(221 days)
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.
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.
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
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.
The provided document describes the Surecan Safety II, a power-injectable safety non-coring needle. The document states that the device has met all established acceptance criteria for performance testing and design verification testing. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted. For most of these, the "reported device performance" is implicitly that the device met the criteria, as stated in the "CONCLUSION" section: "The Surecan Safety II has met all established acceptance criteria for performance testing and design verification testing." Specific quantitative values for acceptance criteria or performance numbers are generally not provided in this summary, but rather the type of test and the standard referenced.
| Test Performed | Standard / Guidance Referenced | Reported Device Performance |
|---|---|---|
| Wing Flexibility | Verify whether wings are able to withstand bending without cracking | Met acceptance criteria (implicitly, as per conclusion) |
| Penetration Force | NF S 94-370 French Standard, Surgical Implants, implantable catheter chambers, intravenous, intra arterial, intraperitoneal, intrathecal and epidural use | Met acceptance criteria (implicitly, as per conclusion) |
| Coring Testing | ASTM F3212-16: Standard test method for coring testing of Huber needles | Met acceptance criteria (implicitly, as per conclusion) |
| Freedom from flow rate blockage | Verify when the set is subjected to 0.2 bar of air pressure and submerged underwater that the needle's flow path is not blocked. | Met acceptance criteria (implicitly, as per conclusion) |
| Freedom from leakage | Verify that no part of the set leaks when connected to 150kPa of water pressure for 15 minutes (JIS T3221:2011 Single use needle for infusion port) | Met acceptance criteria (implicitly, as per conclusion) |
| Joint integrity | Verify all joint connections can withstand 15N of pull for 15 seconds (JIS T3221:2011 Single use needle for infusion port) | Met acceptance criteria (implicitly, as per conclusion) |
| 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; FDA Guidance Medical Devices with Sharps Injury Prevention Features, Issued August 9, 2005 | Met acceptance criteria (implicitly, as per conclusion) |
| Cannula Function | ISO 9626:1991 Stainless steel needle tubing for manufacture of medical devices; 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) | Met acceptance criteria (implicitly, as per conclusion) |
| Ability to withstand power injection pressures | Watertight and resistant to high pressure 22.4 bars (325 psi) | Met acceptance criteria (implicitly, as per conclusion) |
| Ability to function with associated device | ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings | Met acceptance criteria (implicitly, as per conclusion) |
| Power Injection Flow rate | Confirm Maximum flow rates with a power injector are equivalent to predicate device | Met acceptance criteria; 19, 20 gauge – 5mL/s, 22 gauge - 2 mL/s |
| MRI Compatibility | ASTM F2182-09 Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging; ASTM F2052-06 Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment; ASTM 2119-07 Standard test method for evaluation of MR image artifacts from passive implants; ASTM 2213-06 R11 Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment | Met acceptance criteria (implicitly, as per conclusion) |
| Chemical Compatibility | ISO 10993-18:2005 Biological evaluation of medical devices – Part 18 Chemical characterization of materials; ISO 8536-4:2010 Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed | Met acceptance criteria (implicitly, as per conclusion) |
| Simulated Use Study | FDA Guidance Medical Devices with Sharps Injury Prevention Features, Issued August 9, 2005 | Met acceptance criteria (implicitly, as per conclusion) |
| Sterilization | ISO 11135-1:2007 and ISO 11135:2014 Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices | Met acceptance criteria (implicitly, as per conclusion) |
| Biocompatibility (Cytotoxicity, Sensitization, | ISO 10993-5:2009; ISO 10993-10:2010; ISO 10993-11:2006; ISO 10993-4:2002 and 2006 and ASTM F756:2013 | Met acceptance criteria (implicitly, as per conclusion) |
| Intracutaneous Reactivity, Systemic Toxicity | ||
| (Acute and Subchronic), Hemocompatibility, | ||
| Material Mediated Pyrogenicity) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each performance test. It only lists the types of tests performed. The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These are typical of a device rather than software premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The tests performed are engineering and biocompatibility tests on a physical device, not related to medical image analysis or clinical interpretation needing expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The tests are objective measurements and evaluations against established standards, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or similar AI applications, not for a physical medical device like a hypodermic needle.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, this is not applicable. The device is a physical medical device, not an algorithm. Performance tests directly evaluated the physical characteristics and safety features of the device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance tests are the established standards and specifications for various physical and biological properties. For example, for "Freedom from leakage," the ground truth is "no part of the set leaks when connected to 150kPa of water pressure for 15 minutes." For biocompatibility, the ground truth refers to the acceptance criteria within the referenced ISO standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As stated above, there is no "training set" for this type of device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500 |
| Contact: Angela J. CaravellaSr. Regulatory Affairs Specialist | |
| Phone: (610) 596-2966 | |
| Fax: (610) 266-4962 | |
| E-mail: angela.caravella@bbraun.com | |
| DEVICE NAME: | Surecan Safety II |
| COMMON OR USUALNAME: | Intravascular Administration Set |
| CLASSIFICATION: | Class II, Product Code PTI, 880.5570 |
| PREDICATE DEVICE: | SafeStep MAX Power-Injectable Infusion Set, SpecializedHealth Products International Inc., K073050, Class II, FPA,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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T
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 DeviceSurecan Safety II | Predicate Device(K073050) SafeStep MAX Power-Injectable Infusion Set | |
| IntendedUse | Access surgically implantedvascular ports for the infusion offluids, drugs, and blood sampling. | Access surgically implanted vascularports for the infusion of fluids, drugs, andblood sampling. |
| Indicationsfor Use | The Surecan Safety II power-injectable safety non-coringneedle is a device intended forinsertion into the septum of asubcutaneously implanted port forthe infusion of fluids and drugs,as well as blood sampling throughthe port. The Surecan Safety IIsafety feature is manuallyactivated during needle removal,and is designed to aid in theprevention of accidental needle-sticks. When used with ports thatare indicated for power injectionof contrast media into the centralvenous system, the SurecanSafety II needle is also indicatedfor power injection of contrastmedia.For power injection of contrastmedia, the maximum flow rates at325 psi are 5mL/s for 19 gaugeand 20 gauge needles and 2mL/sfor the 22 gauge needles. | The SafeStep MAX Power-InjectableInfusion Set device is an intravascularadministration set with a non-coring rightangle needle and manually activatedneedlestick prevention safety mechanismwhich reduces the risk of accidentalneedlestick injuries by shielding theneedle. The device is used to accesssurgically implanted vascular ports.The SafeStep MAX Power-InjectableInfusion Set is indicated for use in theadministration of fluids and drugs, aswell as blood sampling throughsurgically implanted vascular ports.When used with ports that are indicatedfor power injection of contrast media intothe central venous system, the SafeStepMAX Power-Injectable Infusion Set isalso indicated for power injection ofcontrast media. For power injection ofcontrast media, the maximumrecommended infusion rate is 5mL/s for19 gauge and 20 gauge needles, and2mL/s for 22 gauge needles. |
| Comparison of Surecan Safety II Device with Predicate Device | ||
| Proposed DeviceSurecan Safety II | Predicate Device(K073050) SafeStep MAX Power-Injectable Infusion Set | |
| SafetyMechanismDesign | Manually activated safetymechanism upon removal of theneedle from the implantedvascular port.Safety mechanism locks needleinto place when a firm stop is felt.A green dot appears on the clearbottom plate when safetymechanism is fully engaged. | Manually activated safety mechanismupon removal of the needle from theimplanted vascular port.Safety mechanism locks needle intoplace when a firm stop is felt. |
| Is theengagementof the safetymechanismvisible tothe user? | Yes, green dot appears withsuccessful deployment of safetymechanism | No, tactile confirmation only |
| Do any setscontain anInjectionSite / LuerAccessDevice? | Yes | Yes |
| Needlebevel design | Non-coring angled needle | Non-coring Huber right angle needle |
| Needle sizes | 19 gauge20 gauge22 gauge | 19 gauge20 gauge22 gauge |
| PrimingVolume | 19 ga (without Caresite) - 0.32mL20 ga (without Caresite - 0.24mL22 ga (without Caresite - 0.18mL19 ga (with Caresite) - 0.62mL20 ga (with Caresite) -0.53 mL22 ga (with Caresite) -0.46 mL | Unknown |
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| Comparison of Surecan Safety II Device with Predicate Device | ||||
|---|---|---|---|---|
| Proposed DeviceSurecan Safety II | Predicate Device(K073050) SafeStep MAX Power-Injectable Infusion Set | |||
| Gauge Size | Needle Length(inches) | Gauge Size* | Needle Length(inches)* | |
| Needlelength | 19 (without a y-injection site) | 0.5, 0.6, 0.8,1.0, 1.3, 1.5 | 19 (without a y-injection site) | 0.5, 0.75, 1.0, 1.5 |
| 20 (without a y-injection site) | 0.5, 0.6, 0.8,1.0, 1.3, 1.5 | 20 (without a y-injection site) | 0.5, 0.75, 1.0, 1.5 | |
| 22 (without a y-injection site) | 0.5, 0.6, 0.8,1.0, 1.3 | 22 (without a y-injection site) | 0.5, 0.75, 1.0, 1.5 | |
| 19 (with y-injection siteand Caresite) | 0.5, 0.6, 0.8,1.0, 1.3, 1.5 | 19 (with y-injectionsite and needlelessinjection cap) | 0.5, 0.75, 1.0, 1.5 | |
| 20 (with y-injection siteand Caresite | 0.5, 0.6, 0.8,1.0, 1.3 | 20 (with y-injectionsite and needlelessinjection cap) | 0.5, 0.75, 1.0, 1.5 | |
| 22 (with y-injection siteand Caresite | 0.5, 0.6, 0.8,1.0 | 22 (with y-injectionsite and needlelessinjection cap) | 0.5, 0.75, 1.0, 1.5 | |
| Availablefor use withcontrastmedia? | Yes | Yes | ||
| Flow rateswithcontrastmedia | 19, 20 gauge – 5mL/s | 19, 20 gauge - 5mL/s | ||
| 22 gauge - 2 mL/s | 22 gauge - 2 mL/s | |||
| Does thedevice havewings? | Yes | No, contains a grip as part of the handle | ||
| Sterilizationmethod | Ethylene Oxide | Irradiation* | ||
| SAL | 10-6 | Unknown | ||
| Shelf Life | 5 years for sets without a Caresite3 years for sets with a Caresite | Unknown |
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| Comparison of Surecan Safety II Device with Predicate Device | ||
|---|---|---|
| Proposed DeviceSurecan Safety II | Predicate Device(K073050) SafeStep MAX Power-Injectable Infusion Set | |
| Number ofUses | 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(where applicable) |
|---|---|
| Wing Flexibility | Verify whether wings are able towithstand bending without cracking |
| Penetration Force | NF S 94-370 French Standard, SurgicalImplants, implantable catheter chambers,intravenous, intra arterial,intraperitoneal, intrathecal and epiduraluse |
| Coring Testing | ASTM F3212-16: Standard test methodfor coring testing of Huber needles |
| Freedom from flow rate blockage | Verify when the set is subjected to 0.2 barof air pressure and submerged underwaterthat the needle's flow path is not blocked. |
| Freedom from leakage | Verify that no part of the set leaks whenconnected to 150kPa of water pressure for15 minutes (JIS T3221:2011 Single useneedle for infusion port) |
| Test Performed | Standard / Guidance referenced(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 samplingFDA 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- 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 imagingASTM F2052-06 Standard test method for measurement of magnetically induced displacement force on medical devices in |
| Test Performed | Standard / Guidance referenced(where applicable) |
| the magnetic resonance environment | |
| ASTM 2119-07 Standard test method forevaluation of MR image artifacts frompassive implants | |
| ASTM 2213-06 R11 Standard testmethod for measurement of magneticallyinduced torque on medical devices in themagnetic resonance environment | |
| Chemical Compatibility | ISO 10993-18:2005 Biological evaluationof medical devices – Part 18 Chemicalcharacterization of materials |
| ISO 8536-4:2010 Infusion equipment formedical use – Part 4: Infusion sets forsingle use, gravity feed | |
| Simulated Use Study | FDA Guidance Medical Devices withSharps Injury Prevention Features, IssuedAugust 9, 2005 |
| Sterilization | ISO 11135-1:2007 and ISO 11135:2014Sterilization of health care products –Ethylene oxide – Requirements fordevelopment, validation and routinecontrol of a sterilization process formedical 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 andSubchronic) | 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.
§ 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).