Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site

K170897 · B.Braun Medical, Inc. · PTI · Nov 3, 2017 · General Hospital

Device Facts

• Record ID: K170897
• Device Name: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
• Applicant: B.Braun Medical, Inc.
• Product Code: PTI · General Hospital
• Decision Date: Nov 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

Device Story

Surecan Safety II is a sterile, single-use, non-coring angled needle for accessing subcutaneously implanted vascular ports. Device features flexible wings for secure handling and a clear base/bottom plate for visual confirmation of needle placement. During needle removal, a manually activated safety mechanism shields the needle tip to prevent accidental needlesticks; activation is confirmed by a tactile stop and a visual green dot indicator. Available in 19-22 gauge sizes with lengths 0.5-1.5 inches; configurations include options with or without a Y-site and Caresite luer access device. Used by clinicians in clinical settings to facilitate fluid/drug infusion, blood sampling, and power injection of contrast media (up to 5mL/s at 325 psi for 19/20G, 2mL/s for 22G). Low-profile design assists with securement dressing application. Benefits include reduced risk of needlestick injuries and compatibility with power-injectable ports.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included wing flexibility, penetration force, coring (ASTM F3212-16), flow blockage, leakage, joint integrity, safety mechanism activation (ISO 23908), cannula function, power injection pressure resistance (325 psi), MRI compatibility (ASTM F2182, F2052, F2119, F2213), and chemical compatibility. Biocompatibility testing performed per ISO 10993-1:2009, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemocompatibility, and material-mediated pyrogenicity.

Technological Characteristics

Non-coring angled needle; 19-22 gauge; 0.5-1.5 inch lengths. Materials: clear plastic base/bottom plate, foam pad. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. Mechanical safety mechanism: manual activation with tactile and visual (green dot) confirmation. Complies with ISO 23908, ISO 9626, ISO 594-2, and JIS T3221 standards.

Indications for Use

Indicated for patients with subcutaneously implanted vascular ports requiring infusion of fluids/drugs, blood sampling, or power injection of contrast media into the central venous system.

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

• SafeStep MAX Power-Injectable Infusion Set (K073050)

Reference Devices

• Bard PowerLoc MAX (http://www.bardaccess.com/products/infusion/powerloc-max)
• Bard SafeStep Huber (http://www.bardaccess.com/products/infusion/safestep-huber)

Submission Summary (Full Text)

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November 3, 2017

B. Braun Medical Inc. Angela Caravella Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109

Re: K170897

Trade/Device Name: Surecan Safety II Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: October 6, 2017 Received: October 6, 2017

Dear Angela Caravella:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina
Kiang-S

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) K170897

Device Name Surecan Safety II

#### Indications for Use (Describe)

The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contral venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

For power injection of contrast media, the maximum flow rates at 325 psi are 5mL/s for 19 gauge needles and 2mL/s for the 22 gauge needles.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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B. Braun Medical SAS 510(k) Premarket Notification Surecan Safety II

### 5. 510(k) SUMMARY

| DATE: | October 31, 2017 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500 |
| | Contact: Angela J. Caravella<br>Sr. Regulatory Affairs Specialist |
| | Phone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| DEVICE NAME: | Surecan Safety II |
| COMMON OR USUAL<br>NAME: | Intravascular Administration Set |
| CLASSIFICATION: | Class II, Product Code PTI, 880.5570 |
| PREDICATE DEVICE: | SafeStep MAX Power-Injectable Infusion Set, Specialized<br>Health Products International Inc., K073050, Class II, FPA,<br>880.5440 |

## DESCRIPTION:

The Surecan Safety II power-injectable safety non-coring needle is a single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. This device contains a non-coring angled needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle tip during removal. The intended patient population is for patients with implanted intravenous access ports.

The Surecan Safety II needles are available in different sizes from 19 gauge to 22 gauge and have an overall needle length ranging from 0.5-1.5 inches (12mm-38mm). The Surecan Safety II needles will be available in two configurations:

> -with a Y-site and a preconnected Caresite luer access device -without Y-site or Caresite luer access device

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B. Braun Medical SAS 510(k) Premarket Notification Surecan Safety II

When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

The Surecan Safety II is designed with flexible wings which allow the user to securely hold the device for insertion and removal of the needle. The base and bottom plate are made of clear plastic that allow the user to visualize placement of the needle. A foam pad is present on the patient-contacting side of the safety mechanism. The overall assembly has a low profile to assist with the placement of a securement dressing following insertion of the needle into the port.

## INDICATIONS FOR USE / INTENDED USE:

The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.

For power injection of contrast media, the maximum flow rates at 325 psi are 5mL/s for 19 gauge and 20 gauge needles and 2mL/s for the 22 gauge needles.

### SUBSTANTIAL EQUIVALENCE:

The Surecan Safety II is substantially equivalent to the SafeStep MAX Power-Injectable Infusion Set (K073050) predicate device.

The Surecan Safety II device has the same intended and indications for use, similar safety mechanism design. and does not possess significantly different technological characteristics when compared to the predicate device since the Surecan Safety II is comprised of similar components with a similar design. The Surecan Safety II, as well as the predicate are provided as sterile, individually packaged for single use.

Both devices are designed with a non coring needle and offer straight sets or sets with a y-site. The same needle sizes (19, 20, and 22ga) as well as needle lengths (0.5-1.5 inches) are available for both devices. The same total needle length range is the same as the predicate, however, within that range there are additional lengths offered which differ from the predicate. These additional lengths accommodate patients of different sizes and port implantation depths to minimize the gap between the Surecan Safety II base and the skin.

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B. Braun Medical SAS 510(k) Premarket Notification Surecan Safety II

The Surecan Safety II and the SafeStep MAX both include manually activated safety mechanisms which, when pulled to engage, provide tactile confirmation of the device's needlestick safety mechanism deployment. The Surecan Safety II device has a second feature to confirm the safety mechanism's activation; a green dot is visualized through the clear bottom plate when the safety mechanism is fully engaged. Additionally, the power injection flow rates for each of the gauge sizes are the same (22ga - 2mL/s, 19 and 20ga – 5mL/s) between the Surecan Safety II and SafeStep MAX.

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## Comparison of Technological Characteristics with the Predicate Device

The Surecan Safety II possesses similar technological characteristics as the predicate Specialized Health Products International Inc. SafeStep MAX Power-Injectable Infusion Set cleared under 510(k) K073050.

A table summarizing the comparison between the Surecan Safety II to the predicate device is provided below:

TI

| Comparison of Surecan Safety II Device with Predicate Device | | |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device<br>Surecan Safety II | Predicate Device<br>(K073050) SafeStep MAX Power-<br>Injectable Infusion Set |
| Intended<br>Use | Access surgically implanted<br>vascular ports for the infusion of<br>fluids, drugs, and blood sampling. | Access surgically implanted vascular<br>ports for the infusion of fluids, drugs, and<br>blood sampling. |
| Indications<br>for Use | The Surecan Safety II power-<br>injectable safety non-coring<br>needle is a device intended for<br>insertion into the septum of a<br>subcutaneously implanted port for<br>the infusion of fluids and drugs,<br>as well as blood sampling through<br>the port. The Surecan Safety II<br>safety feature is manually<br>activated during needle removal,<br>and is designed to aid in the<br>prevention of accidental needle-<br>sticks. When used with ports that<br>are indicated for power injection<br>of contrast media into the central<br>venous system, the Surecan<br>Safety II needle is also indicated<br>for power injection of contrast<br>media.<br>For power injection of contrast<br>media, the maximum flow rates at<br>325 psi are 5mL/s for 19 gauge<br>and 20 gauge needles and 2mL/s<br>for the 22 gauge needles. | The SafeStep MAX Power-Injectable<br>Infusion Set device is an intravascular<br>administration set with a non-coring right<br>angle needle and manually activated<br>needlestick prevention safety mechanism<br>which reduces the risk of accidental<br>needlestick injuries by shielding the<br>needle. The device is used to access<br>surgically implanted vascular ports.<br>The SafeStep MAX Power-Injectable<br>Infusion Set is indicated for use in the<br>administration of fluids and drugs, as<br>well as blood sampling through<br>surgically implanted vascular ports.<br>When used with ports that are indicated<br>for power injection of contrast media into<br>the central venous system, the SafeStep<br>MAX Power-Injectable Infusion Set is<br>also indicated for power injection of<br>contrast media. For power injection of<br>contrast media, the maximum<br>recommended infusion rate is 5mL/s for<br>19 gauge and 20 gauge needles, and<br>2mL/s for 22 gauge needles. |
| Comparison of Surecan Safety II Device with Predicate Device | | |
| | Proposed Device<br>Surecan Safety II | Predicate Device<br>(K073050) SafeStep MAX Power-<br>Injectable Infusion Set |
| Safety<br>Mechanism<br>Design | Manually activated safety<br>mechanism upon removal of the<br>needle from the implanted<br>vascular port.<br>Safety mechanism locks needle<br>into place when a firm stop is felt.<br><br>A green dot appears on the clear<br>bottom plate when safety<br>mechanism is fully engaged. | Manually activated safety mechanism<br>upon removal of the needle from the<br>implanted vascular port.<br>Safety mechanism locks needle into<br>place when a firm stop is felt. |
| Is the<br>engagement<br>of the safety<br>mechanism<br>visible to<br>the user? | Yes, green dot appears with<br>successful deployment of safety<br>mechanism | No, tactile confirmation only |
| Do any sets<br>contain an<br>Injection<br>Site / Luer<br>Access<br>Device? | Yes | Yes |
| Needle<br>bevel design | Non-coring angled needle | Non-coring Huber right angle needle |
| Needle sizes | 19 gauge<br>20 gauge<br>22 gauge | 19 gauge<br>20 gauge<br>22 gauge |
| Priming<br>Volume | 19 ga (without Caresite) - 0.32mL<br>20 ga (without Caresite - 0.24mL<br>22 ga (without Caresite - 0.18mL<br>19 ga (with Caresite) - 0.62mL<br>20 ga (with Caresite) -0.53 mL<br>22 ga (with Caresite) -0.46 mL | Unknown |

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| Comparison of Surecan Safety II Device with Predicate Device | | | | |
|--------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------|------------------------------------------------------------------------------|----------------------------|
| | Proposed Device<br>Surecan Safety II | | Predicate Device<br>(K073050) SafeStep MAX Power-<br>Injectable Infusion Set | |
| | Gauge Size | Needle Length<br>(inches) | Gauge Size* | Needle Length<br>(inches)* |
| Needle<br>length | 19 (without a y-<br>injection site) | 0.5, 0.6, 0.8,<br>1.0, 1.3, 1.5 | 19 (without a y-<br>injection site) | 0.5, 0.75, 1.0, 1.5 |
| | 20 (without a y-<br>injection site) | 0.5, 0.6, 0.8,<br>1.0, 1.3, 1.5 | 20 (without a y-<br>injection site) | 0.5, 0.75, 1.0, 1.5 |
| | 22 (without a y-<br>injection site) | 0.5, 0.6, 0.8,<br>1.0, 1.3 | 22 (without a y-<br>injection site) | 0.5, 0.75, 1.0, 1.5 |
| | 19 (with y-<br>injection site<br>and Caresite) | 0.5, 0.6, 0.8,<br>1.0, 1.3, 1.5 | 19 (with y-injection<br>site and needleless<br>injection cap) | 0.5, 0.75, 1.0, 1.5 |
| | 20 (with y-<br>injection site<br>and Caresite | 0.5, 0.6, 0.8,<br>1.0, 1.3 | 20 (with y-injection<br>site and needleless<br>injection cap) | 0.5, 0.75, 1.0, 1.5 |
| | 22 (with y-<br>injection site<br>and Caresite | 0.5, 0.6, 0.8,<br>1.0 | 22 (with y-injection<br>site and needleless<br>injection cap) | 0.5, 0.75, 1.0, 1.5 |
| Available<br>for use with<br>contrast<br>media? | Yes | | Yes | |
| Flow rates<br>with<br>contrast<br>media | 19, 20 gauge – 5mL/s | | 19, 20 gauge - 5mL/s | |
| | 22 gauge - 2 mL/s | | 22 gauge - 2 mL/s | |
| Does the<br>device have<br>wings? | Yes | | No, contains a grip as part of the handle | |
| Sterilization<br>method | Ethylene Oxide | | Irradiation* | |
| SAL | 10-6 | | Unknown | |
| Shelf Life | 5 years for sets without a Caresite<br>3 years for sets with a Caresite | | Unknown | |

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| Comparison of Surecan Safety II Device with Predicate Device | | |
|--------------------------------------------------------------|--------------------------------------|------------------------------------------------------------------------------|
| | Proposed Device<br>Surecan Safety II | Predicate Device<br>(K073050) SafeStep MAX Power-<br>Injectable Infusion Set |
| Number of<br>Uses | Single Use | Single Use |

http://www.bardaccess.com/products/infusion/safestep-huber and http://www.bardaccess.com/products/infusion/powerloc-max

## Performance Testing

Functional performance testing was completed to demonstrate that the Surecan Safety II device performs as intended after ethylene oxide (EO) sterilization.

The following performance tests were evaluated in support of the substantial equivalence determination:

| Test Performed | Standard / Guidance referenced<br>(where applicable) |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wing Flexibility | Verify whether wings are able to<br>withstand bending without cracking |
| Penetration Force | NF S 94-370 French Standard, Surgical<br>Implants, implantable catheter chambers,<br>intravenous, intra arterial,<br>intraperitoneal, intrathecal and epidural<br>use |
| Coring Testing | ASTM F3212-16: Standard test method<br>for coring testing of Huber needles |
| Freedom from flow rate blockage | Verify when the set is subjected to 0.2 bar<br>of air pressure and submerged underwater<br>that the needle's flow path is not blocked. |
| Freedom from leakage | Verify that no part of the set leaks when<br>connected to 150kPa of water pressure for<br>15 minutes (JIS T3221:2011 Single use<br>needle for infusion port) |
| Test Performed | Standard / Guidance referenced<br>(where applicable) |
| Joint integrity | Verify all joint connections can withstand 15N of pull for 15 seconds (JIS T3221:2011 Single use needle for infusion port) |
| Safety Mechanism Activation and Function | ISO 23908:2011 Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling<br><br>FDA Guidance Medical Devices with Sharps Injury Prevention Features, Issued August 9, 2005 |
| Cannula Function | - ISO 9626:1991 Stainless steel needle tubing for manufacture of medical devices<br><br>- Cannula must have enough elasticity to return to its original position after cannula deflection by 8 degrees and holding it for one minute (JIS T3221:2011 Single use needle for infusion port) |
| Ability to withstand power injection pressures | Watertight and resistant to high pressure 22.4 bars (325 psi) |
| Ability to function with associate device | ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings |
| Power Injection Flow rate | Confirm Maximum flow rates with a power injector are equivalent to predicate device |
| MRI Compatibility | ASTM F2182-09 Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging<br><br>ASTM F2052-06 Standard test method for measurement of magnetically induced displacement force on medical devices in |
| Test Performed | Standard / Guidance referenced<br>(where applicable) |
| | the magnetic resonance environment |
| | ASTM 2119-07 Standard test method for<br>evaluation of MR image artifacts from<br>passive implants |
| | ASTM 2213-06 R11 Standard test<br>method for measurement of magnetically<br>induced torque on medical devices in the<br>magnetic resonance environment |
| Chemical Compatibility | ISO 10993-18:2005 Biological evaluation<br>of medical devices – Part 18 Chemical<br>characterization of materials |
| | ISO 8536-4:2010 Infusion equipment for<br>medical use – Part 4: Infusion sets for<br>single use, gravity feed |
| Simulated Use Study | FDA Guidance Medical Devices with<br>Sharps Injury Prevention Features, Issued<br>August 9, 2005 |
| Sterilization | ISO 11135-1:2007 and ISO 11135:2014<br>Sterilization of health care products –<br>Ethylene oxide – Requirements for<br>development, validation and routine<br>control of a sterilization process for<br>medical devices |

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## Biocompatibility

The materials of construction of a fully assembled Surecan Safety II sets were tested according to ISO 10993-1:2009.

The following biocompatibility testing was performed with the reference standard utilized:

| Biocompatibility Test | Standard Referenced |
|---------------------------------------------|----------------------------------------------|
| Cytotoxicity | ISO 10993-5:2009 |
| Sensitization | ISO 10993-10:2010 |
| Intracutaneous Reactivity | ISO 10993-10:2010 |
| Systemic Toxicity (Acute and<br>Subchronic) | ISO 10993-11:2006 |
| Hemocompatibility | ISO 10993-4:2002 and 2006 and ASTM F756:2013 |
| Material Mediated Pyrogenicity | ISO 10993-11:2006 |

# CONCLUSION:

The Surecan Safety II has met all established acceptance criteria for performance testing and design verification testing. Results of functional performance and biocompatibility testing conducted with the Surecan Safety II device along with the same indications for use, the same type of safety mechanism design, and similar technological characteristics demonstrate that the Surecan Safety II is as safe and as effective for its intended use and is substantially equivalent to the predicate device.