(107 days)
The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cord. The electrode is spring mounted into the handle. All materials used in the manufacture of the device are suitable for the use in the device and are the same materials used in the predicate product. As with the predicated device, the device is activated using a hand or footswitch based on user preference and is intended for use with the Ellman Radio-Frequency generators (K082834) labeled for the treatment of wrinkles and rhytides.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
This 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices. It does not contain detailed information about specific acceptance criteria, comprehensive performance outcomes, or a dedicated clinical study report in the way one might expect for a novel device undergoing extensive clinical trials. The provided document is a regulatory submission demonstrating similar safety and effectiveness to already cleared devices.
Given the nature of the document, much of the requested information about a specific "study proving acceptance criteria" is either not explicitly stated or not applicable in the context of a substantial equivalence claim for a minor technological improvement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Safety: Device materials suitable for use | All materials suitable for use (same as predicate). Device functioned as intended. |
| Safety: Device functions as intended | Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System functioned as intended and in conformance with anticipated results. |
| Effectiveness: Same intended use as predicate devices | Same indication for use as predicate: non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV. |
| Technological Characteristics: Similar to predicate devices | Same technological characteristics and principles of operation as predicate device, with minor improvements not altering fundamental scientific technology. |
| Performance: Meets required specifications | All appropriate testing performed and all components, subassemblies, and/or full devices met required specifications. |
Explanation: The document emphasizes substantial equivalence, meaning the acceptance criteria are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, sharing similar indications for use and technological principles. Specific quantitative acceptance thresholds (e.g., "90% reduction in wrinkles") and their corresponding measured performance are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on a specific "test set" sample size or data provenance (country of origin, retrospective/prospective). It only states that "All appropriate testing has been performed." For substantial equivalence based on minor technological changes, the testing might have been limited to engineering, bench, and potentially animal testing, rather than a large-scale human clinical trial with a defined "test set" for performance evaluation in the usual sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided 510(k) summary. The document does not describe a clinical study that required expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not available in the provided 510(k) summary. Given the absence of a described clinical test set, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done/described in this 510(k) summary. This type of study is not relevant for a non-AI, energy-based medical device like the Pellevé GlideSafe™ System.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done/described. This device is not an AI algorithm but a physical electrosurgical system.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to diagnostic algorithms or imaging interpretation is not directly applicable or mentioned in this 510(k) summary for this device. The evaluation focuses on engineering specifications, intended function, and comparison to predicate devices, rather than a diagnostic output requiring ground truth validation.
8. The Sample Size for the Training Set
This information is not available in the provided 510(k) summary. This device is not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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14102698 510(k) Summary
General Information
| Date Prepared | 10/25/2010 |
|---|---|
| Classification | Class II, CFR 878.4400Product Code GEI |
| Common Name | Electrosurgical, cutting & coagulation & accessories |
| Trade Name | Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System |
| Submitter | Ellman International3333 Royal AveOceanside, NY 11572 |
| Contact Information | Mr. Jonathan AchenbachSr. Dir. R&D, Clinical & Regulatory AffairsPh: 516-594-3333Fax: 516-267-6750 |
Intended Use
The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.
Predicate Devices
Ellman Non Ablative Wrinkle Treatment System (K082834, K102368, K101967) manufactured by Ellman International
Technological Characteristics
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cord. The electrode is spring mounted into the handle. All materials used in the manufacture of the device are suitable for the use in the device and are the same materials used in the predicate product. As with the predicated device, the device is activated using a hand or footswitch based on user preference and is intended for use with the Ellman Radio-Frequency generators (K082834) labeled for the treatment of wrinkles and rhytides.
Substantial Equivalence
The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is as safe and effective as the Ellman Non Ablative Wrinkle Treatment System. The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System has the same indication for use, technological characteristics, and principles of operation as its predicate device. The minor technological improvements made to the device from the previous generation predicate device do not alter the fundamental scientific
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technology of the device and raise no new issues of safety or effectiveness. Thus, the Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is substantially equivalent.
Performance Data
All appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. In all instances, the Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System functioned as intended and in conformance with anticipated results.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ellman International Inc. % Mr. Jonathan Achenbach 3333 Royal Ave. Oceanside, NY 11572
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Re: K102698
Trade Name: Pellevé Glidesafe Non-Ablative Wrinkle Treatment System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 29, 2010 Received: January 3, 2011
Dear Mr. Achenbach:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Foond, Or ug and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jonathan Achenbach
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm I I S800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Presi 807.97). For questions regarding the reporting of adverse events under the MDR regulation (1 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ellman International
"INDICATIONS FOR USE" Statement
KIO2698 510(k) Number (if known):
Device Name: Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System
The Device has the following "Indications for Use":
Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV
Prescription Use X
OR
Over-The Counter Use_
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102698
§ 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.