(118 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.
No.
The device is described as being used to inject or withdraw fluids, which are typically diagnostic or procedural actions, not therapeutic treatments in themselves.
No
The device is described as being for injecting or withdrawing fluids from the body, not for diagnosis.
No
The device description clearly outlines physical components (barrel, plunger, nozzle) and the performance studies focus on bench testing of these physical attributes and materials, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluid into, or withdraw fluids from the body." This describes a device used directly on or in a patient for therapeutic or diagnostic purposes within the body.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description of a syringe with a barrel, plunger, and luer lock connector is consistent with a device used for administering or withdrawing substances from a living organism, not for testing samples in a lab.
- Lack of IVD-related information: There is no mention of analyzing samples, reagents, or any other components typically associated with IVD devices.
Therefore, the B.Braun Omnifix® Low Dead Space Luer Lock Syringes are a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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:
- Biocompatibility in accordance with ISO 10993-1:2018
- Sterilization Residual testing in accordance with ISO 10993-7:2008
- Sterilization Validation in accordance with ISO 11135:2014
- Testing in accordance with ISO 7886-1:2017, ISO 80369-7:2016 and ISO 80369-20:2015
- Performance and functional testing to internal specifications
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
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
1
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 Boulevard |
| Allentown, 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
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.
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 Dead
Space (LDS) Luer Lock Syringes | Predicate Device: Omnifix® piston syringes
(K071459) |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | 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 | B. Braun Omnifix® Piston Syringes: The B. Braun
Omnifix® Piston Syringes are intended to be used to
inject fluid into, or withdraw fluids from, the body.
Single use only, disposable |
| Material
Composition | Syringe barrel: Polypropylene
Syringe plunger: Polypropylene or Polystyrene
Plunger tip(piston) Polyisoprene
Lubricant: Silicone fluid | Syringe barrel: Polypropylene
Syringe plunger: Polystyrene or Polypropylene
Plunger tip (piston): Polyisoprene
Lubricant: 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 tip
configurations | Centric tip, luer lock | Syringe tip configurations: centric and eccentric tips,
luer slip and luer lock versions (syringes of