(57 days)
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.
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.
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.
This document is a 510(k) Premarket Notification from the FDA regarding the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set. It establishes substantial equivalence to existing predicate devices, indicating that no new clinical study was required to prove safety and effectiveness for a new medical device. Instead, the submission focuses on demonstrating that the new packaging configurations and additional kit components of the subject devices do not alter their fundamental safety and performance characteristics compared to the previously cleared predicate devices.
Therefore, the typical acceptance criteria and study design for proving the performance of a novel AI-powered medical device are not applicable in this context. This submission is for a conventional medical device (infusion sets and needles) and relies on bench testing, material comparisons, and risk management rather than clinical performance studies with AI.
However, I can extract information related to the acceptance criteria for this specific submission, which pertains to the device's substantial equivalence and safety/performance after changes, rather than a de novo AI device.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance (as applicable to this submission):
For this 510(k) submission, the "acceptance criteria" are not related to a specific performance metric of an AI model (like accuracy, sensitivity, specificity). Instead, they revolve around demonstrating that the new configurations and kit components of the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set maintain the same safety and performance profiles as their cleared predicate devices.
The document implicitly states that for the original devices (the predicates), their performance was deemed acceptable for their stated indications. For this new submission, the acceptance criteria are met by demonstrating "substantial equivalence" based on:
| Acceptance Criterion (Implicit) | Reported Device Performance / Justification |
|---|---|
| Intended Use Equivalence: Subject devices share the same intended use as predicate devices. | Met: "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." (Page 5) |
| Indications for Use Equivalence: Subject devices share the same indications for use as predicate devices. | Met: "Same as predicate." for both PowerLoc® MAX and SafeStep® Huber Needle Set Indications for Use. (Pages 6, 11) |
| Technological Characteristics Equivalence: Subject devices have substantially similar technological characteristics (design, materials, dimensions, etc.) to predicate devices. | Met: Detailed comparison tables (Pages 6-9, 11-14) explicitly state "Same as predicate" for numerous attributes including: - Product Code - Review Branch - Intended Use - Indications for Use - General Device Description - Y-Site presence - Duration of Use - Device Materials - Sterility Method (Ethylene Oxide) - Sterility Assurance Level (SAL 10-6) - Number of Uses (Single-use) - Anatomical Site Use - Principle of Operation - Safety Infusion Set Device Components - Sizes (Needle Gauge, Needle Length) - Needle OD - Tubing Dimensions (ID, OD, Length) Note: The addition of new kit components is acknowledged but they are themselves legally marketed, cleared devices. |
| Safety and Performance After Changes: The new packaging configurations and additional kit components do not negatively impact the biological safety or functional efficacy of the devices. | Met: "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." (Page 14) |
2. Sample Size Used for the Test Set and Data Provenance:
- This 510(k) submission does not involve a "test set" in the context of an AI model's performance on clinical data.
- The evaluation is based on "safety and performance tests" (Page 15) conducted on the physical devices and their components. The document does not specify the sample sizes for these bench tests, but it states that the "kit components met all predetermined acceptance criteria" and that a "risk management" process was followed.
- Data provenance is not applicable in the sense of patient data from specific countries or retrospective/prospective studies. The "data" here refers to engineering and biocompatibility test results.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This is not applicable as there is no "ground truth" in the context of clinical images or patient data being interpreted by AI.
- The ground for proving substantial equivalence relates to regulatory standards, engineering specifications, and established biocompatibility principles. The FDA review team acts as the expert body for evaluating this submission.
4. Adjudication Method for the Test Set:
- Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This submission is for physical medical devices (infusion sets/needles), not an AI algorithm assisting human readers. Therefore, there is no AI assistance component to measure improvement.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is not an AI algorithm.
7. Type of Ground Truth Used:
- The "ground truth" in this submission is the accepted safety and performance of the predicate devices and the physical/chemical characteristics of the materials and design, verified through bench testing and adherence to recognized standards (e.g., sterilization, biocompatibility, risk management according to ISO 14971:2012).
8. Sample Size for the Training Set:
- Not applicable. There is no AI model or training set involved.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons stated above.
In summary, this FDA 510(k) document demonstrates substantial equivalence for conventional medical devices after a minor change (new packaging/kit components), rather than proving the performance of a novel AI-powered medical device through clinical studies. The "acceptance criteria" here refer to meeting regulatory requirements for substantial equivalence and ensuring that the modified devices maintain their established safety and functional efficacy through engineering and biocompatibility testing.
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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.
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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
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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."
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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 WestSalt Lake City, UT 84116Jeremy TidwellQuality/Regulatory Affairs Specialist801-522-5665801-522-4969August 4, 2017 |
|---|---|---|
| Subject Devices | Subject Trade Name:Common Name:Requlation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | PowerLoc® MAX Power-Injectable Infusion SetHuber Needle Intravascular Infusion Set KitNon-Coring (Huber) NeedlePTI21 CFR §880.5570General Hospital |
| Subject Trade Name:Common Name:Requlation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | SafeStep® Huber Needle SetHuber Needle Intravascular Infusion Set KitNon-Coring (Huber) NeedlePTI21 CFR §880.5570General Hospital | |
| Predicate Trade Name:Premarket Notification:Manufacturer:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | PowerLoc® MAX Power-Injectable Infusion SetK153440Bard Access Systems, Inc.Huber Needle Intravascular Administration SetIntravascular Administration SetFPA21 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 SetK153440Bard Access Systems, Inc.Huber Needle Intravascular Administration SetIntravascular Administration SetFPA21 CFR §880.5440General Hospital |
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| 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 legallymarketed devices. |
|---|---|
| Device Descriptions | PowerLoc® MAX Power-Injectable Infusion SetThe PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusionset with a non-coring Huber type right angle needle and a manually activated needle-stickprevention safety mechanism which reduces the risk of accidental needlestick injuries by shieldingthe needle. The device also includes an integrated extension set consisting of infusion tubing, anon-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle andbase. It is used to access surgically implanted vascular ports and is indicated for use in theadministration of fluids and drugs, as well as blood sampling.The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrastmedia into the central venous system only through an implanted port that is also indicated for powerinjection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Setis offered with and without a Y-site.SafeStep® Huber Needle SetThe SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with aneedlestick prevention feature, designed for use with a vascular access infusion system. The devicealso 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 withconventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates asa standard Huber needle with the addition of a safety feature to aid in the prevention of needlestickinjuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.Stabilization accessoryThe stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAXPower-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with thesubject devices. It is placed centrally over the implanted port so that the base surrounds theimplanted port under the skin. The infusion set needle handle is pressed down until the needle hasentered the port septum, then the stabilization accessory is lifted off of the needle. The stabilizationaccessory is then discarded per hospital protocol. |
| Intended Use | Both the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Setwith or without the stabilization accessory, are intended for use in the administration of fluids anddrugs, as well as blood sampling through surgically implanted vascular ports. |
| Indications For Use | PowerLoc® MAX Power-Injectable Infusion SetThe 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 whichreduces the risk of accidental needlestick injuries by shielding the needle. The needle is used toaccess surgically implanted vascular ports.The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluidsand drugs, as well as blood sampling through surgically implanted vascular ports. |
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| When used with ports that are indicated for power injection of contrast media into the central venoussystem, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection ofcontrast media. For power injection of contrast media, the maximum recommended infusion rate at11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles. | |||
|---|---|---|---|
| Indications For UseCont. | SafeStep® Huber Needle SetThe SafeStep® Huber Needle Set is a device intended for insertion into the septum of asubcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® HuberNeedle safety feature is manually activated during needle removal, and is designed to aid in theprevention 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 stabilizationaccessory are the same as those of the predicate devices, PowerLoc® MAX Power-InjectableInfusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory.The following table provides a comparison between the technological characteristics of the subjectand predicate device:Comparison between subject PowerLoc® MAX Power-Injectable Infusion Set (with | |||
| or without the stabilization accessory) and the predicate PowerLoc® MAX Power- | |||
| DeviceAttribute | Subject:PowerLoc® MAX Power-Injectable Infusion Set (with orwithout the stabilizationaccessory) | Predicate K153440:PowerLoc® MAX Power-InjectableInfusion Set (with or without thestabilization accessory) | |
| Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. | |
| TechnologicalCharacteristics | Product Code | PTI21 CFR 880.5570Non-Coring Huber Needle | FPA21 CFR 880.5440Set, Administration, Intravascular |
| ReviewBranch | Center For Devices andRadiological Health (CDRH) | Center For Devices and RadiologicalHealth (CDRH) | |
| 510k Status | Subject of this PremarketNotification | K153440Concurrence Date: August 18, 2016 | |
| Intended Use | Same as predicate. | The PowerLoc® MAX Power-InjectableInfusion Set is intended for use in theadministration of fluids and drugs, as wellas blood sampling through surgicallyimplanted vascular ports. | |
| Indications forUse | Same as predicate. | The PowerLoc® MAX Power-InjectableInfusion Set is an intravascularadministration set with a non-coring rightangle needle and manually activatedneedle stick prevention safety mechanismwhich reduces the risk of accidentalneedlestick injuries by shielding theneedle. The needle is used to access | |
| TechnologicalCharacteristicsCont. | Indications forUseCont. | surgically implanted vascular ports.The PowerLoc® MAX Power-InjectableInfusion Set is indicated for use in theadministration of fluids and drugs, as wellas blood sampling through surgicallyimplanted vascular ports.When used with ports that are indicated forpower injection of contrast media into thecentral venous system, the PowerLoc®MAX Power-Injectable Infusion Set is alsoindicated for power injection of contrastmedia. For power injection of contrastmedia, the maximum recommendedinfusion rate at 11.8 cPs is 5 ml/s for 19gauge and 20 gauge needles, and 2 ml/s | |
| GeneralDeviceDescription | Same as predicate. | for 22 gauge needles.The PowerLoc® MAX Power-InjectableInfusion Set is a non-coring Huber needleinfusion set with an integral needle stickprevention safety feature.The stabilization device is an accessory to | |
| the Huber needle infusion sets which isplaced centrally over the implanted port toassist in the placement of the Huberneedle in the implanted port. | |||
| Y-Site | Same as predicate. | The PowerLoc® MAX Power-InjectableInfusion Set is offered either with or withouta Y-site. | |
| Duration ofUse | PowerLoc® MAX: Same aspredicate.Stabilization accessory: Sameas predicate. | PowerLoc® MAX: Externallycommunicating device with an indirectblood path with a contact duration of >24hours to 30 days.Stabilization accessory: A single-use | |
| device used only for the duration of theinsertion of the needle into the port.Surface device, skin only, limited exposure(≤24 hours). | |||
| Same as predicate. | Huber NeedleStainless Steel | ||
| DeviceMaterials | Same as predicate. | AdhesiveUV Adhesive | |
| Same as predicate. | Safety Guard BaseStyrene, Butadine, Copolymer orPolycarbonate | ||
| Same as predicate. | Needle LubricantMedical Grade Silicones | ||
| Same as predicate. | Safety Guard Inner BaseStyrene, Butadiene, CopolymerInsert Colorants:YellowBrownBlack | ||
| TechnologicalCharacteristicsCont. | DeviceMaterialsCont. | Same as predicate. | Safety Guard SleeveStainless Steel |
| Same as predicate. | Safety Guard ShutterStainless Steel | ||
| Same as predicate. | Pad-print InkInk | ||
| Same as predicate. | Needle CoverPolyethylene | ||
| Same as predicate. | Safety Guard HandleStyrene, Butadiene, Copolymer | ||
| Same as predicate. | Comfort PadPolyethylene | ||
| Same as predicate. | Administration TubingPVC | ||
| Same as predicate. | Female Locking Luer ConnectionPVC | ||
| Same as predicate. | Adaptable Y-Injection Site Female LockingLuer ConnectionPVC | ||
| Same as predicate. | Non-vented Male Luer CapAcrylonitrile butadiene styrene | ||
| Same as predicate. | Pinch ClampsPolypropyleneColorantsYellowBrownBlack | ||
| Same as predicate. | Stabilization accessoryStabilizerPolycarbonate |
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| TechnologicalCharacteristicsCont. | Same as predicate. | Stabilization accessoryNeedle HandlePolypropylene | ||||
|---|---|---|---|---|---|---|
| SterilityMethod | Same as predicate. | Ethylene Oxide | ||||
| SterilityAssuranceLevel (SAL) | Same as predicate. | SAL 10-6 | ||||
| Number ofUses | Same as predicate. | Single-use device | ||||
| AnatomicalSite Use | Same as predicate. | The site of a surgically implanted vascularport. | ||||
| Principle ofOperation | Same as predicate. | The device accesses implanted ports inorder to transport fluid into, and out of, thecentral venous system. It utilizes astandard right angle non-coring Huber typeneedle and infusion set with an integralsafety engineered needlestick preventionfeature in order to do this. | ||||
| SafetyInfusion SetDeviceComponents | Same as predicate. | End CapLuer connectorTubingNon-Winged GripSafety Guard BaseMarked Pinch ClampsNeedleNeedle handleStabilization accessory | ||||
| Sizes | Same as predicate. | Needle Gauge - 19, 20 or 22Needle Length - 0.75 in., 1.00 in., 1.50 in. | ||||
| Needle OD | Same as predicate. | NeedleGauge | Needle OD mm (in.) | ClampColor | ||
| 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 | ||||
| TubingDimensionSummary fordevicewithout Y-Injection Site | Same as predicate. | NeedleGauge | InnerDiameter | OuterDiameter | 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. | |||
| DimensionSummary fordevice 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 – Uncoated1073B Tyvek® nylon, LDPEHDPE | Pouch – 1059B Tyvek® and TPF, PETBased Adhesive Lamination | ||||
| KitComponents-(onlyconfigurationsoffered arewith orwithout thestabilizationaccessory) | Mask (2)Hand Sanitizer (2)Gloves (Silver)Absorbent TowelFenestrated DrapeChloraprep, 3 mLGloves, Purple NitrileGuardIVa® AntimicrobialHemostatic DressingSkin Protectant PadPre-Filled Saline SyringeSentrinex™ 3D Port Dressing | None | ||||
| Comparison between subject SafeStep® Huber Needle Set (with or without thestabilization accessory) and the predicate SafeStep® Huber Needle Set (with orwithout the stabilization accessory) | ||||||
| DeviceAttribute | Subject:SafeStep® Huber Needle Setwith or without the stabilizationaccessory | Predicate K153440:SafeStep® Huber Needle Set with orwithout the stabilization accessory | ||||
| Owner | Same as predicate. | Bard Access Systems, Inc. | ||||
| Product Code | PTI21 CFR 880.5570Non-Coring Huber Needle | FPA | 21 CFR 880.5440 | Set, Administration, Intravascular | ||
| Review Branch | Same as predicate. | Center For Devices and RadiologicalHealth (CDRH) | ||||
| 510k Status | Subject of thisPremarket Notification | K153440 | Concurrence Date: August 18, 2016 | |||
| Same as predicate. | The SafeStep® Huber Needle Set is a | |||||
| TechnologicalCharacteristicsCont. |
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| Indications forUse | Same as predicate. | The SafeStep® Huber Needle Set is adevice intended for insertion into theseptum of a subcutaneously implantedport and for the infusion of fluids into theport. The SafeStep® Huber Needlesafety feature is manually activatedduring needle removal, and is designedto aid in the prevention of accidentalneedlesticks. | |
|---|---|---|---|
| GeneralDeviceDescription | Same as predicate. | The SafeStep® Huber Needle Set is anon-coring Huber needle infusion set withan integral needle stick prevention safetyfeature.The stabilization device is an accessoryto the Huber needle infusion sets which | |
| is placed centrally over the implantedport to assist in the placement of theHuber needle in the implanted port. | |||
| Y-Site | Same as predicate. | The SafeStep® Huber Needle Set isoffered either with or without a Y-site. | |
| TechnologicalCharacteristicsCont. | Duration ofUse | SafeStep®:Same as predicate. | SafeStep®: Externally communicatingdevice with an indirect blood path with acontact duration of >24 hours to 30 days. |
| Stabilization accessory:Same as predicate. | Stabilization accessory: A single-usedevice used only for the duration of theinsertion of the needle into the port.Surface device, skin only, limitedexposure (≤24 hours). | ||
| DeviceMaterials | Same as predicate. | Huber NeedleStainless Steel | |
| Same as predicate. | AdhesiveUV Adhesive | ||
| Same as predicate. | Safety Guard BaseStyrene, Butadine, Copolymer orPolycarbonate | ||
| Same as predicate. | Needle LubricantMedical Grade Silicones - Dow 360 orMED-4149 or MED-361 | ||
| Same as predicate. | Safety Guard Inner BaseStyrene, Butadine, CopolymerInsert Colorants:YellowBrownBlack | ||
| TechnologicalCharacteristicsCont. | DeviceMaterialsCont. | Same as predicate. | Safety Guard SleeveStainless Steel |
| Same as predicate. | Safety Guard ShutterStainless Steel | ||
| Same as predicate. | Needle CoverPolyethylene | ||
| Same as predicate. | Safety Guard HandleStyrene, Butadiene, Copolymer | ||
| Same as predicate. | Comfort PadPolyethylene | ||
| Same as predicate. | Administration TubingPVC | ||
| Same as predicate. | Female Locking Luer ConnectionPVC | ||
| Same as predicate. | Needleless Access Connector Y-SitePolycarbonateSilicone | ||
| Same as predicate. | Non-vented Male Luer CapAcrylonitrile butadiene styrene | ||
| Same as predicate. | Pinch ClampsPolypropyleneColorantsYellowBrownBlack | ||
| Same as predicate. | Stabilization accessoryStabilizerPolycarbonateStabilization accessoryNeedle HandlePolypropylene | ||
| SterilityMethod | Same as predicate | Ethylene Oxide | |
| SterilityAssuranceLevel (SAL) | Same as predicate | SAL 10-6 | |
| Number ofUses | Same as predicate | Single-use device | |
| AnatomicalSite Use | Same as predicate | The site of a surgically implantedvascular port. |
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| Principle ofOperation | Same as predicate | The device accesses implanted ports inorder to transport fluid into, and out of,the central venous system. It utilizes astandard right angle non-coring Hubertype needle and infusion set with anintegral safety engineered needlestickprevention feature in order to do this. | ||||
|---|---|---|---|---|---|---|
| Safety InfusionSet DeviceComponents | Same as predicate | End CapLuer connectorTubingNon-Winged GripSafety Guard BasePinch ClampsNeedleNeedle handleStabilization accessory | ||||
| TechnologicalCharacteristics | Sizes | Needle Gauge - Same aspredicate.Needle Length - Same aspredicate. | Needle Gauge - 19, 20 or 22Needle Length - 0.75 in., 1.00 in., 1.50in. | |||
| Cont. | NeedleOutsideDiameter | Same as predicate. | NeedleGauge | Needle OD mm (in.) | ClampColor | |
| 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 | |||
| TubingDimensionSummary fordevice withoutY-injectionSite | Same as predicate | NeedleGauge | InnerDiameter | OuterDiameter | 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 | NeedleGauge | InnerDiameter | OuterDiameter | Length | |
| Dimension | 19G | 0.048 in. | 0.088 in. | 4 in. | ||
| Summary fordevice 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 1073BTyvek®, nylon, LDPE, HDPE | Pouch - 1059B Tyvek® and TPF, PETBased Adhesive Lamination |
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| TechnologicalCharacteristicsCont. | KitComponents-(onlyconfigurationsoffered arewith or withoutthestabilizationaccessory) | |
|---|---|---|
| Mask (2)Hand Sanitizer (2)Gloves (Silver)Absorbent TowelFenestrated DrapeChloraprep, 3 mLGloves, Purple NitrileGuardIVa® AntimicrobialHemostatic DressingSkin Protectant PadPre-Filled Saline SyringeSentrinex™ 3D Port Dressing | None |
The following table identifies the requlatory information for each component used in the subject device kits.
| Kit Component (TradeName /Manufacturer Name) | RegulationNumber | Classification | RegulatoryCoverage |
|---|---|---|---|
| Mask | 21 CFR878.4040 | Class II | K110455 |
| Hand Sanitizer Packet | N/A | OTC Drug | NDC21749-530-01 |
| STERLING* Nitrile Gloves | 21 CFR880.6250 | Class I | K081089 |
| Absorbent Towel | 21 CFR878.4370 | Class II | K862801 |
| Fenestrated Drape | 21 CFR878.4370 | Class II | K111458 |
| ChloraPrep™ Solution One-Step Applicator, 3 mL | N/A | OTC Drug | NDA020832 |
| PURPLE NITRILE* Gloves | 21 CFR880.6250 | Class I | K051347 |
| GuardIVa® AntimicrobialHemostatic IV Dressing | Unclassified | Unclassified | K121485 |
| Prep Pad, Skin Protectant | 21 CFR880.5090 | Class IExempt | N/A |
| Sentrinex™ 3D PortDressing | 21 CFR878.4020 | Class IExempt | N/A |
| Syringe, Sodium Chloride(Saline) 0.9%, 10 mLª | 21 CFR880.5200 | 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
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| Summary ofSubstantialEquivalence | Based on the intended use, technological characteristics, and safety and performance testing, thesubject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set with orwithout the stabilization accessory included in kit configurations, meet the requirements that areconsidered sufficient for its intended use as compared to the predicate devices cited. Therefore, thesubject devices are substantially equivalent to the predicates. |
|---|---|
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§ 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).