Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (catheter) and its intended use, materials, and performance testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No.
The device description and intended use indicate it is a catheter for vascular access and power injection, not for treating a disease or condition. While used in therapies, it is an access tool rather than a therapeutic agent itself.

Diagnostic

No

The device is a catheter used for vascular access, not for diagnosing medical conditions. Its primary functions are for intravenous therapies, blood sampling, and contrast media injection.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical catheter made from polyurethane materials, which is a hardware component.

IVD (In Vitro Diagnostic)

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 "short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media." This describes a device used in vivo (within the body) for accessing the circulatory system and delivering substances or drawing blood.
Device Description: The description details a catheter made from materials designed for insertion into the body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. IVDs typically involve reagents, test strips, analyzers, etc., which are not described here.

Therefore, the PowerMidline™ Catheters are a medical device used for vascular access, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 media. These catheters 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.

Product codes

PND

Device Description

Bard Access Systems, Inc.'s (BAS) PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The PowerMidline™ catheters are offered in a 3 F Single Lumen (SL) and 4 F Single Lumen (SL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The PowerMidline™ catheters are suitable for use with power injectors.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral venous system

Indicated Patient Age Range

any patient population

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)

The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate/reference devices. Additionally, when technological characteristics between the subject and predicate/reference devices were found to be identical, results of performance testing conducted on the predicate/reference devices were applied to the subject device. The following performance tests were completed on the subject device:

Device Dimensional Characterization
Catheter Assembly Tensile
Catheter Assembly Leak
Burst Pressure Without Power Injection
Burst Pressure Post Power Injection Gravity Flow
Tensile, Modulus and Elongation Requirements
Priming Volume
Catheter Radiopacity
Power Injection Testing
Tip Displacement During Power Injection
Catheter Cyclic Kink

The following sterilization and biological tests were also performed on the subject device:

Sterilant Residual Testing - ISO 10993-7: 2008, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals
Cytotoxicity - ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Sensitization/Irritation ISO 10993-10: 2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate and reference devices.

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.

K141151

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.

K070996, K102159

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

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle with three heads, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 28, 2016

C.R. Bard, Inc. Bard Access Systems. Inc. Mr. Casey Coombs Regulatory Affairs Specialist II 605 North 5600 West Salt Lake City, Utah 84116

Re: K153393

Trade/Device Name: PowerMidline™ Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: May 26, 2016 Received: May 27, 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 (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 yours,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a number 5 present in the image. The signature is complex and illegible, consisting of a series of loops and lines.

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153393

Device Name PowerMidline™ Catheters

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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AC

510(k) Summary 21 CFR 807.92(a)

| General
Provisions | Submitter Name:
Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 | | |
|------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Mr. Casey Coombs
(801) 522-5869
(801) 522-5425
27 June 2016 | | |
| Subject
Device | Trade Name:
Common Name:
Classification Name:
Product Code:
Regulation: | PowerMidline™ Catheter
Midline Catheter
Intravascular Catheter
PND
21 CFR §880.5200 | | |
| Predicate/
Reference
Devices | Predicate Device:
Classification:
Premarket Notification:
Manufacturer: | CT Midline
LJS, 21 CFR §880.5970, Percutaneous, implanted,
long-term intravascular catheter
K141151
Medcomp (Medical Components, Inc.) | | |
| | Reference Device:
Classification Name:
Premarket Notification:
Manufacturer: | 4 F Single Lumen (SL) PowerPICC Catheter
Percutaneous, implanted, long-term intravascular
catheter
K070996
Bard Access Systems, Inc. | | |
| | Reference Device:
Classification Name:
Premarket Notification:
Manufacturer: | 3 F Single Lumen (SL) PowerPICC SV Catheter
Percutaneous, implanted, long-term intravascular
catheter
K102159
Bard Access Systems, Inc. | | |
| Device
Description | | Bard Access Systems, Inc.'s (BAS) PowerMidline™ catheters are a family of
peripherally placed catheters made from radiopaque body-softening
polyurethane materials. Each PowerMidline™ catheter is designed with kink-
resistant, reverse taper design. The PowerMidline™ catheters are offered in a
3 F Single Lumen (SL) and 4 F Single Lumen (SL) configuration for reliable | | |

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| Device
Description | short term (less than 30 days) vascular access. These catheters are offered in
20 cm trimmable lengths. The PowerMidline™ catheters are suitable for use
with power injectors. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PowerMidline™ Catheter is intended for short term peripheral access for
selected intravenous therapies, blood sampling, and power injection of
contrast media. |
| Indications For
Use | 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 media. These catheters 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. |

Technological characteristics of the subject PowerMidline™ Catheters are substantially equivalent with respect to basic design and function to those of the cited predicate and reference devices. The differences are not critical to the intended use of the device and do not raise new or different questions regarding safety or effectiveness.

The following table provides a comparison of the technological characteristics between the subject and predicate/reference devices in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

	Subject and Predicate/Reference Device Comparison Table
	Attribute	Subject Device
PowerMidline™
Catheter	Predicate
Device - CT
Midline
(K141151)	Reference
Device - 3 F SL
PowerPICC SV
Catheter
(K102159)	Reference
Device - 4 F SL
PowerPICC
Catheter
(K070996)
Technological
Characteristics	Intended Use	Same as
predicate/
reference
devices	The CT Midline
is intended to
access the
vascular system
for
administration
of fluids
intravenously,
blood sampling,
and power
injection of
contrast media.	The 3 F SL
PowerPICC SV
Catheter is
intended to
access the
vascular system
for
administration
of fluids
intravenously,
blood sampling,
and power
injection of
contrast media.	The 4 F SL
PowerPICC
Catheter is
intended to
access the
vascular system
for
administration
of fluids
intravenously,
blood sampling,
and power
injection of
contrast media.
	Duration of
Use	Same as
predicate CT
Midline	Short term (30days)	Short term
(30days)
	Means of
Insertion	Same as
predicate/
reference
devices	Percutaneous,
using Modified
Seldinger
Technique and
guidewire	Percutaneous,
using Modified
Seldinger
Technique and
guidewire	Percutaneous,
using Modified
Seldinger
Technique and
guidewire
Subject and Predicate/Reference Device Comparison Table
	Attribute	Subject Device
PowerMidline™
Catheter	Predicate
Device - CT
Midline
(K141151)	Reference
Device - 3 F SL
PowerPICC SV
Catheter
(K102159)	Reference
Device - 4 F SL
PowerPICC
Catheter
(K070996)
Technological
Characteristics	Tip Placement
Location	Same as
predicate CT
Midline	Peripheral
venous system,
with catheter tip
terminating prior
to the axilla	Central venous
system, with
lower 1/3 of the
Superior Vena
Cava (SVC)
preferred	Central venous
system, with
lower 1/3 of the
Superior Vena
Cava (SVC)
preferred
	Insertion Site	Same as
predicate/
reference
devices	Peripheral	Peripheral	Peripheral
	Catheter Base
Materials	Same as
predicate/
reference
devices	Shaft Tubing
Polyurethane	Shaft Tubing
Polyurethane	Shaft Tubing
Polyurethane
			Catheter
Junction
Polyurethane	Catheter
Junction
Polyurethane	Catheter
Junction
Polyurethane
			Extension Leg
Polyurethane	Extension Leg
Polyurethane	Extension Leg
Polyurethane
			Luer Hub
Polyurethane	Luer Hub
Polyurethane	Luer Hub
Polyurethane
			Extension Leg
Clamp
Acetal Resin	Extension Leg
Clamp
Acetal Resin	Extension Leg
Clamp
Acetal Resin
	Catheter
Proximal
Configuration	Same as
predicate/
reference
devices	Luer
Connection	Luer
Connection	Luer
Connection
	Catheter
Distal
Configuration	Same as
predicate/
reference
devices	Open Ended	Open Ended	Open Ended
	Catheter
Dimensions	3 F SL x 20 cm
usable length
4 F SL x 20 cm
usable length	4 F SL x 20 cm
usable length
5 F DL x 20 cm
usable length	3 F SL x 45 cm
usable length	4 Fr SL x 55 cm
usable length
	Number,
Shape of
Lumens	Same as single
lumen predicate/
reference
devices	Single Lumen,
round
Double Lumen,
double D	Single Lumen,
round	Single Lumen,
round
	Subject and Predicate/Reference Device Comparison Table
Technological
Characteristics	Attribute	Subject Device
PowerMidline™
Catheter	Predicate
Device - CT
Midline
(K141151)	Reference
Device - 3 F SL
PowerPICC SV
Catheter
(K102159)	Reference
Device - 4 F SL
PowerPICC
Catheter
(K070996)
	Depth
Markings	Same as
reference
devices	Number every 5
cm and depth
mark every cm	"0" depth
indicator located
1 cm from
catheter
junction on
reverse taper
shaft tubing;
catheter marked
every 1 cm, with
numeric
indicators every
5 cm.	"0" depth
indicator located
1 cm from
catheter
junction on
reverse taper
shaft tubing;
catheter marked
every 1 cm, with
numeric
indicators every
5 cm.
	Pre-inserted
Stylet
Configuration	Same as
predicate/
reference
devices	Stiffening stylet	Stiffening stylet	Stiffening stylet
	Power
Injection
Maximum
Flow Rate	3 F SL = 3 mL/s
4 F SL = 7 mL/s	4 Fr SL = 5
mL/sec
5 Fr DL = 7
mL/sec	1 mL/s	5 mL/s
	Sterility	Same as
predicate/
reference
devices	100% Ethylene
Oxide, SAL of
10-6	100% Ethylene
Oxide, SAL of
10-6	100% Ethylene
Oxide, SAL of
10-6

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6

The indications for use statement is different between the subject device and predicate device. Specifically, the subject device indications for use includes a statement indicating that the device may be used with any patient population when consideration is given to adequacy of vascular anatomy and appropriateness of the procedure, whereas the predicate device indications for use does not include this statement. This difference in the indications for use does not alter the intended use of the device (i.e., access to the vascular system for administration of fluids intravenously, blood sampling, and power injection of contrast media). The purpose of this information is to specify that prior to use of the subject device, the user should consider the patient's vascular anatomy and appropriateness of using the subject device for the intended procedure. The statement does not prescribe a different general purpose or function of the device, nor does it prescribe a different patient population, therapeutic or diagnostic use of the subject device compared to the predicate device. Therefore, this difference in indications for use between the subject and predicate devices does not raise different questions of equivalence.

Performance Tests

The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate/reference devices. Additionally, when technological characteristics between the subject and predicate/reference devices were found to be identical, results of performance testing conducted on the predicate/reference devices were applied to the subject device. The following table identifies the performance tests completed on the subject device, including the standards associated to each test.

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| | Testing Completed | ISO Standard / FDA Guidance /
BAS Protocols Utilized |
|----------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Tests | Device Dimensional
Characterization | |
| | Catheter Assembly Tensile | ISO 10555-1: 2013, Sterile, single-
use intravascular catheters, Part 1:
General requirements |
| | Catheter Assembly Leak | |
| | Burst Pressure Without Power
Injection | |
| | Burst Pressure Post Power Injection
Gravity Flow | ISO 10555-1: 2013, Sterile, single-
use intravascular catheters, Part 1:
General requirements |
| | Tensile, Modulus and Elongation
Requirements | Guidance on Premarket Notification
[510(k)] Submission for Short-Term
and Long-Term Intravascular
Catheters, March 16, 1995 |
| | Priming Volume | Guidance on Premarket Notification
[510(k)] Submission for Short-Term
and Long-Term Intravascular
Catheters, March 16, 1995 |
| | Catheter Radiopacity | BAS Internal Protocols/Procedures
ASTM F640-79 (reapproved 2000),
Standard Test Methods for
Radiopacity of Plastics for Medical
Use |
| | Power Injection Testing | ISO 10555-1: 2013, Sterile, single-
use intravascular catheters, Part 1:
General requirements |
| | Tip Displacement During Power
Injection | BAS Internal Protocols/Procedures |
| | Catheter Cyclic Kink | BAS Internal Protocols/Procedures |

The following sterilization and biological tests were also performed on the subject device:

. Sterilant Residual Testing - ISO 10993-7: 2008, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals
. Cytotoxicity - ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Sensitization/Irritation ISO 10993-10: 2010, Biological evaluation of . medical devices – Part 10: Tests for irritation and skin sensitization

The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate and reference devices.

Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices - Application of risk management to medical devices.

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Summary of Substantial Equivalence

Based on the intended use, technological characteristics, and performance testing, the subject PowerMidline™ Catheters meet the requirements that are considered sufficient for the intended use and are therefore substantially equivalent to the predicate and reference devices cited.