(265 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 safety mechanism 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 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.
The PowerLoc MAX® Power-Injectable Infusion Set is a standard non-coring intravascular administration 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 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.
The SafeStep® Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. 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.
The stabilization device is intended for use as an accessory to the subject PowerLoc MAX® and SafeStep® infusion sets, 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 device is lifted off of the needle. The stabilization device is then discarded per hospital protocol.
The provided document is a 510(k) summary for medical devices (PowerLoc MAX® Power-Injectable Infusion Set and SafeStep® Huber Needle Set). It details the regulatory clearance for these devices. However, the document does not contain information about acceptance criteria and studies proving the device meets these criteria in the context of an AI/algorithm-driven device.
The "Performance Tests" section details a series of tests conducted to ensure the device's physical and functional performance, materials, and safety in relation to its intended use as an intravascular administration set. These tests include:
- Slide Force testing (to ensure easy needle slide within the stabilization device).
- Stabilization Device Removal Force testing (to ensure easy removal of the stabilization device).
- Acceptability of the Stabilization Device (clinical acceptability of placement).
- Acceptability of GuardIVa® with Stabilization Device (validation of antimicrobial dressing use).
- Various ISO standards compliance (e.g., sharps injury protection, infusion equipment, biocompatibility, sterilization, packaging, luer fittings, needle tubing, intravascular catheters, and hypodermic needles).
- FDA Guidance compliance (e.g., sharps injury prevention features, MR compatibility).
- Risk management (FMEA) in accordance with BS EN ISO 14971:2012.
The document states: "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices."
Therefore, it is not possible to extract the requested information (sample size for test/training set, data provenance, number/qualification of experts, adjudication method, MRMC study, standalone performance, type of ground truth) because the supplied document describes the regulatory approval of a physical medical device (infusion set/needle) and not an AI/algorithm-driven device.
The questions posed relate to the validation of AI/ML-based medical devices, which involve different types of studies (e.g., diagnostic accuracy, reader studies) and data considerations than those detailed for this hardware device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2016
Darlene Hull Regulatory Affairs Specialist C.R. Bard, Inc. 605 North 5600 West Salt Lake City, Utah 84116
Re: K153440
Trade/Device Name: PowerLoc Max® Power-Injectable Infusion Set, SafeStep® Huber Needle Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: July 19, 2016 Received: July 20, 2016
Dear Darlene Hull:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name 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 safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.
The PowerLoc MAX® Power-Iniectable 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 qauge 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) 区
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."
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC |
|---|---|---|
| Publishing Services (301) 443-6740 | EF |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31. 2017 See PRA Statement below.
510(k) Number (if known)
Device Name SafeStep® Huber Needle Set
Indications for Use
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.
Type of Use (Select one or both, as applicable)
区 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."
| FORM FDA 3881 (8/14) |
|---|
| Publishing Services (301) 443-6740 |
Page 1 of 1
PSC
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Image /page/4/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below that, in a smaller font, are the words "ACCESS SYSTEMS".
510(k) Summary
21 CFR § 807.92(a)
| GeneralProvisions | Submitter Name:Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 |
|---|---|---|
| Contact Person:Telephone Number:Fax Number:Date of Preparation: | Darlene HullRegulatory Affairs Specialist(801) 522-5613(801) 522-542523 November 2015 | |
| SubjectDevices | Trade Name:Common Name:Classification Name:Product Code/Regulation: | PowerLoc MAX® Power-Injectable Infusion SetHuber Needle Intravascular Administration SetIntravascular Administration SetFPA21 CFR § 880.5440 |
| Trade Name:Common Name:Classification Name:Product Code/Regulation: | SafeStep® Huber Needle SetHuber Needle Intravascular Administration SetIntravascular Administration SetFPA21 CFR § 880.5440 | |
| PredicateDevices | Trade Name:Classification Name:Premarket Notification:Manufacturer: | SafeStep® MAX Power-Injectable Infusion SetIntravascular Administration SetK073050Bard Access Systems, Inc. |
| Trade Name:Classification Name:Premarket Notification:Manufacturer: | Luther Safety Huber Needle SetIntravascular Administration SetK040527Bard Access Systems, Inc. |
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| PowerLoc MAX® Power-Injectable Infusion Set | ||
|---|---|---|
| The PowerLoc MAX® Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber typeright angle needle and a manually activated needle-stick preventionsafety mechanism which reduces the risk of accidental needlestickinjuries by shielding the needle. The device is used to accesssurgically 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 indicatedfor power injection of contrast media into the central venous systemonly through an implanted port that is also indicated for powerinjection. The maximum recommended infusion rate at 11.8 cPs is 5ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gaugeneedles. The PowerLoc MAX® Power-Injectable Infusion Set isoffered with and without a Y-site. | ||
| DeviceDescriptions | SafeStep® Huber Needle Set | |
| The SafeStep® Huber Needle Set is a standard right angle Huberneedle and administration set with a needlestick prevention feature,designed for use with a vascular access infusion system. It ismanufactured with conventional medical grade, biocompatiblematerials. The SafeStep® Huber Needle Set operates as a standardHuber needle with the addition of a safety feature to aid in theprevention of needlestick injuries to the health practitioner. TheSafeStep® Huber Needle Set is offered with and without a Y-site. | ||
| Stabilization Device | ||
| The stabilization device is intended for use as an accessory to thesubject PowerLoc MAX® and SafeStep® infusion sets, and is suppliedpre-loaded with the subject devices. It is placed centrally over theimplanted port so that the base surrounds the implanted port under theskin. The infusion set needle handle is pressed down until the needlehas entered the port septum, then the stabilization device is lifted off ofthe needle. The stabilization device is then discarded per hospitalprotocol. | ||
| Intended Use | Both the subject PowerLoc MAX® Power-Injectable Infusion Set andSafeStep® Huber Needle Sets, with and without the stabilizationdevice, are intended for use in the administration of fluids and drugs,as well as blood sampling through surgically implanted vascular ports. | |
| Indications ForUse | PowerLoc MAX® Power-Injectable Infusion Set | |
| The PowerLoc MAX® Power-Injectable Infusion Set is an intravascularadministration set with a non-coring right angle needle and manuallyactivated needle stick prevention safety mechanism which reduces therisk 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 foruse in the administration of fluids and drugs, as well as blood samplingthrough surgically implanted vascular ports. | ||
| When used with ports that are indicated for power injection of contrastmedia into the central venous system, the PowerLoc MAX® Power-Injectable Infusion Set is also indicated for power injection of contrastmedia. For power injection of contrast media, the maximumrecommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20gauge needles, and 2 ml/s for 22 gauge needles. | ||
| SafeStep® Huber Needle Set | ||
| The SafeStep® Huber Needle Set is a device intended for insertioninto the septum of a subcutaneously implanted port and for the infusionof fluids into the port. The SafeStep® Huber Needle safety feature ismanually activated during needle removal, and is designed to aid in theprevention of accidental needlesticks. | ||
| TechnologicalCharacteristics | Technological characteristics including design and function of thesubject devices, the PowerLoc MAX® Power-Injectable Infusion Setand SafeStep® Huber Needle Set without stabilization device, aresimilar with respect to those of the predicate devices, SafeStep® MAXPower-Injectable Infusion Set and Luther Safety Huber Needle Set. | |
| The subject devices may be used with a pre-loaded stabilization deviceaccessory that is intended to stabilize the port during access and aidinsertion of the needle into the port. The stabilization device utilizesmaterials that are a different formulation than materials used in thepredicate devices, and have not been used in another legally marketeddevice within the same classification regulation with the same intendeduse. The stabilization device constitutes a change to the ergonomics ofthe patient/user interface of the subject devices, but does not changethe design or function of the subject devices when used as anaccessory to these devices. | ||
| PerformanceTests | Verification and validation tests were performed in accordance withDesign Controls per 21 CFR §820.30. The following performance datawere referenced in support of the substantial equivalencedetermination. Testing was performed based on Bard Access Systems(BAS) internal test protocols as well as on existing standards that arerelevant to the subject devices. | |
| Testing performed based on BAS internal test protocols are as follows: | ||
| Slide Force testing was performed to ensure that the forcerequired to slide the needle down the length of the stabilizationdevice did not exceed the force required to insert the needle in |
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| the port septum.Stabilization Device Removal Force testing was performed toensure that it was not difficult to remove the stabilization deviceonce the subject needle was inserted into the port.Acceptability of the Stabilization Device to verify that the | |
|---|---|
| stabilization device was clinically acceptable in the placementof a port access needle. | |
| Acceptability of GuardIVa® with Stabilization Device tovalidate the use as directed in the IFU of the antimicrobialdressing with the stabilization device. | |
| In addition to BAS internal protocols, the following guidancedocuments and standards were used to determine appropriatemethods for evaluating the performance of the device: | |
| • ISO 23908 First edition 2011-06-11 Sharps injury protection -Requirements and test methods - Sharps protection features forsingle-use hypodermic needles, introducers for catheters andneedles used for blood sampling | |
| • ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment formedical use - Part 4: Infusion sets for single use, gravity feed[Including: Amendment 1 (2013)]10. | |
| • BS EN ISO 8536-10:2015 Infusion equipment for medical use -Part 10: Accessories for fluid lines for single use with pressureinfusion equipment. | |
| • ISO 10993-1 Fourth edition, 2009-10-15 - Biological Evaluationof Medical Devices Part 1: Evaluation and Testing within a riskmanagement process. | |
| • ISO 10993-7: 2008 - Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals. | |
| • ISO 11135: 1994 - Medical Devices - Validation and RoutineControl of Ethylene Oxide Sterilization. | |
| • BS EN ISO 11607-1 Packaging for terminally sterilized medicaldevices Part 1: Requirements for materials, sterile barriersystems and packaging systems. | |
| • ISO 594-1: 1986, Conical Fittings with a 6% (Luer) Taper forSyringes, Needles, and Certain Other Equipment. | |
| • ISO 594-2: 1998, Conical Fittings with a 6% (Luer) Taper forSyringes, Needles and Certain Other Medical Equipment - Part2: Lock Fittings. | |
| • ISO 9626 AMD 1: 2001 - Stainless Steel Needle Tubing forManufacture of Medical Devices. | |
| • ISO 10555-1: 2013 – Intravascular catheters – Sterile and | |
| single-use catheters – Part 1: General requirements.• ISO 11137-1: 2006 – Sterilization of health care products –Radiation - Part 1: Requirements for development, validationand routine control of a sterilization process for medicaldevices. | |
| • ISO 7864: 1993 – Sterile hypodermic needles for single use. | |
| • FDA Guidance Medical Devices with Sharps Injury PreventionFeatures issued August 9, 2005. | |
| • FDA Guidance Establishing Safety and Compatibility of PassiveImplants in the Magnetic Resonance (MR) Environment issuedDecember 11, 2014. | |
| The subject devices met all predetermined acceptance criteria derivedfrom the above listed references and demonstrated substantiallyequivalent performance as compared to the cited predicate devices. | |
| Risk management, including a failure modes and effects analysis(FMEA), of the subject device was conducted in accordance with BSEN ISO 14971:2012, Medical Devices – Risk Management for MedicalDevices. | |
| Summary ofSubstantialEquivalence | Based on the intended use, technological characteristics, and safetyand performance testing, the subject PowerLoc MAX® Power-Injectable Infusion Set and SafeStep® Huber Needle Set used withand without the stabilization device meet the requirements that areconsidered sufficient for its intended use as compared to the predicatedevices cited. Therefore, the subject devices are substantiallyequivalent to the predicates. |
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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.