(174 days)
The CardioFocus Diode Laser System is intended for the delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue.
The CardioFocus Diode Laser Ablation System is a generator designed for the delivery of 980nm laser light and may be used in conjunction with surgical treatment for hemostasis, incision, ablation, coagulation and vaporization of tissue as required by the clinician. The instrument includes a diode laser module as the therapeutic energy source, as well as an internal thermal safety system for monitoring and disabling laser power output.
The provided text is a 510(k) summary for the CardioFocus Diode Laser System. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through demonstrating similar intended use, technology, and safety characteristics. It does NOT typically contain detailed clinical study data with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as you might find for a novel device or a Premarket Approval (PMA) application.
Therefore, many of the requested details about acceptance criteria and a "study that proves the device meets the acceptance criteria" are not present in this document. The document's primary "proof" is the demonstration of equivalence to legally marketed predicate devices, and adherence to recognized safety standards.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
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Acceptance Criteria: The document implies that the acceptance criteria for the CardioFocus Diode Laser System are that it is substantially equivalent to the predicate device (Ceralas Diode Laser System) and that its safety characteristics are assured through conformance with applicable U.S. and International standards. These are not quantitative performance metrics in the typical sense of accuracy, sensitivity, or specificity for a diagnostic device.
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Reported Device Performance: Instead of specific performance metrics, the document states: "Both devices output optical energy at similar power levels and similar wavelengths, have similar intended uses and provide for safety though conformance to recognized standards." And, "When used in accordance with the directions for use, by qualified personnel, the CardioFocus Diode Laser System is safe and effective, as indicated, for its intended use."
Acceptance Criteria (Implied) Reported Device Performance Substantial equivalence to predicate device "More similarities than differences" to predicate. Output optical energy at similar power levels and wavelengths. Similar intended uses. Conformance to applicable U.S. and International safety standards Conforms to UL 2601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 1000, and 21 CFR 1040.10/.11. Safe and effective for intended use "Safe and effective, as indicated, for its intended use."
Missing Information (Not provided in the 510(k) Summary):
The sections below require information typically found in clinical studies or performance validation reports, which are not detailed in a 510(k) summary for a device like this.
- 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. This type of information would be relevant for a clinical trial demonstrating efficacy, which is generally not required for a 510(k) for a surgical laser system if substantial equivalence can be shown through technological comparison and adherence to standards.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not provided. This implies a diagnostic or interpretive task that is not the primary focus of this laser system's 510(k) review.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided.
- 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 provided. This is not an AI-assisted diagnostic device, so an MRMC study is not applicable.
- 6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not provided. This is not an algorithmic device in the diagnostic sense.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided.
- 8. The sample size for the training set
- Not provided. No "training set" in the machine learning sense is described.
- 9. How the ground truth for the training set was established
- Not provided.
Study that Proves the Device Meets the Acceptance Criteria:
The "study" presented in this 510(k) summary is a comparative analysis of the CardioFocus Diode Laser System against legally marketed predicate devices, primarily the CeramOptec Ceralas D25 Fiber-Coupled Diode Laser System.
Key elements of this "study" (as presented):
- Objective: To demonstrate substantial equivalence of the CardioFocus Diode Laser System to predicate devices.
- Methodology:
- Comparison of Technical Characteristics: The document outlines the general description, device characteristics (e.g., power levels, wavelength), and technical characteristics (e.g., system controller, thermal safety system, optics module, user interface, foot switch, diode driver, diode module, power supply) of the CardioFocus system.
- Predicate Device Identification: The Ceralas Diode Laser System (K001975) is identified as the primary predicate.
- Comparison Points for Substantial Equivalence:
- Intended Use: Both devices are for "delivery of 980nm laser light to soft tissue in contact or noncontact mode during surgical procedures including via endoscopes, introducers or catheters. Indications include the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue." (Identical wording).
- Technology & Theory of Operation: Both devices use diode laser technology. "Both the predicate devices use the same technology and theory of operation."
- Power Levels & Wavelengths: "Both devices output optical energy at similar power levels and similar wavelengths." Specifics provided are 30W and 60W models for CardioFocus, and "three configurations for different power levels" for Ceralas. Both use 980nm wavelength.
- Safety Standards Conformance: The CardioFocus device's safety is assured through conformance with several recognized U.S. and International standards (UL 2601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, IEC 1000, 21 CFR 1040.10/.11). The predicate device is also stated to conform to recognized standards.
- Results/Conclusion:
- "There are more similarities than differences between the predicate device and the CardioFocus Diode laser System."
- "Both devices output optical energy at similar power levels and similar wavelengths, have similar intended uses and provide for safety though conformance to recognized standards."
- The FDA's decision letter (K013201) confirms the finding of "substantial equivalence (for the indications for use stated in the enclosure) to legally marketed predicate devices."
The 510(k) submission itself serves as the "study" demonstrating that the device meets the implicit acceptance criteria of substantial equivalence and safety through standard adherence. No separate clinical trial with specific performance metrics, ground truth, or expert review is detailed for this type of submission.
§ 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.