BD ECLIPSE BIFURCATED NEEDLE

K032528 · Becton, Dickinson & CO · SCL · Sep 9, 2003 · General Hospital

Device Facts

• Record ID: K032528
• Device Name: BD ECLIPSE BIFURCATED NEEDLE
• Applicant: Becton, Dickinson & CO
• Product Code: SCL · General Hospital
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens. The BD Eclipse™ Bifurcated Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle.

Device Story

BD Eclipse Bifurcated Needle is a manual hypodermic device featuring an integrated safety mechanism. Designed for vaccine administration via scarification or epidermal allergen delivery. Device includes a needle cover that, when activated, shields the needle point to prevent accidental needle sticks during handling and disposal. Used by healthcare professionals in clinical settings. The safety mechanism provides physical protection post-use, reducing risk of sharps injury to the operator.

Technological Characteristics

Hypodermic single lumen needle with integrated safety cover mechanism. Class II device (Product Code SCL).

Indications for Use

Indicated for administration of vaccines via scarification or administration of epidermal allergens. No specific patient population or contraindications provided.

Regulatory Classification

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.

Submission Summary (Full Text)

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Becton Dickinson & Company Peter Zurlo Manager Regulatory Affairs 1 Becton Drive Franklin Lakes, New Jersey 07417-1885 November 1, 2024

Re: K032528

Trade/Device Name: BD Eclipse Bifurcated Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL

Dear Peter Zurlo:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 9, 2003. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480, David.Wolloscheck(@fda.hhs.gov.

Sincerely,

David Wolloscheck -S

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Public Health Service

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Zurlo Manager Regulatory Affairs Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

Re: K032528

Trade/Device Name: BD Eclipse Bifurcated Needle Regulation Number: Unclassified Regulation Name: None Regulatory Class: II Product Code: LDH Dated: August 15, 2003 Received: August 15, 2003

Dear Mr. Zurlo:

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 -Mr. Zurlo

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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runne

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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## Indications for Use Statement

| 510(k) Number (if known) | K032528 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | BD Eclipse™ Bifurcated Needle |
| Indications for Use | The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.<br>The BD Eclipse™ Bifurcated Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over-The-Counter Use_

(Per 21 CFR 801. 109)

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032528

090020