The Omnican fine is a pen needle device that is a sterile, individually packaged, single use, hypodermic single lumen needle; intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Omnican fine is a double-ended needle consisting of a tri-beveled tip, hollow steel cannula, and needle hub packaged in a hard plastic sealed container. Specific versions contain an inner needle shield. The Omnican fine provides a fluid path from a drug container to subcutaneous tissue.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically a hypodermic single lumen needle called "Omnican fine." The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials. Therefore, the "study" referred to will be a collection of non-clinical performance tests and comparisons.

Here's a breakdown of the acceptance criteria and the "study" details based on the document:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document outlines acceptance criteria indirectly through the "Summary of nonclinical performance tests" and lists the intended performance of the "Proposed Device Omnican fine."

Feature/Test	Acceptance Criteria (Predicate/Omnican Fine)	Reported Device Performance (Omnican fine)
Functional Performance
Measurement of needle tube length: Injector end	6.15 +0.5/-0.3 mm	6.15 +0.5/-0.3 mm
Measurement of needle tube length: Patient End	12 +1.1/-0.8 mm (for 12mm size)8 +1.1/-0.8 mm (for 8mm size)6 +1.1/-0.8 mm (for 6mm size)4 + 1.25/-0.0 mm (for 4mm size)	12 +1.1/-0.8 mm8 +1.1/-0.8 mm6 +1.1/-0.8 mm4 + 1.25/-0.0 mm
Dislocation of measuring point at patient end	≤ 1.1 mm (for 12mm needle)≤ 0.9 mm (for 8mm needle)≤ 0.7 mm (for 6mm needle)≤ 0.6 mm (for 4mm needle)	Met criteria (implied by "Omnican fine met all established acceptance criteria")
Bond between needle hub and needle tube	Withstand a 22 N force applied axially for 5 seconds.	Met criteria (implied by "Omnican fine met all established acceptance criteria")
Unscrewing torque of the needle	< 0.1 Nm	< 0.1 Nm
Flow Rate	According to product specification (specific values not provided but implied as meeting a standard)Blockage/Patency of inner lumen	Met criteria (implied by "Omnican fine met all established acceptance criteria")
Tube Tips (Patient end and Cartridge end)	Freedom from damages and defects (implied by standard ISO 7864 and general quality expectations)	Met criteria (implied by "Omnican fine met all established acceptance criteria")
Lubricants (Siliconizing needle tube patient/cartridge end)	Adequate lubrication for intended use (implied by general quality expectations and functional testing without explicit numerical criteria)	Met criteria (implied by "Omnican fine met all established acceptance criteria")
Compatibility with NIS (Torque on/off)	Function correctly with declared compatible NIS (specific torque values not provided, but implies smooth and secure attachment/detachment)	Met criteria (implied by "Omnican fine met all established acceptance criteria" and "Comparison of Technological Characteristics" stating compatibility)
Compatibility with NIS (Dose accuracy)	Not specified as a direct acceptance criterion for the needle itself, but typically assessed as part of the overall injection system performance. The needle's design must not negatively impact the NIS's dose accuracy.	Met criteria (implied by "Omnican fine met all established acceptance criteria" in conjunction with NIS compatibility)
Ease of assembly/disassembly	Easy and intuitive assembly/disassembly (implied by functional testing)	Met criteria (implied by "Omnican fine met all established acceptance criteria")
Biocompatibility	Meet requirements per ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Rabbit Pyrogen - for Externally Communicating Device, Tissue/Bone/Dentin, Limited Contact Duration <24 hrs)	Met requirements (stated as "Meets the requirements per ISO 10993-1")
Sterilization	Ethylene Oxide, SAL 10-6, validated according to ISO 11135:2014(E)	EtO, SAL 10-6, validated (stated as "The sterilization process is the same and has been validated according to the same procedures" and "Ethylene Oxide, SAL 10-6")
Shelf Life	5 years (demonstrated through accelerated aging)	5 years (stated as "5 years" and "Accelerated ageing was conducted to prove a shelf life of 5 years")
Physical Characteristics (Dimensional)	Corresponds to specified OD/ID, Gauge sizes, and absence of an inner needle shield for Pencylcap.	Omnican fine: OD: 0.33 mm; 0.25 mm; ID: 0.19 ± 0.01 mm; 0.125 + 0.035 mm; Gauge sizes: 29 Gauge; 31 Gauge (these are the differences from predicate, but they are tested to ensure they meet the functional criteria of the device as a whole, matching relevant standards)

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

Sample Size: The document does not explicitly state the sample sizes (number of units) for each non-clinical test. It lists the types of tests performed (e.g., Dimensions, Flow Rate, Connection of needle hub to the needle tube, etc.) and refers to compliance with ISO standards (e.g., ISO 7864:2016(E), ISO 9626:2016(E), ISO 11608-2:2012(E)). These standards often specify minimum sample sizes for material and performance testing.
Data Provenance: The testing was conducted by B. Braun Medical Inc. ("assessed by B. Braun" and "conducted along with the same indications for use..."). This would be internal company data. The document does not specify country of origin for the data or whether the test samples were retrospective or prospectively manufactured for the submission. Given it's a premarket submission, the test samples would be representative of the intended manufacturing process.

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

This is a medical device (needle) 510(k) submission, not an AI/Software as a Medical Device (SaMD) submission. As such:

No expert ground truth establishment: The "ground truth" for this device's performance is established by adhering to recognized international and national standards for medical devices (e.g., ISO for needles, biocompatibility, sterilization). The performance is measured directly against physical and functional specifications.
No specific experts mentioned: The testing would be performed by qualified engineers, technicians, and laboratory personnel experienced in medical device testing, quality control, and compliance with the referenced ISO standards. There is no mention of "experts" in the sense of clinicians establishing 'diagnoses' or 'interpretations'.

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

Not applicable. This type of adjudication method is used in studies where human interpretation (e.g., radiology reads) forms the basis of ground truth, typically for AI/SaMD or diagnostic imaging devices. For a hypodermic needle, performance is determined by meeting objective, measurable physical and functional criteria per established 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 a physical medical device (a needle), not an AI-assisted diagnostic or therapeutic system. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this submission.

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

Not applicable. This is not an algorithm or software device. Its performance is entirely mechanical and material-based.

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

The "ground truth" for hypodermic needles is established by:

Compliance with recognized international standards: Such as ISO 7864 (hypodermic needles), ISO 9626 (stainless steel needle tubing), ISO 10993 (biocompatibility), ISO 11135 (sterilization), and ISO 11608-2 (Needle-based injection systems). These standards define test methods and acceptable performance limits.
Engineering specifications and design verification: The device is tested against its own design specifications, which are themselves derived from clinical need and regulatory requirements (e.g., specific lengths, diameters, bonding strength).
Comparison to a predicate device: A key aspect of a 510(k) is demonstrating that the new device is substantially equivalent to a predicate, meaning it performs similarly and presents similar safety and effectiveness profiles. The predicate device's established safe and effective use serves as a benchmark for the "ground truth" of performance for this device type.

8. The sample size for the training set:

Not applicable. There is no AI component or machine learning in this device, so there is no training set.

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

Not applicable. As there is no training set for machine learning, there is no ground truth established for one.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 11, 2018

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

Re: K173803

Trade/Device Name: Omnican fine Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: May 11, 2018 Received: May 11, 2018

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 (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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Tina Kiang -S

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)

K173803

Device Name Omnican fine

Indications for Use (Describe)

Omnican fine is intended for use with compatible needle-based injection for subcutaneous injection of fluid drug products.

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	K173803
SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500
	Contact: Kimberly Smith, Sr. Regulatory Affairs SpecialistPhone: (610) 596-2326Fax: (610) 266-4962E-mail: Kim.smith@bbraun.com
DATE:	December 13, 2017
DEVICE NAME:	Omnican fine
COMMON NAME:	Pen needle; Hypodermic single lumen needle
CLASSIFICATION:	Class II per 21 CFR 880.5570, Needle, hypodermic, single lumenProduct Code: FMIPanel: General Hospital
PREDICATE DEVICE:	PencylcapB. Braun Melsungen AGK152050, Class II, FMI, 880.5570

Description

To utilize the needle, the primary package is opened by removal of the seal and the exposed part of the needle is securely fastened onto the injection device. Once fastened, the needle penetrates the septum of the cartridge inside the injector. The primary container is then removed from the lower (distal) part, the patient end, of the needle. For versions that contain an inner needle shield, the shield is to be removed shortly before injection. The device is now ready for use for subcutaneous injection of fluid drug products.

Intended Use

Omnican fine is intended for use with needle-based injection devices for subcutaneous injection of fluid drug products. Omnican fine is intended for single usage with the needle-based injection

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system (NIS) according to the instructions of the NIS. The Omnican fine pen needle may be used for any patient population. The Omnican fine is a physician prescribed device.

Indications for Use

Omnican fine is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.

Substantial Equivalence

Predicate Device - B. Braun Melsungen AG, Pencylcap (K152050)

The Omnican fine is substantially equivalent to the predicate device. Both devices are sterile, individually packaged, for single use only. Both devices have the same intended use and indications for use. Both devices have the same principle of operation and the same fundamental scientific technology. Both devices are produced at the same manufacturing facility. The sterilization process is the same and has been validated according to the same procedures. Primary packaging that assures sterility and shelf life are the same for the critical sealing area. Besides the product name, the following differences apply to the Omnican fine compared to the predicate:

· The shape of the needle container. This difference has no impact on the finished device.
· The needle tube is glued to the needle hub for Omnican fine, whereas the Pencylcap needle tube is welded to the hub. This difference was assessed by B. Braun and found to have no impact on the safety and effectiveness of the Omnican fine. Both versions comply with the effective standards.
· The material of the needle hub for Omnican fine is Polypropylene, for Pencylcap it is Copolyester. This difference was assessed by B. Braun and found to have no impact on the safety and effectiveness of the Omnican fine.
· The optional needle shield component in the Omnican fine was not a component for the Pencylcap. As the needle shield has no direct body contact to the user and no special safety function, this change does not affect the safety and effectiveness of the Omnican fine.
· Three additional sizes of the needle tube are included in the Omnican fine range.

Comparison of Technological Characteristics with the Predicate Device

The Omnican fine possesses similar technological characteristics as the predicate B. Braun Medical Pencylcap device cleared under 510(k) K152050. The following table provides a side by side summary of comparison.

Feature	Predicate DevicePencylcap K152050	Proposed DeviceOmnican fine
Intended Use	Pencylcap is intended for use with needle-	Omnican fine is intended for use with
	based injection devices for subcutaneous	needle-based injection devices for
	injection of fluid drug products. Pencylcap	subcutaneous injection of fluid drug
	is intended for single usage with the needle-	products. Omnican fine is intended for
	based injection system (NIS) according to	single usage with the needle-based injection
	the instructions of the NIS. The Pencylcap	system (NIS) according to the instructions
	may be used for any patient population. The	of the NIS. The Omnican fine may be used
	Pencylcap pen needle is a physician	for any patient population. The Omnican
	prescribed device.	fine is a physician prescribed device.

Feature	Predicate DevicePencylcap K152050	Proposed DeviceOmnican fine
Indications for Use	The Pencylcap is intended for use withneedle-based injection devices forsubcutaneous injection of fluid drugproducts.	Omnican fine is intended for use withneedle-based injection devices forsubcutaneous injection of fluid drugproducts.
Operating Principle	Manually operated according to theinstructions for use provided with thefinished device.	Manually operated according to theinstructions for use provided with thefinished device.
Mechanism of Action	Allow subcutaneous injection of fluid drugswhen attached to a needle-based injectionsystem (NIS).	Allow subcutaneous injection of fluid drugswhen attached to a needle-based injectionsystem (NIS).
Declared compatibleneedle-based injectionsystems (NIS):	Gonal-f® RFF Redi-ject™	BMS AstraZeneca:Byetta® (BMS = Bristol-Myers Squibb)Lilly:HumaPen® Luxura, HumaPen® LuxuraHD, HumaPen® Memoir, HumaPen®Savvio, KwikPenTMNovo Nordisk:FlexPen®, FlexTouch®, NovoPen Echo®,Victoza®Owen Mumford:Autopen® 24, Autopen® Classic 1,Autopen® Classic 2Sanofi:SoloStar®
Design / TechnologicalCharacteristics	Needle is welded to hub.	Needle is glued to hub.
Lengths:	Needle tube length on patient end:12mm	Needle tube length on patient end:12 mm; 8 mm; 6 mm; 4 mm
OD/ID:	Needle tube diameter:OD: 0.33 mmID: 0.19 ± 0.01 mm	Needle tube diameter:OD: 0.33 mm; 0.25 mmID: 0.19 ± 0.01 mm; 0.125 + 0.035 mm
Gauge Sizes:	Gauge sizes: 29 GaugeFeatures:Tri-beveled needle tip configuration.Single use only.	Gauge sizes: 29 Gauge; 31 GaugeFeatures:Tri-beveled needle tip configuration.Single use only.
Feature	Predicate DevicePencylcap K152050	Proposed DeviceOmnican fine
Summary of nonclinicalperformance tests fordetermination ofsubstantial equivalence	Measurement of needle tube length:Injector end: 6.15 +0.5/-0.3 mmPatient End: 12 +1.1/-0.8 mm	Measurement of needle tube length:Injector end: 6.15 +0.5/-0.3 mmPatient End: 12 +1.1/-0.8 mm8 +1.1/-0.8 mm6 +1.1/-0.8 mm4 + 1.25/-0.0 mm
	Dislocation of measuring point at the end ofthe needle:≤ 1.1 mm based on a needle length of 12 mm	Dislocation of measuring point at the end ofthe needle:≤ 1.1 mm based on a needle length of 12 mm≤ 0.9 mm based on a needle length of 8mm≤ 0.7 mm based on a needle length of 6mm≤ 0.6 mm based on a needle length of 4mm
	Bond between the needle hub and needletube:The needle hub/needle tube bond must becapable of withstanding a 22 N forceapplied axially for 5 seconds.	Bond between the needle hub and needletube:The needle hub/needle tube bond must becapable of withstanding a 22 N forceapplied axially for 5 seconds.
	Unscrewing torque of the needle: < 0.1 Nm	Unscrewing torque of the needle: < 0.1 Nm
Biocompatibility andMaterials	Externally Communicating DeviceTissue/Bone/DentinLimited Contact Duration <24 hrsMeets the requirements per ISO 10993-1• Cytotoxicity• Sensitization• Intracutaneous reactivity• Systemic toxicity• Rabbit Pyrogen	Externally Communicating DeviceTissue/Bone/DentinLimited Contact Duration < 24 hrsMeets the requirements per ISO 10993-1• Cytotoxicity• Sensitization• Intracutaneous reactivity• Systemic toxicity• Rabbit Pyrogen
	Needle hub material: CopolyesterNeedle tube material: Austenitic stainlesssteel (AISI SUS 304)Needle shield material: Styrene-butadiene/SB + 4% Masterbatch green	Needle hub material: PolypropyleneNeedle tube material: Austenitic stainlesssteel (AISI SUS 304)Needle shield material: Styrene-butadiene/SB + 4% Masterbatch green
Packaging	Single-packed and sealed with a highperformance, coated, peelable surgical kraftpaper. 100 pieces are packed in a printedduplex box, transport packing is made ofdouble wall corrugated paper.	Single-packed and sealed with a highperformance, coated, peelable surgical kraftpaper. 100 pieces are packed in a printedduplex box, transport packing is made ofdouble wall corrugated paper.
Sterilization	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL 10-6
Shelf Life	5 years	5 years

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Testing

The following standards were utilized during the testing of the Omnican fine.

ISO 7864:2016(E) "Sterile hypodermic needles for single use - Requirements and test methods"

ISO 9626:2016(E) "Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods"

ISO 10993-7:2008/Cor.1:2009(E) "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals''

ISO 11135:2014(E) "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices"

ISO 11608-2:2012(E) "Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles"

The Omnican fine was subjected to functional performance testing to demonstrate that the device performs as intended. The following tests were performed:

· Dimensions
- o Usable length of needle tube
- o Length cartridge end of needle
Flow Rate
- o According to product specification
- o Blockage/Patency of inner lumen
· Connection of needle hub to the needle tube
- o Connection of needle hub
- o Tensile load
· Tube Tips
- 0 Needle tube tip patient end
- o Needle tube tip cartridge end
Freedom from damages and defects
· Lubricants
- o Siliconizing needle tube patient end
- o Siliconizing needle tube cartridge end
· Dislocation of measuring point at patient end of pen needle
· Compatibility with needle based injection system (NIS)
- o Torque on/off
- o Dose accuracy
· Ease of assembly/disassembly
· Accelerated ageing was conducted to prove a shelf life of 5 years

Conclusion

Omnican fine met all established acceptance criteria required for performance and design verification testing. Results of the functional performance and biocompatibility testing conducted along with the same indications for use, intended use and similar technological characteristics demonstrate that the Omnican fine is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).