(62 days)
BD Pen Needles, Disetronic PenFine Injection Pen Needles
Not Found
No
The device description and summary do not mention any AI or ML components or functionalities. It describes a simple mechanical pen needle for drug injection.
Yes
The device facilitates the administration of drugs, such as insulin, which are used to treat medical conditions, thus serving a therapeutic purpose by delivering medication.
No
The description explicitly states its intended use is for subcutaneous injection of drugs, not for diagnosing any condition. It's an injection device.
No
The device description clearly states it is a physical pen needle consisting of a needle, hub, and shield assembly, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Becton Dickinson Pen Needle is a device used for the delivery of drugs (subcutaneous injection). It is used to administer medication directly into the body, not to analyze samples taken from the body.
The description clearly states its intended use is for "subcutaneous injection of drugs." This is a therapeutic or drug delivery function, not a diagnostic one.
N/A
Intended Use / Indications for Use
Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
Product codes
FMI
Device Description
The BD Pen Needles are designed for use with a pen injector for subcutaneous injection of a desired dose of a drug, including insulin and exenatide. The pen needle consists of a needle, hub, and shield assembly. The Becton Dickinson pen needles are offered various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). BD Pen Needles are sterile (gamma irradiation), non-toxic and non-pyrogenic. The pen needles are disposable, single use devices.
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)
The perform equivalent to the predicate device and is safe and effective when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BD Pen Needles, Disetronic PenFine Injection Pen Needles
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
SEP 1 3 2005
510K SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By: 1.
John Schalago Manager, Regulatory Affairs
Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883
201-847-5663 Phone: 201-848-0457 Fax:
Device Name: 2.
| Trade Name: | BD Pen Needles |
|---|---|
| Common Names: | Insulin Pen Needles |
| Classification Name: | Hypodermic Single Lumen Needle |
Predicate Device: 3.
BD Pen Needles
Manufactured by: Becton Dickinson Consumer Healthcare
Disetronic PenFine Injection Pen Needles
Manufactured by: Dietronic Medical Systems, Incorporated
Device Description: 4.
The BD Pen Needles are designed for use with a pen injector for subcutaneous The DD For Nesired dose of a drug, including insulin and exenatide. The pen meedle consists of a needle, hub, and shield assembly. The Becton Dickinson pen needles are offered various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). BD Pen Needles are sterile (gamma irradiation (2mm), vimn, and non-pyrogenic. The pen needles are disposable, single use devices.
1
510K Summary of Safety and Effectiveness (Continued)
Intended Use: 5.
Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
Technological Characteristics: 6.
The BD Pen Needle and the predicate device have the identical technological characteristics and perform equivalently.
The only difference between the devices is that the principal device is indicated for delivery of exenatide.
Performance: 7.
The perform equivalent to the predicate device and is safe and effective when used as intended.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
SEP 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Schalago Manager, Regulatory Affairs Becton Dickinson Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1880
Re: K051899 Trade/Device: BD Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 8, 2005 Received: July 13, 2005
Dear Mr. Schalago:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be (--) p--------------------------------------------------------------------------------------------------------------------------------------relerenced above and have determined are to tegally marketed predicate devices marketed in indications for use stated in also encreases of the enactment date of the Medical Device interstate colliments, or to triay 20, 1978, 1978, 1978, 1978, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 19 Amendments, on to devices mat nave obct (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment Processor, market the device, subject to the general approval application (1 Mr ). I The general controls provisions of the Act include controls provisions of the rea. "The gastration, listing of devices, good manufacturing practice, requirements for animons against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classinod (see aboutional controls. Existing major regulations affecting (PMA), It may be subject to sating and the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
3
Page 2 - Mr. Schalago
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT - 1.55tazies of that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and regarments, including, but not limited to: registration You must comply with an the Fec b requirements and 801); good manufacturing practice and ifsing (21 CFR Part 607), laceming (21 CFR Part 820), and if 1 CFR Part 820), and if requirements as set form in the quality bjocents (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) This letter will anow you to ocgin maineting , but antial equivalence of your device to a premarket nothleation. The PDA miang of bassification 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), If you desire specific advice for your de recoler at (240) 276-0115 Also, please note the regulation in prease contact the Other or Comphanes or exet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on the mational and Consumer Assistance at its toll-free Division of Binar-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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
510(k) Number (if known):_K051899 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: BD Pen Needles_________________________________________________________________________________________________________________________________________
Indications For Use:
Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 4/13/01
(Division Sign-Off) ( Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ KOS1899