(79 days)
Not Found
No
The device description focuses on mechanical features (safety shield, retraction, locking) and does not mention any computational or data-driven processes indicative of AI/ML.
No.
This device is a pen needle used for drug injection, not a device that provides a therapeutic effect itself. Its function is to facilitate the delivery of therapeutic drugs, rather than performing therapy directly.
No
Explanation: The device is a pen needle intended for injecting drugs, not for diagnosing medical conditions. Its function is drug delivery, not detection or analysis.
No
The device description clearly indicates it is a physical pen needle with a safety shield, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BD AutoShield™ Pen Needle Function: The description clearly states that the BD AutoShield™ Pen Needle is used for the injection of drugs into the body. It's a delivery mechanism for medication, not a tool for analyzing biological samples.
The device's purpose is to facilitate the administration of medication, not to perform diagnostic tests on samples outside of the body.
N/A
Intended Use / Indications for Use
The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The BD AutoShield™ Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The BD AutoShield™ Pen Needles are offered in various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). The BD AutoShield™ Pen Needle is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. It is a disposable, single use device.
Additionally, the BD AutoShield™ Pen Needle is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the AutoShield™ Pen Needle to the pen. The shield of AutoShield™ Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The AutoShield™ Pen Needle should be removed from the pen and discarded.
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 testing and simulated clinical testing was performed to confirm the device's safety and efficacy. Clinical testing was performed to evaluate the function of the of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users.
Based on these performance testing results, the BD AutoShield™ Pen Needle is safe and effective when used as intended.
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
§ 880.5570 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
Confidential & Proprietary
Attachment 4
MAR 2 3 2006
510(k) Summary Of Safety and Effectiveness
- I. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92
Establishment:
| | • Address: | BD Medical – Pharmaceutical Systems
1 Becton Drive
Franklin Lakes, NJ 07417-1885 |
|--------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | • Registration Number:
• Contact Person: | 2243072
James W. Haynes
Senior Regulatory Affairs Specialist
Telephone No.: 201-847-4298
Fax No.: 201-847-7040 |
| | • Date of Summary: | December 28, 2005 |
| Device | • Trade Name: | BD AutoShield™ Pen Needle |
| | • Classification Name:
• Classification:
• Performance Standards: | Single Lumen Hypodermic Needle
Class II
None Established under 514 of the Food, Drug
and Cosmetic Act |
- II. Safety and Effectiveness Information Supporting Substantial Equivalence
- · Device Description
The BD AutoShield™ Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The BD AutoShield™ Pen Needles are offered in various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). The BD AutoShield™ Pen Needle is sterile (gamma irradiation sterilization), non-toxic, and non-pyrogenic. It is a disposable, single use device.
Additionally, the BD AutoShield™ Pen Needle is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the AutoShield™ Pen Needle to the pen. The shield of
1
Confidential & Proprietary
AutoShield™ Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the skin at a 90° angle, the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The AutoShield™ Pen Needle should be removed from the pen and discarded.
- · Intended Use
The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
- · Synopsis of Performance Study Results
Bench testing and simulated clinical testing was performed to confirm the device's safety and efficacy. Clinical testing was performed to evaluate the function of the of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users.
Based on these performance testing results, the BD AutoShield™ Pen Needle is safe and effective when used as intended.
III. Predicate Device Summary Table
· Substantial Equivalence
Based on comparison of the device features, materials, intended use and performance, the BD AutoShield™ Pen Needle was shown to be substantially equivalent to the commercially available predicate device indicated in the table below. The predicate device, K number, and clearance date are also identified in the table below.
| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---|---|---|---|
| Becton | |||
| Dickinson | BD Pen Needle | K051889 | September 13, 2005 |
James W. Haynes
12/30/05
Date
Semor Regulatory Affairs Specialist Becton Dickinson Medical - Pharmaceutical Systems Becton Dickinson and Company
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is surrounded by the words "Department of Health and Human Services USA" in a circular arrangement.
MAR 2 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James W. Haynes Senior Regulatory Affairs Specialist BD Medical-Pharmaceutical Systems Becton, Dickinson and Company 1 Becton Drive (MC 440) Franklin Lakes, New Jersey 07417
Re: K060007
Trade/Device Name: BD AutoShieldTM Pen Needle Regulation Number: 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: February 8. 2006 Received: February 10, 2006
Dear Mr. Haynes:
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 (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 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
3
Page 2 - Mr. James W. Haynes
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 (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 continue 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). please contact the Office of Compliance at (240) 276-0115. 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,
Sytti Y. Michael M.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
4
INDICATIONS FOR USE
510(K) Number (IF Known):
DEVICE NAME: BD AutoShield™ Pen Needle
INDICATIONS FOR USE:
The BD AutoShield™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
PRESCRIPTION USE (Per 21 CFR § 801.109) OR Over-the-Counter Use (OPTIONAL FORMAT 1-2-96)
(Please do not Write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antony D. my
enn logy, General Huspital
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