(254 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a syringe, with no mention of AI or ML.
No
A therapeutic device is one that treats or heals a medical condition. This device is a syringe, which is used for aspiration and injection of fluids, but not to directly treat or heal. It is a delivery mechanism for therapeutic agents, but not a therapeutic device itself.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for aspiration and injection of fluids." This describes a therapeutic or drug delivery function, not a diagnostic one. Diagnostic devices are used to identify or characterize diseases or conditions.
No
The device description clearly outlines a physical syringe with an integral needle, intended for aspiration and injection of fluids. The performance studies listed are related to the physical properties and materials of the syringe, not software functionality.
Based on the provided information, the BD™ Flu+ Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for aspiration and injection of fluids." This describes a device used to physically move substances into or out of the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe with a needle, designed for aspiration and injection. This aligns with a general-purpose medical device for administering or withdrawing fluids.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes (markers, substances)
- Diagnosis, monitoring, or screening of diseases based on sample analysis
- Reagents or test kits
The performance studies listed (leakage, dose accuracy, dead space, etc.) are also typical for a syringe, not an IVD.
Therefore, the BD™ Flu+ Syringe is a medical device for aspiration and injection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD TM Flu+ Syringe is intended for aspiration and injection of fluids.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The BD Flu+ Syringe is a sterile two-piece single use, sterile syringe with an integral needle. It allows for a variable dose up to 1 ml to be aspirated and injected. It is intended for general-purpose aspiration and injection of fluids from a vial or ampoule. The BD Flu+ syringe has been designed for low dead space to reduce medication waste. The BD Flu+ Syringe is a 1.0mL maximum dosage with 0.5mL and 1.0mL barrel marking and 0.25mL incremental markings. The Flu+ syringe is assembled with a pre attached needle in the following gauges and sizes: 23G (0.6mm) x 1 inch (25mm), 25G (0.5mm) x 5/8 inch (16mm.), 25G (0.5mm) x 1 inch (25mm)
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)
BD has performed the following bench and biocompatibility testing on BD™ Flu+ Syringe. Modifications of the subject device's intended use does not affect the results of this analysis.
Bench Performance:
- Leakage (ISO 7886-1:2017) .
- Dose Accuracy (ISO 7886-1:2017) .
- Dead Space (ISO 7886-1:2017)
- Activation Forces (ISO 7886-1:2017)
- Cannula Pull Force (ISO 7864:2016)
- Shield Pull Force (BD Internal Requirement)
- Scale Mark Permanency (BD Internal Requirement)
- Package Integrity (ISO 11607-1:2010).
Material Biocompatibility Performance:
In accordance with ISO 10993-1, the Flu+ Syringe is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( Particulate Matter in Injections and met the USP acceptance criteria.
Clinical testing was not required for this submission.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.
July 28, 2021 Becton, Dickinson and Company Nikita Kumar Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K203359
Trade/Device Name: BD Flu+ Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 26, 2021 Received: June 30, 2021
Dear Nikita Kumar:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203359
Device Name BD™ Flu+ Syringe
| Indications for Use (Describe) |
|---|
| The BD TM Flu+ Syringe is intended for aspiration and injection of fluids. |
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular symbol on the left and the letters "BD" on the right. The circular symbol is orange and features a stylized image of a person with outstretched arms inside of a circle. The letters "BD" are in blue and are written in a bold, sans-serif font.
K203359 510(k) Summary
BD™ Flu+ Syringe
| Submitter
| Information | Submitter Name: | Becton, Dickinson and Company |
|---|---|---|
| Submitter Address: | 1 Becton Drive | |
| Franklin Lakes, NJ 07417 | ||
| Contact Person: | Nikita Abirami Mahendra Kumar | |
| Senior Regulatory Affairs Specialist | ||
| Email Address: | Nikita.Abirami.Mahendra.Kumar@bd.com | |
| Phone Number: | (201) 847-5641 | |
| Date of Preparation: | July 28, 2021 | |
| Subject Device | Trade Name: | BD™ Flu+ Syringe |
| Common Name: | Piston Syringe | |
| Regulation Number: | 21 CFG 880.5860 | |
| Regulation Name: | Piston Syringe | |
| Regulatory Class: | Class II device | |
| Product Code: | FMF | |
| Classification Panel: | General Hospital | |
| Predicate Device | Trade Name: | BD™ FLU+ Syringe |
| 510(k) Reference: | K091377 | |
| Common Name: | Piston Syringe | |
| Regulation Number: | 21 CFR 880.580 | |
| Regulation Name: | Piston Syringe | |
| Regulatory Class: | Class II Device | |
| Product Code: | FMF | |
| Classification Panel: | General Hospital | |
| Reason for | ||
| Submission | The basis of this submission is to modify the indications for use | |
| of the BD™ Flu+ Syringe. | ||
| Device Description | The BD Flu+ Syringe is a sterile two-piece single use, sterile | |
| syringe with an integral needle. It allows for a variable dose up | ||
| to 1 ml to be aspirated and injected. It is intended for general- | ||
| purpose aspiration and injection of fluids from a vial or ampoule. | ||
| The BD Flu+ syringe has been designed for low dead space to | ||
| reduce medication waste. | ||
| The BD Flu+ Syringe is a 1.0mL maximum dosage with 0.5mL | ||
| and 1.0mL barrel marking and 0.25mL incremental markings. | ||
| The Flu+ syringe is assembled with a pre attached needle in the | ||
| following gauges and sizes: | ||
| 23G (0.6mm) x 1 inch (25mm) | ||
| 25G (0.5mm) x 5/8 inch (16mm.) | ||
| Indications for Use | The BD™ Flu+ Syringe is intended for aspiration and injection of fluids. | |
| Technological | ||
| Characteristics | The subject devices are equivalent to the predicate devices in intended use, materials and performance characteristics. |
4
25G (0.5mm) x 1 inch (25mm)
| Element of
Comparison | Subject Device:
BD™ Flu+ Syringe | Predicate Device
BD™ Flu+ Syringe | Comparison |
|----------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------|
| 510(k) Number | K203359 | K091377 | N/A |
| Intended Use | Intended for
aspiration and
injection of fluids | Intended for
aspiration and
injection of the
influenza vaccine | Different; Subject
device is intended
for general use |
| Syringe Type | 2 Piece (barrel and
plunger) | 2 Piece (barrel and
plunger) | Same |
| Dose Saving
Feature | Low Dead
Space/Volume | Low Dead
Space/Volume | Same |
| Integrated
Needle | Yes | Yes | Same |
| Dose
Setting/Volumes | Variable dose scale
markings with
1.0mL max delivery | Variable dose scale
markings with
1.0mL max delivery | Same |
| Needle Size
(Gauge x Length) | 23G x 1"
25G x 1"
25G x 5/8" | 23G x 1"
25G x 1"
25G x 5/8" | Same |
| Barrel Material | Plastic | Plastic | Same |
| Plunger Material | Plastic+Colorant
(Blue, Orange) | Plastic+Colorant
(Blue, Orange) | Same |
| Integrated
Cannula | Stainless Steel | Stainless Steel | Same |
| Shield | Plastic | Plastic | Same |
| Adhesive | Epoxy | Epoxy | Same |
| Cannula
Lubricant | Silicone | Silicone | Same |
| Sterilization | Ethylene Oxide (SAL
10-6) | Ethylene Oxide (SAL
10-6) | Same |
| Shelf Life | 5 years | 5 years | Same |
| Functional Testing: | | | |
| Leakage | ISO 7886-1 | ISO 7886-1 | Same |
| Dose Accuracy | ISO 7886-1 | ISO 7886-1 | Same |
| Dead Space | ISO 7886-1 | ISO 7886-1 | Same |
| Activation Forces | ISO 7886-1 | ISO 7886-1 | Same |
| Cannula Pull Force | ISO 7864 | ISO 7864 | Same |
| Shield Pull Force | BD Internal Requirement | BD Internal Requirement | Same |
| Scale Mark Permanency | BD Internal Requirement | BD Internal Requirement | Same |
| Biocompatibility Testing: | | | |
| Testing per ISO 10993:2018 | | | |
| Cytotoxicity | ISO 10993-5 & USP , Non-cytotoxic
• LLNA: ISO 10993-10 & ASTM F2148 | ISO 10993-5 & USP , Non-cytotoxic
• LLNA: ISO 10993-10 & ASTM F2148 | Same |
| Sensitization | • Maximization: ISO 10993-11
Non-sensitizer | • Maximization: ISO 10993-11
Non-sensitizer | Same |
| Intracutaneous Reactivity | Per ISO 10993-10 & USP, Non-irritant | Per ISO 10993-10 & USP, Non-irritant | Same |
| Primary Dermal Irritation | ISO 10993-10 | ISO 10993-10 | Same |
| Acute Systemic Toxicity | ISO 10993-11 & USP, Non-toxic | ISO 10993-11 & USP, Non-toxic | Same |
| Pyrogenicity | Per ISO 10993-11:2017 & USP, Non-pyrogenic | Per ISO 10993-11:2017 & USP, Non-pyrogenic | Same |
| Extractables/Leachables | Per ISO 10993-18:2005, Acceptable | Per ISO 10993-18:2005, Acceptable | Same |
| Hemolysis | Per ISO 10993-4, Non-hemolytic | Per ISO 10993-4, Non-hemolytic | Same |
5
Performance Tests
BD has performed the following bench and biocompatibility testing on BD™ Flu+ Syringe. Modifications of the subject device's intended use does not affect the results of this analysis.
Bench Performance:
- Leakage (ISO 7886-1:2017) .
- Dose Accuracy (ISO 7886-1:2017) .
Confidential & Proprietary Page 3 of 5
6
- Dead Space (ISO 7886-1:2017) ●
- Activation Forces (ISO 7886-1:2017)
- Cannula Pull Force (ISO 7864:2016) ●
- Shield Pull Force (BD Internal Requirement)
- Scale Mark Permanency (BD Internal Requirement) ●
- Package Integrity (ISO 11607-1:2010). ●
Material Biocompatibility Performance:
In accordance with ISO 10993-1, the Flu+ Syringe is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life
| Sterilization
| Method | Ethylene Oxide (ETO) |
|---|---|
| Sterilization | |
| Residuals | Maximum EO mg/device limit: |
| 4mg/device | |
| Maximum ECH mg/device Limit: | |
| 9mg/device | |
| The above limits are acceptable per | |
| ISO 10993-7:2008 | |
| Validation | |
| Method | The sterilization process is validated |
| in accordance with Standard EN ISO | |
| 11135-1."Sterilization of health care | |
| products-Ethylene oxide- Part 1: | |
| Requirements for development, | |
| validation and routine control of a | |
| sterilization process for medical | |
| devices". | |
| The sterilized product meets the |
7
| | | requirements of EN 556 "Sterilization
of Medical Devices - Requirements for
Medical Devices to be Labelled Sterile
". |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Pyrogenicity
/Endotoxin
Testing | Test methods are per USP 40-NF 35
monographs 85 (Bacterial Endotoxins
Test) and 161 (Medical Devices
Bacterial Endotoxin and Pyrogens
Test). |
| | Packaging integrity testing, after environmental conditioning are
simulated transportation in accordance with ISO 11607-1:2010
and 11135:2014, was conducted on the final packaged, and
sterile device. All packaging deemed acceptable for protection of
product and sterility maintenance. | |
| | Shelf Life of 5 years is validated using the FDA recognized
standards ASTM F1980-16 Standard Guide for Accelerated Aging
of Sterile Barrier Systems for Medical Devices. | |
| | The subject device continue to meet all the predetermined
acceptance criteria for the above-listed performance tests,
demonstrating substantial equivalence to the predicate device. | |
| Clinical Testing | | Clinical testing was not required for this submission |
| Summary of
Substantial
Equivalence | | The BD™ Flu+ Syringe is substantially equivalent to the
predicate device in principles of operation, technology, design, |