Introcan Safety® 2 IV Catheter

K241845 · B.Braun Medical, Inc. · FOZ · Jul 26, 2024 · General Hospital

Device Facts

• Record ID: K241845
• Device Name: Introcan Safety® 2 IV Catheter
• Applicant: B.Braun Medical, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jul 26, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Introcan Safety® 2 Intravascular Catheter is for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

Device Story

Peripheral over-the-needle IV catheter; radiopaque polyurethane construction; integrated septum; passive safety needle-shielding mechanism. Used in clinical settings for short-term vascular access. Clinician inserts catheter into patient's vascular system; needle withdrawal triggers automatic safety shield deployment within catheter hub to prevent needlestick injuries and catheter shearing. Septum seals upon needle removal to contain blood and reduce exposure. Device supports power injection up to 325 psi. Output is established vascular access for fluid/blood administration, blood sampling, or pressure monitoring. Benefits include reduced clinician/patient blood exposure and enhanced safety during disposal.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including ISO 10555-1 and ISO 10555-5 compliance (flow rate, power injection, tip projection), internal performance testing (cannula withdrawal, pull strength, blood flashback, force/gliding tests), and packaging integrity testing (ISO 11607-1, ASTM F2096, ASTM F88, ASTM F1929).

Technological Characteristics

Materials: Polyurethane, Polypropylene, Stainless steel, MABS, Polyisoprene, Polyoximethylene. Single lumen, tapered tip, septum-based blood control. Sterilization: Ethylene Oxide. MRI Conditional. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring short-term vascular access for blood sampling, blood pressure monitoring, or intravascular administration of fluids and blood. Compatible with power injectors up to 325 psi using 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® 2 IV Catheter (K220756)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 26, 2024

B. Braun Medical Inc.
Tracy Larish
Regulatory Affairs Technical Manager
3773 Corporate Parkway
Center Valley, Pennsylvania 18034

Re: K241845
Trade/Device Name: Introcan Safety® 2 IV Catheter
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: June 25, 2024
Received: June 26, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K241845 - Tracy Larish
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


David Wolloscheck, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors

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K241845 - Tracy Larish
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OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K241845 | |
| Device Name Introcan Safety® 2 IV Catheter | |
| Indications for Use (Describe) The Introcam Safety® 2 IV 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 catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only. | |
| 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. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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B. Braun Medical Inc.
510(k) Premarket Notification
Introcan Safety® 2 IV Catheter (Deep Access)

# 510(k) SUMMARY: K241845

## SUBMITTER INFORMATION:

Name: B. Braun Medical Inc.
Address: 824 12th Ave
Bethlehem, PA 18108
Contact Person: Tracy Larish, Regulatory Affairs Technical Manager
Telephone Number: [phone]
Email: [e-mail]
Date Prepared: July 26th, 2024

## DEVICE NAME:

Device Trade Name: Introcan Safety® 2 IV Catheter
Common Name: Short-Term Less than 30 Days Therapeutic Intravascular Catheter Classification
Name: Intravascular catheter, 21 CFR §880.5200: Class II, Product code FOZ

## PREDICATE DEVICE:

- K220756. Introcan Safety® 2 IV Catheter, B. Braun Medical, Inc.

## DEVICE DESCRIPTION

The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated septum, and a passive safety needle-shielding mechanism. Introcan Safety® 2 is designed to protect clinicians and patients from blood exposure. During needle withdrawal through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 2 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 catheters may be used intravascularly with power injectors for which the maximum pressure setting is 325 psi with a luer lock connection only.

## INTENDED USE:

The Introcan Safety® 2 Intravascular Catheter is for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

## INDICATIONS FOR USE:

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B. Braun Medical Inc.

510(k) Premarket Notification

Introcan Safety® 2 IV Catheter (Deep Access)

The Introcan Safety® 2 IV 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 catheters maybe used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

**TECHNOLOGICAL CHARACTERISTICS:**

The Introcan Safety 2 IV Catheters have the same intended use, the same principle of operation, the identical safety clip and the same fundamental scientific technology as the predicate device.

The differences between the proposed Introcan Safety® 2 IV Catheter and predicate Introcan Safety® 2 IV Catheter does not raise new issues of safety and effectiveness and are listed below:

- Longer lengths across the size offerings.
- Longer protective cap to accommodate longer lengths.
- Minor material change in packaging of the 64mm to accommodate the longer length.

These differences do not raise new questions of safety and effectiveness.

| | Proposed Device
Introcan Safety® 2 IV Catheter | | | Predicate Device(K220756.)
Introcan Safety® 2 IV Catheter | | | Comparison |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Indications | The Introcan Safety® 2 IV Catheter is for short term use to sample blood, monitor blood pressure, or administer fluids and blood intravascularly and administer fluids subcutaneously. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only. | | | The Introcan Safety® 2 IV Catheter is for short term use to sample blood, monitor blood pressure, or administer fluids and blood intravascularly and administer fluids subcutaneously. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only. | | | Same |
| Configuration | Single Lumen, Tapered Tip, septum with multi blood control | | | Single Lumen, Tapered Tip, septum with one-time blood control | | | Same. |
| Material Composition | Polyurethane, Polypropylene, Stainless steel, MABS, Polyisoprene, Polyoximethylene | | | Polyurethane, Polypropylene, Stainless steel, MABS, Polyisoprene, Polyoximethylene | | | Same |
| Catheter Sizes | 18ga-24ga from 1 ¼” (45mm) –2 ½” (64mm) | | | 18ga-24ga from 9/16” (14mm) –2” (50mm) | | | Same |
| Gravity Flow Rate | | 18ga x 64mm | 80 mL/min | | 18ga x 32 mm | 105 mL/min | Difference: Flow rate for proposed lengths |
| | | | | | 18ga x 45 mm | 100 mL/min | |
| | | | | | 20ga x 25 mm | 65 mL/min | |
| | | | | | 20ga x 32 mm | 60 mL/min | |
| | | | | | 20ga X 50 mm | 55ml/min | |
| | | | | | 22ga x 25 mm | 35 mL/min | |
| | | | | | 24ga x 14 mm | 26 mL/min | |
| | | | | | 24ga x 19 mm | 22 mL/min | |
| | | | | | (flow rates for winged and wingless versions) | | |
| Sterilization | Ethylene Oxide | | | Ethylene Oxide | | | Same |
| Shelf life | 1 year | | | 1 year | | | Same |

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B. Braun Medical Inc.

510(k) Premarket Notification

Introcan Safety® 2 IV Catheter (Deep Access)

| Bench Testing | Testing according to: • ISO 10555-1:2013 ○ Flow rate through capillary ○ Power injection • ISO 10555-5:2013 ○ Projecting length capillary tip • Internal Requirement: ○ Cannula withdrawal angle test ○ Pull strength protective cap ○ Blood flashback ○ Force Testing ○ Gliding Force | Testing according to ISO 10555-1:2013, Section 4.10, Annex E. Flowrate through capillary, ISO 10555-1:2013 Annex F Burst Pressure and Test for septum opener retention force | Difference: Bench testing demonstrated that the differences do not raise additional questions of safety and effectiveness |
| --- | --- | --- | --- |
| Biocompatibility classification | Externally communicating blood path indirect prolonged contact | Externally communicating blood path indirect prolonged contact | Same |
| MRI labeling | MRI Conditional | MRI Conditional | Same |

# NONCLINICAL TESTING:

Bench testing performed on Introcan Safety® 2 IV Catheters demonstrates that the device performs as intended. No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following testing has been successfully completed for the proposed devices:

- ISO 10555-1 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
○ Flow rate through capillary
○ Projecting length capillary tip
○ Power injection
- ISO 10555-5:2013
○ Projecting length capillary tip
- Performance and functional testing to internal specifications:
○ Cannula withdrawal angle test
○ Pull strength protective cap
○ Blood flashback
○ Force testing
○ Gliding force
- Package Integrity testing
○ ISO 11607-1:2019
○ Visual inspection for cleanliness - product
○ Visual inspection for printing (non-variable data and variable data)
○ Width of sealing (self-sealing side)
○ ASTM F2096
○ Visual inspection for cleanliness – seal
○ ASTM F2096: 2011(reapproved 2019)

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B. Braun Medical Inc.
510(k) Premarket Notification

Introcan Safety® 2 IV Catheter (Deep Access)

- Bubble test (test of packaging with product)
- ASTM F 88: 2015
- Tensile strength of the longitudinal seam (self-sealing)
- ASTM F 1929: 2021
- Intactness of seal (Blue dye test)

**CONCLUSION:**

Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® 2 IV Catheters are substantially equivalent to the predicate device.

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