The B.Braun Omnifix® Low Dead Space Luer Lock Syringes are intended to be used to inject fluid into, or withdraw fluids from the body. Single use only, disposable.

Device Description

The Omnifix® Low Dead Space (LDS) Luer Lock Syringes consist of a graduated hollow barrel and a movable plunger (piston) with a plunger tip. One end of the barrel has a male connector (nozzle), which permits attachment to a female connector (hub) and a needle. The luer lock nozzle has a centric configuration. The Omnifix ® Low Dead Space (LDS) syringes will be available in 1 mL and 2 mL.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, granting B. Braun Medical Inc. the ability to market their Omnifix® Low Dead Space Luer Lock Syringe. This type of FDA clearance relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic capability, as would be the case for AI/ML-driven diagnostic devices.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sensitivity, specificity, MRMC studies, expert consensus ground truth) does not apply to this specific FDA clearance document for a medical syringe.

The document describes nonclinical testing performed to demonstrate that the device performs as intended and supports substantial equivalence. This is primarily focused on confirming the physical and material properties of the syringe meet relevant industry standards and are comparable to the predicate device.

However, I can extract the information provided about the device's characteristics and the nonclinical tests performed, which serve as the basis for its clearance, in a quasi-table format, and explain why other requested information (like MRMC, expert consensus, etc.) is not relevant here.

Based on the provided FDA 510(k) summary for the Omnifix® Low Dead Space Luer Lock Syringe, here's an analysis tailored to the prompt's request, focusing on what is relevant and explaining why other aspects are not applicable:

This FDA clearance is for a physical medical device (syringe), not an AI/ML-driven diagnostic or assistive technology. Therefore, many of the standard "acceptance criteria" and "study types" typically discussed for AI/ML devices (e.g., sensitivity, specificity, human reader improvement, expert consensus for ground truth on images) are not applicable to this submission.

Instead, the "acceptance criteria" for this syringe are primarily based on meeting recognized international standards (ISO standards) and demonstrating substantial equivalence to a legally marketed predicate device through nonclinical (bench) testing.

Table of "Acceptance Criteria" (via ISO Standards and Equivalence) and Reported Device Performance

Acceptance Criterion	Description (as applied to a syringe)	Reported Device Performance / Assessment
Indications for Use (Equivalence)	The device is intended to be used to inject fluid into, or withdraw fluids from, the body, matching the predicate.	The proposed device's Indications for Use are identical to the predicate device the B. Braun Omnifix® Piston Syringes (K071459).
Material Composition (Equivalence)	Materials used (polypropylene, polyisoprene, silicone fluid) are comparable to the predicate.	Syringe barrel: Polypropylene. Syringe plunger: Polypropylene or Polystyrene. Plunger tip (piston): Polyisoprene. Lubricant: Silicone fluid. These match the predicate device.
Sizes (Equivalence)	Available in 1 mL and 2 mL.	Matches corresponding sizes available in the predicate device (predicate also has other sizes).
Syringe Tip Configurations (Equivalence)	Centric tip, luer lock.	Comparable to predicate, which also has centric and eccentric tips, luer slip and luer lock versions. Proposed device is a specific configuration subset of the predicate capabilities.
Markings (Standard Compliance)	Graduated scale markings meet requirements of ISO 7886-1:2017.	Testing confirms compliance with ISO 7886-1:2017. (Predicate met an older version: ISO 7886-1:1993 and ISO 8537:1991).
Maximum Low Dead Space Volume Specification (Performance)	The unique "low dead space" feature specifies a volume of ≤ 0.023 mL or 67% less than ISO 7886-1:2017 requirement.	The document states the device meets ISO 7886-1:2017, and highlights its "low dead space" volume as significantly better than the standard requirement.
Barrel Transparency (Equivalence)	Translucent barrel.	Matches the predicate device's translucent barrel.
Sterilization (Equivalence & Validation)	Sterilized by Ethylene Oxide.	Matches predicate's sterilization method. Sterilization Validation in accordance with ISO 11135:2014 was successfully completed.
Biocompatibility (Standard Compliance)	Materials are biocompatible in accordance with ISO 10993-1:2018.	Testing confirms compliance with ISO 10993-1:2018.
Sterilization Residuals (Standard Compliance)	Ethylene oxide residuals are within acceptable limits per ISO 10993-7:2008.	Testing confirms compliance with ISO 10993-7:2008.
Connector Conformance (Standard Compliance)	Luer lock connectors meet ISO 80369-7:2016 and ISO 80369-20:2015.	Testing confirms compliance with ISO 80369-7:2016 and ISO 80369-20:2015.
General Performance & Functional Testing (Internal Specifications)	Device performs as intended via internal functional tests.	"Performance and functional testing to internal specifications" was successfully completed.

Explanation of Non-Applicable AI/ML Study Information:

The following points are not applicable to this 510(k) submission because it is for a physical medical device (syringe), not an AI/ML product:

Sample size used for the test set and the data provenance: Not relevant for a syringe. Bench testing is performed on manufactured units, not a "test set" of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a syringe's performance is determined by physical measurements against engineering specifications and ISO standards, not expert medical interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 a syringe, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a syringe's performance is compliance with ISO standards and engineering specifications through bench testing, demonstrating its physical and material properties are safe and effective. It's not based on clinical "outcomes data" in the diagnostic sense or expert interpretation of medical images.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

In summary, this FDA clearance demonstrates that the Omnifix® Low Dead Space Luer Lock Syringe is substantially equivalent to a predicate device. This is achieved through rigorous nonclinical (bench) testing that confirms the syringe meets established ISO standards for performance, materials, and safety, and that its design and intended use are consistent with previously cleared devices.

Summary

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March 5, 2020 B. Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109

Re: K193101

Trade/Device Name: Omnifix Low Dead Space Luer Lock Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 21, 2020 Received: February 3, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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.

For CAPT Alan Stevens 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) K193101

Device Name

Omnifix® Low Dead Space Luer Lock Syringe

Indications for Use (Describe)

The B.Braun Omnifix® Low Dead Space Luer Lock Syringes are intended to be used to inject fluid into, or withdraw fluids from the body.

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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5. 510(k) SUMMARY

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:	November 8th, 2019

DEVICE NAME:

Device Trade Name:	Omnifix® Low Dead Space Luer Lock Syringes
Common Name:	Piston Syringes
Classification Name:	Piston Syringe, 21 CFR §880.5860: Class II, Product code
	FMF

PREDICATE DEVICES:

K071459 B. Braun Omnifix® Piston Syringes ●

DEVICE DESCRIPTION

INDICATIONS FOR USE:

The B. Braun Omnifix® Low Dead Space Luer Lock syringes are intended to be used to inject fluid into, or withdraw fluids from, the body.

TECHNOLOGICAL CHARACTERISTICS:

The proposed Omnifix® Low Dead Space Luer Lock Syringe is substantially equivalent to the predicate Omnifix® Piston Syringes in terms of indications for use, intended use, general design, functional performance and materials of construction.

The difference between the proposed Omnifix® Low Dead Space Luer Lock Syringe and the predicate do not raise new issues of safety and effectiveness.

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	Proposed Device:Omnifix® Low DeadSpace (LDS) Luer Lock Syringes	Predicate Device: Omnifix® piston syringes(K071459)
Indications	The B.Braun Omnifix® Low Dead Space LuerLock Syringes are intended to be used to injectfluid into, or withdraw fluids from the body.Single use only, disposable	B. Braun Omnifix® Piston Syringes: The B. BraunOmnifix® Piston Syringes are intended to be used toinject fluid into, or withdraw fluids from, the body.Single use only, disposable
MaterialComposition	Syringe barrel: PolypropyleneSyringe plunger: Polypropylene or PolystyrenePlunger tip(piston) PolyisopreneLubricant: Silicone fluid	Syringe barrel: PolypropyleneSyringe plunger: Polystyrene or PolypropylenePlunger tip (piston): PolyisopreneLubricant: Silicone fluid
Sizes	1 mL, 2 mL	1 mL,2 mL,2.5 mL,3 mL,5 mL,10 mL,20 mL,30 mL, &50 mL
Syringe tipconfigurations	Centric tip, luer lock	Syringe tip configurations: centric and eccentric tips,luer slip and luer lock versions (syringes of < 5 mLcentric only)
Markings	Graduated scale markings meet requirementsof ISO 7886-1:2017	Graduated scale markings meet requirements of ISO7886-1:1993 and ISO 8537:1991 (E)
Maximum lowdead spacevolumespecification	≤ 0.023 mL or 67% less than ISO 7886-1:2017requirement	Meets ISO 7886-1:2017
Barreltransparency:	translucent	translucent
Sterilization	Ethylene Oxide	Ethylene Oxide

NONCLINICAL TESTING

Bench testing performed on Omnifix® Low Dead Space Luer Lock Syringe demonstrates that the device performs as intended and 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 successfully completed for the proposed devices:

O Biocompatibility in accordance with ISO 10993-1:2018
Sterilization Residual testing in accordance with ISO 10993-7:2008 O
Sterilization Validation in accordance with ISO 11135:2014 O
O Testing in accordance with ISO 7886-1:2017, ISO 80369-7:2016 and ISO 80369-20:2015
Performance and functional testing to internal specifications o

CONCLUSION:

Results of the functional and performance testing conducted on the proposed devices demonstrate that the Omnifix® Low Dead Space Luer Lock Syringes are as safe and effective as the predicate devices. The differences, between proposed devices and predicate devices, do not raise any new issues of safety and effectiveness. Therefore, proposed Omnifix® Low Dead Space Luer Lock Syringe are substantially equivalent to 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).