(83 days)
Not Found
No
The device description and intended use describe standard syringes, and there is no mention of AI or ML in the provided text.
No.
The devices are syringes, used for injecting or withdrawing fluids, which are basic medical tools and not inherently therapeutic in nature. Their function is to administer or remove substances, not to directly treat a condition.
No
Explanation: The device is described as syringes intended for injecting or withdrawing fluids from the body, and for subcutaneous injection of insulin. This is a therapeutic/interventional function, not a diagnostic one.
No
The device description clearly outlines physical components (barrel, plunger, nozzle, needle) and does not mention any software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the syringes are for "inject[ing] fluid into, or withdraw[ing] fluids from, the body" and for "subcutaneous injection of insulin." These are actions performed on the body, not on a sample taken from the body for diagnostic purposes.
- Device Description: The description details the physical components of syringes used for administering or withdrawing substances from a living organism. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing diagnostic information about a patient's condition
Therefore, the Omnifix and Omnican syringes described are medical devices used for therapeutic or procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The B. Braun Omnican® and Omnifix® Insulin Syringes are intended for subcutaneous injection of insulin.
The B. Braun Omnifix® Piston Syringes are intended 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 piston syringes consist of a graduated hollow barrel and a movable plunger with a plunger tip. One end of the barrel has a male connector (nozzle), which permits attachment to a female connector (hub). Both luer lock and luer slip nozzles are available, with centric and eccentric configurations. The Omnifix syringes will be available in 1 mL, 2 mL, 2.5 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 50 mL volume sizes, and as a 1 mL insulin syringe. The Omnican insulin syringes have an integrated needle bonded to the nozzle end of the syringes and are graduated in units of insulin. The Omnican insulin syringes will be available in sizes of 0.5 mL and 1 mL, and with a 30 gauge needle in lengths of 8 mm and 12 mm.
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)
Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Omnifix and Omnican syringes.
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.
K063280, K051574, K955235 and K024112
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
Page 1 of 2
5. 510(k) Summary
AUG 1 6 2007
| AUG 16 200 | |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| Contact: Christine Ford, Regulatory Affairs Specialist | |
| phone (610) 596-2367 fax (610) 266-4962 | |
| DEVICE NAME: | Omnifix ® Syringes, Omnican ® and Omnifix Insulin |
| Syringes | |
| COMMON OR USUAL | |
| NAME: | Piston Syringes, Insulin syringes |
| DEVICE | |
| CLASSIFICATION: | Piston Syringe |
| Class II, CFR Title 21 § 880.5860 | |
| PREDICATE DEVICES: | B. Braun Injekt ® Piston Syringe (K063280) |
| NIPRO disposable hypodermic syringes with or without | |
| needle (K051574) | |
| BD Ultra Fine II, Micro Fine and Short Needle Insulin | |
| Syringes (K955235 and K024112) | |
| DESCRIPTION: | The Omnifix piston syringes consist of a graduated hollow |
| barrel and a movable plunger with a plunger tip. One end of | |
| the barrel has a male connector (nozzle), which permits | |
| attachment to a female connector (hub). Both luer lock and | |
| luer slip nozzles are available, with centric and eccentric | |
| configurations. The Omnifix syringes will be available in | |
| 1 mL, 2 mL, 2.5 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, | |
| and 50 mL volume sizes, and as a 1 mL insulin syringe. | |
| The Omnican insulin syringes have an integrated needle | |
| bonded to the nozzle end of the syringes and are graduated | |
| in units of insulin. The Omnican insulin syringes will be | |
| available in sizes of 0.5 mL and 1 mL, and with a 30 gauge | |
| needle in lengths of 8 mm and 12 mm. | |
| INTENDED USE: | The Omnifix piston syringes are intended to be used to |
| inject fluid into, or withdraw fluids from, the body. The | |
| Omnican and Omnifiy insulin curings |
Omnican and Omnifix insulin syringes are intended for
subcutaneous injection of insulin.
. . . . . . .
1
KD71459
page 2 of 2
SUBSTANTIAL EQUIVALENCE:
The Omnifix® piston syringes and Omnican® and Omnifix insulin syringes have the same intended use, operation, and similar design and materials as the stated predicate devices, the B. Braun Injekt piston syringe, the NIPRO disposable hypodermic syringes with or without needle, and the BD Ultra Fine II, Micro Fine and Short Needle Insulin Syringes. Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Omnifix and Omnican syringes. There are no differences between the predicate and proposed devices that raise new issues of safety and effectiveness.
2
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES. USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2007
Ms. Christine Ford Regulatory Affairs Specialist B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K071459
Trade/Device Name: B. Braun Omnifix® Piston Syringes B.Braun Omnican® and Omnifix® Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 24, 2007 Received: May 25, 2007
Dear Ms. Ford:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Ford
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chris Lino, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4.
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K071459
Device Names: B. Braun Omnican® and Omnifix® Insulin Syringes
Indications For Use:
The B. Braun Omnican® and Omnifix® Insulin Syringes are intended for subcutaneous injection of insulin.
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Craton 2011
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: __ Loggy S 9
5
Indications for Use Statement 4.
Page
510(k) Number (if known): K071459
Device Names: B. Braun Omnifix® Piston Syringes
Indications For Use:
The B. Braun Omnifix® Piston Syringes are intended to inject fluid into, or withdraw fluids from, the body.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clues
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071459