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.

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 Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device.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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Introcan Safety® 3 Closed IV Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical trials. Therefore, the "acceptance criteria" discussed here are primarily focused on equivalence to existing devices and performance against relevant standards, rather than clinical efficacy targets. Similarly, the "study" is a series of non-clinical tests.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might expect for a novel device's clinical trial results. Instead, it details that bench testing was performed to support substantial equivalence and that the device meets internal specifications and relevant ISO standards.

Here's a synthesized table based on the "NONCLINICAL TESTING" section:

Acceptance Criteria (Implied by Testing)	Reported Device Performance (Implied)
Biocompatibility (in accordance with ISO 10993-1)	Meets ISO 10993-1 standards
Sterilization Residuals (in accordance with ISO 10993-7)	Meets ISO 10993-7 standards
Sterilization Validation (in accordance with ISO 11135-1)	Meets ISO 11135-1 standards
Performance and Functional Testing (in accordance with ISO 10555-1 and ISO 10555-5)	Meets ISO 10555-1 and ISO 10555-5 standards
Safety Clip Function	Meets internal specifications
Liquid Tightness	Meets internal specifications
Flashback	Meets internal specifications

The document concludes that the "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the non-clinical tests. It states "Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device."

The data provenance is implied to be from the manufacturer's internal testing ("internal specifications"), likely at their facility or a contracted lab. There's no mention of country of origin of data or whether it's retrospective or prospective as these are non-clinical bench tests, not patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of regulatory submission. The "ground truth" for non-clinical testing of a medical device like an IV catheter is typically established by engineering standards, validated testing protocols, and physical measurements, rather than expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple experts review cases and resolve disagreements, often used in clinical trials or studies involving human judgment (e.g., image interpretation). The tests conducted here are bench tests for physical properties and performance against standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an IV catheter, not an AI-powered diagnostic tool. Therefore, MRMC studies or an analysis of "human readers improve with AI vs without AI assistance" are irrelevant to this submission. The device does not involve AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is an IV catheter, not an algorithm, so "standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench testing, the "ground truth" is based on engineering specifications, established international standards (ISO), and documented test methods. For example, for biocompatibility, the ground truth is "toxicity" as defined and measured by ISO 10993-1. For liquid tightness, the ground truth is "no leakage" when tested under specified pressure or conditions.

8. The sample size for the training set

This information is not applicable. This is a non-clinical device submission, not a machine learning or AI algorithm. There is no "training set" in this context.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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:	(610) 596-2941
Fax Number:	(610) 849-9286
Email:	tracy.larish@bbraunusa.com
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

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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:

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 DeviceIntrocan Safety® 3 IV Catheter	Predicate Device(K163358)Introcan Safety® 3 IV Catheter	Predicate Device(K111236)Introcan Safety® 3 IV Catheter
Indications	Introcan Safety® 3 ClosedIntravascular Catheter is insertedinto a patient's vascular system forshort term use to sample blood,monitor blood pressure oradminister fluids and bloodintravascularly.The 18-24 gauge catheters may beused with power injectors at amaximum pressure of 300 psi witha luer lock connection only.	Introcan Safety® 3 ClosedIntravascular Catheter is insertedinto a patient's vascular system forshort term use to sample blood,monitor blood pressure oradminister fluids and bloodintravascularly	Introcan Safety® 3 ClosedIntravascular Catheter is insertedinto a patient's vascular system forshort term use (less than 30 days)to sample blood, monitor bloodpressure or administer fluids andblood intravascularly. The 18-22gauge catheters may be used withpower injectors at a maximumpressure of 300 psi with a luerlock 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)
MaterialComposition	Introcan Safety® 3 IV CatheterCatheter Tube: PolyurethaneCatheter Hub: PolypropyleneNeedle: Stainless steelNeedle Hub: MABSSafety Clip: Stainless steelSeptum: Silicone or PolyisopreneRubberSeptum Opener:PolyoximethyleneSeptum Housing: Polypropylene	Introcan Safety® 3 IV CatheterCatheter Tube: PolyurethaneCatheter Hub: PolypropyleneNeedle: Stainless steelNeedle Hub: MABSSafety Clip: Stainless steelSeptum: Silicone or PolyisopreneRubberSeptum Opener:PolyoximethyleneSeptum Housing: Polypropylene	Introcan Safety® 3 IV CatheterCatheter Tube: PolyurethaneCatheter Hub: PolypropyleneNeedle: Stainless steelNeedle Hub: MABSSafety Clip: Stainless steelSeptum: SiliconeSeptum Opener:PolyoximethyleneSeptum Housing: Polypropylene
CatheterGauge Sizes	14ga-24ga	16ga	18ga-24ga
CatheterLength	3/4" (19mm) – 2" (50mm)	1-1/4" (32mm) – 2" (50mm)	3/4" (19mm) - 1-3/4" (45mm)
Gravity FlowRate	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.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).