(44 days)
Not Found
No
The description focuses on the physical characteristics and intended uses of a catheter, with no mention of AI or ML capabilities.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is a catheter used for administration of fluids, blood products, and withdrawal of blood; it is not directly treating a disease, but rather providing access for other treatments or diagnostics.
No
The device is a catheter designed for administering fluids, blood products, and drugs, as well as blood withdrawal, and central venous pressure monitoring, not for diagnosing conditions.
No
The device description clearly details physical components like catheters, lumens, tubing, hubs, and cuffs, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the central venous system for administering fluids, drugs, and for blood withdrawal and monitoring. These are all in vivo procedures, meaning they are performed within the living body.
- Device Description: The description details a catheter, which is a device inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically reagents, instruments, or systems intended for use in the examination of specimens from the human body. This device is a medical device used for direct access and administration within the body.
N/A
Intended Use / Indications for Use
Intended Use: PowerLine™ catheters are indicated for short or long term access to the central venous system for intravenous therapy and blood sampling.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
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.
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 activities were designed and performed to demonstrate that the subject PowerLine™ catheters met predetermined performance specifications. Tests were performed on sterilized, finished devices. The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating 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 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.
Results: 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. Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2007, Medical Devices - Risk Management for Medical Devices. No new types of safety or efficacy questions were identified for the subject PowerLine™ catheters.
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.
K050185, K051417, K051991, K051672, K053501
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
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
| 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) 522-5696
Fax: (801) 522-5425 | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--|
| | Contact Person: | Sarabjyot Mankoo
Regulatory Affairs Specialist | | |
| | Device Trade Name:
Device Generic Name: | 5 F DL & 6 F TL PowerLine™
Central Venous Catheter (CVC) | | |
| Predicate
Device | 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 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 | | | |
なる。
ﺮ ﺩ
1
| Intended Use | PowerLine™ catheters are indicated for short or long term access to the
central venous system for intravenous therapy and blood sampling. |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. |
| Device
Description | 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. |
| Technological
Characteristics | Technological similarities between the subject PowerLine™ catheters and
the predicate device remain identical. There are no new questions raised
regarding safety or efficacy of the subject PowerLine™ catheters. |
| Verification &
Validation
Activities | Verification and validation activities were designed and performed to
demonstrate that the subject PowerLine™ catheters met predetermined
performance specifications. Tests were performed on sterilized, finished
devices. The following guidance documents and standards in conjunction with
in-house protocols were used to determine appropriate methods for
evaluating 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 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 |
| | 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. |
| | Risk management, including a failure modes and effects analysis (FMEA), of
the subject device was conducted in accordance with ISO 14971:2007,
Medical Devices - Risk Management for Medical Devices . No new types of
safety or efficacy questions were identified for the subject PowerLine™
catheters. |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and safety and
performance testing, the subject PowerLine™ catheters met the minimum
requirements for its intended use/indications for use, and is substantially
equivalent in design, materials, sterilization, principles of operation and
indications for use to current commercially available catheters/cited
predicates. |
.
2
·
3
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.
4
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
5
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