(29 days)
The Pellevé Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cable. The device is activated using a hand or footswitch based on user preference and is used with the Ellman radiofrequency generators labeled for the treatment of wrinkles and rhytides. The radiofrequency generator operates 4 mHz and is used in the CUT or PELLEVE mode for non-ablative wrinkle treatments.
This set of documents describes a 510(k) submission for the Pellevé Non-Ablative Wrinkle Treatment System, seeking to amend its indications for use. It is a modification of an already cleared device, not a new device, and therefore the application does not contain a study to prove acceptance criteria. Instead, it argues for substantial equivalence based on the technological characteristics and intended use.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not provide specific acceptance criteria or performance metrics for a new study. The rationale is based on the system's inherent properties (RF energy interaction with tissue) and equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new test set data was submitted as part of this 510(k) modification.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No new test set data or ground truth establishment was conducted for this submission.
4. Adjudication Method
Not applicable. No new test set data requiring adjudication was submitted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission is for an amendment to indications for use based on existing technology, not for a comparative effectiveness study involving human readers and AI.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is an electrosurgical system, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable. No new ground truth was established for this submission. The rationale relies on the scientific understanding of radiofrequency energy's interaction with tissue as the basis for expanding the indications for use.
8. Sample Size for the Training Set
Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/algorithm device that requires a training set.
Summary of the Submission and Rationale:
The Pellevé Non-Ablative Wrinkle Treatment System was previously cleared for "Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV." This 510(k) submission (K132665) seeks to amend the indication to: "Non-ablative treatment of mild to moderate facial wrinkles and rhytids."
The key change is the removal of the specific mention of "skin phototypes I-IV." The rationale provided is that the system utilizes radiofrequency (RF) energy, and RF interaction with tissue is based on impedance rather than melanin. Therefore, skin phototype does not affect RF treatments.
The applicant asserts that the device has the same technological characteristics as the predicate device and that the modifications for use raise no new issues of safety or effectiveness. Based on this, the FDA determined the device to be substantially equivalent to its predicate.
In essence, no new studies or performance data were submitted because the change was based on a well-established understanding of how RF energy interacts with skin, making the previous limitation on skin phototypes I-IV unnecessary and scientifically unfounded for this type of technology.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.