(447 days)
The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:
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The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, troughing, and removal of inflamed edematous tissue.
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Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
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Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
This submission (K181601) is for a labeling change to the previously cleared Precise SHP Diode Laser (K123443). The key change is that the disposable applicator tips will now be delivered non-sterile, and the end-user will be responsible for sterilization. Therefore, the "device performance" in terms of clinical efficacy of the laser itself is not re-evaluated or specifically measured against acceptance criteria in this document. The focus of the "study" described here is to demonstrate that the new labeling and the end-user sterilization process do not negatively impact safety or effectiveness.
Here's an analysis based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
Since this is a labeling change and not a re-evaluation of the laser's primary performance, the "acceptance criteria" are related to the safety and efficacy of the sterilization process for the tips and the laser's continued compliance with safety standards.
| Acceptance Criteria (for non-sterile tips & user sterilization) | Reported Device Performance |
|---|---|
| End-User Sterilization Efficacy: Achieve a Log 6 reduction in bioburden for the tips when treated with an approved liquid chemical sterilant. | Verification and validation testing indicate treatment with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden. |
| Tip Performance post-sterilization: Sterilization process does not adversely impact the performance or specifications of the tip. | Verification and validation testing show that treatment with the sterilant does not adversely impact the performance or specifications of the tip. |
| Residual Sterilant Removal: Adequate removal of residual sterilant from the tip after treatment. | Verification tests show that rinsing the tips after treatment with the sterilant adequately removes residual sterilant from the tip. |
| Electrical Safety & EMC Compliance: Device continues to comply with relevant electrical safety and electromagnetic compatibility standards. | The Precise SHP Diode Laser is designed to comply with ... 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated June 24, 2007. The device also complies with the recognized standards of IEC 60601-2-22 Edition 3 and IEC 60825-1 Edition 2. The device is designed in compliance to the entirety of IEC 60601-1: 30 Edition, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-1-6. (This part refers to the overall device design, and the labeling change did not alter this performance.) |
| Biocompatibility: No increased risks from materials used. | Risk assessment activities demonstrate that presenting the single-use tips to the end-user in a non-sterile state does not introduce any increased risks or concerns so long as provided instructions for use are followed relative to processing the tips by the end-user prior to use. (This implies that the materials remain biocompatible as per prior clearance and the user sterilization doesn't change this.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size for the "verification and validation testing" performed on the tips for sterilization efficacy or performance. It simply states "Verification and validation testing indicate..."
- Data Provenance: Not specified. The document outlines a submission to the US FDA by a US-based company (CAO Group, Inc., West Jordan, Utah, U.S.A.). However, the location/country where the testing was performed is not mentioned, nor is it explicitly stated if the data is retrospective or prospective, though it would logically be prospective testing conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns a labeling change and the effect of end-user sterilization on a device component. It does not involve establishing ground truth based on expert clinical or radiological reviews. The "ground truth" here is objective laboratory testing against established sterilization standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in studies involving human interpretation or decision-making (e.g., image reading). The testing performed here (sterilization efficacy) is objective laboratory testing.
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 document does not describe an MRMC study or any AI component.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This document does not describe any algorithm or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the sterilization efficacy testing would be objective laboratory standards for sterilization, specifically achieving a Log 6 reduction in bioburden, as measured by standard microbiological assays. For tip performance, it would be instrumental measurements against predefined performance specifications.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning study.
9. How the ground truth for the training set was established
Not applicable. There is no "training set."
§ 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.