Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard intravascular catheter and its physical properties and performance testing, with no mention of AI or ML.

Therapeutic

Yes

Explanation: The device is an intravascular catheter used to administer fluids, sample blood, and monitor blood pressure, all of which are therapeutic or diagnostic interventions aimed at treating or assessing a patient's health.

Diagnostic

No

The device is an intravascular catheter used for sampling blood, monitoring blood pressure, or administering fluids, which are primarily interventional or monitoring functions, not diagnostic ones that involve identifying a disease or condition.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate a physical, hardware-based medical device (intravascular catheter) made of specific materials and undergoing physical testing. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device inserted into the patient's vascular system for direct interaction with the body (sampling blood, monitoring blood pressure, administering fluids). This is an in vivo use, meaning it's used within a living organism.
IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They are used outside the body.
Device Description: The description of catheters made of specific materials and available in different gauges aligns with a device intended for insertion into the body, not for testing samples.
Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples, reagents, or laboratory procedures, which are typical of IVDs.

Therefore, based on the provided information, this intravascular catheter is a medical device used in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FOZ

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vascular system

Indicated Patient Age Range

any patient population

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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: Biocompatibility, Liquid leakage, Air leakage, Separation force, Stress cracking, Unscrewing torque, Ease of assembly, Resistance to overriding, General, Radio-detectability, Biocompatiblity, Surface, Corrosion resistance, Peak tensile force, Freedom from leakage, Hubs, Flowrate, Power injection, Side holes, Distal tip, Color code, Catheter unit, Needle point, Needle hub, Strength of union between needle hub and needle tube, Vent fitting, Needle (Cannula) penetration force, Catheter penetration force, Catheter average drag force, Minimal catheter and cannula tip adhesion. All tests passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K013800

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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 SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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

21 CFR §807.92

BD Angiocath™ and Insyte™ IV Catheters

| Submitter

Information	Submitter Name:	Becton Dickinson Infusion Therapy Systems Inc.
	Submitter Address:	9450 South State Street
Sandy, UT 84070
	Contact Person:	Henry Boland
Senior Regulatory Affairs Specialist
Phone: 801.565.2550
Fax: 801.304.3963
Email: henry_boland@bd.com
	Date of Preparation:	14 May 2015
Subject
Devices	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
Predicate
Devices	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
Device
Description	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

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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 for
Use	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.	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.
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 Catheter
Fluorinated ethylene
propylene (FEP)

Insyte™ IV Catheter
BD Vialon™ polyurethane | Catheter Tubing | Angiocath™ IV Catheter
Fluorinated ethylene
propylene (FEP)

Insyte™ IV Catheter
Propionate | Needle Hub | Angiocath™ IV Catheter
Propionate

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| Materials
(cont.) | Vent Plug | Angiocath™ IV Catheter
Polyethylene | Angiocath™ IV Catheter
Polyethylene | |
|--------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------|--|
| | | Insyte™ IV Catheter
Polypropylene with filter | Insyte™ IV Catheter
Polypropylene with filter | |
| | Catheter Tipping
Lubricant | Polydimethylsiloxane-based
Lubricant | Polydimethylsiloxane-based
Lubricant | |
| | Catheter Lubricant | Polydimethylsiloxane-based
Lubricant | Polydimethylsiloxane-based
Lubricant | |
| | Wedge Lubricant | Polydimethylsiloxane-based
Lubricant | Polydimethylsiloxane-based
Lubricant | |
| | Needle (Cannula)
Lubricant | Two-Part
Polydimethylsiloxane-based
Lubricant | Single-Part
Polydimethylsiloxane-based
Lubricant | |
| Physical /
Mechanical
Specifications | 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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