(33 days)
An intravascular catheter is a device 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. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Insyte™, Insyte-N™, and Insyte-W™ are available in 14-24 gauge and are made of BD Vialon™ Material. Angiocath™ is available in 14-24 gauge and is made of FFP Polymer material
This is an IV catheter from Becton Dickinson, which is a class II device under 21 CFR 880.5200. This device, named BD Angiocath™ and Insyte™ IV Catheters, did not have any AI/ML components in 2015. So, the request for acceptance criteria for such components cannot be fulfilled.
However, I can provide the acceptance criteria and performance data for the mechanical and physical tests performed on the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test Performed | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Per ISO 10993-1 | Meet biocompatibility standards | Pass |
| Liquid leakage | Per ISO 594-1, -2 | No liquid leakage | Pass |
| Air leakage | Per ISO 594-1, -2 | No air leakage | Pass |
| Separation force | Per ISO 594-1, -2 | Withstand specified separation force | Pass |
| Stress cracking | Per ISO 594-1, -2 | No stress cracking | Pass |
| Unscrewing torque | Per ISO 594-2 | Withstand specified unscrewing torque | Pass |
| Ease of assembly | Per ISO 594-2 | Easy assembly | Pass |
| Resistance to overriding | Per ISO 594-2 | Resistant to overriding | Pass |
| General | Per ISO 10555-1 | Meet general requirements | Pass |
| Radio-detectability | Per ISO 10555-1 | Radio-detectable | Pass |
| Biocompatibility (repeated) | Per ISO 10555-1 | Meet biocompatibility standards | Pass |
| Surface | Per ISO 10555-1 | Acceptable surface finish | Pass |
| Corrosion resistance | Per ISO 10555-1 | Corrosion-resistant | Pass |
| Peak tensile force | Per ISO 10555-1 | Withstand specified peak tensile force | Pass |
| Freedom from leakage | Per ISO 10555-1 | Freedom from leakage | Pass |
| Hubs | Per ISO 10555-1 | Meet hub requirements | Pass |
| Flowrate | Per ISO 10555-1 | Meet specified flowrate | Pass |
| Power injection | Per ISO 10555-1 | Suitable for power injection | Pass |
| Side holes | Per ISO 10555-1 | N/A (Not applicable / no side holes) | NA |
| Distal tip | Per ISO 10555-1 | Meet distal tip requirements | Pass |
| Color code | Per ISO 10555-5 | Correct color coding | Pass |
| Catheter unit | Per ISO 10555-5 | Meet catheter unit requirements | Pass |
| Needle point | Per ISO 10555-5 | Meet needle point requirements | Pass |
| Needle hub | Per ISO 10555-5 | Meet needle hub requirements | Pass |
| Strength of union between needle hub and needle tube | Per ISO 10555-5 | Withstand specified union strength | Pass |
| Vent fitting | Per ISO 10555-5 | Meet vent fitting requirements | Pass |
| Needle (Cannula) penetration force | Internal design input, identical to predicate | Penetration force specified by internal design input | Pass |
| Catheter penetration force | Internal design input, identical to predicate | Penetration force specified by internal design input | Pass |
| Catheter average drag force | Internal design input, identical to predicate | Average drag force specified by internal design input | Pass |
| Minimal catheter and cannula tip adhesion | Internal design input, identical to predicate | Minimal adhesion specified by internal design input | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test. It states that "design verification tests were performed based on the risk analysis." The data provenance is internal, as these were tests conducted by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc., as part of their design control process for regulatory submission. The document defines these as "design verification tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical device, and its performance criteria are established through standardized international and internal engineering test methods, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. Performance testing is based on objective measurements against defined standards and specifications, not on subjective interpretations requiring an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that humans interact with, which is not the case for this physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests presented are established international standards (ISO standards like ISO 10993-1, ISO 594-1, ISO 594-2, ISO 10555-1, ISO 10555-5) and internal design inputs that set specific thresholds for physical and mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2015
Becton Dickinson Infusion Therapy Systems, Incorporated c/o Mr. Mark Job Regulatory Technology Services, Inc. 1394 25th Street, NW Buffalo, MN 55313
Re: K151698
Trade/Device Name: BD Angiocath™ and Insyte™ Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: July 15, 2015 Received: July 16, 2015
Dear Mr. Job:
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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Page 2 - Mr. Mark Job
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 vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number ( if known ) | K151698 |
|---|---|
| Device Name | BD Angiocath IV Catheter and Insyte IV Catheter |
Indications for Use (Describe)
An intravascular catheter is a device 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. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section 5
510(k) Summary
510(k) Summary
21 CFR §807.92
BD Angiocath™ and Insyte™ IV Catheters
| SubmitterInformation | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|---|
| Submitter Address: | 9450 South State StreetSandy, UT 84070 | |
| Contact Person: | Henry BolandSenior Regulatory Affairs SpecialistPhone: 801.565.2550Fax: 801.304.3963Email: henry_boland@bd.com | |
| Date of Preparation: | 14 May 2015 | |
| SubjectDevices | Trade Name: | BD Angiocath™ IV Catheter |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Classification Name: | FOZ - Intravascular Catheter | |
| CFR Reference: | 21 CFR 880.5200 - Class II | |
| Classification Panel: | General Hospital | |
| Trade Name: | BD Insyte™ IV Catheter | |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Classification Name: | FOZ - Intravascular Catheter | |
| CFR Reference: | 21 CFR 880.5200 - Class II | |
| Classification Panel: | General Hospital | |
| PredicateDevices | Trade Name: | BD Angiocath™ and Insyte™ IV Catheter |
| 510(k) Reference: | K013800 | |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Classification Name: | FOZ - Intravascular Catheter | |
| CFR Reference: | 21 CFR 880.5200 - Class II | |
| Classification Panel: | General Hospital | |
| DeviceDescription | Insyte™, Insyte-N™, and Insyte-W™ are available in 14-24 gauge and are madeof BD Vialon™ Material. Angiocath™ is available in 14-24 gauge and is made ofFFP Polymer material |
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Indications for An intravascular catheter is a device that is inserted into the patient's vascular Use system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Technological characteristics of the subject devices are equivalent to the Technological predicates. The BD Angiocath™ and Insyte™ IV Catheters achieve their intended Characteristics use based on the same technology and principles of operation. The subject devices have been modified from the predicate devices as listed below. The results of design verification demonstrate that these changes are substantially equivalent to the predicate devices. All other aspects of the subject device are identical to those of the predicate device.
· Change to lubricants used in the assembly on the device
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE | ||
|---|---|---|---|---|
| Indications forUse | An intravascular catheter is a devicethat is inserted into the patient'svascular system for short term use(less than 30 days) to sample blood,monitor blood pressure, or administerfluids intravenously. These cathetersmay be used for any patient populationwith consideration given to adequacyof vascular anatomy andappropriateness of procedure. | An intravascular catheter is a devicethat is inserted into the patient'svascular system for short term use(less than 30 days) to sample blood,monitor blood pressure, or administerfluids intravenously. These cathetersmay be used for any patient populationwith consideration given to adequacyof vascular anatomy andappropriateness of procedure. | ||
| Design | A fluorinated ethylene propylene (FEP)or polyurethane peripheral IV catheter | A fluorinated ethylene propylene (FEP)or polyurethane peripheral IV catheter | ||
| Component | Subject Device | Component | Predicate Device | |
| Materials | Catheter Tubing | Angiocath™ IV CatheterFluorinated ethylenepropylene (FEP)Insyte™ IV CatheterBD Vialon™ polyurethane | Catheter Tubing | Angiocath™ IV CatheterFluorinated ethylenepropylene (FEP)Insyte™ IV CatheterBD Vialon™ polyurethane |
| Catheter Hub | Polypropylene | Catheter Hub | Polypropylene | |
| Metal Wedge | Stainless Steel | Metal Wedge | Stainless Steel | |
| Needle | Stainless Steel | Needle | Stainless Steel | |
| Needle Hub | Angiocath™ IV CatheterPropionateInsyte™ IV CatheterPropionate | Needle Hub | Angiocath™ IV CatheterPropionateInsyte™ IV CatheterPropionate | |
| Needle Cover | Polypropylene | Needle Cover | Polypropylene |
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| Materials(cont.) | Vent Plug | Angiocath™ IV CatheterPolyethylene | Angiocath™ IV CatheterPolyethylene | |
|---|---|---|---|---|
| Insyte™ IV CatheterPolypropylene with filter | Insyte™ IV CatheterPolypropylene with filter | |||
| Catheter TippingLubricant | Polydimethylsiloxane-basedLubricant | Polydimethylsiloxane-basedLubricant | ||
| Catheter Lubricant | Polydimethylsiloxane-basedLubricant | Polydimethylsiloxane-basedLubricant | ||
| Wedge Lubricant | Polydimethylsiloxane-basedLubricant | Polydimethylsiloxane-basedLubricant | ||
| Needle (Cannula)Lubricant | Two-PartPolydimethylsiloxane-basedLubricant | Single-PartPolydimethylsiloxane-basedLubricant | ||
| Physical /MechanicalSpecifications | SUBJECT DEVICES | PREDICATE DEVICES | ||
| Angiocath™ IV Catheter | Angiocath™ IV Catheter | |||
| Catheter Diameters:14G, 16G, 18G, 20G, 22G, 24G | Catheter Diameters:14G, 16G, 18G, 20G, 22G, 24G | |||
| Catheter Lengths:0.75", 1.00", 1.16", 1.88"Non-winged only | Catheter Lengths:0.75", 1.00", 1.16", 1.88"Non-winged only | |||
| Insyte™ IV Catheter | Insyte™ IV Catheter | |||
| Catheter Diameters:14G, 16G, 18G, 20G, 22G, 24G | Catheter Diameters:14G, 16 G, 18G, 20G, 22G, 24G | |||
| Catheter Lengths:0.56", 0.75", 1.00", 1.16", 1.77", 1.88"Winged or Non-winged | Catheter Lengths:0.56", 0.75", 1.00", 1.16", 1.77", 1.88"Winged or Non-winged |
Summary of Performance Tests
Pursuant to 21 CFR 820.30, Design Controls, design verification tests were performed based on the risk analysis, and the results of these tests demonstrate that the BD Angiocath™ and Insyte™IV Catheters are substantially equivalent to the predicate devices. Design verification testing included the following:
| Characteristic / Test Performed | Test Method | Results | |
|---|---|---|---|
| Biocompatibility | Per ISO 10993-1 | Pass | |
| Liquid leakage | Per ISO 594-1, -2 | Pass | |
| Air leakage | Per ISO 594-1, -2 | Pass | |
| Separation force | Per ISO 594-1, -2 | Pass | |
| Stress cracking | Per ISO 594-1, -2 | Pass | |
| Unscrewing torque | Per ISO 594-2 | Pass | |
| Ease of assembly | Per ISO 594-2 | Pass | |
| Resistance to overriding | Per ISO 594-2 | Pass | |
| General | Per ISO 10555-1 | Pass | |
| Radio-detectability | Per ISO 10555-1 | Pass | |
| Biocompatiblity | Per ISO 10555-1 | Pass | |
| Surface | Per ISO 10555-1 | Pass | |
| Corrosion resistance | Per ISO 10555-1 | Pass | |
| Peak tensile force | Per ISO 10555-1 | Pass | |
| Freedom from leakage | Per ISO 10555-1 | Pass | |
| Hubs | Per ISO 10555-1 | Pass | |
| Flowrate | Per ISO 10555-1 | Pass | |
| Power injection | Per ISO 10555-1 | Pass | |
| Side holes | Per ISO 10555-1 | NA | |
| Distal tip | Per ISO 10555-1 | Pass | |
| Color code | Per ISO 10555-5 | Pass | |
| Catheter unit | Per ISO 10555-5 | Pass | |
| Needle point | Per ISO 10555-5 | Pass | |
| Needle hub | Per ISO 10555-5 | Pass | |
| Strength of union between needle hub and needle tube | Per ISO 10555-5 | Pass | |
| Vent fitting | Per ISO 10555-5 | Pass | |
| Needle (Cannula) penetration force | Internal design input, identical to predicate | Pass | |
| Catheter penetration force | Internal design input, identical to predicate | Pass | |
| Catheter average drag force | Internal design input, identical to predicate | Pass | |
| Minimal catheter and cannula tip adhesion | Internal design input, identical to predicate | Pass | |
| Summary of Substantial Equivalence | Based on the indications for use, technological characteristics, and performance testing, the subject BD AngiocathTM and InsyteTM IV Catheters meet all predetermined requirements in accordance with 21 CFR 820.30, Design Controls, and demonstrates that the subject devices are substantially equivalent to the predicate devices. |
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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).