(278 days)
Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
Palm NRG cellulite body device (model: Palm NRG body device) is a portable, non-invasive, at home skin care device. It works for with radio frequency (RF) to help users to enjoy the care skin. The device is a noninvasive, non-ablative device and it is supplied as non-sterile, it has 2 buttons, one for power on/off, the other one for level adjust. The main unit is equipped with accessories of an adapter and a charging base. The charging base is used to connect the adapter and the main unit.
The provided text is a 510(k) summary for a medical device (Palm NRG cellulite body device) and does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or effectiveness.
This document focuses on establishing substantial equivalence to predicate devices based on non-clinical tests and technological characteristics. There is an explicit statement: "There no Clinical Tests."
Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance or a study proving it, as such information is not present in the provided text.
However, I can extract information about the non-clinical tests performed to demonstrate safety and performance:
1. Table of Acceptance Criteria and Reported Device Performance
As there are no clinical performance acceptance criteria or results reported for this device, a table for clinical performance cannot be created. The document focuses on compliance with recognized standards for safety and non-clinical performance:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| Electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57) | Evaluated and confirmed |
| Electromagnetic compatibility (IEC 60601-1-2) | Evaluated and confirmed |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Evaluated and confirmed |
| Usability (FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices") | Usability study conducted, demonstrating it meets requirements for Over-The-Counter Use |
| Software verification and validation (FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | Evaluated and confirmed |
2. Sample size used for the test set and the data provenance:
- Non-clinical tests: The document does not specify sample sizes for the non-clinical tests (electrical safety, EMC, biocompatibility, software V&V). These tests are typically performed on a representative number of devices to demonstrate design conformity, rather than statistical samples like a clinical trial.
- Usability Study: The sample size for the usability study is not explicitly stated.
- Data Provenance: The tests were performed as part of the submission process to the FDA, likely by accredited labs. The country of origin of the data is not specified beyond the sponsor's affiliations in China and the USA. All tests were prospective for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Non-clinical tests: Not applicable in the context of establishing ground truth for performance. These tests evaluate adherence to engineering and safety standards, often performed by qualified engineers and technicians.
- Usability Study: The document does not specify the number or qualifications of experts involved in establishing ground truth for the usability study. Usability studies typically involve a representative user group rather than "experts" establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication of device performance against ground truth was performed.
5. 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 comparative effectiveness study was not done. This device is not an AI-assisted diagnostic or interpretive tool, but rather a physical therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical therapeutic device, not an algorithm, and is intended for over-the-counter human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- No clinical ground truth was established or used, as no clinical studies were performed. The "ground truth" for the non-clinical tests was established by compliance with the defined voluntary design standards. For the usability study, the ground truth would be the ability of users to safely and effectively operate the device according to its instructions for use.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
Heat In A Click LLC. % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China
Re: K214015
Trade/Device Name: Palm NRG cellulite body device (model: Palm NRG body device) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: August 24, 2022 Received: August 25, 2022
Dear Cassie Lee:
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.
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
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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,
for
Long Chen, Ph.D. 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) Applying
Device Name
Palm NRG cellulite body device (model: Palm NRG body device)
Indications for Use (Describe)
Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Heat In A Click LLC
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary updated: 2022-09-24
2. Submitter's Information
510(k) Owner's Name: Heat In A Click LLC Establishment Registration Number: 3008929787 Address: 1975 Tigertail Blvd Dania FL 33034 USA Tel: 1(954)518-9777 Fax: 1(954)320-7984 Contact Person: Guy Levi (CEO) Email: palmnrg@gmail.com
Application Correspondent:
Contact Person: Cassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd.
Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
Tel: +86 20 8266 2446
Email: requlatory@glomed-info.com
3. Subject Device Information
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories Trade Name: Palm NRG cellulite body device Model Name: Palm NRG body device Review Panel: General and Plastic Surgery Product Code: PBX, GEI Regulation Number: 21 CFR 878.4400
Heat In A Click LLC.
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510(k) Number: K214015 Sponsor: Heat In A Click LLC
Regulatory Class: II
4.Predicate Device Information
Predicate Device 1:
Sponsor: Heat In A Click LLC Trade Name: Palm NRG cellulite body device Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories 510(K) Number: K191940 Review Panel: General and Plastic Surgery Product Code: PBX, GEI Regulation Number: 21 CFR 878.4400 Regulation Class: II
Predicate Device 2:
Sponsor: El Global Trade Ltd.
Trade Name: sensiFirm
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
510(K) Number: K170637
Review Panel: General and Plastic Surgery
Product Code: PBX, GEI
Regulation Number: 21 CFR 878.4400
Regulation Class: II
5.Device Description
Palm NRG cellulite body device (model: Palm NRG body device) is a portable, non-invasive, at home skin care device. It works for with radio frequency (RF) to help users to enjoy the care skin.
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510(k) Number: K214015 Sponsor: Heat In A Click LLC
Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
The device is a noninvasive, non-ablative device and it is supplied as non-sterile, it has 2 buttons, one for power on/off, the other one for level adjust. The main unit is equipped with accessories of an adapter and a charging base. The charging base is used to connect the adapter and the main unit.
6. Intended Use / Indications for Use
Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
7. Test Summary
7.1 Non-Clinical Tests Performed
Non-Clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
Palm NRG cellulite body device (model: Palm NRG body device) has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-57 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to guidance "Applying Human Factors and Usability Engineering to Medical Devices".
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
7.2 Discussion of Clinical Tests Performed
There no Clinical Tests.
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Palm NRG cellulite body device (model: Palm NRG body device) substantially equivalent to the predicate devices quoted above.
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Heat In A Click LLC Sponsor:
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Company | Heat In A Click LLC | Heat In A Click LLC | El Global Trade Ltd. | -- |
| ClassificationName | Electrosurgical Cuttingand CoagulationDevice andAccessories | ElectrosurgicalCutting andCoagulation Deviceand Accessories | Electrosurgical Cuttingand Coagulation Deviceand Accessories | Same |
| 510(k) Number | Applying | K191940 | K170637 | -- |
| Product Code | PBX, GEI | PBX, GEI | PBX, GEI | Same |
| Intended Use /Indications forUse | Palm NRG cellulitebody device (model:Palm NRG bodydevice) is intended fordelivering non thermalRF combined withmassage fortemporary reduction inthe appearance ofcellulite. | Palm NRG cellulitebody device (model:Palm NRG bodydevice) is intendedfor delivering nonthermal RFcombined withmassage fortemporary reductionin the appearance ofcellulite. | The sensiFirm device isintended for deliveringnon thermal RFcombined with massagefor temporary reductionin the appearance ofcellulite. | Same |
| RegulationNumber | 878.4400 | 878.4400 | 878.4400 | Same |
| RegulatoryClass | Class II | Class II | Class II | Same |
| Treatment areas | Areas of the bodyother than the faceand injured areas | Areas of the bodyother than the faceand injured areas | Cellulite areas (buttocks,thigh, upper legs) | Same |
| Intendedpopulation | Adult people whodesire to improve theirbody appearance | Adult people whodesire to improvetheir bodyappearance | Adult people who desireto improve their bodyappearance | Same |
| Useenvironment | Home Use, self-operationby an untrained user. | Home Use, self-operationby an untrained user. | Home Use, self-operationby an untrained user. | Same |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| Power Source(s) | Adapter:100-240Vac,50/60Hz | Adapter:100-240Vac,50/60Hz | 100-240 Vac, 50-60 Hz | Same |
| Software/Firmware/Microprocessor Control | Yes | Yes | Yes | Same |
| Automatic ShutOff | Yes | Yes | Yes | Same |
| On/Off Status | Yes | Yes | Yes | Same |
| Low Battery | Yes | Yes | Yes | Same |
| Weight | 0.6kg | 0.6kg | 192 gr/ 0.42 lb | Same |
| Dimensions ofdevice(inch) | Device size:223 x155.5 x 59mmBase size:160.6 x 52.3x 27.1mm | Device size:223 x155.5 x 59mmBase size:160.6 x52.3 x 27.1mm | Hand piece:146 X 74 X63 mm3/ 5.72.92.5inch | Same |
| Device maincomponents | Power adaptor, hand-held handpiece | Power adaptor,hand-held handpiece | Power adaptor, hand-held handpiece | Same |
| Mode ofoperation | Mechanical (vibration)massage combinedwith RF energyemitted from Bi-polarelectrodes via adelivery Handpiece | Mechanical(vibration) massagecombined with RFenergy emitted fromBi-polar electrodesvia a deliveryHandpiece | Mechanical (vibration)massage combined with RFenergy emitted fromBi-polar electrodes via adelivery Handpiece | Same |
| Number ofelectrodes | 1 | 1 | 4 electrodes (2 pairs) | Same |
| Massage | Vibrational massage(1000 rpm, 1.5 [g])assisted by manualmanipulation | Vibrational massage(1000 rpm, 1.5 [g])assisted by manualmanipulation | Vibrational massage(1000 rpm, 1.5 [g])assisted by manualmanipulation | Same |
| Energy Source | RF (Bi-polar), 1 MHz | RF (Bi-polar), 1 MHz | RF (Bi-polar), 1 MHz | Same |
| Electrodestreatment area[mm2] | 26cm²±5% | 26cm²±5% | ~2000 (calculatedaccording to: 2x33x30),where -2 – numbers of | Same |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| electrodes pairs• 33 - average distancebetween electrodes is33 mm• electrodes length 30mm | ||||
| Treatmentregimen | Perform the treatmentfor 5-7 minutes oneach area. 1 time perweek, for 8 weeks. | Perform thetreatment for 5~7minutes on eacharea. 1 time perweek, for 8 weeks. | 20 minutes per eacharea, 1 time per week,for 8 weeks | Same |
| Energy levels(maximal anduser selectable) | Up to $10\pm1$ Watt6 to $10\pm1$ Watt (energylevels 1-5). | Up to $10\pm1$ Watt6 to $10\pm1$ Watt(energy levels 1-5). | Up to 10 Watts. 3energy levels(softwareand hardware limited):6,8 or 10 Watts,depending on the userselection. | Same |
| Safetymechanism | Integrated IRthermometer, withmaximal temperature(skin surface 41 °C/105.8°F) | Integrated IRthermometer, withmaximal temperature(skin surface 41 °C/105.8°F) | Integrated IRthermometer, withmaximal temperature(skin surface 41 °C/105.8°F) | Same |
| Compliance withVoluntaryStandards | AAMI/ES60601-1:2005/(R)2012 AndA1:2012:IEC60601-1-2IEC60601-1-6IEC60601-1-11IEC 60601-2-57 | AAMI/ES60601-1:2005/(R)2012 AndA1:2012:IEC60601-1-2IEC60601-1-6IEC60601-1-11IEC 60601-2-57 | IEC60601-1:2012/EN60601-1:2013IEC 60601-1-2: 2014IEC 60601-1-11:2015 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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Sponsor: Heat In A Click LLC
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510(k) Number: K214015
Sponsor: Heat In A Click LLC
Comparison in Detail(s):
The subject device has all characteristic of predicate device K191940, a usability study is conducted. So, there is no difference between the two predicate devices.
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510(k) Number: K214015 Sponsor: Heat In A Click LLC
9. Conclusion:
The subject device has all characteristic of predicate devices, and the result of usability study demonstrates that the subject device can meet the requirement for Over-The-Counter Use. Thus, the subject device is substantially equivalent to the predicate devices.
§ 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.