(85 days)
The DEKA PHYSIQ 360 is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs, in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
The PHYSIQ 360 is a diode laser device. The device is provided with:
- Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
- An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
- One wavelength, 1060 ±20 nm (infrared)
The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)
This document is a 510(k) summary for the DEKA PHYSIQ 360 device, a diode laser intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to a predicate device (Sculpsure K171992) rather than presenting a study proving that the device meets specific acceptance criteria related to a diagnostic or AI-driven performance.
Therefore, the requested information, such as acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device), clinical study data to demonstrate that the device meets these criteria, sample sizes for test sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.
This document primarily relies on the comparison to a predicate device and non-clinical performance data (electrical safety, EMC, software validation) to demonstrate substantial equivalence, rather than new clinical efficacy or performance studies with specific acceptance criteria that would typically be associated with AI/diagnostic devices.
Here's why the requested information isn't present in this specific type of document:
- Device Type: The DEKA PHYSIQ 360 is a laser for aesthetic use (non-invasive lipolysis). Its clearance is based on demonstrating that it is substantially equivalent to an existing legally marketed predicate device, not on demonstrating a specific diagnostic performance or AI-driven capabilities.
- 510(k) Pathway: The 510(k) premarket notification pathway often relies on comparison to a predicate device and non-clinical testing rather than extensive new clinical studies, especially if the new device has the same technological characteristics and similar indications for use as a cleared predicate.
- "Clinical Performance Data: None": As explicitly stated in the document, no clinical performance data was submitted. This confirms that a study of the type you're asking about (with performance metrics against acceptance criteria) was not part of this submission.
- Focus on Substantial Equivalence: The primary objective of this 510(k) summary is to argue that the DEKA PHYSIQ 360 is "as safe, as effective, and performs as well as the legally marketed predicate device." This is achieved by showing identical or substantially similar technological characteristics and indications for use, and by providing non-clinical safety testing.
In summary, based on the provided document, I cannot fulfill your request for acceptance criteria and a study proving the device meets them, because this type of information is not included in this 510(k) summary for the DEKA PHYSIQ 360.
The document details:
- Non-Clinical Performance Data:
- Electrical safety and electromagnetic compatibility (EMC) testing based on ANSI AAMI ES60601-1 and IEC 60601-1-2.
- Software Validation and Verification Testing as per FDA guidance.
- Additional non-clinical testing per IEC 60601-2-22 and IEC 60825-1.
These non-clinical tests ensure device safety and functionality but are not "performance data" in the sense of diagnostic accuracy or clinical efficacy against specific statistical acceptance criteria for a human performance or AI-driven system.
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September 26, 2023
El.En. S.p.A Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50141 Italy
Re: K231971
Trade/Device Name: Deka Physiq 360 Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: June 30, 2023 Received: July 3, 2023
Dear Paolo Peruzzi:
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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Tanisha L. Hithe -s 2023.09.26 Hithe -S 17:15:35 -04'00'
Tanisha Hithe, MS, MHS Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K231971
Device Name
DEKA PHYSIQ 360
Indications for Use (Describe)
The DEKA PHYSIQ 360 is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs, in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
DEKA PHYSIQ 360
Submitter:
El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
June 30, 2023
Device Trade Name:
DEKA PHYSIQ 360
Common Name:
Laser for aesthetic use
Classification Name:
Laser for disruption of adipocyte cells for aesthetic use
Product Code:
PKT
Regulatory Class:
Class II
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Classification Number:
21 CFR 878.5400
Predicate Device:
Sculpsure (K171992)
Device Description:
The PHYSIQ 360 is a diode laser device. The device is provided with:
- Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
- An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
- One wavelength, 1060 ±20 nm (infrared)
The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)
Indications for Use:
The PHYSIQ 360 device is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
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Comparison with The Predicate Device:
| Device Trade Name | Proposed DeviceDEKA PHYSIQ 360 | Predicate DeviceSculpsure (K171992) | Comment |
|---|---|---|---|
| Indications for Use | The DEKA PHYSIQ 360system is intended fornon-invasive lipolysis ofthe abdomen, flanks,back, and thighs, inindividuals with a BodyMass Index (BMI) of 30 orless. The device isintended to affect theappearance of visible fatbulges in the abdomen,flanks, back, and thighs. | The Cynosure SculpSure isintended for non-invasivelipolysis of the abdomen,flanks, back, and thighs inindividuals with a BodyMass Index (BMI) of 30 orless. In addition, thedevice is intended for non-invasive lipolysis of thesubmental area inindividuals with a BMI of43 or less. The device isintended to affect theappearance of visible fatbulges in the abdomen,flanks, back, thighs andsubmental area | The proposeddevice's indicationsfor use are a subsetof the predicate'sindications for use.The proposed andpredicate devices'key technologicalparameters are thesame, and thus thesubset of thepredicate device'sindications for useare applicable tothe proposed device |
| Regulation number | 21 CFR 878.5400 Laser fordisruption of adipocytecells for aesthetic use | 21 CFR 878.5400 Laser fordisruption of adipocytecells for aesthetic use | Identical |
| Product Code | PKT | PKT | Identical |
| Device Type | Diode Laser | Diode Laser | Identical |
| Lypolysis Method | Heat-assisted | Heat-assisted | Identical |
| Wavelength | 1060 ±20 nm(infrared) | 1060 ±20 nm(infrared) | Identical |
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| Device Trade Name | Proposed Device | Predicate Device | Comment |
|---|---|---|---|
| DEKA PHYSIQ 360 | Sculpsure (K171992) | ||
| Spot Size | 4 x 6 cm on each of theapplicator heads(up to four applicators perbody treatment) | 4 x 6 cm on each of theapplicator heads(up to four applicators perbody treatment)14.28 cm2 (one applicatorhead and frame used forSubmental treatment) | Identical for theproposedIndications for Use |
| Pulse Width(laser ON time) | CW | CW | Identical |
| Power Density | Up to 1.4 W/cm²(body) | Up to 1.4 W/cm²(body)Up to 2.35 W/cm²(submental) | Identical for theproposedIndications for Use |
| Attachment topatient | Belt (body treatment) | Belt (body treatment)Headgear and straps(submental treatment) | Identical for theproposedIndications for Use |
Clinical Performance Data:
None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the PHYSIQ 360 device, according to the following standards:
. ANSI AAMI ES60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Software Validation and Verification Testing
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
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K231971
Additional non-clinical testing conducted
Additional tests were conducted on the PHYSIQ 360 device, according to the following standards:
- . IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements.
Conclusion:
On the basis of the comparison with the predicate device and on the non-clinical performance data, we can conclude that DEKA PHYSIQ 360 is as safe, as effective, and performs as well as the legally marketed predicate device (K171992).
Additional Information:
None
§ 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.