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510(k) Data Aggregation
(145 days)
With its "Polywave" LED with broadband spectrum, Bluephase PowerCure is suitable for the polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.
Bluephase® PowerCure is an LED curing light that produces blue light. It is used for the polymerization of light-curing dental materials immediately in the oral cavity of patients. The intended place of application is in the dental practice, medical practice or in the hospital by the dentist or dental assistant. The curing light must only be operated by trained dental personnel.
- The handpiece has the shape of a pen
- Operational notes: 4 programs (3s, Turbo, High, PreCure)
- Light source: Polywave LED
- Power Source: Li-lons batterv
Here's a breakdown of the acceptance criteria and study information for the Ivoclar Vivadent Bluephase PowerCure, based on the provided FDA 510(k) summary:
This device is not an AI/ML device, therefore some of the requested information (like expert readers, stand-alone performance, MRMC studies, or training set details) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications, safety standards, and functional equivalence for a non-AI medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Predicate) | Reported Device Performance (Bluephase PowerCure) |
|---|---|---|
| Indications for Use | Polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm, including restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays. | Polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm, including restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays. |
| Principles of Operation | Disinfect surfaces, check light irradiance, select curing program/time, start and automatic termination. | Disinfect surfaces, check light irradiance, select curing program/time, start and automatic termination. |
| Delivery Form Content | 1 Charging base, 1 Handpiece, 1 Light probe 10>8 mm, 1 Anti-glare shield, 3 Anti-glare cones, 1 Pack of sleeves, 1 Instructions for use. | 1 Charging base, 1 Handpiece, 1 Handpiece support, 1 Light guide 10>9 mm, 1 Anti-glare shield, 3 Anti-glare cones, 1 Instructions for Use. (Note: Sleeves in US delivery are typically separate, Handpiece support is new accessory, light guide diameter difference is non-significant). |
| Electrical Safety | Tested to IEC 60601-1:2005 and IEC 60601-1-2:2007. | Tested to IEC 60601-1:2012 and IEC 60601-1-2:2007. (Current version of standards met). |
| Operational Modes | 2 programs: Turbo (2,000 mW/cm²), High Power Program (1,200 mW/cm²). | 4 programs: 3s Cure Program (3,050 mW/cm²), Turbo program (2,100 mW/cm²), High power Program (1,200 mW/cm²), PreCure (preset to 2s)(950 mW/cm²). Key difference: Higher irradiance (3,050 mW/cm²) for shorter curing time. Comparable to Xtra Power Mode (3,200 mW/cm²) of reference device. |
| Storage Conditions | Temperature: -20 °C to + 60 °C /+4 °F to +140 °F; Relative humidity: 10% to 75%. | Temperature: -20 °C to + 60 °C /+4 °F to +140 °F; Relative humidity: 10% to 75%. |
| Infection Control | Recommended sterilization cycle for light probe in IFU; validated according to ISO 14937. | Recommended sterilization cycle for light probe in IFU; validated according to ISO 14937. |
| Biocompatibility | (Not explicitly stated for predicate in summary, but implied that direct contact with tissue is not intended, making ISO 10993-1 not applicable). | Direct contact with tissue is not intended; ISO 10993-1 not applicable. Toxicological statement of LED unit included. |
| Software Validation | (Not explicitly stated for predicate in summary, but assumed to meet similar standards). | Fully validated software/firmware meeting Design Specifications and following FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
Notes on "Reported Device Performance": For a 510(k) submission, "reported device performance" typically refers to how the new device matches or exceeds the performance characteristics of the predicate device, or meets relevant recognized standards. The summary indicates that the Bluephase PowerCure either has "no difference" or "conforms to the current version of the same standards" or offers an "innovation... with higher irradiance" but still achieves the same functional objective.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific test sets in this summary document.
- Data Provenance: The document does not specify country of origin for testing data. The "study" itself is a comparison to a predicate device and adherence to recognized standards. It's a regulatory submission, not a clinical trial with a "test set" in the traditional sense of patient data. The testing mentioned pertains to engineering, electrical safety, software, and sterilization validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a dental curing light, not a diagnostic device requiring expert interpretation of results, nor does it involve a "ground truth" derived from expert consensus in a clinical context. The "truth" is established by adherence to technical specifications and recognized standards.
4. Adjudication Method for the Test Set
- Not Applicable. See explanation above.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- Not Applicable. This device is an LED polymerization light and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device does not use an algorithm for diagnostic purposes. Its standalone performance is demonstrated by its physical and electrical specifications (e.g., light irradiance, wavelength, safety standards).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by:
- Technical Specifications: Measuring the irradiance, wavelength, and other physical properties to ensure they meet the design specifications and are suitable for the intended use (polymerization of dental materials).
- Compliance with Recognized Standards: Adherence to standards like IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility), and ISO 14937 (Sterilization).
- Functional Equivalence: Demonstrating that the device performs the same function as the legally marketed predicate device (Bluephase Style 20i) and reference device (VALO Grand Corded) in polymerizing dental materials.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See explanation above.
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