(83 days)
The Omnifix piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body. The Omnican and Omnifix insulin syringes are intended for subcutaneous injection of insulin.
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.
The provided document is a 510(k) summary for the B. Braun Omnifix® Piston Syringes and Omnican® and Omnifix® Insulin Syringes. It states that biocompatibility and functional testing were performed to verify the safety and effectiveness of the devices. However, it does not provide specific acceptance criteria or detailed results of these tests (e.g., specific thresholds for force, volume accuracy, etc.), nor does it describe the study methodology, sample sizes, or ground truth establishment.
Based on the provided text, the exact details needed for this request (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) are not available. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's description and intended use.
Therefore, the table and detailed answers below reflect the absence of this specific information in the provided 510(k) summary.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Biocompatibility standards met. | "Biocompatibility testing... performed to verify safety and effectiveness." (No specific results provided) |
| Functional performance standards met (e.g., consistent injection/withdrawal force, accurate volume delivery, leak-proof). | "Functional testing... performed to verify safety and effectiveness." (No specific results provided) |
| No differences from predicate devices that raise new safety/effectiveness issues. | "There are no differences between the predicate and proposed devices that raise new issues of safety and effectiveness." (Qualitative statement) |
1. A table of acceptance criteria and the reported device performance
As indicated in the table above, the 510(k) summary states that "Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Omnifix and Omnican syringes." However, it does not explicitly define specific quantitative acceptance criteria or provide detailed numerical performance results for these tests. The document focuses on the conclusion that testing was performed and demonstrated safety and effectiveness in comparison to predicate devices, rather than presenting the raw data or specific thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not disclose the sample size used for the biocompatibility or functional testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for any testing, as the testing appears to be primarily laboratory-based functional and biocompatibility assessments, not diagnostic interpretative tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no expert review or adjudication method is mentioned for establishing ground truth in this type of device submission.
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 device is a medical syringe, not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this device is a physical medical device (syringe), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied in AI/diagnostic device studies (e.g., expert consensus, pathology) is not applicable here. For physical medical devices like syringes, "ground truth" would typically refer to established engineering standards, material properties, and biological responses (e.g., cell viability in biocompatibility, accurate force measurements for functional tests) rather than human expert interpretation of data. The document implies compliance with such standards through "biocompatibility and functional testing."
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model, 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 this device.
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Page 1 of 2
5. 510(k) Summary
AUG 1 6 2007
| AUG 16 200 | |
|---|---|
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341 |
| Contact: Christine Ford, Regulatory Affairs Specialistphone (610) 596-2367 fax (610) 266-4962 | |
| DEVICE NAME: | Omnifix ® Syringes, Omnican ® and Omnifix InsulinSyringes |
| COMMON OR USUALNAME: | Piston Syringes, Insulin syringes |
| DEVICECLASSIFICATION: | Piston SyringeClass II, CFR Title 21 § 880.5860 |
| PREDICATE DEVICES: | B. Braun Injekt ® Piston Syringe (K063280) |
| NIPRO disposable hypodermic syringes with or withoutneedle (K051574) | |
| BD Ultra Fine II, Micro Fine and Short Needle InsulinSyringes (K955235 and K024112) | |
| DESCRIPTION: | The Omnifix piston syringes consist of a graduated hollowbarrel and a movable plunger with a plunger tip. One end ofthe barrel has a male connector (nozzle), which permitsattachment to a female connector (hub). Both luer lock andluer slip nozzles are available, with centric and eccentricconfigurations. The Omnifix syringes will be available in1 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 needlebonded to the nozzle end of the syringes and are graduatedin units of insulin. The Omnican insulin syringes will beavailable in sizes of 0.5 mL and 1 mL, and with a 30 gaugeneedle in lengths of 8 mm and 12 mm. |
| INTENDED USE: | The Omnifix piston syringes are intended to be used toinject fluid into, or withdraw fluids from, the body. TheOmnican and Omnifiy insulin curings |
Omnican and Omnifix insulin syringes are intended for
subcutaneous injection of insulin.
. . . . . . .
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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.
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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.
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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
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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
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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
§ 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).