BD Eclipse Hypodermic Needle

K161170 · Becton, Dickinson and Company · FMI · May 27, 2016 · General Hospital

Device Facts

• Record ID: K161170
• Device Name: BD Eclipse Hypodermic Needle
• Applicant: Becton, Dickinson and Company
• Product Code: FMI · General Hospital
• Decision Date: May 27, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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-lock syringes. The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint 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 Story

Hypodermic needle with integrated pivoting safety cover; manual activation after use encapsulates needlepoint for safe disposal. Used for fluid injection/aspiration; compatible with luer-lock syringes. Operated by clinicians; used in clinical settings. Safety mechanism reduces risk of accidental needle sticks during handling and disposal. Subject device replaces HCFC-containing lubricant with HCFC-free silicone lubricant; expands gauge/length offerings.

Clinical Evidence

Bench testing only. No clinical data. Verification activities included cannula pull-out force, activation/unlocking forces, impact resistance, and shipping tests. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, sensitization, pyrogenicity, and chemical extractable analysis. All results met internal specifications or applicable standards.

Technological Characteristics

Hub: Polypropylene; Cannula: Stainless Steel; Lubricant: HCFC-free silicone. Features pivoting safety shield (polypropylene). Gauge: 18-30G; Length: 0.5-1.5 inches. Bevels: regular, short, intradermal. Luer-lock connector. Sterilization: ISO 11135 (SAL 10^-6). Biocompatibility: ISO 10993-1.

Indications for Use

Indicated for general purpose injection and aspiration of fluid from vials, ampoules, and body parts below the skin surface. Compatible with standard luer-lock syringes. Includes a safety mechanism to cover the needlepoint after use to guard against accidental needle sticks.

Regulatory Classification

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.

Predicate Devices

• BD Eclipse™ Hypodermic Needle (K010188)

Submission Summary (Full Text)

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

May 27, 2016

Becton, Dickinson and Company Ms. Priyanka Apte Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K161170

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: April 22, 2016 Received: April 28, 2016

Dear Ms. Apte:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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) K161170

Device Name BD Eclipse™ Hypodermic Needles

#### Indications for Use (Describe)

The BD Eclipse™M Hypodermic Need 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-lock syringes.

The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards accidental needle sticks during normal handling and disposal of the used needle/ syringe combination.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary

| Submitted By: | Priyanka Apte<br>Regulatory Affairs Specialist<br>Becton, Dickinson and Company<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Phone: [phone]<br>Fax: [phone] | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Date Prepared: | May 27, 2016 | |
| Subject Devices: | | |
| | Trade Name: | BD EclipseTM Hypodermic Needle |
| | Common Name: | Hypodermic Single Lumen Needle |
| | Classification: | Class II, 21 CFR §880.5570, Hypodermic Single Lumen<br>Needle |
| | Product Code: | FMI: Needle, Hypodermic, Single Lumen |
| Predicate Devices: | | |
| | Trade Name: | BD EclipseTM Hypodermic Needle |
| | 510(k) Reference: | K010188 |
| | Common Name: | Hypodermic Single Lumen Needle |
| | Classification: | Class II, 21 CFR §880.5570, Hypodermic Single Lumen<br>Needle |
| | Product Code: | FMI: Needle, Hypodermic, Single Lumen |

#### Device Description

The BD Eclipse™ Hypodermic Needle 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 pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal. These needles have a regular, short or intradermal bevel type. The needle assembly is protected with a polypropylene shield.

The Eclipse™ Hypodermic Needles are offered in a variety of gauge sizes (18-30 gauge) and needle length (½''- 1/2''). The needle hub is color-coded to the appropriate gauge needle per ISO 6009.

The BD Eclipse™ Hypodermic Needle hub incorporates a female 6% (Luer) connector which can be used with a compatible male 6% (Luer) connector. The BD Eclipse™ Hypodermic Needle is not to be used with luer-slip syringe as the needle may become disengaged from the syringe when activating the safety cover. This product is single use and provided sterile.

The change described in this submission is the replacement of current silicone based HCFC-containing needle lubricant with silicone based HCFC-free lubricant.

#### Intended Use

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-lock syringes.

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The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint 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 subject BD Eclipse™ Hypodermic Needles are equivalent to that of the predicate BD Eclipse™ Hypodermic Needles in intended use, fundamental scientific technology, operating principles, product design, and performance characteristics.

| Device Characteristics | Subject Device<br>BD Eclipse™ Hypodermic | Predicate Device<br>BD Eclipse™ Hypodermic |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Needle (K161170) | Needle (K010188) |
| Manufacturer | Becton, Dickinson and Company | Becton, Dickinson and Company |
| Intended Use | The BD Eclipse™ Hypodermic<br>Needle is used for general<br>purpose injection and aspiration<br>of fluid from vials, ampoules and<br>parts of the body below the<br>surface of the skin. The BD<br>Eclipse Hypodermic Needle is<br>compatible for use with standard<br>luer-lock syringes.<br><br>The BD Eclipse™ Hypodermic<br>Needle contains a mechanism<br>that covers the needlepoint after<br>use. In the activated position the<br>needle cover guards against<br>accidental needle sticks during<br>normal handling and disposal of<br>the used needle/syringe<br>combination. | The BD Eclipse™ Hypodermic<br>Needle is used for general<br>purpose injection and aspiration<br>of fluid from vials, ampoules and<br>parts of the body below the<br>surface of the skin. The BD<br>Eclipse Hypodermic Needle is<br>compatible for use with standard<br>luer-slip and luer-lock syringes.<br><br>The BD Eclipse™ Hypodermic<br>Needle contains a mechanism<br>that covers the needlepoint after<br>use. In the activated position the<br>needle cover guards against<br>accidental needle sticks during<br>normal handling and disposal of<br>the used needle/syringe<br>combination. |
| Operating Principle | BD Eclipse™ Hypodermic<br>Needles are devices that are<br>composed of a typical<br>hypodermic needle with a one<br>piece hub/adapter and pivoting<br>cover that is connected to the<br>adapter. The device consists of a<br>mechanism that covers the needle<br>point after use | BD Eclipse™ Hypodermic<br>Needles are devices that are<br>composed of a typical<br>hypodermic needle with a one<br>piece hub/adapter and pivoting<br>cover that is connected to the<br>adapter. The device consists of a<br>mechanism that covers the needle<br>point after use |
| Materials | Hub: Polypropylene<br><br>Cannula: Stainless Steel<br><br>Cannula Lubricant: HCFC-free<br>silicone<br><br>Needle/Safety Shield: | Hub: Polypropylene<br><br>Cannula: Stainless Steel<br><br>Cannula Lubricant: HCFC<br>containing silicone<br><br>Needle/Safety Shield: |
| | Polypropylene | Polypropylene |
| Packaging | Blister Pouch | Blister Pouch |
| | Shelf Carton | Shelf Carton |
| | Case Carton | Case Carton |
| | | |
| Specification | Needle Length: ½'' - 1½'' | Needle Length: ½'' - 2'' |
| | Needle Gauge: 18-30 Gauge | Needle Gauge: 18-25 Gauge |
| | Bevel: Regular, Short,<br>Intradermal | Bevel: Regular, Short,<br>Intradermal |
| | | |
| Functional Testing | Hub Color: Per ISO 6009 | Hub Color: Per ISO 6009 |
| | Hub/Needle Bond Strength: Met<br>internal BD specification | Hub/Needle Bond Strength: Met<br>internal BD specification |
| | Needle Penetration Test: Met<br>internal BD specification | Needle Penetration Test: Met<br>internal BD specification |
| | Needle Shield Removal Forces:<br>Met internal BD specification | Needle Shield Removal Forces:<br>Met internal BD specification |
| | Leak Testing: Per ISO 594-2 | Leak Testing: Per ISO 594-2 |
| | | |
| | | |
| Sterilization | Per ISO 11135 | Per ISO 11135 |
| SAL Level | SAL 10-6 | SAL 10-6 |
| Shelf Life | 5 Years | 5 Years |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 |

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# Performance Data

Additional length /gauge size have been validation/verification/verification activities which included cannula pull out forces to ensure hub/cannula bonding, activation/unlocking forces, impact resistance to ensure safety mechanism of a needle and a ship test to ensure needle/safety shield integrity. 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 Eclipse™ Hypodermic Needle evaluated using risk management plan. This risk assessment process is performed in accordance with ISO14971. Biocompatibility testing included 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) and chemical extractable analysis (per ISO 10993-18). The results were acceptable according to ISO 10993-1.

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

The results of these activities mentioned in table above (Risk Management, Biocompatibility and Design Verification activities) either met BD's internal specification or performed according to the standard.

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Thus these activities demonstrated that the subject device is substantially equivalent to the predicate device.

### Substantial Equivalence

The subject BD Eclipse™ Hypodermic Needle has the same intended use, fundamental scientific technology and operating principles when compared to the predicate BD Eclipse™ Hypodermic Needle and is substantially equivalent to its legally marketed predicate K010188.

### Conclusion

The BD Eclipse™ Hypodermic Needles have been verified to meet the established performance criteria above. The results of design verification testing demonstrate that the BD Eclipse™ Hypodermic Needles perform as intended and perform as well as the legally marketed predicate device.