(44 days)
The PowerLine™ catheter is indicated for short or long term access to the central venous system. PowerLine™ catheters are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal. In addition, PowerLine™ catheters allow for power injection of contrast media and central venous pressure monitoring. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
The PowerLine™ catheters are open-ended polyurethane catheters with a reverse taper design. Catheters are available in 5 F Dual-Lumen and the 6 F Triple-Lumen configurations. The usable length of the catheter is 50 cm. Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point. The catheters have a tissue ingrowth cuff bonded to the catheter shaft. Purple colorants added to the catheter extension legs and shaft aid in distinguishing the catheter as power-injectable. The molded hub is labeled to identify the catheter as PowerLine™. The catheter extension leg and clamp are labeled with information to facilitate proper use of the device. The PowerLine™ catheters are provided in sterile tray configurations.
The provided text is a 510(k) Pre-market Notification for the Bard Access Systems PowerLine Central Venous Catheters. It describes the device, its intended use, and substantial equivalence to predicate devices, along with verification and validation activities. However, it does not contain information related to software or AI device performance, ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.
Therefore, I cannot fulfill most of your request directly from the provided text.
Based on the information available:
1. A table of acceptance criteria and the reported device performance:
The document states: "The subject PowerLine™ catheters met all predetermined acceptance criteria derived from the above mentioned references. Design validation was conducted on the subject PowerLine™ configuration and yielded acceptable results."
The "above mentioned references" refer to:
- 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, Part 1. General requirements, Amendment 2
- BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
- AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- AAMI/ANSI/ISO 10993-7:1995, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results
Actual specific acceptance criteria and detailed quantitative performance results are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given text. The document mentions "Tests were performed on sterilized, finished devices," but does not specify the number of devices tested or any data provenance details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as the document describes a physical medical device (catheter) and its performance based on engineering and biocompatibility standards, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for a physical medical device performance study as described here.
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:
This information is not applicable as the document is about a physical medical device (catheter), not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this physical device's performance would be established by physical measurements, material science testing, biocompatibility assays, and sterilization effectiveness indicators, all against established industry standards (ISO, AAMI/ANSI). It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set:
This information is not applicable as this is not an AI device.
9. How the ground truth for the training set was established:
This information is not applicable as this is not an AI device.
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Bard Access Systems
PowerLine Central Venous Catheters
Special 510(k) Premarket Notification
K093927
Section 5 – 510(k) Summary
Page 2 of 5
Section 5
510(k) Summary 21 CFR 807.92(a)
FEB - 4 2010
PowerLine™ Central Venous Catheters
| GeneralProvisions | Submitter of 510(k)Premarket Notification: | Bard Access Systems, Inc. (BAS)[Subsidiary of C.R. Bard, Inc.]Salt Lake City, Utah 84116Phone: (801) 522-5696Fax: (801) 522-5425 | ||
|---|---|---|---|---|
| Contact Person: | Sarabjyot MankooRegulatory Affairs Specialist | |||
| Device Trade Name:Device Generic Name: | 5 F DL & 6 F TL PowerLine™Central Venous Catheter (CVC) | |||
| PredicateDevice | Primary Predicate: | |||
| Trade Name: | PowerLine™ | |||
| Common/Usual Name: | Central Venous Catheter | |||
| Classification Name: | 80LJS - Long term Intravascular Catheter | |||
| CFR Reference: | 21 CFR §880.5970- Class II | |||
| Classification Panel: | General Hospital | |||
| Premarket Notification: | See table below | |||
| Secondary Predicate: | ||||
| Trade Name: | PowerPICC™ | |||
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) | |||
| Classification Name: | 80LJS – Long term Intravascular Catheter | |||
| CFR Reference: | 21 CFR §880.5970– Class II | |||
| Classification Panel: | General Hospital | |||
| Premarket Notification: | See table below | |||
| Predicate Device Name | 510(k) | Concurrence Date | ||
| 5 F Single Lumen (SL) PowerLine™ | K050185 | May 26, 2005 | ||
| 6 F Dual Lumen (DL) PowerLine™ | K051417 | June 30, 2005 | ||
| CVP Monitoring - PICC & CVC | K051991 | October 20, 2005 | ||
| 5F Dual Lumen (DL) PowerPICC™ | K051672 | November 23, 2005 | ||
| 6F Triple Lumen (TL) PowerPICC™ | K053501 | January 13, 2006 | ||
| Classification | 21 CFR §880.5970- Class II80LJS – Long term Intravascular Catheter | |||
| PerformanceStandards | Performance standards have not been established by FDA under section 514of the Federal Food, Drug and Cosmetic Act |
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| Intended Use | PowerLine™ catheters are indicated for short or long term access to thecentral venous system for intravenous therapy and blood sampling. |
|---|---|
| Indications forUse | The PowerLine™ catheter is indicated for short or long term access to thecentral venous system. PowerLine™ catheters are designed for theadministration of I.V. fluids, blood products, drugs, parenteral nutritionsolutions, as well as blood withdrawal. In addition, PowerLine™ cathetersallow for power injection of contrast media and central venous pressuremonitoring. The maximum recommended infusion rate is 5ml/sec. Forcentral venous pressure monitoring, it is recommended that a catheter lumenof 20 gauge or larger be used. |
| DeviceDescription | The PowerLine™ catheters are open-ended polyurethane catheters with areverse taper design. Catheters are available in 5 F Dual-Lumen and the 6 FTriple-Lumen configurations. The usable length of the catheter is 50 cm.Catheter shaft tubing is marked with depth indicators, with "0" indicated toserve as a reference for the catheter insertion point. The catheters have atissue ingrowth cuff bonded to the catheter shaft. Purple colorants added tothe catheter extension legs and shaft aid in distinguishing the catheter aspower-injectable. The molded hub is labeled to identify the catheter asPowerLine™. The catheter extension leg and clamp are labeled withinformation to facilitate proper use of the device. The PowerLine™ cathetersare provided in sterile tray configurations. |
| TechnologicalCharacteristics | Technological similarities between the subject PowerLine™ catheters andthe predicate device remain identical. There are no new questions raisedregarding safety or efficacy of the subject PowerLine™ catheters. |
| Verification &ValidationActivities | Verification and validation activities were designed and performed todemonstrate that the subject PowerLine™ catheters met predeterminedperformance specifications. Tests were performed on sterilized, finisheddevices. The following guidance documents and standards in conjunction within-house protocols were used to determine appropriate methods forevaluating the performance of the device: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, Part 1.General requirements, Amendment 2 BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters,Part 3. Central venous catheters AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing, and the FDA Modified ISO10993 Test Profile AAMI/ANSI/ISO 10993-7:1995, Biological Evaluation of MedicalDevices Part 7: Ethylene Oxide Sterilization Results |
| The subject PowerLine™ catheters met all predetermined acceptance criteriaderived from the above mentioned references. Design validation wasconducted on the subject PowerLine™ configuration and yielded acceptableresults. | |
| Risk management, including a failure modes and effects analysis (FMEA), ofthe subject device was conducted in accordance with ISO 14971:2007,Medical Devices - Risk Management for Medical Devices . No new types ofsafety or efficacy questions were identified for the subject PowerLine™catheters. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject PowerLine™ catheters met the minimumrequirements for its intended use/indications for use, and is substantiallyequivalent in design, materials, sterilization, principles of operation andindications for use to current commercially available catheters/citedpredicates. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Sarabjyott Mankoo Regulatory Affairs Specialist C. R. Bard, Incorporated Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116
FEB - 4 2010
Re: K093927
Trade/Device Name: PowerLine™ Central Venous Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II
Product Code: LJS Dated: December 17, 2010 Received: January 5, 2010
Dear Mr. Mankoo:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 - Mr. Mankoo
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Bard Access Systems PowerLine Central Venous Catheters Special 510(k) Premarket Notification Section 4 - Indications for Use Statement
Page 14 of 92
510(k) Number (if known):
Device Name:
PowerLine™ Central Venous Catheters
Indications for Use:
The PowerLine™ catheter is indicated for short or long term access to the central venous system. PowerLine™ catheters are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal. In addition, PowerLine "" catheters allow for power iniection of contrast media and central venous pressure monitoring. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that a 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093227
§ 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.”