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 may be used intravascularly with power injectors at a maximum pressure of 300 psi with a luer lock connection only.

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 that controls the flow of blood during and after cannulation, 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 During needle withdrawal, the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device.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 needleshielding 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. The devices will be available in 18, 20, 22, and 24-gauge versions with and without a stabilization platform.

AI/ML Overview

The document does not describe the acceptance criteria and study for an AI/ML powered medical device. Instead, it is a 510(k) summary for the Introcan Safety® 2 IV Catheter, a physical medical device. Therefore, the requested information about acceptance criteria for AI algorithms, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training is not present in the provided text.

The document discusses non-clinical bench testing to demonstrate the device performs as intended and is substantially equivalent to a predicate device. This testing includes:

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

The document does not explicitly present a table of acceptance criteria for a device performance metric in the context of an AI/ML algorithm. However, it does list specific performance characteristics and indicates "Same per size" for gravity flow rate when compared to the predicate device, implying that the acceptance criterion for flow rate is to match the predicate's performance for equivalent sizes.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Gravity Flow Rate (e.g., 24ga x 14 mm)	Matches predicate device for corresponding size	26 mL/min (for 24ga x 14 mm)
Safety Clip function	Meets internal specifications	Successfully completed
Liquid Tightness for blood control (During cannula Withdrawal)	Meets internal specifications	Successfully completed
Liquid Tightness for blood control (After Cannula Withdrawal)	Meets internal specifications	Successfully completed
Flashback	Meets internal specifications	Successfully completed
Force Testing	Meets internal specifications	Successfully completed
Shelf life Testing	Supports 1 year shelf life	Testing on subject device supports 1 year shelf life
MRI Testing	MRI Conditional, in accordance with standards	MRI Conditional
Biocompatibility	In accordance with ISO 10993-1	Successfully completed
Sterilization Residual testing	In accordance with ISO 10993-7	Successfully completed
Sterilization Validation	In accordance with ISO 11135	Successfully completed
Performance to standards	In accordance with ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 80369-20, and ISO 9626	Successfully completed
MRI Testing accordance	In accordance with ASTM F2052-15, ASTM F2213-17, ASTM F2182-11A, and ASTM F2119-07	Successfully completed

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 mentions "Bench testing performed" and "verification testing" but does not specify sample sizes for these tests. It also does not provide information on data provenance as it refers to laboratory/bench testing of a physical device, not data for an algorithm.

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 and not present in the document because the device is a physical medical device, not an AI/ML software. Ground truth for an AI algorithm is not relevant here.

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

This information is not applicable and not present in the document.

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 and not present in the document. The device is a physical IV catheter, not an AI-assisted diagnostic or clinical decision support tool.

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

This information is not applicable and not present in the document.

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

Not applicable as this is a physical device. Performance is assessed against established engineering standards and internal specifications for physical properties and functionality.

8. The sample size for the training set:

Not applicable as this is a physical device and does not involve AI/ML training data.

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

Not applicable as this is a physical device and does not involve AI/ML training data.

Summary

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April 1, 2020

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

Re: K192676

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: February 28, 2020 Received: March 2, 2020

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,

for Tina Kiang, Ph.D. 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) K192676

Device Name Introcan Safety® 2 IV Catheter

Indications for Use (Describe)

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 - K192676

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:	(610) 596-2941
Fax Number:	(610) 849-9286
Email:	tracy.larish@bbraunusa.com
Date Prepared:	March 30, 2020

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:

K182870 Introcan Safety® 3 Closed IV Catheter, B. Braun Medical, Inc. ●

DEVICE DESCRIPTION

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

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intravascularly. The catheters may be 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 and the same fundamental scientific technology as the predicate device. They are comprised of the same materials of composition and contain the identical safety clip design as the predicate device

The differences between the proposed Introcan Safety® 2 IV Catheter and predicate Introcan Safety® 3 Closed IV Catheter devices are listed below. These differences do not raise new issues of safety and effectiveness.

The size offerings are 18-24ga with lengths from 14mm-50mm. Performance of the ● 14mm Introcan Safety® 2 IV Catheters was confirmed through verification testing to meet the performance requirements of the predicate and proposed device and does not raise concerns of safety and effectiveness when compared to the predicate device.
The septum provides closed catheter capabilities until the first connection, one-time ● blood control. The blood control septum of the predicate Introcan Safety® 3 Closed IV Catheter maintains closed catheter capabilities, before and after cannulization and through multiple connections of an infusion device or luer access device. The blood control septum was successfully verified to maintain closed catheter capabilities until first connection using the same verification testing as applied to the predicate device and does not raise new issues of safety and effectiveness when compared to the predicate device.
A slimmer hub profile which is available with and without securement wings. ● Performance of the proposed device was confirmed through verification testing to meet the requirements of the predicate and proposed device and does not raise concerns of safety and effectiveness when compared to the predicate device

	Proposed Device	Predicate Introcan Safety® 3Closed IV Catheter(K182870)	Comments
Indications	The Introcan Safety® 2 IV Catheter isinserted into a patient's vascularsystem for short term use to sampleblood, monitor blood pressure, oradminister fluids and bloodintravascularly. The catheters may beused intravascularly with powerinjectors at a maximum pressure of300 psi with a luer lock connectiononly.	Introcan Safety® 3 ClosedIntravascular Catheter is insertedinto a patient's vascular system forshort term use to sample blood,monitor blood pressure or administerfluids and blood intravascularly. The18-24 gauge catheters may be usedwith power injectors at a maximumpressure of 300 psi with a luer lockconnection only.	Same
Configuration	Single Lumen, Tapered Tip, withone-time blood control septum	Single Lumen, Tapered Tip, withrepeat blood control septum	Similar, blood control atinsertion providing forclosed catheter capabilitiesuntil the first connection.See discussion above.
Material Composition	Polyurethane, Polypropylene,Stainless steel, MABS, Polyisoprene	Polyurethane, Polypropylene,Stainless steel, MABS	Similar, Polyoximethyleneand silicone not required

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	Proposed DeviceIntrocan Safety® 2 IV Catheter	Predicate Introcan Safety® 3Closed IV Catheter(K182870)	Comments
Catheter Sizes	18ga-24ga from 9/16 " (14mm) –2"(50mm)	Polyisoprene, Polyoximethylene,silicone14ga-24ga from 3/4" (19mm) -2"(50mm)	for the slimmer hub profilesee discussion above.Similar, see discussionabove.
Safety Clip Conformsto ISO 23908	Yes	Yes	Same
Gravity Flow Rate	18ga x 32 mm 105 mL/min	14ga x 32 mm 325 ml/min	Same per size
	18ga x 45 mm 100 mL/min	14ga x 50 mm 310 ml/min
	20ga x 25 mm 65 mL/min	16ga x 32 mm 195 mL/min
	20ga x 32 mm 60 mL/min	16ga x 50 mm 185 mL/min
	20ga X 50 mm 55ml/min	18ga x 32 mm 105 mL/min
	22ga x 25 mm 35 mL/min	18ga x 45 mm 100 mL/min
	24ga x 14 mm 26 mL/min	20ga x 25 mm 65 mL/min
	24ga x 19 mm 22 mL/min(all flow rates are for both wingedand wingless versions)	20ga x 32 mm 60 mL/min20ga X 50 mm 55ml/min22ga x 25 mm 35 mL/min24ga x 19 mm 22 mL/min
Sterilization	Ethylene Oxide	Ethylene Oxide	Same
Biocompatibilityclassification	Externally communicating blood pathindirect prolonged contact	Externally communicating bloodpath indirect prolonged contact	Same
Shelf Life	1 year	5 year	Testing on subject devicesupports 1 year shelf life
MRI Testing	Yes	No	Testing performed inaccordance to standards
MRI Test results	MRI Conditional	Labeling does not contain MRISafety Information	MRI Testing performed onsubject device

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:

Biocompatibility in accordance with ISO 10993-1 (leveraged from K182870)
Sterilization Residual testing in accordance with ISO 10993-7
Sterilization Validation in accordance with ISO 11135 ●
Testing in accordance with ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 80369-. 20, and ISO 9626
MRI Testing in accordance with ASTM F2052-15, ASTM F2213-17, ASTM F2182-11A, and ASTM F2119-07.
Performance and functional testing to internal specifications that include:
- o Safety Clip function
- o Liquid Tightness for blood control
  - During cannula Withdrawal .
  - . After Cannula Withdrawal
- o Flashback
- o Force Testing
- o Shelf life Testing

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CONCLUSION:

Results of the functional and performance testing conducted on the proposed devices demonstrate that the Introcan Safety® 2 IV Catheters are substantially equivalent to 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).