(29 days)
The AccuCath™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath™ IV Catheter is suitable for use with power injectors.
The AccuCath™ Intravascular Catheter has usable length catheters of 1.25 and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The AccuCath™ IV Catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. The AccuCath™ IV Catheter is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, and a guidewire within the lumen of the needle which is connected to a slider, spring and release button.
This document is a 510(k) premarket notification for the AccuCath™ Intravascular Catheter. It is a submission to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating the performance of an AI/ML device against acceptance criteria.
The document does not contain any information about a study proving a device meets acceptance criteria in the context of AI/ML performance metrics such as accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating that a modification to a previously cleared medical device (an intravascular catheter) is substantially equivalent to its predicate.
Specifically:
- It describes a traditional medical device (intravascular catheter), not an AI/ML device.
- The "Performance Tests" section explicitly states that "no verification or validation activities were required" and "it is not necessary to conduct additional performance tests including verification and validation" because the changes are limited to labeling modifications and do not impact design, materials, performance, or risk profile.
Therefore, I cannot provide the requested information as it is not present in the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
C.R. Bard, Inc. Jacob Lee Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K162894
Trade/Device Name: AccuCath™ Intravascular Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 13, 2016 Received: October 17, 2016
Dear Mr. Jacob Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name AccuCath Intravascular Catheter
Indications for Use (Describe)
The AccuCath Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath IV Catheter is suitable for use with power injectors.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary 21 CFR 807.92(a) | |||
|---|---|---|---|
| GeneralProvisions | Submitter Name:Submitter Address:Contact Person:Telephone Number:Fax Number:Date of Preparation: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116Jacob LeeRegulatory Affairs Specialist(801) 522-5823(801) 522-5425October 13, 2016 | |
| SubjectDevice | Trade Name:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | AccuCath™ Intravascular CatheterIntravascular CatheterIntravascular CatheterFOZ21 CFR §880.5200Class IIGeneral Hospital | |
| PredicateDevices | Predicate Trade Name:Premarket Notification:Manufacturer:Common Name:Regulation Name:Regulation:Regulatory Class:Classification Panel: | AccuCath™ Intravascular CatheterK153298 (cleared December 10, 2015)Bard Access Systems, Inc.Intravascular CatheterIntravascular Catheter21 CFR §880.5200Class IIGeneral Hospital | |
| DeviceDescription | The AccuCath™ Intravascular Catheter has usable length catheters of 1.25and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use,sterile intravascular catheters designed to be inserted into a patient'svascular system to sample blood, monitor blood pressure, or administerfluids intravenously. The AccuCath™ IV Catheter's hub has a built in bloodcontrol septum. The blood control feature is a single-use septum thatautomatically activates to stop the blood flow in the catheter hub when theneedle is removed from the catheter during initial insertion by the clinician.Blood flow from the catheter hub will be restricted immediately after needleretraction until a secure luer connection is made. The flow path ispermanently opened once a secure luer connection has been made. TheAccuCath™ IV Catheter is provided with a safety mechanism which allowsthe needle to be shielded following placement of the catheter. All deviceshave the basic structure of a protective cover, a catheter with a luer lockfitting, a needle connected to a flashback chamber, a safety container, and aguidewire within the lumen of the needle which is connected to a slider,spring and release button. | ||
| Intended Use | The AccuCath™ Intravascular Catheter is intended to be inserted in thepatient's vascular system for short term use to sample blood, monitor bloodpressure, or administer fluids intravenously. | ||
| Attribute | Subject Device - AccuCath™ Intravascular Catheter | Predicate Device – AccuCath™ Intravascular Catheter (K153298) | |
| Owner | Same as predicate | Bard Access Systems, Inc. | |
| Classification | Same as predicate | FOZ - 21 CFR 880.5200 -Short-term - IntravascularCatheter | |
| 510(k) Status | Subject of this PremarketNotification | K153298 - Concurrence dateDecember 10, 2015 | |
| Indications forUse | Proposed Indications for Use toremove the pressure setting andflow rate:The AccuCath™ IntravascularCatheter is inserted into apatient's vascular system tosample blood, monitor bloodpressure, or administer fluidsintravenously. This device maybe used with consideration givento adequacy of vascularanatomy, appropriateness of thesolution being infused, andduration of therapy. The | The AccuCath™ IntravascularCatheter is inserted into apatient's vascular system tosample blood, monitor bloodpressure, or administer fluidsintravenously. This device maybe used with considerationgiven to adequacy of vascularanatomy, appropriateness ofthe solution being infused, andduration of therapy. TheAccuCath™ IV Catheter issuitable for use with lowpressure power injectors | |
| TechnologicalCharacteristics | Name | Catheter | |
| CatheterDimensions | Same as predicate | ||
| Duration ofUse | Same as predicate | ||
| Primary DeviceComponents | Same as predicate | ||
| Means ofInsertion | Same as predicate | ||
| Insertion Site | Same as predicate | ||
| Primary DeviceMaterials | Same as predicate | ||
| CatheterProximalConfiguration | Same as predicate | ||
| Catheter DistalConfiguration | Same as predicate | ||
| Number ofLumens | Same as predicate | ||
| Power InjectionMaximum FlowRate | Same as predicate | ||
| Sterility | Same as predicate | ||
| PackagingConfigurations | Basic ConfigurationIntermediate Configuration | ||
| PerformanceTests | As part of Bard Access Systems, Inc.'s design controls, a risk analysis wasconducted to assess the impact of the proposed subject device labelingmodifications. The results of the risk analysis determined that no verificationor validation activities were required because the subject device labelingmodifications to the Indications for use and instructions for use do not includeany changes to the design, materials, performance, or risk profile of the citedpredicate device. Therefore, it is not necessary to conduct additionalperformance tests including verification and validation. | ||
| Summary ofSubstantialEquivalence | The modification to the indications for use and product instructions for usehas no impact on the intended use, technological characteristics, or riskprofile of the subject device because there are no changes to the design orperformance of the predicate device. Therefore, the subject AccuCathTMIntravascular Catheter is substantially equivalent to the cited predicatedevice. |
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AccuCath™ IV Catheter is
suitable for use with power
Same as predicate
injectors.
Commercial
setting of 300 psi and maximum flow rate of
AccuCath™ Intravascular
6mL/second.
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§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).