(129 days)
BC-5 Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
BC-5 Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
BC-5 Red and Blue light in combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
BC-5 Red and Infrared light in combination is intended to emit energy in the red and infrared region of the spectrum to treat dermatological conditions, specifically indicated to treat periorbital wrinkles.
BC-5 Infrared is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
BC-5 is a light-based photobiomodulation system intended for performing non-invasive, low-level light therapy (LLT). It is used to deliver visible light wavelengths to treat dermatological conditions or to apply near infrared to the skin for topical heating.
BC-5 is a transportable, vertical system with an attached, four-panel treatment head that is manually adjusted to an appropriate distance above the patient's skin. The device does not contact the patient.
System components include a mains-powered control unit with touch-input control panel and microprocessor circuit; adjustable treatment head; and base with casters for transportability. An autolift pole connects the treatment head to the top of the main unit. An emergency stop switch allows the user to quickly shut the system down.
The technological heart of the system is RGB-IR chips (red-green-blue-near infrared). The user can select from the following five different programs, depending on type of dermatological condition and desired electromagnetic wavelength or combination of wavelengths: red, blue, red and blue, red and infrared. The first four are intended to treat skin conditions, while the fifth is intended for topical heating indications.
The entire system is reusable and is cleaned before each use.
The provided document is a 510(k) summary for the BC-5 device, a light-based photobiomodulation system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Lightwave Professional Deluxe) through comparison of features and non-clinical bench testing. It does not present clinical study data for device performance against specific acceptance criteria related to its stated indications for use (e.g., treatment of acne, wrinkles, pain relief).
Therefore, I cannot directly answer your request for acceptance criteria and a study proving the device meets those criteria with specific performance numbers, sample sizes, expert involvement, or MRMC studies, as this information is not contained within the provided 510(k) summary.
The document discusses non-clinical bench testing to demonstrate the device's safety and performance with respect to electrical safety, EMC, risk management, software, non-laser light, and usability engineering. These are tests to ensure the device itself is safe and functions as designed, not clinical efficacy trials.
Here's an attempt to structure the information based on your request, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria presented in this document are primarily related to substantial equivalence to a predicate device and adherence to non-clinical safety and performance standards, rather than clinical efficacy metrics for the specified dermatological and pain relief indications.
| Acceptance Criteria Category (from document) | Specific Standard/Test | Reported Device Performance and Determination |
|---|---|---|
| Biocompatibility | ISO 10993-1 | No testing required (does not touch patient) - Met |
| Software Validation | IEC 62304:2006 + A1:2015; SW Function Validation Tests | Passed - Met |
| Risk Management | EN ISO 14971:2012 | Passed - Met |
| Electrical Safety | IEC 60601-1:2005 +C1:2006+C2:2007+A1:2012 | Passed - Met |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2:2014 | Passed - Met |
| Usability | IEC 62366-1:2015 | Passed - Met |
| Mechanical Safety/Non-Laser Light Equipment | IEC 60601-2-57:2011 | Passed - Met |
| Label Symbols | ISO 15223:2012 | Met |
| Software Verification & Validation (Guidance) | FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005) | Performed, reports included. SW considered "minor level of concern." - Met |
Important Note: This table reflects the engineering and safety performance criteria for device clearance via 510(k), not clinical efficacy outcomes for treating medical conditions. The document asserts that the device is substantially equivalent to a predicate device which already has established clinical indications, implying that similar clinical performance is expected. No new clinical studies are presented to prove the BC-5's efficacy against its indications.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "tests" described are non-clinical bench tests (e.g., electrical safety, EMC), not clinical trials involving patient data.
- Data Provenance: Not applicable for clinical study data. The data provenance discussed relates to compliance with international standards for device manufacturing and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for the type of testing presented. Ground truth in this context refers to established engineering standards (e.g., IEC, ISO) and the device's performance against these standards. The experts involved would be engineers and quality assurance professionals performing and reviewing the bench tests.
4. Adjudication Method for the Test Set
Not applicable, as there are no clinical results needing adjudication. The testing involved passing/failing against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a type of clinical study typically used for diagnostic devices to assess the performance of human readers with and without AI assistance. This document describes a therapeutic device and no such clinical study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The BC-5 is a physical medical device (light therapy system), not an algorithm or software-only diagnostic tool.
7. The Type of Ground Truth Used
The "ground truth" for the substantial equivalence claim is based on:
- Predicate Device Equivalence: The legally marketed Lightwave Professional Deluxe (K082586) and its established indications and performance.
- Compliance with Recognized Standards: International standards for medical device safety, electrical performance, software, risk management, and usability (e.g., IEC 60601-series, ISO 14971, IEC 62304, IEC 62366).
- Physical and Technical Characteristics Comparison: Demonstrating that the BC-5's specifications (wavelengths, dose ranges, dimensions, power, etc.) are comparable or do not raise new safety/effectiveness concerns compared to the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI algorithm submission requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.