(105 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a pen needle, with no mention of AI or ML technologies.
No.
A therapeutic device is one that treats, prevents, or diagnoses a disease or condition. This device, a pen needle, is used for injection of drugs (which may be therapeutic), but it does not inherently provide therapy itself. It is a delivery mechanism for therapeutic agents.
No
The device is a pen needle, intended for the subcutaneous injection of drugs. It is a delivery device, not a device used to diagnose a medical condition.
No
The device description clearly details a physical medical device (pen needles) made of materials like cannula, hub, adhesive, and outer cover, and mentions manufacturing processes like injection molding and sterilization. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide." This describes a device used to administer medication into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a needle assembly designed to connect to a pen injector and penetrate skin and a drug cartridge. This is consistent with a drug delivery device, not a diagnostic device.
- No mention of testing or analysis: The text does not mention any process of analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are used to perform tests in vitro (outside the body) on samples to provide information about a person's health. This device is used in vivo (inside the body) to deliver medication.
N/A
Intended Use / Indications for Use
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peelaway (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized.
The purpose of the 510(k) is to expand the needle range to include the 23G x 7 mm pen needle size. Future needle range expansions may include 24G to 28G in various lengths for which appropriate verification and validation activities will be conducted. The intended use for the modified device remains the same as the predicate device.
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
consumers, caregivers and health care professionals
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 BD 23G X 7mm Pen Needle were conducted.
The principal device demonstrated equivalent performance to the predicate devices during bench testing. Bench testing consisted of:
- Tubing diameters: Per ISO 11608-2, section 4.3.1 (tubing dimensions meet OD and ID requirement).
- Patency of lumen: Per ISO 11608-2, section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely).
- Needle points: Per ISO 11608-2, section 4.5 (visually sharp at 2.5X magnification, designed to minimize coring and fragmentation).
- Non-Type A Needle (length): Per ISO 11608-2, section 4.3.3 (patient end within indicated length ± 1.25 mm)
- Cannula load test (No pre-conditioning): Per ISO 11608-2, section 4.9 and 9. ISO 7864 Section 13.1 (cannula holds force of 34N for 5 seconds).
- Cannula load test (with pre-conditioning): Per ISO 11608-2, section 4.9 and 9. ISO 7864 (cannula holds force of 34N for 5 seconds).
- Lubrication: Per ISO 11608-2, section 4.7 (no visible droplets inside/outside surfaces of cannula).
- Compatibility Testing: Per ISO 11608-2, section 4.10 (connectivity (torque).
- Cover Impact Testing: BD design verification protocol Meets acceptance criteria
The results of these tests demonstrate that the BD 23G X 7mm Pen Needle, modified, perform equivalent to the predicate devices and 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
1 Becton Drive
Franklin Lakes, New Jersey 07417
tel: 201.847.6800
www.bd.com
APR 2 8 2011
Image /page/0/Picture/3 description: The image shows the logo for BD, formerly known as Becton, Dickinson and Company. The logo consists of a circular emblem on the left and the letters 'BD' on the right. The emblem features a stylized sun rising above a figure, all enclosed within a circle. The letters 'BD' are in a bold, sans-serif font.
Helping all ne live healthy lives
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Date of Summary Preparation: January 10, 2011
-
- Submitted By:
Pasquale Amato Senior Regulatory Affairs Specialist
- Submitted By:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417
Phone: 201-847-4513 Fax: 201-848-8830
Contact Person:
James Haynes Manager, Regulatory Affairs Phone: 201-847-4298 Fax: 201-847-4859 Email: James Haynes@BD.com
-
- Device Name:
Trade Name: BD 23G X 7mm Pen Needle
- Device Name:
Common Names: Insulin Pen Needle
Classification Name: Needle, Hypodermic, Single Lumen
Classification: Class II, 21 CFR 880.5570 FMI
3. Predicate Device:
BD Pen Needle- K100005 and K051899
Manufactured by: Becton, Dickinson and Company
1
4. Device Description:
BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peelaway (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized.
The purpose of the 510(k) is to expand the needle range to include the 23G x 7 mm pen needle size. Future needle range expansions may include 24G to 28G in various lengths for which appropriate verification and validation activities will be conducted. The intended use for the modified device remains the same as the predicate device.
న. Statement of Intended Use/Indications for Use:
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
ર. Technological Characteristics:
The principal device of this premarket notification is the result of a design change to the predicate devices conducted in accordance with Quality System Regulations. The BD 23G X 7mm Pen Needle, modified, is equivalent to the predicate devices, given that:
- . Has the same intended use and indications for use as the predicate devices
- Uses the same operating principles .
- Incorporates the same basic design .
2
- Is manufactured from the same materials .
- Is sterilized using the same mode .
- Is sterilized with SAL of 10-6 .
- Is packaged using similar unit and case materials .
The only differences between the BD 23G X 7mm Pen Needle, modified, and the predicate devices are the gauge size, needle length and a larger hub which has the same basic design.
7. Performance:
Bench tests relating to the performance of the BD 23G X 7mm Pen Needle were conducted.
The principal device demonstrated equivalent performance to the predicate devices during bench testing. Bench testing consisted of:
| Tubing diameters | Per ISO 11608-2, section 4.3.1 (tubing
dimensions meet OD and ID requirement). |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Patency of lumen | Per ISO 11608-2, section 4.4 (stylet, having a
diameter equivalent to 80% ±2% of lumen ID
passes through freely). |
| Needle points | Per ISO 11608-2, section 4.5 (visually sharp at
2.5X magnification, designed to minimize
coring and fragmentation). |
| Non-Type A Needle (length) | Per ISO 11608-2, section 4.3.3 (patient end
within indicated length ± 1.25 mm) |
| Cannula load test | Per ISO 11608-2, section 4.9 and 9. |
| (No pre-conditioning) | ISO 7864 Section 13.1 (cannula holds force of
34N for 5 seconds). |
| Cannula load test | Per ISO 11608-2, section 4.9 and 9. |
| (with pre-conditioning) | ISO 7864 (cannula holds force of 34N for 5
seconds). |
| Lubrication | Per ISO 11608-2, section 4.7 (no visible
droplets inside/outside surfaces of cannula). |
| Compatibility Testing | Per ISO 11608-2, section 4.10 (connectivity
(torque). |
| Cover Impact Testing | BD design verification protocol
Meets acceptance criteria |
The results of these tests demonstrate that the BD 23G X 7mm Pen Needle, modified, perform equivalent to the predicate devices and is safe and effective when used as intended.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pasquale Amato, RAC, CQA Senior Regulatory Affairs Specialist Becton Dickinson and Company (BD) Medical Diabetes Care 1 Becton Drive MC372 Franklin Lakes, New Jersey 07417-1885
APR 2 8 2011
Re: K110105 Trade/Device Name: BD 23G X 7mm Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle
· Regulatory Class: II Product Code: FMI Dated: April 21, 2011 Received: April 22, 2011
. . . . . . . . . . . .
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. 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.
4
Page 2- Mr. Amato
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hows I Rosotas
Fer 2
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: BD 23G X 7mm Pen Needle
Indications For Use:
BD 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
X Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RHH C. Oge 4/28/11
(Division Sign-Off)
Page 1 of 1
(Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110105