(69 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a pen needle for insulin injection, with no mention of AI or ML.
No.
The device is a pen needle intended for insulin injection, which is an accessory to the administration of a therapeutic drug, not a therapeutic device itself.
No
The device is a pen needle intended for injecting insulin, not for diagnosing a condition.
No
The device description clearly states it is a physical pen needle consisting of a needle, hub, and shields, which are hardware components.
Based on the provided information, the Becton Dickinson Pen Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of insulin" using a pen injector device. This describes a device used for administering medication directly into the body, not for testing samples outside the body.
- Device Description: The description details a needle, hub, and shields designed for injection. It focuses on the physical components and their function in delivering a substance.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body. The Becton Dickinson Pen Needle is a drug delivery device.
N/A
Intended Use / Indications for Use
Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Becton Dickinson Ultra-Fine™ Pen Needle is designed for use with a pen injector for subcutaneous injection of a desired dose of insulin. The pen needle consists of a needle, hub, needle shield and outer needle shield assembly. The Ultra-Fine Pen Needles are offered in various needles sizes and lengths. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. BD 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)
Bench tests relating to the performance of the outer needle shield were conducted. The penetration force tests demonstrated that the polypropylene material had a greater penetration resistance capability then the polyethylene material.
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.
BD Ultra-Fine™ Pen Needle BD Ultra-Fine™ III Pen Needle
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
§ 880.5570 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
JUN 2 4 2003
510K SUMMARY OF SAFETY AND EFFECTIVENESS
1. Submitted By:
Cynthia Lacatena Product Registration Coordinator
Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883
Phone: 201-847-6869 201-847-5486 Fax:
2. Device Name:
| Trade Name: | BD Ultra-Fine™ Original Pen Needle
BD Ultra-Fine™ III Short Pen Needle
BD Ultra-Fine™ III Pen Needle |
|----------------------|------------------------------------------------------------------------------------------------------------|
| 3. Common Names: | Insulin Pen Needle |
| Classification Name: | Hypodermic Single Lumen Needle |
4. Predicate Device:
BD Ultra-Fine™ Pen Needle BD Ultra-Fine™ III Pen Needle
Manufactured by: Becton Dickinson Consumer Healthcare
ડ. Device Description:
The Becton Dickinson Ultra-Fine™ Pen Needle is designed for use with a pen injector for subcutaneous injection of a desired dose of insulin. The pen needle consists of a needle, hub, needle shield and outer needle shield assembly. The Ultra-Fine Pen Needles are offered in various needles sizes and lengths. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. BD Pen Needles are disposable, single use devices.
స్ Intended Use:
Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
1
510K Summary of Safety and Effectiveness (Continued)
6. Technological Characteristics:
The BD Ultra-Fine™ Original Pen Needle, BD Ultra-Fine™ III Short Pen Needle and BD Ultra-Fine™ III Pen Needle have the identical technological characteristics and perform equivalently as the predicate device.
The only difference from the predicate device is the outer needle shield material was changed from polyethylene to polypropylene enhancing the puncture resistance properties of the outer needle shield.
7. Performance:
Bench tests relating to the performance of the outer needle shield were conducted. The penetration force tests demonstrated that the polypropylene material had a greater penetration resistance capability then the polyethylene material.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
Ms. Cynthia Lacatena Product Registration Coordinator Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, New Jersey 07417-1883
Re: K031200
Trade/Device Name: Becton Dickinson Pen Needles Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 15, 2003 Received: May 28, 2003
Dear Ms. Lacatena:
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.
3
Page 2 - Ms. Lacatena
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Puarer
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Becton Dickinson Pen Needle
Indications For Usc:
Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Paloma Guccente
(Division Sign-Off) (Division of Anesthesiology, General Hospit Infection Control, Dental Devices
510(k) Number: 403/200
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