Introcan Safety 3 Closed IV Catheter

K163358 · B.Braun Melsungen AG · FOZ · Apr 28, 2017 · General Hospital

Device Facts

• Record ID: K163358
• Device Name: Introcan Safety 3 Closed IV Catheter
• Applicant: B.Braun Melsungen AG
• Product Code: FOZ · General Hospital
• Decision Date: Apr 28, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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.

Device Story

Over-the-needle peripheral intravascular catheter; radiopaque polyurethane tube; integrated bidirectional septum; stabilization platform; passive safety needle-shielding mechanism. Clinician inserts catheter into patient vascular system; needle withdrawn through septum; septum seals to contain blood and wipe needle; safety shield deploys automatically upon needle withdrawal to prevent needlestick injuries and catheter shearing. Used in clinical settings for blood sampling, pressure monitoring, or fluid/blood administration. Benefits include reduced blood exposure for clinicians/patients and improved catheter stability.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including dynamic tensile, air/liquid tightness, flow rate, withdrawal/clip drag force, pull strength, and blood flashback testing.

Technological Characteristics

Materials: Polyurethane (tube), Polypropylene (hub/housing), Stainless steel (needle/clip), MABS (needle hub), Silicone or Polyisoprene (septum), Polyoximethylene (septum opener). Passive safety mechanism; Ethylene Oxide sterilization; 16G gauge; 32mm-50mm lengths.

Indications for Use

Indicated for patients requiring short-term vascular access for blood sampling, blood pressure monitoring, or intravascular administration of fluids and blood. Use depends on vascular anatomy and therapy requirements.

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® 3 Closed IV Catheter (K111236)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

B. Braun Melsungen Ag % Kimberly Smith Senior Regulatory Affairs Specialist B. Braun Medical Inc. 901 Marcon Blvd. Allentown, Pennsylvania 18109

Re: K163358

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: March 29, 2017 Received: March 30, 2017

Dear Kimberly Smith:

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 and Part 809: medical device 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 and Part 809, 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/ResourcesforYou/Industry/default.htm. 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 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.

Tina
Kiang -S

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) K163356

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.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| 510(k) Summary | K163358 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500<br>Contact: Kimberly Smith, Sr. Regulatory Affairs Specialist |
| DATE: | April 28, 2017 |
| DEVICE NAME: | Introcan Safety® 3 Closed IV Catheter |
| COMMON OR<br>USUAL NAME: | Safety Intravascular Catheter |
| DEVICE<br>CLASSIFICATION: | Class II per 21 CFR §880.5200<br>Intravascular Catheter<br>Product Code FOZ |
| PREDICATE<br>DEVICE: | Introcan Safety® 3 Closed IV Catheter<br>B. Braun Medical Inc., K111236<br>General Hospital, Class II, per 21 CFR §880.5200<br>Intravascular Catheter |

SUBJECT OF 510(K): Addition of 16G Catheter Size to Product PortfolioSUBJECT OF 510(K): Addition of 16G Catheter Size to Product Portfolio

## 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 Closed IV Catheter design is described as 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 Closed IV Catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel.

The passive safety needle-shielding mechanism of the Introcan Safety® 3 Closed IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the

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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.

The 16ga includes the incremental changes to the predicate since clearance that were implemented in accordance with 21 CFR 820.30. The changes included an alternative septum material, establishment of a 5 year shelf life, instructions for use update to include precise flow rates, and product enhancements.

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.

### INTENDED USE:

The 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.

### 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.

### SUBSTANTIAL EQUIVALENCE:

### Technological Characteristics

The Introcan Safety® 3 Closed IV Catheter 16ga x 1-1/4 in. (32mm) and 16ga x 2 in. (50mm) sizes has a slightly modified indications to remove the regulatory language (< 30 days) and the reference to additional sizes in the product family which are not part of this review. These minor differences between the Indications for Use do not change the intended use of the predicate devices or raise different questions of safety and effectiveness.

The subject device is similar in the principals of operation and technological characteristics as the predicate device. The subject devices are constructed of the same materials, are manufactured, and sterilized utilizing the same processes.

### Performance Testing

The Introcan Safety® 3 Closed IV Catheter 16ga x 1-1/4 in. (32mm) and 16ga x 2 in. (50mm) sizes were subjected to functional and performance testing to demonstrate that the devices perform as intended. The following testing was performed:

- . Dynamic Tensile
- Air Tightness ●

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- Flow Rate •
- Projecting/Trim Length Capillary Tip
- Liquid Tightness •
- . Withdrawal Force
- Clip Drag Force •
- Pull Strength
- Blood Flashback
- Clip Function

## Substantial Equivalence Comparison

| Parameter | Proposed Device<br>Introcan Safety® 3 Closed IV Catheter | Predicate Device<br>Introcan Safety® 3 Closed IV Catheter<br>510(k) K111236 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Introcan Safety®3 Closed Intravascular<br>Catheter is inserted into a patient's vascular<br>system for short term use to sample blood,<br>monitor blood pressure or administer fluids and<br>blood intravascularly. | Introcan Safety®3 Closed Intravascular<br>Catheter is inserted into a patient's vascular<br>system for short term use (less than 30 days)<br>to sample blood, monitor blood pressure or<br>administer fluids and blood intravascularly.<br>The 18-22 gauge catheters may be used with<br>power injectors at a maximum pressure of 300<br>psi with a luer lock connection only. |
| Intended Use | Prescription Use<br>The Introcan Safety® 3 Closed Intravascular<br>Catheter is inserted into a patient's vascular<br>system for short term use to sample blood,<br>monitor blood pressure or administer fluids and<br>blood intravascularly. | Prescription Use<br>The Introcan Safety® 3 Closed Intravascular<br>Catheter is inserted into a patient's vascular<br>system for short term use (less than 30 days)<br>to sample blood, monitor blood pressure or<br>administer fluids and blood intravascularly. |
| Configuration | Single Lumen, Tapered Tip | Single Lumen, Tapered Tip |
| Material<br>Composition | 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 Rubber<br>Septum Opener: Polyoximethylene<br>Septum Housing: Polypropylene | 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: Polyoximethylene<br>Septum Housing: Polypropylene |
| Catheter Gauge<br>Sizes | 16ga | 18ga-24ga |
| Catheter Length | 1-1/4 in. (32mm) – 2 in. (50mm) | 3/4 in. (19mm) – 1-3/4 in. (45mm) |
| Gravity Flow<br>Rate | 16ga x 32mm 95 mL/min<br>16ga x 50mm 105 mL/min | 18ga x 45 mm 95 mL/min<br>18ga x 32 mm 105 mL/min<br>20ga x 32 mm 60 mL/min<br>20ga x 25 mm 65 mL/min<br>22ga x 25 mm 35 mL/min<br>24ga x 19 mm 22 mL/min |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Shelf-Life | 5 years | 2 years |

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Results of the performance testing demonstrate that the proposed devices perform similarly to the predicate device. No clinical testing was performed, as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

## CONCLUSION:

Results of functional and performance testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheter 16ga x 1-1/4 in. (32mm) and 16ga x 2 in. (50mm) sizes are safe and perform as intended. The differences between the subject devices and the predicate do not raise different questions of safety and effectiveness.