(115 days)
Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.
Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and mav be used to reach and cross a target lesion.
The Sunmed Guide Wires are available in three versions with a variety of tips:
Stainless steel guide wire Hydrophilic coated quide wire PTFE (Teflon®) coated guide wires
The Seldinger technique is used with these quidewires.
The stainless steel guide wires are standard wires with various tip configurations. The guide wire construction consists of a safety wire, a core wire, and a wound spring for flexibility. The features that distinguish individual wires consist of the core type (fixed or moveable), a straight or "J" tip configuration, diameters and lengths.
The Hydrophilic coated guide wires are constructed from the stainless steel core wire, with varying core lengths and diameters for each design.
The PTFE (Teflon®) coated guide wires are also manufactured from stainless steel wire, with PTFE (Teflon®) coating, or Benzalkonium Heparin (BH) coating applied over the PTFE (Teflon®) coating.
These guide wires are radiodetectable and fluoroscopy may be used to confirm position.
These medical devices are single use and supplied sterile by EQ.
The Sunny Medical Device (Shenzhen) Co., Ltd. (K120119) describes the performance testing and technological characteristics of its Sunmed Guide Wires to establish substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a direct table format. Instead, it lists various tests performed and states that the device was found to have "identical technological characteristics and to be equivalent" to the predicate devices. This implies that the acceptance criteria for each test were met sufficiently to demonstrate equivalence.
Here's a breakdown of the tests performed, which inherently serve as the areas where the device needed to perform comparably to its predicates:
| Acceptance Criteria (Inferred from Tests) | Reported Device Performance (Summary Statement) |
|---|---|
| Degradation Test on Disposable Guide Wire | "found to have identical technological characteristics and to be equivalent" |
| Physical Performance (General) | "found to have identical technological characteristics and to be equivalent" |
| Appearance | "found to have identical technological characteristics and to be equivalent" |
| Radiodetectability | "found to have identical technological characteristics and to be equivalent" |
| Eroding Resistance | "found to have identical technological characteristics and to be equivalent" |
| Breakage Resistance | "found to have identical technological characteristics and to be equivalent" |
| Deformation Resistance | "found to have identical technological characteristics and to be equivalent" |
| Connection Strength | "found to have identical technological characteristics and to be equivalent" |
| Package Performance | "found to have identical technological characteristics and to be equivalent" |
| Sterility | "found to have identical technological characteristics and to be equivalent" |
| ETO Residue | "found to have identical technological characteristics and to be equivalent" |
| ECH Residue | "found to have identical technological characteristics and to be equivalent" |
| Indications for Use (Match) | "identical technological characteristics" and "equivalent" |
| Target Population (Match) | "identical technological characteristics" and "equivalent" |
| Design Technique (Match) | "identical technological characteristics" and "equivalent" |
| Biocompatibility (Match) | "identical technological characteristics" and "equivalent" |
| Anatomical Sites (Match) | "identical technological characteristics" and "equivalent" |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the "Performance Testing." It broadly lists the types of tests conducted. As this is a 510(k) submission for a Class II medical device, the studies would primarily be bench and material testing rather than clinical trials with human subjects. The data provenance is not specified, but it's assumed to be from internal testing conducted by Sunny Medical Device (Shenzhen) Co., Ltd. or its contracted laboratories, likely in China (given the company's address). The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable in the context of this 510(k) submission. The performance testing described consists of objective, quantifiable physical and chemical tests (e.g., degradation, resistance, sterility) rather than diagnostic accuracy studies requiring expert interpretation of results to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the tests are objective and do not involve human interpretation or adjudication for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. These types of studies are typically for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Sunmed Guide Wires are interventional devices, and their evaluation focuses on physical and material properties, not diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or an AI-enabled device. Its performance is hardware-based and evaluated through physical and chemical testing.
7. Type of Ground Truth Used:
The "ground truth" for the performance tests would be defined by established engineering standards, material specifications, and regulatory requirements for guide wires. For example:
- Physical Performance: Mechanical properties (e.g., tensile strength, flexibility, lubricity) would be compared against predetermined specifications or the properties of the predicate devices.
- Sterility: Absence of viable microorganisms, confirmed by validated sterilization methods and sterility testing.
- Chemical Residues: Levels of ETO and ECH residues within acceptable regulatory limits.
- Biocompatibility: Demonstrated compliance with ISO 10993 standards.
The comparison is primarily against the performance of the legally marketed predicate devices, K993000 (Bard Hydrophilic Coated Guide Wires) and K082094 (PTFE (Teflon) Coated Guide Wires), as well as pre-amendment devices for the stainless steel versions. The statement "found to have identical technological characteristics and to be equivalent" suggests that the Sunmed Guide Wires met or exceeded the performance characteristics of these predicates.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as above.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.