The BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is a sterile, single use, medical device specifically intended to be used by trained healthcare professionals in accordance with the instructions for use for the collection of multiple blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. 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.

Device Description

The BD Vacutainer® Eclipse™ Blood Collection Needle consists of a double-ended hollow stainless steel cannula, a threaded polystyrene hub, a sleeve that interrupts blood flow between filling multiple tubes, a polystyrene collar, and a safety shield which can be activated to cover the needle immediately after venipuncture to protect against accidental needle sticks. The device is available in two versions: non-integrated holder and Pre-Attached Holder. The Pre-Attached model features a pre-attached needle holder, whereas the non-integrated model requires the user to obtain a compatible holder.

The device is single-use and supplied sterile. The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have limited (≤24 hours) duration surface contact with intact skin of the health care professional user and the patient. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to collect blood from the vein puncture.

AI/ML Overview

The provided FDA 510(k) summary describes the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving it meets those criteria, especially in the context of AI/ML devices.

This document is for a medical device (a hypodermic needle), not an AI/ML diagnostic or therapeutic device. Therefore, many of your questions, particularly those related to expert adjudication, MRMC studies, standalone algorithm performance, and training sets, are not applicable to the information provided.

However, I can extract and present the available information regarding performance data and acceptance relevant to this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative "reported device performance" values for each criterion in a comparative format as one might find for an AI/ML device's metrics (e.g., sensitivity, specificity thresholds). Instead, it lists various tests performed and states that the device "meets preestablished functional design requirements" or "meets its performance specifications."

Therefore, I will present the types of performance assessments conducted and the general conclusion.

Study Conclusion: "The testing performed demonstrates the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is substantially equivalent to its predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states "Samples of venous blood obtained with the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle were assessed..." and "Simulated use assessment was conducted..." as well as "Mechanical verification testing was performed..."
However, specific sample sizes for each test are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated. These are typically detailed in the full 510(k) submission, not the summary.

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

This question is not applicable to this type of device (a hypodermic needle). The "ground truth" for a medical device like this is established through engineering and performance testing against predefined specifications and recognized standards, not expert consensus on medical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the reasons stated in point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools where human interpretation is involved. This device is a blood collection needle and does not involve "human readers" or "AI assistance" in the context of diagnosis or interpretation.

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

This question is not applicable as this device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or basis for evaluation for this device consists of:

Established engineering specifications and design requirements.
Compliance with recognized international consensus standards (e.g., ISO 23908 for sharps injury protection, ISO 9626 for stainless steel tubing, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization).
Measurements of objective physical and biological parameters (e.g., hemolysis indicators, penetration force, tube fill time, pull force, activation force).

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device that requires a training set.

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

This question is not applicable for the reasons stated in point 8.

Summary

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Becton, Dickinson and Company % John Smith Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004

Re: K181730

Trade/Device Name: BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: February 1, 2019 Received: February 1, 2019

Dear Mr. Smith:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sarah B. Mollo -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K181730

Device Name

BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle

Indications for Use (Describe)

The BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is a sterile, single use, medical device specifically intended to be used by trained healthcare professionals in accordance with the instructions for use for the collection of multiple blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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K181730 510(k) SUMMARY

BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle

Submitter

Becton Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885

Phone: (201) 847-4570 Facsimile: (201) 847-4858

Contact Person: Eileen Hiller, Senior Staff Regulatory Affairs Specialist

Date Prepared: March 1, 2019

Name of Device: BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle

Common or Usual Name: Blood collection needle

Classification Name: Hypodermic Single-Lumen Needle

Classification Regulation: 21 C.F.R. § 880.5570

Regulatory Class: Il

Product Code: FMI

Classification Panel: General Hospital

Predicate Device: BD Vacutaine® Eclipse™ Blood Collection Needle (K982541)

Device Description

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Intended Use / Indications for Use

Comparison with Predicate Device

The BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle has the same intended use and principles of operation, and similar indications for use and technological characteristics, as the previously cleared BD Vacutainer® Eclipse™ Blood Collection Needle (K982541). The subject device has the same intended use as the predicate, namely multiple-sample blood collection via venipuncture. Its indications for use are also substantively the same: the device is indicated for use in clinical environments where venipuncture is performed. The minor differences in the wording of the indications for use statement-namely, the inclusion of language specifying that the device is intended to be used by trained healthcare professionals in accordance with the instructions for use for the collection of multiple blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing-are for enhanced clarity; they do not affect the device's diagnostic/therapeutic use or raise new questions of safety or effectiveness as compared to the predicate, because they do not alter how the device is used in any way.

Venous flow through the inner diameter of the cannula into attached blood collection tubes is the technological principle for both the subject and predicate devices. The subject and predicate devices are based on the following same technological elements:

. Same overall design, including safety shield feature and use of a holder
Same cannula material, geometry and gauge (Outer Diameter)
. Same method of use and very limited duration of contact (≤ 3 min.) with patient's blood

The primary technological differences between the subject and predicate devices are an increase in the cannula's inner diameter (ultra-thin wall), and introduction of a Pre-Attached Holder configuration with corresponding packaging as another option for the health care practitioner and added more detail and clarifications to the labeling. Minor differences in certain component materials/suppliers have been appropriately verified not to impact device performance. A table comparing the key features of the subject and predicate devices is provided below.

In addition, the minor differences in technological characteristics do not raise any new types of safety or effectiveness questions. Furthermore, performance data (design verification testing) demonstrates that the modified device is as safe and effective as the cited predicate. Thus, the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is substantially equivalent to its predicate device.

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	Subject Device: BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle	Predicate Device: BD Vacutainer® Eclipse™ Blood Collection Needle (K982541)	Discussion / Comment
Regulation Number	21 C.F.R. § 880.5570	21 C.F.R. § 880.5570	Same
Classification Name	Needle, Hypodermic, Single-Lumen	Needle, Hypodermic, Single-Lumen	Same
Regulatory Class	Class II	Class II	Same
Product Code	FMI	FMI	Same
Intended Use / Indications for Use	The BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is a sterile, single use, medical device specifically intended to be used by trained healthcare professionals in accordance with the instructions for use for the collection of multiple blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. 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.	The BD Vacutainer® 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.	The indications for use have been updated for enhanced clarity
Sterility	Gamma Irradiation to SAL of 10-6		Same
Single Use?	Yes		Same
Cannula Material	304 Stainless Steel		Same
Cannula Lubricants	Silicone-based oils		Same
Needle Wall Thickness	Ultra-Thin Wall (UTW)	Thin Wall (TW)	The needle wall thickness has been decreased to increase the inner-diameter of the needle for faster fill time.
Needle Length	1 ¼ inch		Same
Safety Shield Activation Method	User activates with the thumb after venipuncture, shield "pivots" around the hinge, locking into place at the needle base and at the cannula		Same
Shelf Life	5 years (Eclipse™ UltraFill™);3 years (Eclipse™ UltraFill™Pre-Attached)	5 years	Same

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Performance Data

Design verification and validation were performed to ensure that the Eclipse™ UltraFill™ Needle meets its performance specifications and demonstrates equivalence to the specified predicate device.

. Samples of venous blood obtained with the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle were assessed to verify performance as measured by analytical indicators of hemolysis.
. Simulated use assessment was conducted to validate the performance of the safety shield feature of the BD Vacutainer® Eclipse™ UltraFill™ Needle.
. Mechanical verification testing was performed to assess product characteristics including mechanical integrity, penetration force, tube fill time, cannula pull force, safety shield activation force, safety shield override force (snag resistance), sleeve function, 3 point stiffness, resistance to breakage, and external blood splatter. The results confirmed that the 21- and 22-gauge BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needles meet preestablished functional design requirements and that the changes incorporated in the subject device as compared to the predicate do not impact the product's ability to be used safely and perform as intended.

The device complies with the following recognized consensus standards:

. ISO 23908, Sharps Injury Protection - Requirements and Test Methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
. ISO 9626, Stainless steel needle tubing for the manufacture of medical devices (including amendment I: 2001)
. AAMI/ANSI/ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
. ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11737-1, Sterilization of health care products - Microbiological methods, Part 1: Estimation of the population of microorganisms
. ISO 11737-2, Sterilization of health care products - Microbiological methods, Part 2: Tests for sterility performed in the validation of sterilization process
ISO 10993-2, Biological evaluation of medical devices - Part 2: Animal welfare
. ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
. ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ●
ISO 10993-6, Biological evaluation of medical devices – Part 6: Tests for local effect affer implantation

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. ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
. ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
. ISO 10993-12, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
. ISO 10993-13. Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-15, Biological evaluation of medical devices Part 15: Identification and . quantification of degradation products from metals and alloys
. ISO 10993-17、Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
. ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials
. ISO 6009, Hypodermic needle for single use - Color coding for identification
. IEC 62366-1, Medical devices - Part 1: Application of usability engineering to medical devices

Conclusion

The testing performed demonstrates the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is substantially equivalent to its predicate device.

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).

Performance Aspect	Acceptance Criteria (Implied/Stated Goal)	Reported Device Performance
Hemolysis Assessment	Verify performance as measured by analytical indicators of hemolysis. (Implied: Acceptable levels of hemolysis in collected blood samples.)	Samples of venous blood obtained were assessed to verify performance regarding hemolysis.
Safety Shield Feature	Validate the performance of the safety shield feature. (Implied: Effective protection from accidental needle sticks.)	Simulated use assessment was conducted to validate the performance of the safety shield feature.
Mechanical Integrity	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
Penetration Force	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
Tube Fill Time	Meet preestablished functional design requirements. (Note: The new device is designed for faster fill time due to Ultra-Thin Wall.)	Confirmed met preestablished functional design requirements, and changes do not impact safe use/intended performance.
Cannula Pull Force	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
Safety Shield Activation Force	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
Safety Shield Override Force (Snag Resistance)	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
Sleeve Function	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
3 Point Stiffness	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
Resistance to Breakage	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
External Blood Splatter	Meet preestablished functional design requirements.	Confirmed met preestablished functional design requirements.
Biocompatibility	Compliance with ISO 10993 series.	Device complies with relevant ISO 10993 standards.
Sterilization	Compliance with ISO 11137 series.	Device complies with relevant ISO 11137 standards.
Sharps Injury Protection	Compliance with ISO 23908.	Device complies with ISO 23908.