(69 days)
Becton Dickinson Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
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.
Here is a breakdown of the acceptance criteria and study information based on the provided 510K summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent Technological Characteristics | The BD Ultra-Fine™ Original Pen Needle, BD Ultra-Fine™ III Short Pen Needle and BD Ultra-Fine™ III Pen Needle have identical technological characteristics and perform equivalently as the predicate device. |
| Enhanced Puncture Resistance (Outer Needle Shield) | Bench tests demonstrated that the polypropylene material had a greater penetration resistance capability than the previous polyethylene material. This change was the only difference from the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The summary only mentions "Bench tests relating to the performance of the outer needle shield were conducted."
- Data Provenance: The document does not specify the country of origin or whether the tests were retrospective or prospective. Given the nature of a 510K submission for a medical device, these would typically be internal laboratory tests conducted by Becton Dickinson.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical medical device (pen needle), not an AI or diagnostic imaging device that requires expert ground truth for interpretation of complex data. The performance evaluation was based on bench tests for material properties.
4. Adjudication Method for the Test Set
Not applicable. Performance was measured directly through bench tests of material properties, not through human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical device, not a diagnostic or AI-assisted system that would involve human readers or image interpretation.
6. Standalone Performance Study
Yes, a standalone study (bench testing) was performed on the device. However, "standalone" in this context refers to the device's physical properties being tested in a controlled laboratory setting, not an algorithm's performance without human intervention. The tests focused on the penetration resistance of the outer needle shield material.
7. Type of Ground Truth Used
The "ground truth" for this device's performance was the measured properties of the material (polypropylene vs. polyethylene) under specific bench test conditions, particularly penetration resistance. This is a direct physical measurement rather than an expert consensus, pathology, or outcomes data typically associated with diagnostic or AI systems.
8. Sample Size for the Training Set
Not applicable. This device's development and testing do not involve a "training set" in the context of machine learning or AI. Its design and material selection would be based on engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The understanding of material properties (polypropylene vs. polyethylene) and their respective penetration resistance would be established through standard material science testing and engineering knowledge.
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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 NeedleBD Ultra-Fine™ III Short Pen NeedleBD 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.
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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.
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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.
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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
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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
PAGE 19
§ 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).