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 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.

AI/ML Overview

The document describes a 510(k) premarket notification for a modified BD Eclipse™ Hypodermic Needle. The primary focus of the submission is to demonstrate substantial equivalence to a predicate device, which is the original BD Eclipse™ Hypodermic Needle.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define quantitative acceptance criteria for specific performance metrics in a readily digestible table. Instead, it relies on demonstrating equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Performs equivalently to the predicate device	Bench tests and Simulated Use Tests demonstrate equivalence to the predicate device.
Safe and effective when used as intended	Bench tests and Simulated Use Tests demonstrate the device is safe and effective when used as intended.
Maintains basic needle dimensions (diameter, injection length, needle tip geometry, materials, lubrication)	The basic needle dimensions are the same as the predicate device.
Attached with sufficient force to a luer slip syringe	The metal clip ensures the device is attached to a luer slip syringe with sufficient force.
Securely encapsulates the needlepoint after use	The pivoting cover can be manually rotated forward after use, allowing for secure encapsulation.
Guards against accidental needle sticks in activated position	The needle cover guards against accidental needle sticks during normal handling and disposal.

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

Sample Size: The document does not specify the exact sample sizes for the "Bench tests" and "Simulated Use Test."
Data Provenance: The data appears to be prospective, as new "Bench tests and Simulated Use Test" were conducted for the modified device. The country of origin is not explicitly stated, but the submission is to the US FDA and the manufacturer is based in New Jersey, USA, suggesting the tests were likely conducted in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This type of information is not applicable to this device submission. The tests performed are engineering-focused (bench tests and simulated use) rather than clinical studies requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for these tests would be objective measurements and observations of the device's physical performance, not expert consensus on medical findings.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially for assessing diagnostic accuracy where expert disagreement on ground truth might occur. The tests described are direct performance evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid (like AI) on physician performance. The BD Eclipse™ Hypodermic Needle is a physical medical device, not a diagnostic aid or software, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

This question is not applicable as the device is a physical hypodermic needle and not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the BD Eclipse™ Hypodermic Needle would be:

Objective Engineering Measurements: For characteristics like needle dimensions, attachment force, and the functionality of the safety mechanism.
Direct Observation and Verification: During "Simulated Use Tests" to confirm proper function, secure encapsulation, and protection against accidental needle sticks.
Comparison to Predicate Device Performance: The primary ground truth is the established performance characteristics and safety profile of the legally marketed predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the AI sense.

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

This information is not applicable as there is no training set.

Summary

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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: 201-847-4855 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:

043397 1 of 2

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5. Intended Use:

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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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

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 (240) 276-0115. 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 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:

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

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).