(62 days)
Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
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 in 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.
The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. Instead, it is a 510(k) summary for the BD Pen Needles, focusing on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, here's what can be inferred and what is explicitly stated regarding performance and equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (as stated in submission) |
|---|---|---|
| Technological Characteristics | Identical to predicate device | "The BD Pen Needle and the predicate device have the identical technological characteristics." |
| Performance | Equivalent to predicate device (safe and effective for intended use) | "The perform equivalent to the predicate device and is safe and effective when used as intended." |
| Intended Use | For subcutaneous injection of drugs, including insulin and exenatide. | "Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide." (The only difference noted for the new device is indication for exenatide.) |
| Sterility | Sterile (gamma irradiation) | Stated device characteristic: "BD Pen Needles are sterile (gamma irradiation)." |
| Non-pyrogenic | Non-pyrogenic | Stated device characteristic: "BD Pen Needles are non-pyrogenic." |
| Disposable | Disposable, single-use | Stated device characteristic: "The pen needles are disposable, single use devices." |
No specific quantitative or qualitative acceptance criteria (e.g., minimum tensile strength, flow rate parameters, sharpness index) are listed, nor is a study proving that these criteria were met described. The submission relies entirely on the assertion of "identical technological characteristics" and "equivalent performance" to the predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document does not describe a test set or specific testing performed for this 510(k) submission.
- Data Provenance: Not applicable, as no new clinical or performance data is presented. The submission relies on the established safety and effectiveness of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment by experts is described, as no new performance data or clinical study results are provided for evaluation.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medical needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The submission is based on substantial equivalence and regulatory compliance with existing device performance standards for the predicate device, rather than new ground truth derived from a specific study for this submission.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/ML device or a device requiring a training phase in this context.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
Summary of the Study (or lack thereof) to Prove Acceptance Criteria:
The 510(k) summary primarily argues for substantial equivalence to a predicate device ("BD Pen Needles" manufactured by the same company and "Disetronic PenFine Injection Pen Needles"). The core of the submission's "proof" is the statement that:
- "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."
Therefore, this 510(k) package does not describe a specific study with acceptance criteria, sample sizes, experts, or ground truth generation to "prove" the device meets acceptance criteria in the way one might expect for a novel device or a device requiring new clinical evidence. Instead, it asserts that because the device is technologically identical and performs equivalently to already cleared predicate devices, it is safe and effective when used as intended. The FDA's clearance (K051899) confirms they accepted this substantial equivalence argument.
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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.
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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.
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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.
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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
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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
§ 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).