PowerMidline Catheter
Device Facts
| Record ID | K162900 |
|---|---|
| Device Name | PowerMidline Catheter |
| Applicant | C.R. Bard, Inc. |
| Product Code | PND · General Hospital |
| Decision Date | Dec 14, 2016 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PowerMidline™ Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
Device Story
PowerMidline Catheter is a peripherally placed, dual-lumen intravascular catheter; constructed from radiopaque, body-softening polyurethane. Designed with kink-resistant, reverse-taper geometry; offered in 4F and 5F configurations with 20 cm trimmable lengths. Used for short-term (<30 days) vascular access; inserted percutaneously via Modified Seldinger Technique. Enables intravenous therapy, blood sampling, and power injection of contrast media. Operated by clinicians in clinical settings. Output is direct venous access; allows delivery of fluids/medications or withdrawal of blood samples. Benefits include reliable peripheral access for patients requiring short-term therapy.
Clinical Evidence
Bench testing only. No clinical data. Performance testing included shaft tensile, modulus/elongation, assembly burst, assembly leak, assembly tensile, gravity flow, dimensional characterization, cyclic kink, tip displacement, and power injection testing per ISO 10555-1:2013 and internal protocols. Biocompatibility evaluation performed per ISO 10993-1:2009.
Technological Characteristics
Radiopaque body-softening polyurethane construction. Dual-lumen (two 'D' shaped lumens) or single-lumen configuration. 4F and 5F sizes. 20 cm trimmable length. Reverse-taper design. Luer hub connection. Open-ended distal tip. Sterilized via Ethylene Oxide (EO). Complies with ISO 10555-1:2013 for intravascular catheters.
Indications for Use
Indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. May be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. Suitable for use with power injectors.
Regulatory Classification
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Predicate Devices
- PowerMidline™ Catheter (K153393)
Reference Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
C.R. Bard, Inc. % Casey Coombs Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K162900
Trade/Device Name: PowerMidline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: November 17, 2016 Received: November 18, 2016
Dear Mr. Coombs:
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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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K162900
Device Name PowerMidline Catheter
#### Indications for Use (Describe)
The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
21 CFR 807.92(a)
| General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. |
|-----------------------|-------------------------|--------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Mr. Casey Coombs<br>Regulatory Affairs Specialist |
| | Telephone Number: | (801) 522-5869 |
| | Fax Number: | (801) 522-4969 |
| | Date of Preparation: | November 27, 2016 |
| Subject<br>Device | Trade Name: | PowerMidline™ Catheter |
| | Common Name: | Intravascular Catheter |
| | Regulation Name: | Intravascular Catheter |
| | Product Code: | PND |
| | Regulation: | 21 CFR § 880.5200 |
| | Regulatory Class: | Class II |
| | Classification Panel: | General Hospital |
| Predicate<br>Device | Predicate Trade Name: | PowerMidline™ Catheter |
| | Common Name: | Intravascular Catheter |
| | Regulation Name: | Intravascular Catheter |
| | Premarket Notification: | K153393 (cleared June 28, 2016) |
| | Manufacturer: | Bard Access Systems, Inc. |
| | Product Code: | PND |
| | Regulation: | 21 CFR § 880.5200 |
| | Regulatory Class: | Class II |
| | Classification Panel: | General Hospital |
| Reference<br>Device | Reference Trade Name: | PowerPICCT™ SV Catheter |
| | Common Name: | Peripherally Inserted Central Catheter (PICC) |
| | Regulation Name: | Percutaneous, implanted, long-term intravascular<br>catheter |
| | Premarket Notification: | K102159 (cleared November 17, 2010) |
| | Manufacturer: | Bard Access Systems, Inc. |
| | Product Code: | LJS |
| | Regulation: | 21 CFR § 880.5970 |
| | Regulatory Class: | Class II |
| | Classification Panel: | General Hospital |
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| Reference<br>Device | Reference Trade Name: 6 F Triple Lumen PowerPICCT™ Catheter<br>Common Name: Peripherally Inserted Central Catheter (PICC)<br>Regulation Name: Percutaneous, implanted, long-term intravascular<br>catheter<br>Premarket Notification: K053501 (cleared January 13, 2006)<br>Manufacturer: Bard Access Systems, Inc.<br>Product Code: LJS<br>Regulation: 21 CFR § 880.5970<br>Regulatory Class: Class II<br>Classification Panel: General Hospital |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The dual lumen PowerMidline™ catheters are a family of peripherally placed<br>catheters made from radiopaque body-softening polyurethane materials. Each<br>dual lumen PowerMidline™ catheter is designed with kink-resistant, reverse<br>taper design. The dual lumen PowerMidline™ catheters are offered in a 4 F<br>dual lumen (DL) and 5 F dual lumen (DL) configuration for reliable short term<br>(less than 30 days) vascular access. These catheters are offered in 20 cm<br>trimmable lengths. The dual lumen PowerMidline™ catheters are suitable for<br>use with power injectors. |
| Intended Use | The PowerMidline™ Catheter is intended for short term peripheral access for<br>selected intravenous therapies, blood sampling, and power injection of<br>contrast media. |
| Indications For<br>Use | The PowerMidline™ Catheters are indicated for short term access to the<br>peripheral venous system for selected intravenous therapies, blood sampling,<br>and power injection of contrast media. These catheters may be used for any<br>patient population with consideration given to adequacy of vascular anatomy<br>and appropriateness of the procedure. The PowerMidline™ Catheters are<br>suitable for use with power injectors. |
| Technological<br>Characteristics | The technological characteristics of the subject PowerMidline™ Catheters are<br>substantially equivalent with respect to basic design, materials and function to<br>those of the cited predicate device.<br><br>Key modifications made to the subject device when compared to the predicate<br>device are as follows:<br>Modifications made to the number of lumens and extension legs to<br>introduce the dual lumen configurations Dimensional modifications made to introduce a 5 French size dual<br>lumen catheter Modifications made to the catheter junctions to accommodate the dual<br>lumen configurations Material modifications to the extension leg, luer hub, and catheter<br>junction components to introduce the dual lumen configurations Labeling modifications to reflect the dual lumen configurations The following table provides a comparison between the subject and predicate<br>device. |
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| Subject and Predicate Device Comparison Table | | | |
|-----------------------------------------------|--------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Attribute | Subject Device:<br>Dual Lumen<br>PowerMidline™ Catheter | Predicate Device:<br>Single Lumen<br>PowerMidline™ Catheter<br>(K153393) |
| Technological<br>Characteristics | Owner | Same as predicate | Bard Access Systems, Inc. |
| | Classification | Same as predicate | PND - 21 CFR 880.5200 -<br>Short-term - Intravascular<br>Catheter |
| | 510(k) Status | Subject of this Premarket<br>Notification | K153393 - Clearance date<br>June 28, 2016 |
| | Indications<br>for Use | Same as predicate | The PowerMidline™<br>Catheters are indicated for<br>short term access to the<br>peripheral venous system for<br>selected intravenous<br>therapies, blood sampling,<br>and power injection of<br>contrast media. These<br>catheters may be used for<br>any patient population with<br>consideration given to<br>adequacy of vascular<br>anatomy and<br>appropriateness of the<br>procedure. The<br>PowerMidline™ Catheters<br>are suitable for use with<br>power injectors. |
| | Duration of<br>Use | Same as predicate | Short term (<30 days) |
| | Means of<br>Insertion | Same as predicate | Percutaneous, using<br>Modified Seldinger<br>Technique and guidewire |
| | Insertion Site | Same as predicate | Peripheral |
| | Tip<br>Placement<br>Location | Same as predicate | Peripheral venous system,<br>with catheter tip terminating<br>prior to the axilla |
| | Catheter<br>Base<br>Materials | Same as predicate | Shaft Tubing<br>Polyurethane<br>Catheter Junction<br>Polyurethane<br>Extension Leg<br>Polyurethane<br>Luer Hub<br>Polyurethane |
| | | | |
| | | | Extension Leg Clamp<br>Acetal Resin |
| Technological<br>Characteristics | Catheter<br>Proximal<br>Configuration | Same as predicate | Luer Connection |
| | Catheter<br>Distal<br>Configuration | Same as predicate | Open Ended |
| | Catheter<br>Dimensions | 4 F DL x 20 cm usable<br>length | 3 F SL x 20 cm usable<br>length |
| | | 5 F DL x 20 cm usable<br>length | 4 F SL x 20 cm usable<br>length |
| | Number,<br>Shape of<br>Lumens | Dual Lumen, two "D" shaped<br>lumens | Single Lumen, round |
| | Depth<br>Markings | Same as predicate | "0" depth indicator located 1<br>cm from catheter junction on<br>reverse taper shaft tubing;<br>catheter marked every 1 cm,<br>with numeric indicators<br>every 5 cm. |
| | Pre-inserted<br>Stylet<br>Configuration | Same as predicate | Stiffening stylet |
| | Power<br>Injection<br>Maximum<br>Flow Rate | 4 F DL = 4 mL/s | 3 F SL = 3 mL/s |
| | Maximum<br>Flow Rate | 5 F DL = 7 mL/s | 4 F SL = 7 mL/s |
| | Sterility | Same as predicate | Provided Sterile (EO) |
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As part of Bard Access Systems, Inc.'s design controls, a risk analysis was conducted to assess the impact of the proposed device modifications. Based upon the results of the risk analysis, the necessary design control activities were identified to ensure that specified design requirements were met. The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. In addition, when technological characteristics between the subject and predicate device were found to be identical, results of the performance testing conducted on the predicate device were applied to the subject device. As required by the risk analysis, the following table identifies the performance tests completed on the subject device based upon the specific modifications made to develop the subject device. The table includes a description of testing completed and the standard(s) utilized with each test.
| Testing Completed | ISO Standard / FDA Guidance /<br>BAS Protocols Utilized | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Test and Report Priming Volume | Guidance on Premarket Notification<br>[510(k)] Submission for Short-Term<br>and Long-Term Intravascular<br>Catheters, March 16, 1995 | |
| | BAS Internal Protocols/Procedures | |
| Performance<br>Tests | Shaft Tensile | ISO 10555-1: 2013, Sterile, single-<br>use intravascular catheters, Part 1:<br>General requirements |
| | Test and Report Modulus and<br>Elongation Requirements | Guidance on Premarket Notification<br>[510(k)] Submission for Short-Term<br>and Long-Term Intravascular<br>Catheters, March 16, 1995 |
| | Assembly Burst (Burst Pressure<br>with Power Injection) | |
| | Catheter Assembly Leak | |
| | Catheter Assembly Tensile | ISO 10555-1: 2013, Sterile, single-<br>use intravascular catheters, Part 1:<br>General requirements |
| | Test and Report Gravity Flow | |
| | Device Dimensional<br>Characterization | |
| | Catheter Cyclic Kink | |
| | Tip Displacement During Power<br>Injection | BAS Internal Protocols/Procedures |
| | Power Injection Testing | ISO 10555-1: 2013, Sterile, single-<br>use intravascular catheters, Part 1:<br>General requirements |
| | | BAS Internal Protocols/Procedures |
| | Per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk Management Process, a biocompatibility<br>evaluation was performed based upon the modifications made to develop the<br>subject device. | |
| | Per design control requirements as specified in 21 CFR 820.30, the subject<br>device met all predetermined acceptance criteria derived from the above listed<br>tests and demonstrated substantial equivalence as compared to the cited<br>predicate device. | |
| | Risk management, including a failure modes and effects analysis (FMEA), of<br>the subject device was conducted in accordance with BS EN ISO 14971:2012,<br>Medical Devices – Application of Risk Management to Medical Devices. | |
| Summary of<br>Substantial<br>Equivalence | The subject dual lumen PowerMidline™ Catheter has the same intended use<br>and fundamental technological characteristics as the cited predicate device<br>cleared under K153393. Based on the intended use, technological<br>characteristics, and results of performance testing, the subject dual lumen<br>PowerMidline™ Catheter is considered substantially equivalent to the cited<br>predicate device. | |
Performance Tests
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