The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture salery only accidental needle sticks needle sticks.

Device Description

The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needle sticks.

AI/ML Overview

The provided text describes the Becton Dickinson VACUTAINER® Brand ECLIPSE™ Blood Collection Needle, a sterile, multiple sample, single-use device for blood collection with an attached safety shield.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Acceptable forces to activate the safety shielding, including lock engagement.	Confirmed through Mechanical Testing.
Evaluation of conditions and forces under which the safety mechanism can be defeated.	Evaluated through Mechanical Testing.
Reliable shield activation in a blood drawing environment.	Confirmed through Simulated Use Testing by a panel of twenty healthcare professionals.
Observe blood splatter.	Observed during Simulated Use Testing.
Evaluate ease of activation.	Evaluated during Simulated Use Testing, considering technique, right/left handedness, and single-handed operation.
Provide performance in blood collection equivalent to the predicate conventional blood collection needle.	Believed to be equivalent based on the use of identical components to the conventional VACUTAINER® Brand Blood Collection Needle and inherent functional equivalence.
Provide convenient and effective cannula shielding.	Believed to be effective and convenient based on the design and testing.

2. Sample size used for the test set and the data provenance

Sample size for the test set: A panel of twenty healthcare professionals was used for Simulated Use Testing. The specific number of individual tests or cases performed by these professionals is not detailed.
Data provenance: Prospective, as it involved "Simulated Use Testing by a panel of twenty healthcare professionals." The country of origin of the data is not explicitly stated, but given the submission is to the FDA, it is likely US-based or for the US market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Twenty healthcare professionals.
Qualifications of those experts: Not explicitly detailed beyond "healthcare professionals." Their specific roles (e.g., phlebotomists, nurses) or years of experience are not mentioned.

4. Adjudication method for the test set

The text does not specify a formal adjudication method (like 2+1 or 3+1). The "Simulated Use Testing" implies a direct observation and evaluation by the healthcare professionals themselves, who served as the de facto evaluators of reliable activation and ease of use.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of comparing human readers' performance with and without AI assistance. This device is a physical medical device, not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical blood collection needle with a safety mechanism, not an algorithm. The "standalone" performance refers to the mechanical function of the safety shield and its activation, which was evaluated through "Mechanical Testing" and "Simulated Use Testing."

7. The type of ground truth used

The ground truth for the mechanical aspects (forces, lock engagement, defeat conditions) was established through objective mechanical measurements and evaluations.
For the simulated use aspects (reliable activation, blood splatter observation, ease of activation, technique, handedness, single-handed operation), the ground truth was based on the direct observation and feedback/assessment of the twenty healthcare professionals during the simulated use scenarios. This falls under expert judgment/assessment in a practical use setting.

8. The sample size for the training set

The concept of a "training set" is not applicable here as the device is a physical medical device, not an AI model requiring a dataset for training. The device's design is stated to use "components that are identical to the conventional VACUTAINER® Brand Blood Collection Needle," implying its functional basis is derived from an established design.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI algorithm. The device's performance is based on its mechanical design and human-factors testing for safety and ease of use.

Summary

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K982541

.. .

I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary Of Safety and Effectiveness

I. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

Establishment:

• Address:	Becton Dickinson VACUTAINER Systems1 Becton DriveFranklin Lakes, NJ 07417-1885
Registration Number:	2243072
Contact Person:	Andrea HroncichRegulatory Affairs CoordinatorTelephone no.: 201-847-6173Fax No. 201-847-4858
• Date of Summary:	July 16, 1998

Device

Trade Name:	VACUTAINER ® Brand ECLIPSE™ Blood Collection Needle
Classification Name:	Blood Specimen Collection Device

. Classification: Class II
- Performance Standards: None Established under 514 of the Food, Drug and Cosmetic Act

Hawaii

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II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Substantial Equivalence Declaration:

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR § 807, Subpart E, under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

Device Description:
The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needle sticks.
. Intended Use:
VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is designed for use with VACUTAINER® Brand Blood Collection Needle Holders in performing venipuncture to obtain blood samples. After venipuncture, the safety shield is activated with thumb pressure. The hinged safety shield pivots up and over the needle, locking into place. In the activated position, the safety shield protects against accidental needle stick during normal handling and disposal.

Synopsis of Test Methods and Results .

The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle will be made using components that are identical to the conventional VACUTAINER® Brand Blood Collection Needle and function in blood collection is inherently equivalent. It is similar to the VACUTAINER® Brand Safety Blood Collection Assembly in that it has an attached safety shield that can be conveniently activated by the user after phlebotomy to provide protection from accidental needle stick injury. Mechanical Testing was used to confirm acceptable forces to activate the safety shielding including lock engagement and to evaluate conditions and forces under which the safety mechanism can be defeated. Simulated Use Testing by a panel of twenty healthcare professionals was used to confirm reliable shield activation in a blood drawing environment, to observe blood splatter, and to evaluate ease of activation. Other considerations such as technique, right/left handedness, and single-handed operation were also observed. Based on the above, the device is believed to provide performance in blood collection equivalent to the predicate

要

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conventional blood collection needle and to provide a convenient and effective cannula shielding.

Substantial Equivalence .
Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand ECLIPSE™ Blood Collection Needle can be shown to be substantially equivalent to the commercially available predicate devices identified below:

Manufacturer	Predicate Device	K-Number	Clearance Date
Becton DickinsonVACUTAINER®Systems	VACUTAINER® BrandBlood Collection Needle	N/A	Pre-amendment
Becton DickinsonVACUTAINER®Systems	VACUTAINER® BrandSafety Blood CollectionAssembly	K972404	July 22, 1997.

us thonaci

7/20/98
Date

. . . . . . . . . . .

Andrea Hroncich Regulatory Affairs Coordinator Regulatory Affairs Department

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and features the department's name around the perimeter. In the center is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines and a ribbon-like element at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 1998

Ms. Andrea Hroncich Regulatory Affairs Associate Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

Re : K982541 VACUTAINER® Brand Eclipse™ Blood Collection Trade Name: Needle, Models Regulatory Class: II Product Code: FMI Dated: September 18, 1998 Received: September 21, 1998

Dear Ms. Hroncich:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Hronicich

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ﻬﺎ

G. INDICATIONS FOR USE

. .- .-510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

(Please do not Write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	Or	Over-the-Counter Use ______
------------------	----------------------------------------------------------------------------------------------	----	-----------------------------

(Per 21 CFR § 801 109)

	Patricia Cuenta
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K982541

(510(k) Number (Optional format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

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).