(72 days)
Not Found
No
The summary describes a change in needle lubricant carrier and does not mention any AI or ML related terms, image processing, or performance studies typically associated with AI/ML devices.
No
The device, a needle, is intended for fluid injection/aspiration, infusion, venipuncture, and insulin injection, which are diagnostic or drug delivery procedures, not therapeutic applications.
No
The intended uses of the device (fluid injection/aspiration, infusion, venipuncture for blood collection, and insulin injection) are all therapeutic or collection-based procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description and intended use clearly describe physical needles, which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (fluid injection/aspiration, infusion, venipuncture for blood collection, and insulin injection) are all procedures performed on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The device described is a needle, which is a tool used for accessing the body, not for analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
The needles are intended for general purpose fluid injection/aspiration, infusion, venipucture to obtain blood collection and insulin injection.
Product codes
FMF, FMF, FMI, JKA
Device Description
This change in needle lubricant carrier is across the BD product lines.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Pre-Amendment, K955235, K013073, K002938, K970737, K950466, K013304, K982541, K951254, K982922, K931367, K965202, K972404, K980414, K003461, K011984
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
BD Medical Systems 1 Becton Drive Franklın Lakes, New Jersey 07417 tel. 201.847.6800 fax: 201.847 4896 www.bd com
KO21475
JUL 1 9 2002
Image /page/0/Picture/3 description: The image shows the BD logo. The logo consists of a circular symbol on the left and the letters "BD" on the right. The circular symbol features a stylized sun with rays emanating from a central figure, possibly representing a person. The letters "BD" are in a bold, sans-serif font.
Indispensable to human health
్లాలు
గ్రామం
Change to the Formulation of the Lube Carrier for Needle Products
Summary of Safety and Effectiveness
1 BD Contact person: Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847-4513 Fax (201) 847-4855
2 Device Name: BD Single Lumen Needle, Syringe and Blood Collection Set
- 3 Predicate Device(s):
| Predicate Devices | 510(k) Number |
|---|---|
| BD Hypodermic Needles | Pre-Amendment |
| BD Ultra Fine II, Micro Fine + Short Needle | |
| Insulin | K955235 |
| BD Intravascular Catheters | K013073 |
| BD Pen Needles | K002938; K970737; K950466 |
| BD Introcyte Introducers | K013304 |
| Eclipse Safety Needle | K982541 |
| SafetyGlide Needle | K951254 |
| Blood Collection Syringe | K982922 |
| Safety-Lok Blood Collection Set | K931367 |
| K965202 | |
| K972404 | |
| K980414 | |
| Passive Shielding Blood Collection Needle | K003461 |
| Push Button Blood Collection Set | K011984 |
1
- 4 Product Description / Function: This change in needle lubricant carrier is across the BD product lines.
- Intended Uses: These needles are intended for general purpose fluid 5 injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
- 6 Comparison of Modified and Predicate Device:
The table provides a comparison of the single lumen needles, insulin syringes and blood collection set with the predicate devices:
| Element of
Comparison | Single lumen needles, insulin
syringes and blood collection set | Similarity to
Predicate Devices |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Intended Use | These needles are intended for
general purpose fluid
injection/aspiration, infusion,
venipuncture to obtain blood collection
and insulin injection | Predicate devices identical |
| Sterility | Sterile fluid path | Predicate devices identical |
| Sterilization | Gamma or EtO. Remains unchanged | Predicate devices identical |
| Design | Design remains unchanged | Predicate devices identical |
| Needle Material | Needle materials remain unchanged | Predicate devices identical |
| Packaging | Packaging remains unchanged | Predicate devices identical |
- 7 Equivalence determination:
Single lumen needles, insulin syringes and blood collection sets are being compared to themselves. The indications for use, components, silicone proportions in the lubricants, labeling, performance and product claims remain the same. The only product modification is in the carrier used to disperse the silicone. Since the carrier evaporates, leaving only the silicone on the device, the modified devices are substantially equivalent to the currently marketed devices.
Intended uses: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
Materials: The needle materials remain unchanged. Predicate device is identical.
Physical, Mechanical, and Biological Specifications: These specifications are unaffected by the lubricant carrier formulation change and the predicate device are equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for 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 an eagle with three human profiles embedded within the eagle's body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville .MD 20850
JUL 1 9 2002
Mr. Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical 1 Becton Drive MC 226 Franklin Lakes, New Jersey 07417
Re: K021475
Trade/Device Name: BD Single Lumen Needle, Syringe and Blood Collection Set Regulation Number: 880.5570, 880.5860 and 862.1675 Regulation Name: Hypodermic Single Lumen Needle, Piston Syringe and Blood Specimen Collection Device Regulatory Class: II Product Code: FMF, FMF, FMI and JKA Dated: May 6, 2002 Received: May 8, 2002
Dear Mr. Amato:
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.
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.
3
Page 2 - Mr. Amato
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qoy/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runpp
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement.
510(k) Number (if known): ূ长 0214 75
Device Name: BD Single Lumen Needle, Syringe and Blood Collection Set
Indications for Use:
The needles are intended for general purpose fluid injection/aspiration, infusion, venipucture to obtain blood collection and insulin injection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Insulin
Syringes/Needles
Pasture Crescent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _