
This document describes the premarket notification (510(k)) for the PowerPICC SOLO™ Catheter, specifically addressing its substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on regulatory compliance, device description, and safety testing rather than a clinical study evaluating specific performance metrics against acceptance criteria that are typically found in AI/ML-based device submissions.
Therefore, many of the requested sections (e.g., acceptance criteria, test set details, expert ground truth, MRMC study, training set details) are not directly applicable or available from the provided text for this non-AI/ML device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This section is largely Not Applicable in the way it's typically understood for AI/ML device performance. For this medical device (a catheter), "acceptance criteria" and "performance" are framed in terms of meeting established industry standards and demonstrating substantial equivalence to predicate devices, rather than achieving specific numerical targets on a test set.
| Criteria Category | Acceptance Criteria (Not explicit as numerical targets, but compliance with standards) | Reported Device Performance and Study Type |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1: Evaluation and Testing and FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices. | Met. Biocompatibility requirements have been met. (Study type: Laboratory testing against ISO 10993 standards). |
| Catheter Performance | Compliance with various FDA guidance documents and international standards including: - FDA 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 - 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 | Met. Performance testing was conducted in accordance with the listed documents and standards, yielding "acceptable safety & performance outcomes." (Study type: Laboratory testing against numerous specific standards). |
| Substantial Equivalence | Demonstration of substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to current commercially available/cited predicate devices. | Achieved. The device "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." (Study type: Comparison to predicate devices and documentation of compliance with standards). |
2. Sample size used for the test set and data provenance
Not Applicable (N/A) for this type of device submission. The provided text details engineering and biocompatibility testing against established standards and predicate devices, not a test set of data (e.g., medical images for an AI algorithm). The provenance of data refers to the source of materials or components used in the device, rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). This concept is for AI/ML models that rely on expert annotations for ground truth. This is a physical medical device.
4. Adjudication method for the test set
Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable (N/A). This is not an AI-assisted device, and thus, no MRMC study involving human readers with/without AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). This is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable (N/A) in the context of clinical "ground truth" for diagnostic or prognostic endpoints. The "ground truth" for this device's performance is its adherence to established international and FDA medical device performance standards and its physical and material properties, as demonstrated through laboratory testing.
8. The sample size for the training set
Not Applicable (N/A). This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant.
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Page 20 of 112
510(k) Summary 21 CFR 807.92(a)
| OCT 5 | 2007PowerPICC SOLOTM Catheter FamilyPrepared August 9, 2007 | |||
|---|---|---|---|---|
| GeneralProvisions | Submitter of 510(k)Premarket Notification: | Bard Access Systems, Inc. (BAS)[Subsidiary of C.R. Bard, Inc.]Salt Lake City, Utah 84116Phone: (801) 595-0700, Ext. 7136(801) 595-5425Fax: | ||
| Contact Person: | Lynn M. KirchoffRegulatory Affairs Specialist | |||
| Device Trade Name:Device Generic Name: | PowerPICC SOLO™ CatheterPeripherally 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® Catheter21 CFR §880.5970, Class IIGeneral 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 | ||
| PredicateDevices | 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 Catheter21 CFR §880.5970, Class IIGeneral Hospital | 80 LJS- Long Term Intravascular Catheter | ||
| Predicate Device Name | 510(k) | Concurrence Date | ||
| 5 Fr SL PowerGroshong™PICC Catheter | K063848 | April 4, 2007 |
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Page 21 of 112
| PredicateDevicesContinued | Trade Name: Vaxcel® PICC with PASV® Valve TechnologyCommon/Usual Name: Peripherally Inserted Central Catheter (PICC)Classification Name: 80 LJS-Long Term Intravascular CatheterCFR Reference: 21 CFR §880.5970, Class IIClassification Panel: General HospitalPremarket Notification: See below | K072230Pg2 | ||||||
|---|---|---|---|---|---|---|---|---|
| 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 | |||||||
| PerformanceStandards | Performance standards have not been established by FDA under section 514of the Federal Food, Drug and Cosmetic Act. | |||||||
| Intended Use | The PowerPICC SOLO™ catheters are intended for short or long termperipheral access to the central venous system for intravenous therapy andblood sampling.The intended use has not changed from the predicate PowerPICC® catheters. | |||||||
| Indications forUse | The PowerPICC SOLO™ catheter is indicated for short or long term peripheralaccess to the central venous system for intravenous therapy, power injection ofcontrast media and allows for central venous pressure monitoring. For bloodsampling, infusion or therapy, use a 4 French or larger catheter. The maximumrecommended infusion rate is 5ml/sec. For central venous pressuremonitoring, it is recommended that catheter lumen of 20 gauge or larger beused.The indications for use have not changed from the predicate PowerPICC®catheters. | |||||||
| DeviceDescription | 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 |
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Bard Access Systems
PowerPICC SOLO™ Catheter
Special 510(k) Premarket Notification
Section 5 – 510(k) Summary
Page 22 of 112
K072230
Pg3
| DeviceDescriptionContinued | Bard's power injectable catheters from other manufacturers' catheters.Lower portion of luer hub is blue to identify the catheter as PowerPICCSOLO™ catheter.The catheter extension leg, luer hub and junction were printed withmarkings to identify the catheter as PowerPICC SOLO™ and toinclude information to facilitate proper use of the device. |
|---|---|
| TechnologicalCharacteristics | Technological similarities between the subject PowerPICC SOLO™ cathetersand the predicate devices remain identical. There are no new questions raisedregarding safety or efficacy of the PowerPICC SOLO™ catheters. |
| Safety andPerformanceTests | Biocompatibility requirements of ISO 10993 Biological Evaluation of MedicalDevices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 TestProfile for externally communicating, blood contacting, long-term devices havebeen met. |
| Performance testing of the PowerPICC SOLO™ catheters were conducted inaccordance with the following FDA guidance documents and internationalstandards: | |
| 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 intravascularcatheters, Part 1. General requirements ISO 10555-1:2004, Sterile, single-use intravascular catheters, Part1. General requirements, Amendment 2 ASTM F640-79 (reapproved 2000), Standard Test Methods forRadiopacity of Plastics for Medical Use BS/EN/ISO 10555-3:1997, Sterile, single-use intravascularcatheters, Part 3. Central venous catheters ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medical equipment - Part 2:Lock Fittings AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation andRoutine Control of Ethylene Oxide Sterilization AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing, and the FDA Modified ISO10993 Test Profile IEC 60601-2-34: 2000-10, Medical electrical equipment -Particular requirements for the safety, including essentialperformance, of invasive blood pressure monitoring equipment AAMI TIR9: 1992, Evaluation of Clinical Systems for InvasiveBlood Pressure Monitoring ANSI/AAMI BP22: 1994, Blood Pressure Transducers | |
| Subject product testing has yielded acceptable safety & performanceoutcomes. | |
| The results of these tests, in conjunction with the substantial equivalenceclaims as outlined in the premarket notification, effectively demonstrate thePowerPICC SOLO™ catheters' substantial equivalence to the cited predicatedevices. |
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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.
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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.
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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.
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
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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:
§ 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.”