(126 days)
The Zeltig System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
Zeltiq Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.
The Zeltig System is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered or pulsatile vacuum massage and an optional paging device.
The provided FDA 510(k) summary for the Zeltiq System (K090094) indicates that the device's acceptance criteria and performance data are primarily based on demonstrating substantial equivalence to a predicate device, the Zeltiq CLN1 Dermal Cooling Device (K080118).
Here's an breakdown of the information requested based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The Zeltiq System must be functionally equivalent to the Zeltiq CLN1 Dermal Cooling Device (K080118). This inherently implies meeting the predicate device's established performance in terms of cooling, heating, and massage capabilities. | "Testing confirms that the Zeltiq System can be used in an equivalent manner to the predicate device." "A technological comparison and bench testing demonstrate that the Zeltiq System is functionally equivalent to the predicate device." |
| Same Intended Use as Predicate Device: The Zeltiq System's intended use must be the same as that of the predicate device. | "The indications for use for the Zeltiq System are the same as for the predicate device cited in this application." |
| Same Mechanism of Action as Predicate Device: The Zeltiq System must employ the same mechanism of action as the predicate device. | "The Zeltiq System has the same intended use and mechanism of action to the Zeltiq CLN1 Dermal Cooling Device (K080118)." |
Note: This submission primarily relies on demonstrating equivalence rather than establishing new, specific performance metrics or thresholds for the device's acceptance. The details of the "testing" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify any sample size for a test set (e.g., in a clinical trial) or the data provenance (country of origin, retrospective/prospective). The document refers to "bench testing" and "technological comparison" but does not elaborate on clinical studies with human subjects for independent performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided 510(k) summary does not mention the use of experts to establish ground truth for a test set. The evaluation focuses on equivalence through "bench testing" and "technological comparison."
4. Adjudication Method for the Test Set
The provided 510(k) summary does not describe any adjudication method for a test set, as it does not detail clinical testing involving interpretation or assessment that would require such a method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The provided 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to a predicate device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the device itself is a standalone system (not an AI algorithm), the performance data provided refers to "bench testing" and "technological comparison" to the predicate device. This implies a standalone (device-only) evaluation was performed to confirm its functional and technical characteristics, but not in the context of an "algorithm only" as typically understood for AI/software devices. The entire submission is about the device's technical capabilities and equivalence.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is implicitly the performance and functional characteristics of the predicate device (Zeltiq CLN1 Dermal Cooling Device, K080118). The new device's ability to perform in an "equivalent manner" based on "bench testing" and "technological comparison" serves as the basis for its substantial equivalence. There is no mention of pathology, expert consensus, or outcomes data as typical "ground truth" in the context of diagnostic or interpretive devices.
8. The Sample Size for the Training Set
The provided 510(k) summary does not mention a training set sample size. This type of submission, for a physical device rather than an AI algorithm, does not typically involve training sets in the same way.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the document, there is no information on how its ground truth might have been established.
§ 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.