(72 days)
The Cutera CMMCD optional infrared/RF device is indicated for the relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation. The Cutera CMMCD massage device is indicated for the temporary improvement in the appearance of cellulite.
The Cutera CMMCD infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The Cutera CMMCD massage device is intended to provide a temporary reduction in the appearance of cellulite.
The Cutera CMMCD treatment consists a massage device and an infrared light(optional)/RF device. Topical heating for the purpose of elevating tissue temperature is derived from conducted RF energy/optional infrared light. Mechanical manipulation is derived from a vacuum assisted massage with rollers. The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied.
This 510(k) submission for the Cutera CMMCD (K092195) is a Special 510(k), which indicates that it is a modification to a previously cleared device. Special 510(k)s typically do not require new clinical studies if the changes do not affect the fundamental scientific technology or intended use. Instead, they rely on demonstrating that the performance and technical specification changes fall within FDA regulations for such modifications and that the modified device is substantially equivalent to predicate devices.
Therefore, the provided document does not contain a detailed study with acceptance criteria, sample sizes, ground truth establishment, or human reader performance data as would be found in a traditional 510(k) or PMA for an entirely new device or a significant change in indications. The core of this submission is a declaration of substantial equivalence based on the nature of the modifications.
Here's a breakdown based on the information available, and what cannot be answered from this specific document:
1. Table of Acceptance Criteria and Reported Device Performance:
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Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "acceptance criteria" for a Special 510(k) primarily revolve around the device's technical specifications and safety profile remaining within acceptable bounds given the modifications, and demonstrating substantial equivalence to predicate devices. The implicit acceptance criterion is that the modified device performs as safely and effectively as its predicate and the original device, for the stated indications.
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Reported Device Performance: The document states:
- "The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied."
- The device is indicated for "relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation" (for the optional infrared/RF device) and "temporary improvement in the appearance of cellulite" (for the massage device).
Since this is a Special 510(k) for modifications, these performance claims are likely based on the performance demonstrated by the original device and the predicate devices, rather than new performance data for these specific modifications.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided: This document does not describe a new clinical study with a test set. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) is not available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable / Not Provided: As no new clinical study test set is described, there's no mention of experts used for ground truth.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided: No test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No: This document does not mention an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study was Done:
- No: This device is a physical medical device (massage and RF/infrared) and does not involve an algorithm in the AI/standalone software sense. Therefore, this is not applicable.
7. The Type of Ground Truth Used:
- Not Applicable / Not Provided: No new clinical study requiring ground truth establishment is described. The "ground truth" for the device's indications (e.g., temporary improvement in cellulite) would have been established through previous clinical studies for the original device and its predicates, usually involving clinical assessments, patient reported outcomes, and potentially photographic documentation.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided: As there is no AI algorithm involved, there is no training set in this context.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Not Provided: No AI algorithm or training set.
Summary for K092195 (Cutera CMMCD):
This submission is a Special 510(k) for modifications to an existing device. It establishes substantial equivalence by demonstrating that the changes do not raise new questions of safety or effectiveness, and that the device's performance and technical specifications align with its predicate. It does not present new clinical study data with explicit acceptance criteria, performance metrics, sample sizes, or ground truth establishment based on a new study for the modified device. The performance claims listed are based on the cleared indications for the original device and predicate devices.
§ 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.