(63 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML.
Yes
A therapeutic device is one that treats, corrects, or prevents a disease or condition. This device is used to inject insulin, which is a treatment for diabetes, thus making it a therapeutic device.
No
Explanation: The device is an insulin syringe intended for subcutaneous injection of insulin, which is a therapeutic treatment. It does not perform any diagnostic function such as identifying a disease or condition.
No
The device description clearly outlines a physical syringe with a barrel, plunger rod, and needle/hub assembly, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous injection of U100 insulin." This describes a device used to administer a substance into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe designed for injecting fluid. It doesn't mention any components or functions related to analyzing biological samples (like blood, urine, etc.).
- Performance Studies: The performance studies focus on the physical and functional characteristics of the syringe (biocompatibility, cannula-syringe bond, scale mark permanency, drug compatibility), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This insulin syringe does not fit that definition.
N/A
Intended Use / Indications for Use
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The subject BD Insulin Syringes (BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle) are a 1.0mL self-contained plastic syringe designed for subcutaneous injection of a desired dose of insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, 12.7mm and 16mm). The BD Insulin Syringes are sterile, single use, and non-toxic. The fluid path of the syringe is sterile and non-pyrogenic. These devices operate on the principles of a piston syringe.
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
Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C)
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 conducted non-clinical testing which supports substantial equivalence of the modifications made to the subject device. The device functional performance risk include risk to cannula-syringe bonding, scale mark permanency and scale mark legibility. The biocompatibility risk include any new chemical and toxicological risk that may result from the material changes. The non-clinical testing included assessments related to device material biocompatibility and device functional performance. Results of these were found to be acceptable and demonstrated the subject insulin syringe device met requirements for its intended use and is substantially equivalent to its predicate device. As a part of the biocompatibility evaluation of the subject device, many factors were considered including materials of of manufacture/ chemical constituents, intended additives, potential residues, leachable substances, degradation products, physical characteristics of the final device, impact of manufacturing processes and product morphology. The consideration of these factors along with the preclinical biocompatibility testing performed adequately supports the assessment that the subject device is appropriate from a biological and toxicological perspective for its intended use.
Non-Clinical Testing: BD has performed non-clinical performance testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA). This testing includes device material biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices and device functional performance testing per ISO 8537 Sterile single-use syringes, with or without needle, for insulin. The following tests were performed to validate the modifications made to the subject device and also serve to mitigate the identified risks: 1. Biocompatibility testing included: cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, pyrogenicity, sensitization, comparative extractables/ leachables, and primary dermal irritation. 2. Device functional performance testing included: cannula-syringe bond, scale mark permanency and legibility, and drug compatibility/ stability. Results of non-clinical testing both validated the modifications made and served to mitigate the identified risks such that the subject BD Insulin Syringe device met requirements for its intended use demonstrating substantial equivalence to its predicate device.
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.
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2017
Becton, Dickinson and Company Mr. Riddhish Patel Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07666
Re: K170386
Trade/Device Name: BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 13, 2017 Received: March 15, 2017
Dear Mr. Riddhish Patel:
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,
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Tina Kiang, Ph.D. Acting 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) K170386
Device Name
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
Indications for Use (Describe)
Becton Dickinson insulin syringes are intended for subcutaneous injection of U100 insulin.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K170386 510(k) Summary
| Submitted By: | Becton, Dickinson and Company
Riddhish Patel
Regulatory Affairs Specialist, BD Medical
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: (201) 847-5571
Fax: (201) 847-5307 | | | | | | | | | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------|----------------------|----------------|-----------------|---------------------------|---------------|-----|
| Date Prepared: | April 11, 2017 | | | | | | | | | | |
| Device Name: | Trade Name:BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV NeedleCommon Name:Insulin SyringeClassification Name:Piston SyringeClassification:Class II, 21 CFR 880.5860Product Code:FMF | Trade Name: | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle | Common Name: | Insulin Syringe | Classification Name: | Piston Syringe | Classification: | Class II, 21 CFR 880.5860 | Product Code: | FMF |
| Trade Name: | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle | | | | | | | | | | |
| Common Name: | Insulin Syringe | | | | | | | | | | |
| Classification Name: | Piston Syringe | | | | | | | | | | |
| Classification: | Class II, 21 CFR 880.5860 | | | | | | | | | | |
| Product Code: | FMF | | | | | | | | | | |
Legally marketed predicate devices to which substantial equivalence is being claimed:
- . K941657: BD Ultra-Fine™ Insulin Syringe and BD Insulin Syringes with Micro-Fine™ IV Needle
- K955235: BD Ultra-Fine™ II Insulin Syringe ●
- K024112: BD Insulin Syringes with the BD Ultra-Fine™ needle ●
Device Description:
The subject BD Insulin Syringes (BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle) are a 1.0mL self-contained plastic syringe designed for subcutaneous injection of a desired dose of insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, 12.7mm and 16mm). The BD Insulin Syringes are sterile, single use, and non-toxic. The fluid path of the syringe is sterile and non-pyrogenic. These devices operate on the principles of a piston syringe.
4
| Models |
|---|
| BD Insulin Syringes with Micro-Fine™ IV Needle 27G X 16mm |
| BD Insulin Syringes with Micro-Fine™ IV Needle 28G X 12.7mm |
| BD Ultra-Fine™ Insulin Syringe 29G X 12.7mm |
| BD Ultra-Fine™ II Insulin Syringe 30G X 8mm |
| BD Insulin Syringes with the BD Ultra-Fine™ needle 30G X |
| 12.7mm |
| BD Insulin Syringes with the BD Ultra-Fine™ needle 31G X 6mm |
| BD Insulin Syringes with the BD Ultra-Fine™ needle 31G X 8mm |
Indications for Use:
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulin.
Comparison with Predicate Devices:
The subject device has the same device design, fundamental scientific technology and device performance as its predicate devices. The purpose of this submission is to gain 510(k) marketing clearance for a modification to the 1.0mL BD Insulin Syringes which includes two new cannula adhesive materials and a new scale print ink formulation. The table below provides a side by side comparison of the subject device compared to its predicate.
| Feature | Subject Device: BD Ultra-Fine™
Insulin Syringe, BD Ultra-Fine™ II
Insulin Syringe, BD Insulin Syringes
with the BD Ultra-Fine™ needle
and BD Insulin Syringes with
Micro-Fine™ IV Needle | Predicate Device: BD Ultra-Fine™
Insulin Syringe, BD Ultra-Fine™ II
Insulin Syringe, BD Insulin Syringes
with the BD Ultra-Fine™ needle
and BD Insulin Syringes with
Micro-Fine™ IV Needle |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K170386 | K941657, K955235 and K024112 |
| Manufacturer | Becton, Dickinson and Company | Becton, Dickinson and Company |
| Indications for Use | Becton Dickinson insulin syringes are
intended for subcutaneous injection of
U-100 insulin. | Becton Dickinson insulin syringes are
intended for subcutaneous injection of
U-100 insulin. |
| Specific Drug Use | U-100 Insulin | U-100 Insulin |
| Principle of Operation | Piston Syringe | Piston Syringe |
| Cannula cover color | Orange | Orange |
| Cannula Gauge Size(s) | 27G, 28G, 29G, 30G and 31G | 27G, 28G, 29G, 30G and 31G |
| Cannula Length Size(s) | 6mm, 8mm, 12.7mm and 16mm | 6mm, 8mm, 12.7mm and 16mm |
| Cannula bonding
adhesive | Three different UV cured adhesive
material options | A single UV cured adhesive material |
| Scale markings | 2 unit lines | 2 unit lines |
| Scale marking ink | Solvent based ink or UV cured ink
option | Solvent based ink |
| Scale marking ink color | Black | Black |
| Sterile | Yes (Gamma Irradiation) | Yes (Gamma Irradiation) |
| SAL10-6 | Yes | Yes |
| Single Use Only | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
5
| Materials for Cannula
shield, Barrel body,
Plunger rod, & Plunger
| rod cap | Plastic | Plastic |
|---|---|---|
| Cannula Material | Stainless Steel | Stainless Steel |
| Plunger stopper | ||
| Material | Natural Rubber | Natural Rubber |
| Cannula lubricant | Medical Grade Silicone | Medical Grade Silicone |
BD has conducted non-clinical testing which supports substantial equivalence of the modifications made to the subject device. The device functional performance risk include risk to cannula-syringe bonding, scale mark permanency and scale mark legibility. The biocompatibility risk include any new chemical and toxicological risk that may result from the material changes. The non-clinical testing included assessments related to device material biocompatibility and device functional performance. Results of these were found to be acceptable and demonstrated the subject insulin syringe device met requirements for its intended use and is substantially equivalent to its predicate device. As a part of the biocompatibility evaluation of the subject device, many factors were considered including materials of of manufacture/ chemical constituents, intended additives, potential residues, leachable substances, degradation products, physical characteristics of the final device, impact of manufacturing processes and product morphology. The consideration of these factors along with the preclinical biocompatibility testing performed adequately supports the assessment that the subject device is appropriate from a biological and toxicological perspective for its intended use.
Non-Clinical Testing:
BD has performed non-clinical performance testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA). This testing includes device material biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices and device functional performance testing per ISO 8537 Sterile single-use syringes, with or without needle, for insulin.
The following tests were performed to validate the modifications made to the subject device and also serve to mitigate the identified risks:
-
- Biocompatibility testing included: cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, pyrogenicity, sensitization, comparative extractables/ leachables, and primary dermal irritation.
-
- Device functional performance testing included: cannula-syringe bond, scale mark permanency and legibility, and drug compatibility/ stability.
Results of non-clinical testing both validated the modifications made and served to mitigate the identified risks such that the subject BD Insulin Syringe device met requirements for its intended use demonstrating substantial equivalence to its predicate device.
Conclusion:
The analysis and testing performed demonstrated that the subject device is substantially equivalent to its predicate devices.