BD Angiocath IV Catheter, BD Insyte IV Catheter

K151698 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Jul 27, 2015 · General Hospital

Device Facts

• Record ID: K151698
• Device Name: BD Angiocath IV Catheter, BD Insyte IV Catheter
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jul 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

Peripheral IV catheters (Angiocath and Insyte) designed for short-term vascular access; inserted into patient's vascular system by healthcare professionals. Used for blood sampling, blood pressure monitoring, or fluid administration. Subject devices feature modified needle lubricant compared to predicate. Design verification confirms substantial equivalence. No electronic or software components; purely mechanical device.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through design verification testing per ISO 594-1, ISO 594-2, ISO 10993-1, and ISO 10555-1/5, covering biocompatibility, leakage, tensile force, flow rate, and penetration force.

Technological Characteristics

Peripheral IV catheters. Materials: FEP or BD Vialon (polyurethane) tubing, polypropylene hubs/covers, stainless steel needles/wedges, polyethylene vent plugs. Lubricants: Polydimethylsiloxane-based. Dimensions: 14G-24G. Sterilization: Not specified. No software or electronic components.

Indications for Use

Indicated for any patient population requiring short-term (less than 30 days) vascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration, provided vascular anatomy is adequate.

Regulatory Classification

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.

Predicate Devices

• BD Angiocath™ and Insyte™ IV Catheter (K013800)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

**Indications for Use**

| 510(k) Number ( <i>if known</i> ) | 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 ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

| <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">Over-The-Counter Use</span> (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|

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## Section 5

# 510(k) Summary

# 510(k) Summary

## 21 CFR §807.92

## BD Angiocath™ and Insyte™ IV Catheters

| Submitter<br>Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | Submitter Address: | 9450 South State Street<br>Sandy, UT 84070 |
| | Contact Person: | Henry Boland<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Date of Preparation: | 14 May 2015 |
| Subject<br>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<br>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<br>Description | Insyte™, Insyte-N™, and Insyte-W™ are available in 14-24 gauge and are made<br>of BD Vialon™ Material. Angiocath™ is available in 14-24 gauge and is made of<br>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<br>Use | An intravascular catheter is a device<br>that is inserted into the patient's<br>vascular system for short term use<br>(less than 30 days) to sample blood,<br>monitor blood pressure, or administer<br>fluids intravenously. These catheters<br>may be used for any patient population<br>with consideration given to adequacy<br>of vascular anatomy and<br>appropriateness of procedure. | An intravascular catheter is a device<br>that is inserted into the patient's<br>vascular system for short term use<br>(less than 30 days) to sample blood,<br>monitor blood pressure, or administer<br>fluids intravenously. These catheters<br>may be used for any patient population<br>with consideration given to adequacy<br>of vascular anatomy and<br>appropriateness of procedure. | | |
| Design | A fluorinated ethylene propylene (FEP)<br>or polyurethane peripheral IV catheter | A fluorinated ethylene propylene (FEP)<br>or polyurethane peripheral IV catheter | | |
| | Component | Subject Device | Component | Predicate Device |
| Materials | Catheter Tubing | Angiocath™ IV Catheter<br>Fluorinated ethylene<br>propylene (FEP)<br><br>Insyte™ IV Catheter<br>BD Vialon™ polyurethane | Catheter Tubing | Angiocath™ IV Catheter<br>Fluorinated ethylene<br>propylene (FEP)<br><br>Insyte™ IV Catheter<br>BD 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 Catheter<br>Propionate<br><br>Insyte™ IV Catheter<br>Propionate | Needle Hub | Angiocath™ IV Catheter<br>Propionate<br><br>Insyte™ IV Catheter<br>Propionate |
| | Needle Cover | Polypropylene | Needle Cover | Polypropylene |

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| Materials<br>(cont.) | Vent Plug | Angiocath™ IV Catheter<br>Polyethylene | Angiocath™ IV Catheter<br>Polyethylene | |
|--------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------|--|
| | | Insyte™ IV Catheter<br>Polypropylene with filter | Insyte™ IV Catheter<br>Polypropylene with filter | |
| | Catheter Tipping<br>Lubricant | Polydimethylsiloxane-based<br>Lubricant | Polydimethylsiloxane-based<br>Lubricant | |
| | Catheter Lubricant | Polydimethylsiloxane-based<br>Lubricant | Polydimethylsiloxane-based<br>Lubricant | |
| | Wedge Lubricant | Polydimethylsiloxane-based<br>Lubricant | Polydimethylsiloxane-based<br>Lubricant | |
| | Needle (Cannula)<br>Lubricant | Two-Part<br>Polydimethylsiloxane-based<br>Lubricant | Single-Part<br>Polydimethylsiloxane-based<br>Lubricant | |
| Physical /<br>Mechanical<br>Specifications | SUBJECT DEVICES | | PREDICATE DEVICES | |
| | Angiocath™ IV Catheter | | Angiocath™ IV Catheter | |
| | Catheter Diameters:<br>14G, 16G, 18G, 20G, 22G, 24G | | Catheter Diameters:<br>14G, 16G, 18G, 20G, 22G, 24G | |
| | Catheter Lengths:<br>0.75", 1.00", 1.16", 1.88"<br>Non-winged only | | Catheter Lengths:<br>0.75", 1.00", 1.16", 1.88"<br>Non-winged only | |
| | Insyte™ IV Catheter | | Insyte™ IV Catheter | |
| | Catheter Diameters:<br>14G, 16G, 18G, 20G, 22G, 24G | | Catheter Diameters:<br>14G, 16 G, 18G, 20G, 22G, 24G | |
| | Catheter Lengths:<br>0.56", 0.75", 1.00", 1.16", 1.77", 1.88"<br>Winged or Non-winged | | Catheter Lengths:<br>0.56", 0.75", 1.00", 1.16", 1.77", 1.88"<br>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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