Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

Device Description

The Introcan Safety® IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors for which the maximum pressure setting is 325 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions and consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, and a passive safety needle-shielding mechanism.

The passive safety needle-shielding mechanism of the Introcan Safety® IV Catheter 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 with power injectors with a maximum pressure setting is 325 psi with a luer lock connection only.

AI/ML Overview

This document is a 510(k) summary for the Introcan Safety® IV Catheter from B. Braun Medical Inc. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an existing one, rather than presenting a study of the device's independent performance against predefined acceptance criteria for AI or a detailed clinical study with human readers.

Therefore, the requested information cannot be fully extracted or is not applicable in this context. Here's why and what information can be provided:

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

This document does not refer to "acceptance criteria" in the sense of performance metrics for an AI device (e.g., accuracy, sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the proposed device performs comparably to its predicate device, particularly regarding "power injection capabilities" and "flow rate."

The relevant performance information is for the power injection capabilities and gravity flow rate, presented as a comparison:

Performance Characteristic	Proposed Device (Introcan Safety® IV Catheter)	Predicate Device (K020785) / Reference Device (K021094)	Comparison/Difference
Power Injection	May be used with power injectors at a maximum pressure of 325 psi (for all gauge sizes)	K020785: 14-22g may be used with power injectors at a maximum pressure of 300 psi. K021094: None claimed.	Difference: All sizes to max pressure injection of 325psi. Bench testing performed to demonstrate this.
Gravity Flow Rate	Listed for all gauge sizes (e.g., 14ga x 32mm (1 1/4") 350 mL/min)	K020785: Listed for some gauge sizes. K021094: Listed for all gauge sizes.	Same (for comparable sizes), but the proposed device combines the full product offering's flow rates.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document refers to "bench testing" but does not specify the sample size (number of catheters tested). It mentions testing for "flowrate and device pressure per ISO 10555-1 Section 4.10 9 AnnexG" and "burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F." The number of units needed to demonstrate equivalence per these standards would be part of the full submission, but not typically detailed in the public 510(k) summary.
Data Provenance: This is not applicable in the typical sense of AI algorithm evaluation (country of origin, retrospective/prospective). The data comes from bench testing of the physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. This is a physical medical device (IV catheter), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance is assessed via engineering bench tests against industry standards (ISO).

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

This is not applicable. There is no human interpretation of data for ground truth establishment as it's a physical device being tested via engineering methods.

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 is not applicable. This is not an AI-powered diagnostic device; it's an IV catheter. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable. This is not an algorithm, but a physical medical device. Performance is measured through bench testing of the device itself.

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

The "ground truth" for the device's performance here is defined by standard engineering test methods (ISO 10555-1), which dictate how concepts like "flow rate" and "burst pressure" are measured objectively and quantitatively.

8. The sample size for the training set:

This is not applicable. This is a manufactured physical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary of what the document focuses on:

The document focuses on demonstrating substantial equivalence of the Introcan Safety® IV Catheter to its predicate device (K020785 and K021094). The key "differences" and how they were addressed are:

Increased Power Injection Pressure: The proposed device is capable of handling a maximum pressure of 325 psi, an increase from the predicate's 300 psi for certain gauges. This extended capability was supported by bench testing (Power Injection test for flowrate and device pressure per ISO 10555-1).
Combined Indications for Use: The new 510(k) combines indications for use across the product family, which doesn't alter the device's fundamental performance but rather its labeling and marketing scope.
e-IFU: The Instructions for Use were revised to align with other Introcan products and to utilize an electronic format.

The conclusion states that "Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate device." This indicates that the bench testing results met the necessary criteria to show comparable safety and effectiveness, allowing for the 510(k) clearance despite the slight change in power injection capability.

Summary

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May 14, 2022

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

Re: K220626

Trade/Device Name: Introcan Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: April 13, 2022 Received: April 14, 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

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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/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 mediation-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,

Paval 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

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Indications for Use

510(k) Number (if known) K220626

Device Name Introcan Safety® IV Catheter

Indications for Use (Describe)

Introcan Salety® IV Catheter is a passive ani-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used 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)

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510(k) SUMMARY - K220626

SUBMITTER INFORMATION:

Name:	B. Braun Medical Inc.
Address:	901 Marcon BoulevardAllentown, PA 18109-9341
Telephone Number:	610-266-0500, ext. 2966
Contact Person:	Tracy Larish, Sr. Regulatory Affairs Specialist
Telephone Number:	(484) 375-9064
Email:	tracy.larish@bbraunusa.com
Date Prepared:	March 2, 2022

DEVICE NAME:

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

PREDICATE DEVICES:

K020785 Introcan Safety® IV Catheter, B. Braun Medical, Inc. ●

DEVICE DESCRIPTION

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INTENDED USE:

The Introcan Safety® IV Catheter is for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

INDICATIONS FOR USE:

TECHNOLOGICAL CHARACTERISTICS:

The proposed Introcan Safety® IV Catheter is substantially equivalent to the predicate Introcan Safety® 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 Safety® IV Catheter in formulation, processing, and sterilization, and no other chemicals have been added. The Introcan Safety device includes the identical design as the predicate and does not raise any new issues of safety and effectiveness.

The difference between the proposed and predicate Introcan Safety® IV Catheter device do not impact substantial equivalence and are listed below:

Power injection capabilities were tested to higher pressure injections rates to meet . 325psi for all gauge sizes
. Combined the indications for use of the same device to allow one 510k) to cover the full product offering.
Instructions for Use revised to update the power injection capabilities, align with the . rest of the Introcan product family and utilize an e-IFU.

	Proposed DeviceIntrocan Safety® IV Catheter	Reference Device(K021094)Introcan Safety® IV Catheter	Predicate Device(K020785)Introcan Safety® IV Catheter	Comparison
Use:	Indications for Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maxirnum pressure of 325 psi with a luer lock connection only.	The Introcan Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.	Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.	Difference:All sizes to max pressure injection of 325psi. Combines indications for use and adds with a luer lock connection only to align the Introcan product family
	Proposed DeviceIntrocan Safety® IV Catheter	Reference Device(K021094)Introcan Safety® IV Catheter	Predicate Device(K020785)Introcan Safety® IVCatheter	Comparison
	Configuration Single Lumen, Tapered Tip	Single Lumen, Tapered Tip	Single Lumen, Tapered Tip	Same
MaterialComposition	Catheter Tube: Polyurethane/FEPCatheter Hub: Polypropylene[Needle: Stainless steel[Needle Hub: MABSSafety Clip: Stainless steel	Catheter Tube: Polyurethane or FEPCatheter Hub: Polypropylene[Needle: Stainless steel[Needle Hub: MABSSafety Clip: Stainless steel	Catheter Tube: PolyurethaneCatheter Hub: Polypropylene[Needle: Stainless steel[Needle Hub: MABSSafety Clip: Stainless steel	Same
CatheterGauge Sizes	14ga-24ga	14ga-24ga	14ga-24ga	Same
Catheterlength	9/16" (14mm)-2 1/2" (64mm)	9/16" (14mm)-2 1/2" (64mm)	9/16" (14mm)-2 1/2" (64mm)	Same
Gravity FlowRate	14ga x 32mm (1 1/4") 350 mL/min14ga x 45mm (1 3/4") 345mL/min14ga x 50mm (2") 345 mL/min16ga x 32mm(1 1/4") 215 mL/min16ga x 50mm (2") 210 mL/min18ga x 32 mm (1 1/4") 105 mL/min18ga x 45 mm (1 3/4") 100 mL/min18ga x 50 mm (2") 95 mL/min18ga x 64 mm (2½") 85 mL/min20ga x 25 mm (1") 65 mL/min20ga x 32 mm (1 1/4") 60 mL/min20ga x 45mm (1 3/4") 57 mL/min20ga x 50 mm (2") 55 mL/min20ga x 64 mm (2½") 51 mL/min22ga x 25 mm (1") 35 mL/min22ga x 45mm (1 3/4") 26 mL/min22ga x 64mm (2½") 24 mL/min24ga x 14mm (9/16") 26 mL/min24ga x 19 mm(3/4") 22 mL/min24ga x 32 mm (1 1/4") 17 mL/min	14ga x 32mm (1 1/4") 350 mL/min14ga x 45mm (1 3/4") 345mL/min14ga x 50mm (2") 345 mL/min16ga x 32mm (1 1/4") 215 mL/min16ga x 50mm (2") 210 mL/min18ga x 32 mm (1 1/4") 105 mL/min18ga x 45 mm (1 3/4") 100 mL/min18ga x 50 mm (2") 95 mL/min18ga x 64 mm (2½") 85 mL/min20ga x 25 mm (1") 65 mL/min20ga x 32 mm (1 1/4") 60 mL/min20ga x 45mm (1 3/4") 57 mL/min20ga x 50 mm (2") 55 mL/min20ga x 64 mm (2½") 51 mL/min22ga x 25 mm (1") 35 mL/min22ga x 45mm (1 3/4") 26 mL/min22ga x 64mm (2½") 24 mL/min24ga x 14mm (9/16") 26 mL/min24ga x 19 mm(3/4") 22 mL/min24ga x 32 mm (1 1/4") 17 mL/minFlow rate as indicated on labeling.Flow rate was not included inoriginal submission	14ga x 32mm (1 1/4") 350 mL/min	Same
			14ga x 45mm (1 3/4") 345mL/min
			14ga x 50mm (2") 345 mL/min
			16ga x 32mm (1 1/4") 215 mL/min
			16ga x 50mm (2") 210 mL/min
			18ga x 32 mm (1 1/4") 105 mL/min
			18ga x 45 mm (1 3/4") 100 mL/min
			18ga x 50 mm (2") 95 mL/min
			18ga x 64 mm (2½") 85 mL/min
			20ga x 25 mm (1") 65 mL/min
			20ga x 32 mm (1 1/4") 60 mL/min
			20ga x 45mm (1 3/4") 57 mL/min
			20ga x 50 mm (2") 55 mL/min
			20ga x 64 mm (2½") 51 mL/min
			22ga x 25 mm (1") 35 mL/min
			22ga x 45mm (1 3/4") 26 mL/min
			22ga x 64mm (2½") 24 mL/min
			24ga x 14mm (9/16") 26 mL/min
			24ga x 19 mm(3/4") 22 mL/min
			24ga x 32 mm (1 1/4") 17 mL/min
			Flow rate as indicated onlabeling. Flow rate was notincluded in originalsubmission
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Same
Shelf-LifePowerInjection	5 year14ga-24ga may be used withpower injectors at a maximumpressure of 325 psi	5 yearNone claimed	5 year14-22g may be used withpower injectors at a maximumpressure of 300 psi	SameBench testingperformedwhichdemonstratedthat thedifferences donot raiseadditionalquestions ofsafety andeffectiveness

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NONCLINICAL TESTING

Bench testing performed on Introcan Safety® 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:

Power Injection test for flowrate and device pressure per ISO 10555-1 Section 4.10 9 AnnexG
Test for burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F .

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CONCLUSION:

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

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).