(59 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of AI or ML capabilities.
No.
The device is a syringe for aspiration/injection of fluids and does not directly provide therapy. It is a delivery mechanism for therapeutic or diagnostic substances.
No
This device is a syringe for fluid aspiration and injection, with no stated function or capability for diagnosing medical conditions.
No
The device description clearly outlines physical components (barrel, stopper, plunger rod) and mentions bench testing related to physical properties and connections (ISO 80369-6 testing, biocompatibility, particulate matter, packaging tests), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration/injection of fluids used by healthcare professionals in healthcare facilities" for "neuraxial use". This describes a device used for administering or withdrawing substances directly from the body, not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe with specific fittings for neuraxial applications. This is a medical device used for direct patient care, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing in vitro.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This syringe does not perform such a function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QEH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuraxial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Professionals / Healthcare Facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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
- Neurotoxicity assessment
Packaging: Per ASTM F2096:2011 Bubble Leak Testing Per ASTM F88/F88M:2015 Seal Strength Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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
2
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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3
510(k) Summary
Submitter Information
| Name: | B. Braun Medical Inc. |
|---|---|
| Address: | 824 Twelfth Avenue |
| Bethlehem, 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 |
4
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
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.
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.
5
| | Proposed Omnifix Syringe NRFit | Predicate Device (K071459)
B. Braun Piston Syringes | Differences | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Omnifix piston syringes
are intended to be used to
inject fluid into, or withdraw
fluids from, the body. | The proposed device is
limited to neuraxial use. | |
| Product Code | QEH | FMF | The proposed device is
limited to neuraxial use.
Predicate device was for
general use. | |
| Intended Use | The B. Braun Omnifix Syringe
NRFit is intended to be used to
inject fluid into, or withdraw fluids
from, the body. | The Omnifix piston syringes
are intended to be used to
inject fluid into, or withdraw
fluids from, the body. | None, Same | |
| Intended User | Healthcare Professionals | Healthcare Professionals | None, Same | |
| Environment of Use | Healthcare Facilities | Healthcare Facilities | None, Same | |
| Syringe
components/materials | Barrel | Polypropylene | Polypropylene | None, Same |
| | Plunger | Polyisoprene | Polyisoprene | None, Same |
| | Stopper | Silicone | Silicone | None, Same |
| | Lubricant | Silicone | Silicone | None, Same |
| | Plunger Rod | Yellow
1mL Polystyrene /
3, 5, 10, 20 mL
Polypropylene | Clear
1mL Polystyrene /
3, 5, 10, 20 mL Polypropylene | Base material is the same.
Color is different - change
to the plunger from clear to
yellow to differentiate the
NRFit syringes from the
general piston syringes. |
| Tip Type
smallbore 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 device
contains a NRFit smallbore
connector which is | |
| Functional Testing
Summary of ISO
80369-6 compliant
nonclinical tests | • 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 | • Gauging
• Liquid leakage
• Air leakage
• Separation force
• Unscrewing torque
• Ease of assembly
• Resistance to overriding
• Stress cracking | intended for neuraxial use.
ISO 80369-6 testing
performed to demonstrate
safety and effectiveness of
the neuraxial smallbore
connector for the neuraxial
intended use and to
confirm substantial
equivalence. | |
| Patient Contact
category/ Duration | Externally Communicating,
Tissue/Bone/Dentin, prolonged
exposure | Externally Communicating,
Blood Path Indirect, limited
exposure | The proposed device is
intended for neuraxial use
which may have indirect
contact with cerebral
spinal fluid (CSF). For this
reason,
Tissue/Bone/Dentin with a
longer duration exposure
was chosen. | |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | None, Same | |
| Hypodermic Syringe
Functional | Conforms to ISO 7886-1 | Conforms to ISO 7886-1 | None, Same | |
| | Proposed Omnifix Syringe NRFit | Predicate Device (K071459)
B. Braun Piston Syringes | Differences | |
| Neurotoxicity
Assessment | No signs of systemic toxicity or
neurological impairment from
exposure of leachable compounds
from the test article. | N/A. Not required previously
for predicate device. | The proposed device is
intended for neuraxial use
which may have indirect
contact with CSF. For this
reason, a neurotoxicity
evaluation was
performed. | |
| Pyrogenicity | Spinal limit of 2.15 EU/device | Limit of 20 EU/device | The proposed device is
intended for neuraxial use
which may have indirect
contact with CSF. The
proposed devices are
therefore tested for
endotoxin at the spinal
limit 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 | |
6
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
7
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
- · 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.