Omnifix Low Dead Space Luer Lock Syringe

K193101 · B.Braun Medical, Inc. · FMF · Mar 5, 2020 · General Hospital

Device Facts

• Record ID: K193101
• Device Name: Omnifix Low Dead Space Luer Lock Syringe
• Applicant: B.Braun Medical, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Mar 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Omnifix Low Dead Space (LDS) Luer Lock Syringe is a manual, single-use, disposable piston syringe. Device consists of a graduated polypropylene barrel, a movable plunger (polypropylene or polystyrene), and a polyisoprene plunger tip. Features a centric luer lock nozzle for secure attachment to needles or hubs. Available in 1 mL and 2 mL sizes. Operated manually by clinicians to inject or withdraw fluids. Low dead space design reduces residual fluid volume compared to standard syringes. Output is the delivery or aspiration of fluids. Benefits include reduced medication waste and improved dosing accuracy for high-cost or critical medications.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1:2018), sterilization validation (ISO 11135:2014), residual testing (ISO 10993-7:2008), and functional performance testing per ISO 7886-1:2017, ISO 80369-7:2016, and ISO 80369-20:2015.

Technological Characteristics

Materials: Polypropylene barrel, polypropylene/polystyrene plunger, polyisoprene tip, silicone lubricant. Design: Centric luer lock, 1 mL and 2 mL volumes. Sterilization: Ethylene Oxide. Standards: ISO 7886-1:2017, ISO 80369-7:2016, ISO 80369-20:2015, ISO 10993 series.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body in patients requiring syringe-based delivery or aspiration.

Regulatory Classification

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.

Predicate Devices

• B. Braun Omnifix® Piston Syringes (K071459)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: ;">☐</span> 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<br>Allentown, PA 18109-9341 |
| Telephone Number: | 610-266-0500, ext. 2966 |
| Contact Person: | Tracy Larish, Sr. Regulatory Affairs Specialist |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Email: | [e-mail] |
| 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<br>Space (LDS) Luer Lock Syringes | Predicate Device: Omnifix® piston syringes<br>(K071459) |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The B.Braun Omnifix® Low Dead Space Luer<br>Lock Syringes are intended to be used to inject<br>fluid into, or withdraw fluids from the body.<br>Single use only, disposable | B. Braun Omnifix® Piston Syringes: The B. Braun<br>Omnifix® Piston Syringes are intended to be used to<br>inject fluid into, or withdraw fluids from, the body.<br>Single use only, disposable |
| Material<br>Composition | Syringe barrel: Polypropylene<br>Syringe plunger: Polypropylene or Polystyrene<br>Plunger tip(piston) Polyisoprene<br>Lubricant: Silicone fluid | Syringe barrel: Polypropylene<br>Syringe plunger: Polystyrene or Polypropylene<br>Plunger tip (piston): Polyisoprene<br>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, &<br>50 mL |
| Syringe tip<br>configurations | Centric tip, luer lock | Syringe tip configurations: centric and eccentric tips,<br>luer slip and luer lock versions (syringes of < 5 mL<br>centric only) |
| Markings | Graduated scale markings meet requirements<br>of ISO 7886-1:2017 | Graduated scale markings meet requirements of ISO<br>7886-1:1993 and ISO 8537:1991 (E) |
| Maximum low<br>dead space<br>volume<br>specification | ≤ 0.023 mL or 67% less than ISO 7886-1:2017<br>requirement | Meets ISO 7886-1:2017 |
| Barrel<br>transparency: | 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.