(159 days)
The Zerona®-Z6 is indicated for use as non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
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Here's a breakdown of the acceptance criteria and study information for the Zerona®-Z6 device, based on the provided FDA 510(k) clearance letter.
It's important to note that the provided text is an FDA clearance letter, which summarizes the FDA's decision and the device's indications for use. It typically references the underlying study data submitted by the manufacturer but does not contain the full study report itself. Therefore, some details (like specific sample sizes for training sets, detailed expert qualifications, or adjudication methods) may not be explicitly stated in this document but would be found in the manufacturer's 510(k) submission.
Study Context:
The Zerona®-Z6 is indicated for use an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the indication for use, which implies the clinical effect the device is intended to achieve. However, it does not explicitly state a numerical "acceptance criteria" (e.g., "must reduce circumference by X cm") or specific "reported device performance" metrics. The FDA's 510(k) clearance process focuses on substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The specific performance data and statistical significance that justified this substantial equivalence would be in the full submission, not typically in the clearance letter.
To fully answer this, one would need access to the full 510(k) submission document (Premarket Notification file K133718), which would contain the clinical trial results.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the clinical study that supported the 510(k) submission.
Data Provenance: The document does not specify the country of origin or whether the study was retrospective or prospective. Clinical trials for FDA clearance are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided document does not mention the number or qualifications of experts used to establish ground truth. For a device like this, "ground truth" would likely refer to objective measurements of circumference reduction, potentially taken by trained medical professionals.
4. Adjudication Method for the Test Set
The provided document does not specify an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The provided document does not indicate if an MRMC comparative effectiveness study was done. This type of study is more typically associated with imaging diagnostic devices where multiple readers interpret images. For a device like the Zerona®-Z6, which focuses on circumference reduction, the primary outcome would be objective measurements, not reader interpretation.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
The Zerona®-Z6 is described as a "non-invasive dermatological aesthetic treatment," implying a device that directly applies a treatment. It is not an algorithm, so the concept of "standalone performance" for an algorithm does not apply in this context.
7. The Type of Ground Truth Used
Based on the device's indication for use ("reduction of circumference of hips, waist, and thighs"), the most probable "ground truth" would be objective anthropometric measurements (e.g., tape measurements) of the circumference of the target areas, taken by trained personnel using standardized protocols. These measurements would likely be compared to baseline measurements to determine reduction. Outcomes data relevant to patient satisfaction or changes in body contour could also be considered secondary ground truth.
8. The Sample Size for the Training Set
The concept of a "training set" primarily applies to machine learning algorithms. Since the Zerona®-Z6 is a treatment device, not an AI/ML algorithm, a "training set" in that sense would not be applicable.
If "training set" refers to the cohort used to establish the efficacy and safety parameters of the device during its development prior to the pivotal study, that information is not present in this document.
9. How the Ground Truth for the Training Set Was Established
As with point 8, the concept of a "training set" in the AI/ML context is not directly applicable here. If referring to early development data, the ground truth would likely be established through objective circumference measurements, similar to the test set.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Asenie Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2014
Erchonia Medical Incorporated % Mr. Kevin Wall, RAC Regulatory Insight Incorporated 33 Golden Eagle Lanc Littleton, Colorado 80127
Re: K133718
Trade/Device Name: Zerona® -Z6 Regulation Number: 21 CFR 878.5400 Regulatory Class: Class II Product Code: OLI Dated: April 7, 2014 Received: April 8, 2014
Dear Mr. Wall:
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 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not mislcading.
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
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Page 2 - Mr. Kevin Wall, RAC
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address <
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133718
Device Name Zerona@-Z6
Indications for Use (Describe)
The Zerona®-Z6 is indicated for use as non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Oaden 2014.05.12 08:43:30 -04'00' For BSA
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§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.