(365 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, material biocompatibility, functional performance (volumetric accuracy), human factors, and sterilization of a standard insulin syringe. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an insulin syringe, which is used to administer a drug (insulin), but it does not inherently provide therapy itself. The drug administered through it provides the therapeutic effect.
No
This device is a syringe intended for the injection of U-500 insulin. It is used for administering a substance, not for diagnosing a condition or disease.
No
The device description clearly describes a physical syringe with a needle, barrel, and scale markings. The performance studies focus on material biocompatibility, functional performance (volumetric accuracy), human factors related to physical use, sterilization, and extractables/leachables, all of which are related to a physical hardware device. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of U-500 insulin". This describes a method of administering a substance into the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is a "standard single use 0.5mL plastic syringe intended for the injection of U-500 insulin". This is a delivery device, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the syringe (biocompatibility, volumetric accuracy, usability, sterilization, etc.) and the stability of the insulin, not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This syringe's function is solely to deliver medication.
N/A
Intended Use / Indications for Use
The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The U-500 Insulin Syringe is a standard single use 0.5mL plastic syringe intended for the injection of U-500 insulin into the subcutaneous tissue. It features a 31G needle and 6 mm needle length with unique U-500 scale markings on the syringe barrel. The U-500 syringe also features a green needle shield and a green U-500 symbol. It is a single use, sterile, nontoxic syringe. The fluid path of the syringe is sterile and non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
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)
BD has performed non-clinical performance testing to demonstrate substantial equivalence to the predicate device. This testing includes the following:
- Device material biocompatibility per ISO 10993-1, Biological evaluation of medical devices:
- Device functional performance at time-zero and shelf-life per ISO 8537, Sterile single-use syringes, with or without needle, for insulin. This includes Volumetric Accuracy; both what was described within the standard, and an evaluation at the lowest selectable dose.
- o At volumes
§ 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2016
Becton, Dickinson and Company Mr. Matthew Trachtenberg Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07666
Re: K151870
Trade/Device Name: BD U-500 Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 5. 2015 Received: July 6, 2015
Dear Mr. Trachtenberg:
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. 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.
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Tina Kiang
-2
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151870
Device Name BD U-500 Insulin Syringe
Indications for Use (Describe)
The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.
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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510(k) Summary
| Submitted By: | Matthew S. Trachtenberg
Staff Regulatory Affairs Specialist, BD Medical
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 201 847 6337
Fax: 201 847 5307 |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | March 29, 2016 |
| Device Name: | Trade Name: BD U-500 Insulin Syringe
Common Name: U-500 Insulin Syringe
Classification: Class II device; 21 CFR 880.5860, Piston Syringe
Product Code: FMF (Syringe, Piston) |
Legally marketed predicate device(s) to which substantial equivalence is being claimed: K024112 - BD Insulin Syringe
Reason for Submission
To introduce the new BD U-500 Insulin Syringe that comprises modifications to an existing device with new packaging, labeling, and indications for use.
Device Description:
The U-500 Insulin Syringe is a standard single use 0.5mL plastic syringe intended for the injection of U-500 insulin into the subcutaneous tissue. It features a 31G needle and 6 mm needle length with unique U-500 scale markings on the syringe barrel. The U-500 syringe also features a green needle shield and a green U-500 symbol. It is a single use, sterile, nontoxic syringe. The fluid path of the syringe is sterile and non-pyrogenic.
Indications for Use:
The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.
Comparison with Predicate Devices:
The BD U-500 Insulin Syringe has a similar intended use and operational principle as its predicate device for the subcutaneous injection of insulin. It also shares several similarities in technology compared to its predicate device consisting of a barrel, a movable plunger, the needle, and needle cover. These syringes are Gamma sterilized and are for single use only.
The only differences between the subject device and the predicate device are the syringe barrel scale markings, the color of the needle shield (green) and the packaging graphics. Each scale mark line on the U-500 Insulin Syringe measures 5 units of U-500 insulin due to the 5times concentrated U-500 insulin product. Caution should be observed in the measurement of dosage to avoid overdose. The green needle shield, green U-500 symbol on the syringe, and the syringe packaging graphics are designed to match the color of the U-500 insulin vial labeling.
4
| Feature | Subject Device:
BD U-500 Insulin Syringe | Predicate Device:
BD Insulin Syringe - Ultra-
Fine™ and Ultra-Fine™ II |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) Number | K151870 | K024112 |
| Manufacturer | BD | BD |
| Syringe Type | Insulin | Insulin |
| Intended Use | For the subcutaneous
injection of U-500 insulin
for patients requiring more
than 200 units per day. | For subcutaneous injection of
insulin. |
| Principle of Operation | Piston Syringe | Piston Syringe |
| Specific Drug Use | U-500 Insulin | U-100 Insulin |
| Needle (Cannula) Cover Color | Green | Orange |
| Needle (Cannula) Gauge | 31G | 30G and 31G |
| Scale Marking | 5 unit lines | 1 unit lines |
| Needle (Cannula) Length | 6mm | 6mm, 8mm, and 12.7mm |
| Single Use Only | Yes | Yes |
| Non-Pyrogenic | Yes | Yes |
| Sterile | Yes | Yes |
| Sterility Assurance Level (SAL) | 10-6 | 10-6 |
Testing:
BD has performed non-clinical performance testing to demonstrate substantial equivalence to the predicate device. This testing includes the following:
- Device material biocompatibility per ISO 10993-1, Biological evaluation of medical devices:
- . Device functional performance at time-zero and shelf-life per ISO 8537, Sterile singleuse syringes, with or without needle, for insulin. This includes Volumetric Accuracy; both what was described within the standard, and an evaluation at the lowest selectable dose.
- o At volumes