Introcan Safety 3 Closed IV Catheter

K182870 · B.Braun Medical, Inc. · FOZ · Mar 7, 2019 · General Hospital

Device Facts

• Record ID: K182870
• Device Name: Introcan Safety 3 Closed IV Catheter
• Applicant: B.Braun Medical, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Mar 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Introcan Safety® 3 Closed Intravascular Catheter is for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

Device Story

Peripheral intravascular catheter; over-the-needle design; radiopaque polyurethane tube; integrated bidirectional septum; stabilization platform; passive safety needle-shielding mechanism. Device inserted into patient vascular system by clinician; needle withdrawn through septum; septum seals to contain blood; passive shield automatically deploys over needle tip upon withdrawal to prevent needlestick injuries; prevents needle re-insertion to avoid catheter shearing. Used in clinical settings for fluid/blood administration, blood sampling, or pressure monitoring. Benefits include reduced clinician/patient blood exposure and improved catheter stability.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only, including biocompatibility (ISO 10993-1), sterilization residuals (ISO 10993-7), sterilization validation (ISO 11135-1), and performance testing per ISO 10555-1/5 (safety clip function, liquid tightness, flashback).

Technological Characteristics

Materials: Polyurethane (tube), Polypropylene (hub/housing), Stainless steel (needle/clip), MABS (needle hub), Silicone/Polyisoprene (septum), Polyoximethylene (septum opener). Passive safety needle-shielding mechanism. Sterilization: Ethylene Oxide. 5-year shelf life. Single lumen, tapered tip.

Indications for Use

Indicated for patients requiring short-term vascular access for blood sampling, blood pressure monitoring, or intravascular administration of fluids and blood. 18-24 gauge catheters are indicated for use with power injectors at a maximum pressure of 300 psi with luer lock connections.

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

• Introcan Safety® IV Catheter (K111236)
• Introcan Safety® IV Catheter (K163358)

Submission Summary (Full Text)

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March 7, 2019

B. Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K182870

Trade/Device Name: Introcan Safety® 3 Closed IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: February 4, 2019 Received: February 8, 2019

Dear Tracy Larish:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sapana Patel -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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# Indications for Use

510(k) Number (if known) K182870

Device Name Introcan Safety® 3 Closed IV Catheter

Indications for Use (Describe)

Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

The 18-24-gauge catheters may be used with power injectors at a maximum pressure of 300 psi with luer lock connection only.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) SUMMARY K182870

#### SUBMITTER INFORMATION:

| Name: | B. Braun Medical Inc. |
|-------------------|-------------------------------------------------|
| Address: | 901 Marcon Boulevard |
| | Allentown, PA 18109-9341 |
| Telephone Number: | 610-266-0500, ext. 2966 |
| Contact Person: | Tracy Larish, Sr. Regulatory Affairs Specialist |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | February 4th, 2019 |

#### DEVICE NAME:

| Device Trade Name: | Introcan Safety® 3 Closed IV Catheter |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name: | Safety Intravascular Catheter |
| Classification Name: | Catheter, intravascular, therapeutic, short-term less than 30 day, 21 CFR §880.5200: Class II, Product code FOZ |

### PREDICATE DEVICES:

- K111236 Introcan Safety® IV Catheter, B. Braun Medical, Inc. ●
- K163358 Introcan Safety® IV Catheter, B. Braun Medical, Inc. ●

### DEVICE DESCRIPTION

The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle-shielding mechanism.

Introcan Safety® 3 design is a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure.

The Introcan Safety® 3 catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure.

The passive safety needle-shielding mechanism of the Introcan Safety® 3 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.

This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The 18-24 gauge catheters may be used with power injectors with a rate of injection based on gauge size and for which the maximum pressure setting is 300 psi with a luer lock connection only.

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### INTENDED USE:

The Introcan Safety® 3 Closed Intravascular Catheter is for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

### INDICATIONS FOR USE:

Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

The 18-24-gauge catheters may be used with power injectors at a maximum pressure of 300 psi with luer lock connection only.

## TECHNOLOGICAL CHARACTERISTICS:

The proposed Introcan Safety® 3 Closed IV Catheter is substantially equivalent to the predicate Introcan Safety® 3 Closed IV Catheters in terms of indications for use, intended use, general design, functional performance and materials of construction. The materials of the final sterilized device are identical to the currently marketed Introcan product family in formulation, processing, and sterilization, and no other chemicals have been added.

The differences between the proposed and predicate Introcan Safety® 3 Closed IV Catheter devices are listed below. These differences, do not impact the statement of substantial equivalence.

- . line extension to the size offerings to include an additional length for the 20Ga in a 50mm size and a 14 Ga. x 1-1/4" (32mm) and 14 Ga. x 2" (50mm)
- power injection capabilities are extended to the 24 Ga. device. The 16Ga. and the ● proposed 14 Ga. devices are not indicated for power injection.

Changes were made to the Instructions for Use to update the gauge sizes cleared for power injection and to reflect the verbiage of the most recently cleared device. These differences do not impact the statement of substantial equivalence.

The proposed Introcan Safety® 3 Closed IV Catheter 18-24 gauge devices include the identical septum, clip design and injection capabilities as the predicates and do not raise any different issues of safety and effectiveness.

| | Proposed Device<br>Introcan Safety® 3 IV Catheter | Predicate Device(K163358)<br>Introcan Safety® 3 IV Catheter | Predicate Device(K111236)<br>Introcan Safety® 3 IV Catheter |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Introcan Safety® 3 Closed<br>Intravascular Catheter is inserted<br>into a patient's vascular system for<br>short term use to sample blood,<br>monitor blood pressure or<br>administer fluids and blood<br>intravascularly.<br>The 18-24 gauge catheters may be<br>used with power injectors at a<br>maximum pressure of 300 psi with<br>a luer lock connection only. | Introcan Safety® 3 Closed<br>Intravascular Catheter is inserted<br>into a patient's vascular system for<br>short term use to sample blood,<br>monitor blood pressure or<br>administer fluids and blood<br>intravascularly | Introcan Safety® 3 Closed<br>Intravascular Catheter is inserted<br>into a patient's vascular system for<br>short term use (less than 30 days)<br>to sample blood, monitor blood<br>pressure or administer fluids and<br>blood intravascularly. The 18-22<br>gauge catheters may be used with<br>power injectors at a maximum<br>pressure of 300 psi with a luer<br>lock connection only. |
| Configuration | Single Lumen, Tapered Tip | Single Lumen, Tapered Tip | Single Lumen, Tapered Tip |

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| | Proposed Device | Predicate Device(K163358) | Predicate Device(K111236) | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Material<br>Composition | Introcan Safety® 3 IV Catheter<br>Catheter Tube: Polyurethane<br>Catheter Hub: Polypropylene<br>Needle: Stainless steel<br>Needle Hub: MABS<br>Safety Clip: Stainless steel<br>Septum: Silicone or Polyisoprene<br>Rubber<br>Septum Opener:<br>Polyoximethylene<br>Septum Housing: Polypropylene | Introcan Safety® 3 IV Catheter<br>Catheter Tube: Polyurethane<br>Catheter Hub: Polypropylene<br>Needle: Stainless steel<br>Needle Hub: MABS<br>Safety Clip: Stainless steel<br>Septum: Silicone or Polyisoprene<br>Rubber<br>Septum Opener:<br>Polyoximethylene<br>Septum Housing: Polypropylene | Introcan Safety® 3 IV Catheter<br>Catheter Tube: Polyurethane<br>Catheter Hub: Polypropylene<br>Needle: Stainless steel<br>Needle Hub: MABS<br>Safety Clip: Stainless steel<br>Septum: Silicone<br>Septum Opener:<br>Polyoximethylene<br>Septum Housing: Polypropylene | |
| Catheter<br>Gauge Sizes | 14ga-24ga | 16ga | 18ga-24ga | |
| Catheter<br>Length | 3/4" (19mm) – 2" (50mm) | 1-1/4" (32mm) – 2" (50mm) | 3/4" (19mm) - 1-3/4" (45mm) | |
| Gravity Flow<br>Rate | 14ga x 32 mm | 325 ml/min | | |
| | 14ga x 50 mm | 310 ml/min | | |
| | 16ga x 32 mm | 195 mL/min | 16ga x 32 mm | 195 mL/min |
| | 16ga x 50 mm | 185 mL/min | 16ga x 50 mm | 185 mL/min |
| | 18ga x 32 mm | 105 mL/min | 18ga x 32 mm | 105 mL/min |
| | 18ga x 45 mm | 100 mL/min | 18ga x 45 mm | 95 mL/min |
| | 20ga x 25 mm | 65 mL/min | 20ga x 25 mm | 65 mL/min |
| | 20ga x 32 mm | 60 mL/min | 20ga x 32 mm | 60 mL/min |
| | 20ga X 50 mm | 55ml/min | 22ga x 25 mm | 35 mL/min |
| | 22ga x 25 mm | 35 mL/min | 24ga x 19 mm | 22 mL/min |
| | 24ga x 19 mm | 22 mL/min | | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | |
| Shelf Life | 5 years | 5 years | 5 years | |

# NONCLINICAL TESTING

Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following testing has been completed for the proposed devices:

- Biocompatibility in accordance with ISO 10993-1 O
- Sterilization Residual testing in accordance with ISO 10993-7 O
- Sterilization Validation 11135-1 O
- Testing in accordance with ISO 10555-1 and ISO 10555-5 O
- Performance and functional testing to internal specifications that include: o
- Safety Clip function .
- Liquid Tightness
- 트 Flashback

# CONCLUSION:

Results of the functional and performance testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheters is as safe and effective as the predicate devices. The proposed Introcan Safety® 3 Closed IV Catheter are substantially equivalent to the predicate devices.