BD U-500 INSULIN SYRINGE

K151870 · Becton, Dickinson and Company · FMF · Jul 8, 2016 · General Hospital

Device Facts

• Record ID: K151870
• Device Name: BD U-500 INSULIN SYRINGE
• Applicant: Becton, Dickinson and Company
• Product Code: FMF · General Hospital
• Decision Date: Jul 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

BD U-500 Insulin Syringe is a 0.5mL single-use plastic piston syringe; features 31G, 6mm needle; includes unique barrel scale markings where each line represents 5 units of U-500 insulin. Device includes green needle shield and green U-500 symbol to match U-500 insulin vial labeling. Used by patients for subcutaneous insulin delivery. Healthcare providers use the device to facilitate accurate dosing of concentrated insulin. Benefits include reduced risk of dosing errors through specialized scale markings and color-coded visual cues matching the medication container.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), functional performance/volumetric accuracy (ISO 8537), human factors evaluation (ANSI/AAMI/IEC 62366-1), sterilization validation (ISO 11737), U-500 insulin stability, and extractables/leachables testing. Results confirmed the device met all requirements for its intended use.

Technological Characteristics

Piston syringe; 0.5mL capacity; 31G, 6mm needle. Materials: plastic. Sterilization: Gamma (SAL 10^-6). Standards: ISO 10993-1 (biocompatibility), ISO 8537 (functional performance), ISO 11737 (sterilization), ANSI/AAMI/IEC 62366-1 (usability). Features: U-500 specific scale markings (5 units/line), green color-coded needle shield and symbols.

Indications for Use

Indicated for subcutaneous injection of U-500 insulin in patients requiring >200 units per day.

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

• BD Insulin Syringe (K024112)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang

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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

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# 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<br>Staff Regulatory Affairs Specialist, BD Medical<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Tel: [phone]<br>Fax: [phone] |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | March 29, 2016 |
| Device Name: | Trade Name: BD U-500 Insulin Syringe<br>Common Name: U-500 Insulin Syringe<br>Classification: Class II device; 21 CFR 880.5860, Piston Syringe<br>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.

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| Feature | Subject Device:<br>BD U-500 Insulin Syringe | Predicate Device:<br>BD Insulin Syringe - Ultra-<br>Fine™ and Ultra-Fine™ II |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) Number | K151870 | K024112 |
| Manufacturer | BD | BD |
| Syringe Type | Insulin | Insulin |
| Intended Use | For the subcutaneous<br>injection of U-500 insulin<br>for patients requiring more<br>than 200 units per day. | For subcutaneous injection of<br>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 < half of nominal capacity (including the lowest selectable dose), volumetric accuracy shall be within ± [1.5% of nominal capacity + 2% of expelled volumel.
- At volumes ≥ half of nominal capacity, volumetric accuracy shall be ± 5%. o
- Human factor evaluations per ANSVAAMI/IEC 62366-1 Medical devices –Application ● of usability engineering to medical devices;
- Device sterilization per ISO 11737 Sterilization of Medical Devices; ●
- U-500 Insulin Stability: and ●
- Extractables and Leachables Testing. ●

Results of testing demonstrated the BD U-500 Insulin Syringe device met requirements for its intended use.

## Conclusion:

The analysis and testing performed demonstrate that the BD U-500 Insulin Syringe device is substantially equivalent to its predicate device.