Who is the manufacturer of B. Braun Introcan Safety 2 IV Catheter?

B.Braun Medical, Inc. filed the 510(k) submission for B. Braun Introcan Safety 2 IV Catheter (K213664).

What is the FDA product code for B. Braun Introcan Safety 2 IV Catheter?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for B. Braun Introcan Safety 2 IV Catheter?

510(k) clearance (submission type: Special).

What are the predicate devices for B. Braun Introcan Safety 2 IV Catheter?

Introcan Safety® 2 IV Catheter (K192676).

Who can help prepare an FDA 510(k) submission like B. Braun Introcan Safety 2 IV Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

B. Braun Introcan Safety 2 IV Catheter

K213664 · B.Braun Medical, Inc. · FOZ · Feb 11, 2022 · General Hospital

Device Facts

Record ID	K213664
Device Name	B. Braun Introcan Safety 2 IV Catheter
Applicant	B.Braun Medical, Inc.
Product Code	FOZ · General Hospital
Decision Date	Feb 11, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5200
Device Class	Class 2

Intended Use

The Introcan Safety® 2 IV Catheter is inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe used intravascularly with power injectors at a maximum pressure of 300 psi with a luer lock connection only.

Device Story

Over-the-needle peripheral IV catheter; radiopaque polyurethane construction; features integrated one-directional septum and passive safety needle-shielding mechanism. Used in clinical settings by healthcare providers for vascular access. Septum seals upon needle withdrawal to contain blood; needle passes through septum to wipe blood, reducing exposure. Safety shield deploys automatically upon needle withdrawal to cover needle tip, preventing needlestick injuries and catheter shearing. Enables blood sampling, pressure monitoring, and fluid/blood administration. Power injector compatible (max 300 psi).

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including flow rate (ISO 10555-1 Annex E), burst pressure (ISO 10555-1 Annex F), septum opener retention force, and biocompatibility (ISO 10993-1).

Technological Characteristics

Materials: Polyurethane, Polypropylene, Stainless steel, MABS, Polyisoprene, Polyoximethylene. Single lumen, tapered tip. Passive safety needle-shielding mechanism. Sterilization: Ethylene Oxide. MRI Conditional. Complies with ISO 10555-1:2013.

Indications for Use

Indicated for any patient population requiring short-term vascular access for blood sampling, blood pressure monitoring, or intravascular administration of fluids and blood. Compatible with power injectors up to 300 psi via luer lock connection.

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 (K192676)

Related Devices

K241845 — Introcan Safety® 2 IV Catheter · B.Braun Medical, Inc. · Jul 26, 2024
K220756 — Introcan Safety 2 IV Catheter · B.Braun Medical, Inc. · Jun 23, 2022
K192676 — Introcan Safety 2 IV Catheter 18-24 gauge · B.Braun Medical, Inc. · Apr 1, 2020
K220626 — Introcan Safety IV Catheter · B.Braun Medical, Inc. · May 14, 2022
K213085 — Introcan Safety 3 Closed IV Catheter · B.Braun Medical, Inc. · Oct 25, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 11, 2022 B. Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109 Re: K213664 Trade/Device Name: B. Braun Introcan Safety 2 IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 12, 2022 Received: January 13, 2022 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. 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Gang Peng for Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213664 Device Name Introcan Safety® 2 IV Catheter #### Indications for Use (Describe) The Introcan Safety® 2 IV Catheter is inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe used intravascularly with power injectors at a maximum pressure of 300 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ ### K213664. 510(k) SUMMARY #### 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: | (610) 596-2941 | | Fax Number: | (610) 849-9286 | | Email: | tracy.larish@bbraunusa.com | | Date Prepared: | February 12th, 2022 | #### DEVICE NAME: | Device Trade Name: | Introcan Safety® 2 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 DEVICE: - K192676 Introcan Safety® 2 IV Catheter, B. Braun Medical, Inc. ● - Product code FOZ o - 0 21 CFR §880.5200 Catheter, intravascular, therapeutic, short-term less than 30 day ## DEVICE DESCRIPTION The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated one directional septum, and a passive safety needle-shielding mechanism. Introcan Safety® 2 is designed to reduce blood exposure at insertion until first connection of an infusion line or luer device 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 300 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. {4}------------------------------------------------ ## INDICATIONS FOR USE: 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 300 psi with a luer lock connection only. # TECHNOLOGICAL CHARACTERISTICS: The Introcan Safety 2 IV Catheters have the same indications for use, the same intended use, the same principle of operation, the identical safety clip and the same fundamental scientific technology as the predicate device. The difference between the proposed Introcan Safety® 2 IV Catheter and predicate Introcan Safety® 2 IV Catheter is the septum holder material. This difference does not raise new issues of safety and effectiveness. | | Proposed Device Introcan Safety® 2 IV Catheter | Predicate Device (K192676) 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 300 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 300 psi with a luer lock connection only. | Same | | Configuration | Single Lumen, Tapered Tip, septum with one-time 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 | Different: Performance and biocompatibility evaluation demonstrates that the addition of Polyoximethylene does not raise additional questions of safety and effectiveness. | | Catheter Sizes | 18ga-24ga from 9/16" (14mm) -2" (50mm) | 18ga-24ga from 9/16" (14mm) -2" (50mm) | Same | | Gravity Flow Rate | 18ga x 32 mm 105 mL/min 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 (all flow rates are for both winged and wingless versions) | 18ga x 32 mm 105 mL/min 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 (all flow rates are for both winged and wingless versions) | Same | | Sterilization | Ethylene Oxide | Ethylene Oxide | Same | {5}------------------------------------------------ | | Proposed Device Introcan Safety® 2 IV Catheter | Predicate Device (K192676) Introcan Safety® 2 IV Catheter | Comparison | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Shelf life | 1 year | 1 year | Same | | Bench Testing | 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 | Testing according to ISO 10555-1:2013, Section 4.10, Annex E. Flowrate through capillary and Test for septum opener retention force | Different: 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: - Flowrate through capillary per ISO 10555-1 Intravascular catheters Sterile and ● single-use intravascular catheters - Part 1: General requirements, Annex E - Burst Pressure per ISO 10555-1:2013 Annex F ● - Septum opener retention force to internal specifications . - Biocompatibility per ISO 10993-1 ● ## 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.