(123 days)
The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks. The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments. The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems: Power Supply, Main Controller unit (CPU), Water cooling system (Chiller), Touchscreen display monitor, System on Module (SOM) and proprietary software, Applicator docking panel (cradle), Four designated applicator connector ports.
The provided text details a 510(k) premarket notification for the ReBorn device, an LED-based system for non-invasive lipolysis. However, it does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.
The document primarily focuses on establishing substantial equivalence to a predicate device (Venus Bliss, K190743) based on shared indications for use, technological characteristics, and performance data from non-clinical (bench) testing. There is no mention of an AI/ML component, a test set for AI performance, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the provided text does not contain this information.
To directly answer your specific points based on the provided text:
-
A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe acceptance criteria for an AI/ML device's performance, nor does it report performance metrics relevant to AI/ML. It focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and bench testing. Bench tests performed include:
- Temperature Control Test
- Cooling Capacity Test
- Applicator Power Performance Test
- Applicator Contact Sensor Test
- Lifetime Rationale
- Ex-vivo Animal Study
- Not applicable. The document does not describe acceptance criteria for an AI/ML device's performance, nor does it report performance metrics relevant to AI/ML. It focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and bench testing. Bench tests performed include:
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Sample sized used for the test set and the data provenance:
- Not applicable. There is no mention of a test set for AI/ML performance. The "ex-vivo animal study" is mentioned, but details on sample size or specific "data provenance" (e.g., country) are not provided beyond it being ex-vivo porcine abdominal skin and adipose tissue.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No experts or ground truth establishment relevant to AI/ML performance is described.
-
Adjudication method for the test set:
- Not applicable. No test set for AI/ML performance is described, so no adjudication method is mentioned.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not done, as this is not an AI/ML device for diagnostic assistance. The device is for non-invasive lipolysis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This isn't an AI/ML algorithm-only device. The "software" mentioned refers to control software for the device's operation.
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The type of ground truth used:
- Not applicable. There is no AI/ML component for which ground truth would be established. The "ex-vivo animal study" used the thermal effect on tissue as a measure, compared to the predicate device.
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The sample size for the training set:
- Not applicable. There is no mention of an AI/ML training set.
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How the ground truth for the training set was established:
- Not applicable. There is no mention of an AI/ML training set or its ground truth establishment.
In summary, the provided document pertains to the regulatory clearance of a medical device (ReBorn) based on substantial equivalence to an existing predicate, not on a study demonstrating AI/ML performance against specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2024
LightFective Ltd. % Ahava Stein Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str. Kfar Saba, 4442518 Israel
Re: K233962
Trade/Device Name: ReBorn (1050nm) Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: PKT Dated: December 14, 2023 Received: December 15, 2023
Dear Ahava Stein:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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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-devices/deviceadvice-comprehensive-regulatory-assistance/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. Digitally signed by Hithe -S _ Date: 2024.06.20
19:17:29 -04'00'
Tanisha Hithe 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
510(k) Number (if known) K233962
Device Name ReBorn (1050)
Indications for Use (Describe)
The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
LIGHTFECTIVE REBORN DEVICE
510(k) Number K233962
| Applicant Name: | Lightfective Ltd. |
|---|---|
| Company Name: | 2 Hatochen Str. |
| Caesarea, 3079533, Israel. | |
| Tel: +972-54-3003187 | |
| E-mail: bahat@lightfective.com | |
| Contact Person: | |
| Official Correspondent: | Ahava Stein |
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 18 Hata'as Str., Suite 21 |
| Kfar Saba 4442520 Israel | |
| Tel: + 972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com | |
| Date Prepared: | April 10, 2024 |
| Trade Name: | ReBorn |
| Classification Name: | CFR Classification section 878.5400; (Product Code PKT) |
| Classification: | Class II Medical Device |
| Predicate Device: |
The ReBorn device is substantially equivalent to the following predicate device:
| Manufacturer | Device Predicate | 510(k) No. |
|---|---|---|
| Venus Concept Ltd. | Venus Bliss | K190743 |
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ReBorn Device 510(k)
Device Description:
The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks.
The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments.
The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:
- . Power Supply
- Main Controller unit (CPU)
- Water cooling system (Chiller) ●
- Touchscreen display monitor ●
- System on Module (SOM) and proprietary software
- Applicator docking panel (cradle) ●
- Four designated applicator connector ports .
Intended Use/Indication for Use:
The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
Performance Standards:
The ReBorn device complies with the following FDA recognized consensus standards:
- IEC 60601-2-57 Edition 1.0 2011-01 Medical electrical equipment Part 2-57: . Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic. diagnostic, monitoring and cosmetic/aesthetic use
- . IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009((R)2012 and ● A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
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- IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical . equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices ●
- Part 5: Tests for in vitro cytotoxicity ●
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices ●
- Part 10: Tests for irritation and skin sensitization .
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software ● - Software life cycle processes
- ISO 14971 Medical devices Application of risk management to medical devices .
Non-Clinical (Bench) Performance Data:
Following is a description of the non-clinical performance tests performed on the device and provided in the 510(k) submission:
- . Temperature Control Test - evaluated the accuracy of the ReBorn temperature sensors, by comparing the temperature measured by the temperature sensors of the ReBorn device to calibrated thermocouples.
- . Cooling Capacity Test - evaluated the cooling capacity of the system's cooling unit during various types of treatments and verified that the cooling temperature remains within the predetermined range at all times.
- Applicator Power Performance Test verified that the deviation between the user-set ● power and the actual power output from the applicator falls within the permitted range.
- . Applicator Contact Sensor Test - tested the functionality of the contact sensors in multiple scenarios and demonstrated the proper display of the sensor indicator lights according to the device functionality.
- Lifetime Rationale the expected life time or operational life of the ReBorn device and . the applicator were evaluated.
- Ex-vivo Animal Study evaluated the thermal effect of the ReBorn device on porcine . abdominal skin and adipose tissue and demonstrated substantial equivalence to the FDA-cleared, predicate device, i.e., the Venus Bliss™.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
Not Applicable
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Substantial Equivalence:
The ReBorn system is substantially equivalent to the Venus Bliss device (Venus Concepts USA Inc.) cleared by FDA in 510(k) K190743.
| Characteristic | Subject DeviceReBorn(Lightfective Ltd.) | Predicate DeviceVenus Bliss(Venus Concepts USA Inc., K190743 |
|---|---|---|
| Device Classification, Indication for Use, Intended Use | ||
| Device Classification | Class II | Class II |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery |
| Classification ProductCode | PKT | PKT |
| Regulation Number | 878.5400 | 878.5400 |
| Indications For Use | The ReBorn System is a LEDsystem intended for non-invasivelipolysis of the abdomen andflanks in individuals with a BodyMass Index (BMI) of 30 or less. | The Venus Bliss device is a diodelaser system intended for non-invasive lipolysis of the abdomenand flanks in individuals with aBody Mass Index (BMI) of 30 orless. |
| Target Population | Adult subjects | Adult subjects |
| Anatomical Sites | Abdomen and flanks | Abdomen and flanks |
| Environment Used | Clinic | Clinic |
| Technological Characteristics | ||
| Device Description | The ReBorn is a Light Emitting Diode(LED) system delivering opticalenergy, which can disrupt adipocytecells to provide a non-invasiveapproach to achieve a desiredaesthetic effect. The ReBorn system isspecifically indicated for treatment ofthe abdomen and flanks. | The Venus Bliss device is a diode lasersystem delivering optical energy, whichcan disrupt adipocyte cells to provide anon-invasive approach to achieve adesired aesthetic effect. The VenusBliss is specifically indicated fortreatment of the abdomen and flanks. |
| Device Components | • Power supply unit• Controller unit• Cooling system• Touchscreen display monitor• PC and proprietary software• 4 Applicators• Applicator belt | • Power supply unit• Controller unit• Cooling System• Touchscreen display monitor• PC and proprietary software• 4 Applicators• Applicator belt |
| Energy Source | Light Emitting Diode (LED) | Diode Laser |
| Mechanism for HeatGeneration | An array of LED's delivering opticalenergy | Diode laser delivering optical energy |
| Wavelength | 1050 nm + 20 nm | 1064 nm + 10 nm |
| Spot Size | 35cm2 (5x7cm) | 36cm2 (6 x 6 cm) |
| Characteristic | Subject DeviceReBorn(Lightfective Ltd.) | Predicate DeviceVenus Bliss(Venus Concepts USA Inc., K190743 |
| Pulse Width (laser ON time) | CW | CW |
| Maximum Power Density | 1.4 W/cm² | 1.4 W/cm² |
| Attachment to Patient | Applicator Belt | Applicator Belt |
| Duration of Treatment | 25 minutes of treatment | 25 minutes of treatment |
| Treatment Temperature:Adipose Tissue | 42-47°C | 42-47°C |
| Skin | 14°C | 14°C |
| Temperature regulation | Temperature at the applicator iscontinuously monitored to ensure itdoes not exceed the maximumallowable temperature. | Temperature at the applicator iscontinuously monitored to ensure itdoes not exceed the maximumallowable temperature. |
| Cooling System | Water based | Water based |
| Rate of Heating (time toreach target temp) | 4 minutes | ~5 minutes |
| Power supply | AC/DC power:50-60 Hz120-240VAC12ASingle phase | AC/DC power:50-60 Hz100-240VAC<10ASingle phase |
| Dimensions | 35cm(W) x 52.5cm(D) x131.5cm(H)13.75"(W) x 20.75"(D) x 51.75"(H) | 55cm(W) x 65cm(D) x 135cm(H)21.7"(W) x 25.6"(D) x 53.2"(H) |
| Weight | 50 kg (110 lbs) | 62 kg (137 lbs) |
| Sterilization | The ReBorn system is non-sterile | The Venus Bliss device is non-sterile |
| Single Use or Reusable | ReBorn system: reusableApplicators: reusable | Venus Bliss device: reusableApplicators: reusable |
| Performance Testing | ||
| Biocompatible patient-contacting materials(ISO 10993-1) | Yes, medical-grade materials | Yes, medical-grade materials |
| Thermal Safety | Bench testing verified thermal safetyrequirements | Information not available |
| Software | Testing was performed to validate thatthe software met all requirements | Testing was performed to validate thatthe software met all requirements |
| Electrical Safety per IEC60601-1 | Meets requirements | Meets requirements |
| ElectromagneticCompatibility (EMC) perIEC 60601-1-2 | Meets requirements | Meets requirements |
Table 1: Comparison of the ReBorn Device to the predicate Venus Bliss device (K190743)
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ReBorn Device 510(k)
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Conclusions:
The ReBorn system has the same intended use and indication for use as the Venus Bliss device and the technological characteristics are similar or even identical, including similar device components (i.e., power supply, control unit, water-based cooling system, operator interface and display monitor, software and applicators), similar mechanism of action (heating tissue using optical energy to achieve adipose tissue disruption and thus achieve lipolysis of the abdomen and flanks), similar treatment administration, similar energy regulation methods, biocompatible materials, validation of software component, and similar compliance with electrical, EMD and optical energy emitting device standards. The most important technological characteristic, i.e., using optical energy to deliver heat to the body area to induce the adipose tissue disruption for lipolysis of the abdomen and flanks, is the same in both devices.
The minor difference between the devices in the optical energy delivery elements (light emitting diode vs laser diodes) and configuration of the spot size does not raise new types of questions about safety and effectiveness. That is, the questions regarding the safety and effectiveness of the optical energy output in the Reborn system are the same questions that were asked of the predicate, Venus Bliss device. Furthermore, there are acceptable scientific methods to evaluate these aspects of the device, including compliance with FDA recognized methods and standards to demonstrate optical safety and testing to validate the generated optical energy output in the ReBorn system is at least as safe and effective as the legally marketed, predicate Venus Bliss device. The compliance with standards information is provided in Section 8 (Software Validation), and Section 9 (Electrical and EMD) and Section 5 provides the Performance Testing in this 510(k) submission.
Consequently, the safety and effectiveness information provided in the 510(k) submission performance testing sections (hence, sections 5, 8, and 9) provide the supportive data necessary to demonstrate that the ReBorn system is substantially equivalent to the predicate Venus Bliss device (FDA-Cleared under 510(k) K190743).
§ 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.