The BD Eclipse™ Needle with SmartSlip™ Technology 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™ Needle with SmartSlip™ Technology is compatible for use with standard luer-slip and luer-lock syringes.

The BD Eclipse™ Needle with SmartSlip™ Technology 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 Description

The BD Eclipse™ Hypodermic Needle (BD) Eclipse™ Hypodermic Needle 510(k): K010188 and K043397 with the metal clip) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting safety cover that is connected to the adapter. The metal clip is inserted into the hub to minimize the incidence of needle detachment from a luer slip tip syringe.

The modified device, BD Eclipse™ Needle with SmartSlip™ Technology, has the same characteristics as the predicate devices except for the clip in the hub. The material of the clip has been changed from metal to plastic. The function of the plastic clip remains the same as the metal. When assembled into the hub. the clip ensures that the needle is attached to a luer slip syringe with sufficient force by the user. The pivoting safety cover can be manually rotated forward after use allowing for secure encapsulation of the needleroint 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™ Needle with SmartSlip™ Technology modified device, the standard BD Hypodermic Needle and the predicate device BD Eclipse™ Hypodermic Needle with the metal clip.

AI/ML Overview

The provided text describes the BD Eclipse™ Needle with SmartSlip™ Technology and its substantial equivalence to predicate devices, focusing on a material change in a clip within the hub. The document details performance testing specifically for this change.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Clip engagement force must meet force requirements as specified in the product specification	"The principal device demonstrated equivalent performance to the predicate device during bench testing."
Snap Clip Drop Test: clip must remain intact in the hub	"The principal device demonstrated equivalent performance to the predicate device during bench testing." and "The results of these tests demonstrate that the The BD Eclipse™ Needle with SmartSlip™ Technology, modified, perform equivalent to the predicate device and is safe and effective when used as intended."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the bench tests. It broadly states "Bench tests relating to the performance...were conducted."
Data Provenance: Not explicitly stated, but given it's a submission to the FDA by Becton, Dickinson and Company (a US-based company), the testing was likely conducted in the US or under conditions acceptable for US regulatory submission. The document implies these were internal company tests. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable to this submission. The "ground truth" for this device's performance is objective physical measurements and functional tests (e.g., force measurements, structural integrity after a drop test) against predefined engineering specifications, not expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is based on objective physical measurements and performance against specifications, expert adjudication methods (like 2+1 or 3+1 for clinical assessments) are not relevant here. The tests likely involved standardized methods and measurement tools to determine compliance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., radiologists reading images) and the AI's impact on their performance is being evaluated. This submission is for a medical device (a hypodermic needle) where performance is assessed through bench testing against engineering specifications, not through human interpretation of clinical cases.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent in its physical and mechanical properties.

7. Type of Ground Truth Used

The ground truth used for these performance tests was based on objective engineering specifications and physical measurements. For example:

Predefined "force requirements" for clip engagement.
The criterion that the "clip must remain intact" after a drop test.

These are verifiable, quantitative, or qualitative outcomes determined by a product's design specifications.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is based on the physical design and material properties of the needle and its components.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML algorithm requiring training, there is no training set ground truth to establish.

Summary

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BD Medical 1 Becton Drive Franklin Lakes, New Jersey 07417 16: 201 847 6800 fax: 201 847 4896

K100209

FEB 1 9 2010

Image /page/0/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular symbol on the left and the letters "BD" on the right. The circular symbol contains a stylized image of a sun rising over a smiling face. The letters "BD" are in a bold, sans-serif font.

Helping all people live healthy lives

510(K) SUMMARY

Date of Summary Preparation: January 22, 2010

】. Submitted By: Pasquale Amato Senior Regulatory Affairs Specialist
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417

Phone: 201-847-4513 Fax: 201-847-5307

Contact Person:

Eileen Hiller Manager, Regulatory Affairs Phone: 201-847-4570 Fax: : 201-847-5307 Email: Eileen Hiller@BD.com

1. Device Name:

Trade Name:	BD Eclipse™ Needle with SmartSlip™ Technology
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Common Names: Eclipse Hypodermic Needle

Classification Name: Needle, Hypodermic, Single Lumen

Classification: Class II, 21 CFR 880.5570 FMI

3. Predicate Device:

BD Eclipse™ Hypodermic Needle- K010188 and K043397

Manufactured by: Becton, Dickinson and Company

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Device Description: 4.

5. Intended Use:

The BD EclipseTM Needle with SmartSlip™ Technology 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.

Technological Characteristics:

The principal device of this premarket notification is the result of a design change to the predicate device (K()43397) conducted in accordance with Quality System Regulations. The BD Eclipse™ Needle with SmartSlip™ Technology, modified, is equivalent to the predicate devices, the BD EclipseTM Hypodermic Needle (K010188 and K043397) given that:

The principal device has the same hypodermic needle cannula as the predicate BD Eclipse™ Hypodermic Needle.

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The principle device has the same safety components and assembly as the predicate BD Eclipse™ Hypodermic Needle.

The principal device has the same intended use and indications for use as the . predicate device.

The devices are manufactured from the same materials.

The devices are sterilized with SAL of 10°.

The devices operate under the same principles.

The only difference between the The BD Eclipse™M Needle with SmartSlip™ Technology, modified, and the predicate device is the material of the clip in the hub.

6. Performance:

Bench tests relating to the performance of the The BD Eclipse™ Needle with SmartSlip™ Technology were conducted.

The principal device demonstrated equivalent performance to the predicate device during bench testing. Bench testing consisted of:

i. Clip engagement force must meet force requirements as specified in the product specification
ii. Snap Clip Drop Test clip must remain intact in the hub

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 1 9 2010

Mr. Pasquale Amato Senior Regulatory Affairs Specialist Becton Dickinson and Company 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K100209

Trade/Device Name: BD Eclipse™ Needle with SmartSlip™ Technology Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 22, 2010 Received: January 25, 2010

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) régulation (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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Turner

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

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Indications for Use

510(k) Number (if known):

Device Name; BD Eclipse "34 Needle with SmartSlip™ Technology

Indications For Use:

Prescription Use X (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)

Charkes

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

Page 1 of 1

510(k) Number: K100201

Regulation Number and Section

§ 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).