MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE

K043397 · Becton, Dickinson & CO · FMI · Dec 29, 2004 · General Hospital

Device Facts

• Record ID: K043397
• Device Name: MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
• Applicant: Becton, Dickinson & CO
• Product Code: FMI · General Hospital
• Decision Date: Dec 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD Eclipse™ Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes. The BD Eclipse™ Hypodermic 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/syringe combination.

Device Story

BD Eclipse™ Hypodermic Needle is a single-lumen hypodermic needle featuring a one-piece hub/adapter and a pivoting safety cover. The modified design incorporates a metal clip within the hub to ensure secure attachment to luer-slip syringes. After use, the clinician manually rotates the pivoting cover forward to encapsulate the needle tip, protecting against accidental needle sticks during disposal. The device is used in clinical settings for fluid injection and aspiration. It functions as a standard needle with an integrated safety feature, maintaining identical dimensions, tip geometry, and materials as the predicate device.

Clinical Evidence

Bench testing and simulated use testing were conducted to evaluate performance. No clinical data was required or provided. Results demonstrated that the device performs equivalently to the predicate.

Technological Characteristics

Single-lumen hypodermic needle with pivoting safety cover. Features a metal clip in the hub for enhanced luer-slip syringe attachment. Materials, dimensions, injection length, needle tip geometry, and lubrication are identical to the predicate device. Manual activation of safety cover.

Indications for Use

Indicated for general purpose injection and aspiration of fluids from vials, ampoules, and body sites below the skin surface. Compatible with standard luer-slip and luer-lock syringes. Includes a safety mechanism to cover the needle point post-use to prevent accidental needle sticks.

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.

Predicate Devices

• BD Eclipse™ Hypodermic Needle (K010188)

Submission Summary (Full Text)

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# DEC 2 9 2004

## 510K SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. Submitted By:

Pasquale Amato Regulatory Affairs Coordinator

BD Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417

201-847-4513 Phone: [phone] Fax:

#### 2. Device Name:

| Trade Name: | BD Eclipse™ Hypodermic Needle |
|---------------|-------------------------------|
| Common Names: | Eclipse Hypodermic Needle |

Needle, Hypodermic, Single Lumen Classification Name:

#### 3. Predicate Device:

BD Eclipse™ Hypodermic Needle

Manufactured by: Becton Dickinson and Company

#### 4. Device Description:

The BD Eclipse™ Hypodermic Needle (BD Eclipse™ Hypodermic Needle 510(k): K010188) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting cover that is connected to the adapter. The hub of the modified device has a metal clip assembled in it to ensure that the BD Eclipse™ Hypodermic Needle is attached to a luer slip syringe with sufficient force by the user. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal.

The basic needle dimensions (diameter, injection length, needle tip geometry, materials and lubrication) are the same for the BD Eclipse™ Hypodermic Needle, modified device, the standard BD Hypodermic Needle and the predicate device BD Eclipse™ Hypodermic Needle.

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#### 5. Intended Use:

The BD Eclipse™ Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes.

The BD Eclipse™ Hypodermic 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/syringe combination.

#### 6. Technological Characteristics:

The B-D Eclipse™ Hypodermic Needle and the predicate device have the identical technological characteristics and perform equivalently.

The only difference between the BD Eclipse™ Hypodermic Needle and the predicate device is the metal clip in the hub.

#### 7. Performance:

Bench tests and Simulated Use Test relating to the performance of the BD Eclipse™ Hypodermic Needle were conducted.

The results of these tests demonstrate that the BD Eclipse™ Hypodermic Needle perform equivalent to the predicate device and is safe and effective when used as intended.

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2004

Mr. Pasquale Amato Regulatory Affairs Coordinator Becton Dickinson & Company BD Medical Surgical Systems 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K043397

Trade/Device Name: BD Eclipse™ Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 8, 2004 Received: December 10, 2004

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.

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. 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); 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 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 vours.

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): K043397

Device Name: BD Eclipse™ Hypodermic Needle

Indications For Use:

The BD Eclipse™ Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes.

The BD Eclipse™ Hypodermic 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/syringe combination.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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)

Arlene Nereau for ADW 12/29/04

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

510(k) Number. K043397