(57 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, sterilization, and risk management, with no mention of AI or ML capabilities.
No
The device is an infusion set and needle set used for administering fluids and drugs, and for blood sampling, through surgically implanted vascular ports. While it facilitates the delivery of therapeutics, it is a tool for administration rather than a therapeutic device itself.
No
The device is an infusion set used for administering fluids, drugs, and for blood sampling. It does not perform diagnostic functions.
No
The device description clearly details physical components such as needles, tubing, Luer caps, adapters, pinch clamps, and a safety guard handle and base, indicating it is a hardware device.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "intravascular administration set" used for "accessing surgically implanted vascular ports," "administration of fluids and drugs," "blood sampling," and "power injection of contrast media."
- Lack of Specimen Analysis: The device's function is to facilitate access to the vascular system and administer or withdraw substances. It does not perform any analysis or testing of a specimen in vitro (outside the body).
The device is a medical device used for accessing and interacting with the patient's vascular system, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
PowerLoc® MAX Power-Injectable Infusion Set:
Indications for Use
The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.
The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
SafeStep® Huber Needle Set:
The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.
Intended Use (for both devices):
Both the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory, are intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
Product codes (comma separated list FDA assigned to the subject device)
PTI
Device Description
PowerLoc® MAX Power-Injectable Infusion Set:
The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling. The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set is offered with and without a Y-site.
SafeStep® Huber Needle Set:
The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a needlestick prevention feature, designed for use with a vascular access infusion system. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.
Stabilization accessory:
The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization accessory is then discarded per hospital protocol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The site of a surgically implanted vascular port.
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)
Testing was performed to show that the kit components maintain their biological safety and functional efficacy after ethylene oxide (EO) sterilization. The kit components met all predetermined acceptance criteria. 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 – Risk Management for Medical Devices. The risks were analyzed, mitigated and reduced to an acceptable level, and re-evaluation showed that the remaining risks are outweighed by the benefits of the device, and that the device is acceptable for its intended use.
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.
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2017
C.R. Bard. Inc. Jeremy Tidwell Quality/Regulatory Specialist 605 North 5600 West Salt Lake Citv. Utah 84116
Re: K171735
Trade/Device Name: PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle. Regulatory Class: Class II Product Code: PTI Dated: July 11, 2017 Received: July 13, 2017
Dear Jeremy Tidwell:
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.
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 device-
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
1
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 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,
James P. Bertram -S
for
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
PowerLoc® MAX Power-Injectable Infusion Set
Indications for Use (Describe)
Indications for Use
The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.
The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K171735
Device Name SafeStep® Huber Needle Set
Indications for Use (Describe)
The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
21 CFR 807.92(a)
| General Provisions | Submitter Name:
Address:
Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116
Jeremy Tidwell
Quality/Regulatory Affairs Specialist
801-522-5665
801-522-4969
August 4, 2017 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Devices | Subject Trade Name:
Common Name:
Requlation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | PowerLoc® MAX Power-Injectable Infusion Set
Huber Needle Intravascular Infusion Set Kit
Non-Coring (Huber) Needle
PTI
21 CFR §880.5570
General Hospital |
| | Subject Trade Name:
Common Name:
Requlation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | SafeStep® Huber Needle Set
Huber Needle Intravascular Infusion Set Kit
Non-Coring (Huber) Needle
PTI
21 CFR §880.5570
General Hospital |
| | Predicate Trade Name:
Premarket Notification:
Manufacturer:
Common Name:
Regulation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | PowerLoc® MAX Power-Injectable Infusion Set
K153440
Bard Access Systems, Inc.
Huber Needle Intravascular Administration Set
Intravascular Administration Set
FPA
21 CFR §880.5440
General Hospital |
| Predicate Devices | Predicate Trade Name:
Premarket Notification:
Manufacturer:
Common Name:
Requlation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | SafeStep® Huber Needle Set
K153440
Bard Access Systems, Inc.
Huber Needle Intravascular Administration Set
Intravascular Administration Set
FPA
21 CFR §880.5440
General Hospital |
5
| Purpose Statement | The purpose of this submission is to clear the subject devices (i.e., PowerLoc® MAX Power-
Injectable Infusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory)
in new packaging configurations that include additional kit components, all of which are legally
marketed devices. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Descriptions | PowerLoc® MAX Power-Injectable Infusion Set
The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion
set with a non-coring Huber type right angle needle and a manually activated needle-stick
prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding
the needle. The device also includes an integrated extension set consisting of infusion tubing, a
non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and
base. It is used to access surgically implanted vascular ports and is indicated for use in the
administration of fluids and drugs, as well as blood sampling.
The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast
media into the central venous system only through an implanted port that is also indicated for power
injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20
gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set
is offered with and without a Y-site.
SafeStep® Huber Needle Set
The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a
needlestick prevention feature, designed for use with a vascular access infusion system. The device
also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap,
female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with
conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as
a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick
injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-
site.
Stabilization accessory
The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX
Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the
subject devices. It is placed centrally over the implanted port so that the base surrounds the
implanted port under the skin. The infusion set needle handle is pressed down until the needle has
entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization
accessory is then discarded per hospital protocol. |
| Intended Use | Both the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set
with or without the stabilization accessory, are intended for use in the administration of fluids and
drugs, as well as blood sampling through surgically implanted vascular ports. |
| Indications For Use | PowerLoc® MAX Power-Injectable Infusion Set
The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-
coring right angle needle and manually activated needle stick prevention safety mechanism which
reduces the risk of accidental needlestick injuries by shielding the needle. The needle is used to
access surgically implanted vascular ports.
The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids
and drugs, as well as blood sampling through surgically implanted vascular ports. |
6
| | When used with ports that are indicated for power injection of contrast media into the central venous
system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of
contrast media. For power injection of contrast media, the maximum recommended infusion rate at
11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles. | | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use
Cont. | SafeStep® Huber Needle Set
The SafeStep® Huber Needle Set is a device intended for insertion into the septum of a
subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® Huber
Needle safety feature is manually activated during needle removal, and is designed to aid in the
prevention of accidental needlesticks. | | |
| | Technological characteristics including design and function of the subject devices, the PowerLoc®
MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set with or without the stabilization
accessory are the same as those of the predicate devices, PowerLoc® MAX Power-Injectable
Infusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory.
The following table provides a comparison between the technological characteristics of the subject
and predicate device:
Comparison between subject PowerLoc® MAX Power-Injectable Infusion Set (with | | |
| | or without the stabilization accessory) and the predicate PowerLoc® MAX Power- | | |
| | Device
Attribute | Subject:
PowerLoc® MAX Power-
Injectable Infusion Set (with or
without the stabilization
accessory) | Predicate K153440:
PowerLoc® MAX Power-Injectable
Infusion Set (with or without the
stabilization accessory) |
| | Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. |
| Technological
Characteristics | Product Code | PTI
21 CFR 880.5570
Non-Coring Huber Needle | FPA
21 CFR 880.5440
Set, Administration, Intravascular |
| | Review
Branch | Center For Devices and
Radiological Health (CDRH) | Center For Devices and Radiological
Health (CDRH) |
| | 510k Status | Subject of this Premarket
Notification | K153440
Concurrence Date: August 18, 2016 |
| | Intended Use | Same as predicate. | The PowerLoc® MAX Power-Injectable
Infusion Set is intended for use in the
administration of fluids and drugs, as well
as blood sampling through surgically
implanted vascular ports. |
| | Indications for
Use | Same as predicate. | The PowerLoc® MAX Power-Injectable
Infusion Set is an intravascular
administration set with a non-coring right
angle needle and manually activated
needle stick prevention safety mechanism
which reduces the risk of accidental
needlestick injuries by shielding the
needle. The needle is used to access |
| | | | |
| Technological
Characteristics
Cont. | Indications for
Use
Cont. | | surgically implanted vascular ports.
The PowerLoc® MAX Power-Injectable
Infusion Set is indicated for use in the
administration of fluids and drugs, as well
as blood sampling through surgically
implanted vascular ports.
When used with ports that are indicated for
power injection of contrast media into the
central venous system, the PowerLoc®
MAX Power-Injectable Infusion Set is also
indicated for power injection of contrast
media. For power injection of contrast
media, the maximum recommended
infusion rate at 11.8 cPs is 5 ml/s for 19
gauge and 20 gauge needles, and 2 ml/s |
| | General
Device
Description | Same as predicate. | for 22 gauge needles.
The PowerLoc® MAX Power-Injectable
Infusion Set is a non-coring Huber needle
infusion set with an integral needle stick
prevention safety feature.
The stabilization device is an accessory to |
| | | | the Huber needle infusion sets which is
placed centrally over the implanted port to
assist in the placement of the Huber
needle in the implanted port. |
| | Y-Site | Same as predicate. | The PowerLoc® MAX Power-Injectable
Infusion Set is offered either with or without
a Y-site. |
| | Duration of
Use | PowerLoc® MAX: Same as
predicate.
Stabilization accessory: Same
as predicate. | PowerLoc® MAX: Externally
communicating device with an indirect
blood path with a contact duration of >24
hours to 30 days.
Stabilization accessory: A single-use |
| | | | device used only for the duration of the
insertion of the needle into the port.
Surface device, skin only, limited exposure
(≤24 hours). |
| | | Same as predicate. | Huber Needle
Stainless Steel |
| | Device
Materials | Same as predicate. | Adhesive
UV Adhesive |
| | | Same as predicate. | Safety Guard Base
Styrene, Butadine, Copolymer or
Polycarbonate |
| | | | |
| | | Same as predicate. | Needle Lubricant
Medical Grade Silicones |
| | | Same as predicate. | Safety Guard Inner Base
Styrene, Butadiene, Copolymer
Insert Colorants:
Yellow
Brown
Black |
| Technological
Characteristics
Cont. | Device
Materials
Cont. | Same as predicate. | Safety Guard Sleeve
Stainless Steel |
| | | Same as predicate. | Safety Guard Shutter
Stainless Steel |
| | | Same as predicate. | Pad-print Ink
Ink |
| | | Same as predicate. | Needle Cover
Polyethylene |
| | | Same as predicate. | Safety Guard Handle
Styrene, Butadiene, Copolymer |
| | | Same as predicate. | Comfort Pad
Polyethylene |
| | | Same as predicate. | Administration Tubing
PVC |
| | | Same as predicate. | Female Locking Luer Connection
PVC |
| | | Same as predicate. | Adaptable Y-Injection Site Female Locking
Luer Connection
PVC |
| | | Same as predicate. | Non-vented Male Luer Cap
Acrylonitrile butadiene styrene |
| | | Same as predicate. | Pinch Clamps
Polypropylene
Colorants
Yellow
Brown
Black |
| | | Same as predicate. | Stabilization accessory
Stabilizer
Polycarbonate |
7
8
9
| Technological
Characteristics
Cont. | | Same as predicate. | Stabilization accessory
Needle Handle
Polypropylene | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------|--------|
| | Sterility
Method | Same as predicate. | Ethylene Oxide | | | |
| | Sterility
Assurance
Level (SAL) | Same as predicate. | SAL 10-6 | | | |
| | Number of
Uses | Same as predicate. | Single-use device | | | |
| | Anatomical
Site Use | Same as predicate. | The site of a surgically implanted vascular
port. | | | |
| | Principle of
Operation | Same as predicate. | The device accesses implanted ports in
order to transport fluid into, and out of, the
central venous system. It utilizes a
standard right angle non-coring Huber type
needle and infusion set with an integral
safety engineered needlestick prevention
feature in order to do this. | | | |
| | Safety
Infusion Set
Device
Components | Same as predicate. | End Cap
Luer connector
Tubing
Non-Winged Grip
Safety Guard Base
Marked Pinch Clamps
Needle
Needle handle
Stabilization accessory | | | |
| | Sizes | Same as predicate. | Needle Gauge - 19, 20 or 22
Needle Length - 0.75 in., 1.00 in., 1.50 in. | | | |
| | Needle OD | Same as predicate. | Needle
Gauge | Needle OD mm (in.) | Clamp
Color | |
| | | | 19G | 1.054 - 1.080
(0.0415 - 0.0425) | Brown | |
| | | | 20G | 0.889 - 0.914
(0.0350 - 0.0360) | Yellow | |
| | | | 22G | 0.699 – 0.724
(0.0275 - 0.0285) | Black | |
| Tubing
Dimension
Summary for
device
without Y-
Injection Site | | Same as predicate. | Needle
Gauge | Inner
Diameter | Outer
Diameter | Length |
| | | | 19G | 0.048 in. | 0.088 in. | 8 in. |
| | | | 20G | 0.041 in. | 0.088 in. | 8 in. |
| | | | 22G | 0.034 in. | 0.088 in. | 8 in. |
| Dimension
Summary for
device with Y-
Injection Site | | Gauge | Diameter | Diameter | | |
| | | 19G | 0.048 in. | 0.088 in. | 4 in. | |
| | | 20G | 0.041 in. | 0.088 in. | 4 in. | |
| | | 22G | 0.034 in. | 0.088 in. | 4 in. | |
| Packaging | Header Pouch – Uncoated
1073B Tyvek® nylon, LDPE
HDPE | Pouch – 1059B Tyvek® and TPF, PET
Based Adhesive Lamination | | | | |
| Kit
Components
-(only
configurations
offered are
with or
without the
stabilization
accessory) | Mask (2)
Hand Sanitizer (2)
Gloves (Silver)
Absorbent Towel
Fenestrated Drape
Chloraprep, 3 mL
Gloves, Purple Nitrile
GuardIVa® Antimicrobial
Hemostatic Dressing
Skin Protectant Pad
Pre-Filled Saline Syringe
Sentrinex™ 3D Port Dressing | None | | | | |
| Comparison between subject SafeStep® Huber Needle Set (with or without the
stabilization accessory) and the predicate SafeStep® Huber Needle Set (with or
without the stabilization accessory) | | | | | | |
| Device
Attribute | Subject:
SafeStep® Huber Needle Set
with or without the stabilization
accessory | Predicate K153440:
SafeStep® Huber Needle Set with or
without the stabilization accessory | | | | |
| Owner | Same as predicate. | Bard Access Systems, Inc. | | | | |
| Product Code | PTI
21 CFR 880.5570
Non-Coring Huber Needle | FPA | 21 CFR 880.5440 | Set, Administration, Intravascular | | |
| Review Branch | Same as predicate. | Center For Devices and Radiological
Health (CDRH) | | | | |
| 510k Status | Subject of this
Premarket Notification | K153440 | Concurrence Date: August 18, 2016 | | | |
| | Same as predicate. | The SafeStep® Huber Needle Set is a | | | | |
| Technological
Characteristics
Cont. | | | | | | |
10
11
| | Indications for
Use | Same as predicate. | The SafeStep® Huber Needle Set is a
device intended for insertion into the
septum of a subcutaneously implanted
port and for the infusion of fluids into the
port. The SafeStep® Huber Needle
safety feature is manually activated
during needle removal, and is designed
to aid in the prevention of accidental
needlesticks. |
|-------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General
Device
Description | Same as predicate. | The SafeStep® Huber Needle Set is a
non-coring Huber needle infusion set with
an integral needle stick prevention safety
feature.
The stabilization device is an accessory
to the Huber needle infusion sets which |
| | | | is placed centrally over the implanted
port to assist in the placement of the
Huber needle in the implanted port. |
| | Y-Site | Same as predicate. | The SafeStep® Huber Needle Set is
offered either with or without a Y-site. |
| Technological
Characteristics
Cont. | Duration of
Use | SafeStep®:
Same as predicate. | SafeStep®: Externally communicating
device with an indirect blood path with a
contact duration of >24 hours to 30 days. |
| | | Stabilization accessory:
Same as predicate. | Stabilization accessory: A single-use
device used only for the duration of the
insertion of the needle into the port.
Surface device, skin only, limited
exposure (≤24 hours). |
| | Device
Materials | Same as predicate. | Huber Needle
Stainless Steel |
| | | Same as predicate. | Adhesive
UV Adhesive |
| | | Same as predicate. | Safety Guard Base
Styrene, Butadine, Copolymer or
Polycarbonate |
| | | Same as predicate. | Needle Lubricant
Medical Grade Silicones - Dow 360 or
MED-4149 or MED-361 |
| | | Same as predicate. | Safety Guard Inner Base
Styrene, Butadine, Copolymer
Insert Colorants:
Yellow
Brown
Black |
| Technological
Characteristics
Cont. | Device
Materials
Cont. | Same as predicate. | Safety Guard Sleeve
Stainless Steel |
| | | Same as predicate. | Safety Guard Shutter
Stainless Steel |
| | | Same as predicate. | Needle Cover
Polyethylene |
| | | Same as predicate. | Safety Guard Handle
Styrene, Butadiene, Copolymer |
| | | Same as predicate. | Comfort Pad
Polyethylene |
| | | Same as predicate. | Administration Tubing
PVC |
| | | Same as predicate. | Female Locking Luer Connection
PVC |
| | | Same as predicate. | Needleless Access Connector Y-Site
Polycarbonate
Silicone |
| | Same as predicate. | Non-vented Male Luer Cap
Acrylonitrile butadiene styrene | |
| | Same as predicate. | Pinch Clamps
Polypropylene
Colorants
Yellow
Brown
Black | |
| | Same as predicate. | Stabilization accessory
Stabilizer
Polycarbonate
Stabilization accessory
Needle Handle
Polypropylene | |
| | Sterility
Method | Same as predicate | Ethylene Oxide |
| | Sterility
Assurance
Level (SAL) | Same as predicate | SAL 10-6 |
| | Number of
Uses | Same as predicate | Single-use device |
| | Anatomical
Site Use | Same as predicate | The site of a surgically implanted
vascular port. |
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13
| | Principle of
Operation | Same as predicate | The device accesses implanted ports in
order to transport fluid into, and out of,
the central venous system. It utilizes a
standard right angle non-coring Huber
type needle and infusion set with an
integral safety engineered needlestick
prevention feature in order to do this. | | | |
|----------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------|----------------|
| | Safety Infusion
Set Device
Components | Same as predicate | End Cap
Luer connector
Tubing
Non-Winged Grip
Safety Guard Base
Pinch Clamps
Needle
Needle handle
Stabilization accessory | | | |
| Technological
Characteristics | Sizes | Needle Gauge - Same as
predicate.
Needle Length - Same as
predicate. | Needle Gauge - 19, 20 or 22
Needle Length - 0.75 in., 1.00 in., 1.50
in. | | | |
| Cont. | Needle
Outside
Diameter | Same as predicate. | Needle
Gauge | | Needle OD mm (in.) | Clamp
Color |
| | | | 19G | | 1.054 — 1.080
(0.0415-0.0425) | Brown |
| | | | 20G | | 0.889-0.914
(0.0350-0.0360) | Yellow |
| | | | 22G | (0.0275-0.0285) | 0.699-0.724 | Black |
| | Tubing
Dimension
Summary for
device without
Y-injection
Site | Same as predicate | Needle
Gauge | Inner
Diameter | Outer
Diameter | Length |
| | | | 19G | 0.048 in. | 0.088 in. | 8 in. |
| | | | 20G | 0.041 in. | 0.088 in. | 8 in. |
| | | | 22G | 0.034 in. | 0.088 in. | 8 in. |
| | Tubing | Same as predicate | Needle
Gauge | Inner
Diameter | Outer
Diameter | Length |
| | Dimension | | 19G | 0.048 in. | 0.088 in. | 4 in. |
| | Summary for
device with Y-
injection Site | | 20G | 0.041 in. | 0.088 in. | 4 in. |
| | | | 22G | 0.034 in. | 0.088 in. | 4 in. |
| | Packaging | Header Pouch – Uncoated 1073B
Tyvek®, nylon, LDPE, HDPE | Pouch - 1059B Tyvek® and TPF, PET
Based Adhesive Lamination | | | |
14
| Technological
Characteristics
Cont. | Kit
Components-
(only
configurations
offered are
with or without
the
stabilization
accessory) | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | Mask (2)
Hand Sanitizer (2)
Gloves (Silver)
Absorbent Towel
Fenestrated Drape
Chloraprep, 3 mL
Gloves, Purple Nitrile
GuardIVa® Antimicrobial
Hemostatic Dressing
Skin Protectant Pad
Pre-Filled Saline Syringe
Sentrinex™ 3D Port Dressing | None |
The following table identifies the requlatory information for each component used in the subject device kits.
| Kit Component (Trade
Name /Manufacturer Name) | Regulation
Number | Classification | Regulatory
Coverage |
|----------------------------------------------------|----------------------|-------------------|------------------------|
| Mask | 21 CFR
878.4040 | Class II | K110455 |
| Hand Sanitizer Packet | N/A | OTC Drug | NDC21749-
530-01 |
| STERLING* Nitrile Gloves | 21 CFR
880.6250 | Class I | K081089 |
| Absorbent Towel | 21 CFR
878.4370 | Class II | K862801 |
| Fenestrated Drape | 21 CFR
878.4370 | Class II | K111458 |
| ChloraPrep™ Solution One-
Step Applicator, 3 mL | N/A | OTC Drug | NDA020832 |
| PURPLE NITRILE* Gloves | 21 CFR
880.6250 | Class I | K051347 |
| GuardIVa® Antimicrobial
Hemostatic IV Dressing | Unclassified | Unclassified | K121485 |
| Prep Pad, Skin Protectant | 21 CFR
880.5090 | Class I
Exempt | N/A |
| Sentrinex™ 3D Port
Dressing | 21 CFR
878.4020 | Class I
Exempt | N/A |
| Syringe, Sodium Chloride
(Saline) 0.9%, 10 mLª | 21 CFR
880.5200 | Class II | K120836 |
4 Component is included in kits as a post-sterile operation; it is sterilized separately, prior to kitting.
Testing was performed to show that the kit components maintain their biological safety and functional efficacy after ethylene oxide (EO) sterilization. The kit components met all predetermined acceptance criteria. 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 – Risk Management for Medical Devices. The risks were analyzed, mitigated and reduced to an acceptable level, and re-evaluation showed that the remaining risks are outweighed by the benefits of the device, and that the device is acceptable for its intended use.
Safety & Performance Tests
15
| Summary of
Substantial
Equivalence | Based on the intended use, technological characteristics, and safety and performance testing, the
subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set with or
without the stabilization accessory included in kit configurations, meet the requirements that are
considered sufficient for its intended use as compared to the predicate devices cited. Therefore, the
subject devices are substantially equivalent to the predicates. |
| ------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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