The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.

Device Description

B. Braun Medical Inc. Omnifix Syringe NRFit configurations are sterile, single use syringes with ISO 80369-6 NRFit compliant fittings. They are available in 1mL, 3mL, 10mL, and 20mL lock and slip configurations. The NRFit tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a barrel with a printed graduated scale in milliliters (mL), a stopper and a plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Omnifix Syringe NRFit. This document focuses on demonstrating the substantial equivalence of the new device to a predicate device (B. Braun Piston Syringes, K071459) rather than presenting a traditional clinical study with acceptance criteria for an AI/algorithm-driven device.

Therefore, the request for a table of acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device meeting acceptance criteria by an AI/algorithm is not applicable to this document.

This FDA clearance is for a physical medical device (a syringe) that has been modified to include a new type of connector (NRFit) for neuraxial use. The "performance" being described in the document relates to mechanical and material properties of the syringe, and its biocompatibility, according to established ISO and ASTM standards, not to the performance of an artificial intelligence algorithm.

Instead, the document details nonclinical performance tests conducted to demonstrate the modified syringe's safety and effectiveness. Here's a breakdown of what is provided and why it doesn't fit the requested AI/algorithm performance criteria:

Summary of Device Performance (as presented in the document):

The document states that the Omnifix Syringe NRFit configurations are "equivalent to that of the predicate B. Braun Medical Inc. Omnifix Syringe in intended use, materials and performance characteristics." The differences primarily relate to the connector type (NRFit vs. Luer) and the
resulting change in indicated use (neuraxial vs. general purpose).

The device's performance is demonstrated through compliance with various international standards, which serve as the "acceptance criteria" for a physical medical device. These are detailed under "Functional Testing Summary of ISO 80369-6 compliant nonclinical tests" and other sections.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical device and not an AI algorithm, the "acceptance criteria" are the successful demonstration of compliance with the listed ISO and ASTM standards. The document explicitly states "Bench testing performed on the proposed devices supports substantial equivalence." This implies that the device successfully met the requirements of these tests.

Acceptance Criterion (Standard Compliance)	Reported Device Performance (Implied)
ISO 80369-6:2016 for NRFit Connectors	Conforms / Passed
- Dimensional Requirements	Conforms / Passed
- Fluid leakage requirement	Conforms / Passed
- Leakage by pressure decay	Conforms / Passed
- Subatmospheric pressure air leakage	Conforms / Passed
- Stress cracking	Conforms / Passed
- Resistance to separation from axial load	Conforms / Passed
- Resistance to separation from unscrewing	Conforms / Passed
- Resistance to overriding	Conforms / Passed
Biocompatibility per ISO 10993-1:2018	Conforms / Passed (specific tests listed)
- Cytotoxicity	Conforms / Passed
- Intracutaneous reactivity	Conforms / Passed
- Sensitization	Conforms / Passed
- Acute systemic toxicity	Conforms / Passed
- Subacute/subchronic systemic toxicity	Conforms / Passed
- Genotoxicity	Conforms / Passed
- Material-mediated pyrogenicity	Conforms / Passed
- Hemolysis	Conforms / Passed
Particulate Matter per USP <788>	Conforms / Passed
Neurotoxicity assessment	No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article. (Conforms / Passed)
Packaging: ASTM F2096:2011 (Bubble Leak)	Conforms / Passed
Packaging: ASTM F88/F88M:2015 (Seal Strength)	Conforms / Passed
Hypodermic Syringe Functional per ISO 7886-1	Conforms / Passed
Pyrogenicity (Spinal limit 2.15 EU/device)	Conforms / Passed

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

The document implies that standard test methods prescribed by each ISO/ASTM standard were followed. Therefore, the "sample size" would be the number of devices required by these standards for each respective test (e.g., number of syringes for leakage tests, number of samples for biocompatibility, etc.). These specific numbers are not provided in this high-level summary but would be detailed in the underlying test reports.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is internal lab testing of the manufactured product.

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):

Not applicable. Ground truth for a physical device's mechanical integrity and biocompatibility is established by adherence to reproducible, standardized test methods, not by expert consensus (like in imaging diagnosis). The "experts" would be qualified laboratory technicians and scientists performing and interpreting these standardized tests.

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

Not applicable. This concept applies to human reader studies or algorithmic output interpretation, not to physical device testing against objective 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:

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance is objective compliance with engineering and biocompatibility standards (e.g., specific dimensions, leakage rates, material reactions in biological assays). It is not expert consensus for diagnostic interpretation or patient outcomes data in the sense of a clinical trial for an AI.

8. The sample size for the training set:

Not applicable. There is no AI algorithm being trained.

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

Not applicable. There is no AI algorithm being trained.

In conclusion, the provided FDA 510(k) clearance letter and its summary are for a modified physical medical device. The "study" proving it meets acceptance criteria refers to a battery of nonclinical, laboratory-based functional and biocompatibility tests against established international standards (ISO, ASTM, USP), not an AI algorithm validation study. Therefore, most of the specific questions posed are not relevant to the content of this document.

Summary

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July 12, 2024

B. Braun Medical Inc. Kimberly Smith Technical Manager I - Regulatory Affairs 824 Twelfth Avenue Bethlehem, Pennsylvania 18018

Re: K241385

Trade/Device Name: Omnifix Syringe NRFit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: May 15, 2024 Received: May 15, 2024

Dear Kimberly Smith:

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" (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).

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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 OS 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 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-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 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-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,

ForGang Peng)-S

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K241385

Device Name Omnifix Syringe NRFit

Indications for Use (Describe)

The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healtheare professionals in healthcare facilities.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information

Name:	B. Braun Medical Inc.
Address:	824 Twelfth AvenueBethlehem, PA 18018 USA
Contact Person:	Kimberly Smith
Title:	Technical Manager I – Regulatory Affairs
Tel:	(610) 596-2326
Email:	kim.smith@bbraunusa.com
Date Prepared:	July 12, 2024

Device Name and Classification

Device Trade Name:	Omnifix Syringe NRFit
Common Name:	Piston Syringe
Classification Name:	Piston Syringe With Neuraxial Connector – Epidural, Peripheral,And/Or Indirect Cerebral Spinal Fluid Contact
Regulation Number:	21 CFR §880.5860
Regulation Name:	Piston Syringe
Device Class:	2
Product Code:	QEH

Predicate Device

510(k) Number:	K071459
Device Trade Name:	B. Braun Piston Syringes
Common Name:	Piston Syringe
Classification Name:	Piston Syringe
Regulation Number:	21 CFR §880.5860
Regulation Name:	Piston Syringe
Device Class:	2
Product Code:	FMF

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Reason for Submission

The purpose of this submission is for the modification of the current B. Braun Medical Inc. Single Use, Piston Syringe (previously cleared under K071459) from the current Luer connections per ISO 594-1 and ISO 594-2 to the new ISO 80369-6 connectors referred to as NRFit. The new syringes with NRFit connectors will be referred to as Omnifix Syringe NRFit and will be supplied in luer slip and luer lock configurations. B. Braun Medical Inc. will continue to market the current B. Braun Medical Inc. Single Use, Piston Syringes with Luer connections for general purpose use, while the new B. Braun Medical Inc. Omnifix Syringe NRFit will be indicated for neuraxial use per ISO 80369-6.

Device Description

Indications for Use

The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.

Intended Use

The B. Braun Omnifix Syringe NRFit is intended to inject fluid into, or withdraw fluids from, the body.

Technological Characteristics

The B. Braun Medical Inc. Omnifix Syringe NRFit configurations are equivalent to that of the predicate B. Braun Medical Inc. Omnifix Syringe in intended use, materials and performance characteristics.

The difference between the proposed and predicate B. Braun Medical Inc. Omnifix Syringe is the modification of the tip of the current B. Braun Medical Inc. Single Use, Piston Syringe from the current Luer connections per ISO 594-1 and ISO 594-2 to the new ISO 80369-6 connectors referred to as NRFit. This modification therefore revises the Indications for Use for a neuraxial use application but does not modify the intended use. These differences do not impact the statement of substantial equivalence.

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	Proposed Omnifix Syringe NRFit	Predicate Device (K071459)B. Braun Piston Syringes	Differences
Indications for Use	The B. Braun Omnifix SyringeNRFit is intended for neuraxial usefor aspiration/injection of fluids usedby healthcare professionals inhealthcare facilities.	The Omnifix piston syringesare intended to be used toinject fluid into, or withdrawfluids from, the body.	The proposed device islimited to neuraxial use.
Product Code	QEH	FMF	The proposed device islimited to neuraxial use.Predicate device was forgeneral use.
Intended Use	The B. Braun Omnifix SyringeNRFit is intended to be used toinject fluid into, or withdraw fluidsfrom, the body.	The Omnifix piston syringesare intended to be used toinject fluid into, or withdrawfluids from, the body.	None, Same
Intended User	Healthcare Professionals	Healthcare Professionals	None, Same
Environment of Use	Healthcare Facilities	Healthcare Facilities	None, Same
Syringecomponents/materials	Barrel	Polypropylene	Polypropylene	None, Same
	Plunger	Polyisoprene	Polyisoprene	None, Same
	Stopper	Silicone	Silicone	None, Same
	Lubricant	Silicone	Silicone	None, Same
	Plunger Rod	Yellow1mL Polystyrene /3, 5, 10, 20 mLPolypropylene	Clear1mL Polystyrene /3, 5, 10, 20 mL Polypropylene	Base material is the same.Color is different - changeto the plunger from clear toyellow to differentiate theNRFit syringes from thegeneral piston syringes.
Tip Typesmallbore connector	NRFit lock or slip per ISO 80369-6:2016	Lock or Slip per ISO 594-1:1986 and ISO 594-2:1998	The proposed devicecontains a NRFit smallboreconnector which is
Functional TestingSummary of ISO80369-6 compliantnonclinical tests	• Dimensional Requirements• Fluid leakage requirement• Leakage by pressure decay• Subatmospheric pressure airleakage• Stress cracking• Resistance to separation fromaxial load• Resistance to separation fromunscrewing• Resistance to overriding	• Gauging• Liquid leakage• Air leakage• Separation force• Unscrewing torque• Ease of assembly• Resistance to overriding• Stress cracking	intended for neuraxial use.ISO 80369-6 testingperformed to demonstratesafety and effectiveness ofthe neuraxial smallboreconnector for the neuraxialintended use and toconfirm substantialequivalence.
Patient Contactcategory/ Duration	Externally Communicating,Tissue/Bone/Dentin, prolongedexposure	Externally Communicating,Blood Path Indirect, limitedexposure	The proposed device isintended for neuraxial usewhich may have indirectcontact with cerebralspinal fluid (CSF). For thisreason,Tissue/Bone/Dentin with alonger duration exposurewas chosen.
Biocompatibility	Conforms to ISO 10993-1	Conforms to ISO 10993-1	None, Same
Hypodermic SyringeFunctional	Conforms to ISO 7886-1	Conforms to ISO 7886-1	None, Same
	Proposed Omnifix Syringe NRFit	Predicate Device (K071459)B. Braun Piston Syringes	Differences
NeurotoxicityAssessment	No signs of systemic toxicity orneurological impairment fromexposure of leachable compoundsfrom the test article.	N/A. Not required previouslyfor predicate device.	The proposed device isintended for neuraxial usewhich may have indirectcontact with CSF. For thisreason, a neurotoxicityevaluation wasperformed.
Pyrogenicity	Spinal limit of 2.15 EU/device	Limit of 20 EU/device	The proposed device isintended for neuraxial usewhich may have indirectcontact with CSF. Theproposed devices aretherefore tested forendotoxin at the spinallimit of 2.15 EU/device.
Packaging	Individual Unit Package	Individual Unit Package	None, Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	None, Same
SAL	10-6	10-6	None, Same
Shelf Life	5 Years	5 Years	None, Same

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The intended use of the proposed and predicate devices are the same in that both are intended for use by healthcare professionals for aspiration/injection of fluids. However, due to the ISO 80369-6 connector, the Omnifix Syringe NRFit configurations are limited to neuraxial applications. As such, the neuraxial indication, is a subset of the predicate indications for use, which is for general use. Therefore, the above difference in indications for use is not critical to the intended use as the intended use remains for aspiration of fluids. It further does not affect the safety and effectiveness of the device when used as labeled as demonstrated through functional testing. ISO 10993-1 biocompatibility testing, a neurotoxicological assessment, and ISO 80369-6 functional performance testing were conducted to address the changes in indications for neuraxial use and tip design.

Nonclinical Performance Tests

Bench testing performed on the proposed devices supports substantial equivalence. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following ISO 80369-6 testing has been completed for the proposed device.

· Dimensional Requirements
· Fluid leakage requirement
· Leakage by pressure decay
· Subatmospheric pressure air leakage
· Stress cracking
· Resistance to separation from axial load
· Resistance to separation from unscrewing
· Resistance to overriding

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A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2018. The contact classification is external communicating, indirect contact with blood and tissue with a prolonged use. Based on the evaluation, the following biological tests were conducted:

· Cytotoxicity
· Intracutaneous reactivity
· Sensitization
· Acute systemic toxicity
· Subacute/subchronic systemic toxicity
· Genotoxicity
· Material-mediated pyrogenicity
Hemolysis

Additionally, the following tests were performed:

· Particulate Matter per USP <788>
· Neurotoxicity assessment

Packaging: Per ASTM F2096:2011 · Bubble Leak Testing Per ASTM F88/F88M:2015 · Seal Strength Testing

Summary of Substantial Equivalence

The B. Braun Medical Inc. Omnifix Syringe NRFit configuration is substantially equivalent to the predicate device in intended use, principles of operation, technology, design, materials and performance and are as safe and effective as the predicate devices.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).