The BD Vacutainer® Eclipse™ Signal™ 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 device incorporates a flash technology to indicate venous access and a hinged safety shield. In the activated position, the safety shield protects against an accidental needle stick injury during normal handling and disposal.

Device Description

The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle is a sterile, single use, straight blood collection needle intended to be used by a trained Healthcare Worker (HCW) for conducting venipuncture. The device consists of a stainless steel cannula bonded into the front needle hub which is the intravenous (IV) end that is inserted into the patient's vein and nonpatient (np) cannula that is inserted into a holder. Blood collection tubes are inserted for venous blood collection. The device contains an additional blood flash visibility feature to provide the HCW with confirmation that the vein has been accessed.

After blood collection, when the needle is removed from a vein, a drop of blood may form at the IV patient end of the needle. This droplet may cause blood splatter during activation of the safety shield. The Eclipse™ Signal™ Blood Collection Needle minimizes the size of the blood droplet and by design, draws the blood into the lumen of the needle and away from the healthcare professional.

The Eclipse™ Signal™ BCN has the same pivoting safety shield as the predicate Eclipse™ BCN. The device has a pivoting safety shield which is designed to be activated using a single-handed technique and gives an audible confirmation of the safety lock engagement. The shield locks over and covers the needle after use, protecting the healthcare worker from an accidental needle stick injury.

The needles are manufactured in specific diameters and lengths. The color of the IV shield indicates the needle gauge (green shield for the 21G needle and black shield for the 22G needle).

The purpose of this Traditional 510(k) is to expand the product family with an additional safety blood collection needle with a flash visibility feature. The premarket notification also includes other small modifications to the needle hub, needle cannula, integrated holder and safety shield, The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle has the same intended use, operating principles and performance and scientific technology as the predicate device.

There are two variants of Eclipse™ Signal™ Blood Collection Needle (BCN) and a total of 4 models.

BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle, 21G and 22G .
BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle with Integrated Holder, . 21G and 22G.

AI/ML Overview

The document provided describes the BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle (K170824) and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

Description of Device and Claims:

The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle is a sterile, single-use blood collection needle intended for use by trained healthcare professionals for collecting multiple blood samples for in vitro diagnostic testing. Key features include:

Flash technology to indicate venous access.
Hinged safety shield for protection against accidental needle stick injuries during handling and disposal.
Minimizes blood droplet size and draws blood into the lumen to reduce blood splatter during safety shield activation.

Acceptance Criteria and Reported Device Performance:

The document does not explicitly list "acceptance criteria" in a separate section with specific numerical targets. Instead, it states that "The results of all these tests either met the predetermined acceptance criteria and BD's internal specification or performed to the standard." and "The results of these activities... either met BD's internal specification or performed according to the standard." The performance data section broadly describes the types of tests conducted:

Acceptance Criteria Category	Specific Tests / Performance Metrics Mentioned	Reported Device Performance
Specimen Quality	Examining the specimen for hemolysis and specimen quality after blood collection.	"The results of all these tests either met the predetermined acceptance criteria and BD's internal specification or performed to the standard." (Implies no adverse impact on specimen quality due to flash chamber and related components).
Biocompatibility	Cytotoxicity (per ISO10993-5), Hemolysis (per ISO10993-4), Acute Systemic Toxicity (per ISO10993-11), Intracutaneous Reactivity (per ISO10993-10), Sensitization (per ISO10993-10), Pyrogenicity (per ISO 10993-11), Chemical Extractable Analysis (per ISO 10993-18).	"The results were acceptable according to ISO 10993-1."
Device Integrity/Function	Needle Penetration, Hub/Needle Bond Strength, Leak Testing, Needle Shield Removal Forces, Flash Reliability, Activation Force, Holder Detachment, Splatter Testing.	"performed to demonstrate that the subject device met BD's internal predetermined acceptance criteria." and "The results... either met BD's internal specification or performed according to the standard." (Implies satisfactory performance for all listed functions).
Risk Management	Risk assessment in accordance with ISO14971.	"Modifications proposed... were evaluated using a risk management plan." (Implies risks were identified and mitigated to acceptable levels).

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify the numerical sample sizes for any of the performance tests (e.g., number of needles tested for bond strength, number of samples for hemolysis).
- Data Provenance: The studies appear to be internal laboratory studies conducted by Becton, Dickinson and Company ("BD's internal specification"). No information is provided regarding the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) submission for a medical device (not AI), these are typically lab-based design verification and validation tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this device and submission. The device is a physical blood collection needle, not a diagnostic AI algorithm that requires expert adjudication of image data or similar. The "ground truth" for its performance is objective physical characteristics and material compatibility, measured by instruments and standardized methods, not expert consensus.
Adjudication method for the test set:
- Not applicable. See point 2.
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:
- Not applicable. This study is for a physical medical device (blood collection needle), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance metrics are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This study is for a physical medical device.
The type of ground truth used:
- The "ground truth" for the performance studies of the blood collection needle is based on objective measurements, quantitative results from standardized tests, and compliance with recognized industry standards (e.g., ISO 10993 for biocompatibility, ISO 6009 for hub color) and BD's own internal product specifications. For example, "Needle Penetration" would involve measuring force or success rate, not expert opinion.
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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August 20, 2018

Becton, Dickinson and Company Eileen Hiller Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K170824

Trade/Device Name: BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 19, 2018 Received: July 19, 2018

Dear Eileen Hiller:

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/cdrh/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.

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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 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 mediation-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, Tina Kiang

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) K170824

Device Name

BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle

Indications for Use (Describe)

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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510(k) Summary K170824

Submitted By:	Eileen HillerSenior Staff Regulatory Affairs SpecialistBecton, Dickinson and Company1 Becton DriveFranklin Lakes, NJ 07417Phone: (201)847-4570Email: Eileen_Hiller@BD.com
Date Prepared:	August 20, 2018
Subject Devices:	Trade Name: BD Vacutainer® Eclipse™ Signal™ Blood Collection NeedleCommon Name: Hypodermic Single Lumen NeedleClassification: Class II, 21 CFR § 880.5570, Hypodermic Single Lumen NeedleProduct Code: FMI: Needle, Hypodermic, Single Lumen
Predicate Device:	Trade Name: BD Vacutainer® Eclipse™ Blood Collection Needle510(k) Reference: K982541Common Name: Hypodermic Single Lumen NeedleClassification: Class II, 21 CFR § 880.5570, Hypodermic Single Lumen NeedleProduct Code: FMI: Needle, Hypodermic, Single Lumen

1. Device Description

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over and covers the needle after use, protecting the healthcare worker from an accidental needle stick injury.

The needles are manufactured in specific diameters and lengths. The color of the IV shield indicates the needle gauge (green shield for the 21G needle and black shield for the 22G needle).

There are two variants of Eclipse™ Signal™ Blood Collection Needle (BCN) and a total of 4 models.

BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle, 21G and 22G .
BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle with Integrated Holder, . 21G and 22G.

2. Intended Use

3. Technological Characteristics

The principal BD Vacutainer® Eclipse™ Signal ™ Blood Collection Needles are equivalent to the predicate BD Vacutainer® Eclipse™ Blood Collection Needles in intended use, fundamental scientific technology, operating principles, product design, and performance characteristics.

DeviceCharacteristics	Principal Device	Predicate Device
	BD Vacutainer® Eclipse™ Signal™Blood Collection Needle (K170824)	BD Vacutainer® Eclipse™ BloodCollection Needle (K982541)
Manufacturer	Becton, Dickinson and Company	Becton, Dickinson and Company
Intended Use	The BD Vacutainer® Eclipse™ Signal™Blood Collection Needle is a sterile,single use, medical device specificallyintended to be used by trained healthcareprofessionals in accordance with theinstructions for use for the collection ofmultiple blood samples into evacuatedblood collection tubes, for the purpose of	The VACUTAINER® BrandEclipse™ Blood Collection Needleis a sterile, multiple sample, single-use device for blood collection. Theneedle is designed with an attachedsafety shield, which can be activatedto cover the needle immediatelyafter venipuncture to provide

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	in vitro diagnostic testing. The deviceincorporates a flash technology to indicatevenous access and a hinged safety shield.In the activated position, the safety shieldprotects against an accidental needle stickinjury during normal handling anddisposal.	protection from accidental needlesticks.
OperatingPrinciple	BD Vacutainer® Eclipse™ Signal™Blood Collection Needles are devicesthat are composed of two piece stainlesssteel cannula mounted into a two piecehub/adapter and pivoting safety shield tocover the needle after removal from thevein. This device also has a flashchamber for vein access confirmation.	BD Vacutainer® Eclipse™ BloodCollection Needles are devicescomposed of one piece stainlesssteel cannula mounted into a onepiece hub/adapter and pivotingsafety shield to cover the needleafter removal from the vein.
Materials	Cannula- stainless steelHub- polycarbonatePorous Plug- polyethyleneSafety Shield-polypropyleneRubber Sleeve- synthetic rubberHolder (integrated model)-polypropyleneLubricant- silicone	Cannula- stainless steelHub- polystyreneSafety Shield-polypropyleneRubber Sleeve- synthetic rubberHolder (integrated model)-polypropyleneLubricant- silicone
Packaging	Protective Shields or Foil SealShelf CartonCase CartonIFU	Protective Shields or Blister PouchShelf CartonCase CartonIFU
Specification	Needle Length: 1.0 inchNeedle Gauge: 21 or 22 GaugeDiameter - extra thin wallBevel: 3 bevelHub Color: Per ISO 6009	Needle Length: 1 ¼ inchNeedle Gauge: 21 or 22 GaugeDiameter - thin wallBevel: 3 bevelHub Color: Per ISO 6009

4. Performance Data

Performance data was collected to ensure the modifications to the blood collection needle were not impacted by the addition of the flash chamber and related components in the blood fluid path. Performance studies include examining the specimen for hemolysis and specimen quality.

The results of all these tests either met the predetermined acceptance criteria and BD's internal specification or performed to the standard.

Modifications proposed to BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle were evaluated using a risk management plan. This risk assessment process is performed in accordance with ISO14971. Biocompatibility testing included cytotoxicity (per ISO10993-5),

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hemolysis (per ISO10993-4), acute systemic toxicity (per ISO10993-11), intracutaneous reactivity (per ISO10993-10), sensitization (per ISO10993-10), pyrogenicity (per ISO 10993-11) and chemical extractable analysis (per ISO 10993-18). The results were acceptable according to ISO 10993-1.

Design Verification activities such as Needle Penetration, Hub/Needle Bond Strength, Leak Testing and Needle Shield Removal Forces, Flash Reliability, Activation Force and Holder Detachment and Splatter Testing were performed to demonstrate that the subject device met BD's internal predetermined acceptance criteria.

The results of these activities mentioned in the table above (Risk Management, Biocompatibility and Design Verification activities) either met BD's internal specification or performed according to the standard. Thus these activities demonstrated that the subject device is substantially equivalent to the predicate device.

5. Substantial Equivalence

The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle is substantially equivalent to the legally marketed predicate device, BD Vacutainer® Eclipse™ Blood Collection Needle (K982541) in intended use, principles of operation, technology, design, materials and performance.

Specifically, the BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle and predicate device have the same intended use, namely single-patient, multiple-sample blood collection by health care professionals. The minor differences in the wording of the subject device's indications statement are for enhanced clarity and to reflect the updated flash technology; they do not alter the diagnostic/therapeutic purpose of the device or raise any new types of safety or effectiveness questions, as they do not alter how the device is used as compared to the predicate. Similarly, the minor differences in technological characteristics between the two devices do not raise any new questions of safety or effectiveness, with the additional flash feature not altering the subject device's blood collection functionality.

6. Conclusion

The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle has been verified to meet the established performance criteria above. The results of the design verification testing demonstrate that the BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle performs as intended and performs as well as the legally marketed 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).