Search Results
Found 1 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
Page 1 of 1