(76 days)
The DEFINE System with the non-invasive applicators employs RF energy for various applications:
The DEFINE System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain. relief of muscle spasm. and for the temporary improvement of local blood circulation.
The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite.
The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed.
At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.
The DEFINE device is designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF energy is transmitted to the Applicators and delivered to the treatment area throughout the set of RF electrodes positioned on the treatment units. The invested RF energy is transformed into local heating of the treatment area. Local heating of the skin and underlying tissue layers temporarily ease the symptoms of muscle aches, pain & spasm. It also contributes to the temporary improvement of local blood circulation.
The DEFINE device platform comprises a AC/DC power supply unit, main controller, two RF generators, distributor card and user interface including a touch screen. The system platform contains four designated connectors for the following applicators:
- Cheek Applicator (hands-free) ●
- Chin Applicator (hands-free) ●
- FORMA Applicator ●
- MiniFX ●
- MORPHEUS8 Applicator with the resurfacing, 12 and 24 pin tip heads ●
The DEFINE device RF Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a "Start"/"Stop" button on the LCD screen or by a foot pedal. The DEFINE device incorporates a treatment deactivation button. Pressing the deactivation button by either the patient or caregiver would immediately halt the treatment and switch the device into a Pause mode until the operator re-enables it.
The provided text is a 510(k) summary for the InMode Ltd. DEFINE System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment for a study proving the device meets acceptance criteria is not present in this type of regulatory submission.
The 510(k) process primarily relies on showing that a new device is as safe and effective as a legally marketed predicate device. This is often achieved through:
- Comparison of technological characteristics: Demonstrating that the new device has the same fundamental technology, intended use, and similar design as the predicate.
- Non-clinical performance data (bench testing): Verifying that the device meets safety and performance standards (e.g., electrical safety, electromagnetic compatibility, RF energy output).
- Absence of clinical performance data for substantial equivalence: In many cases, if technological characteristics are sufficiently similar and non-clinical testing confirms equivalence, new clinical data is not required.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of specific "acceptance criteria" and "reported device performance" as typically seen in a clinical trial or performance study (e.g., sensitivity, specificity, accuracy for a diagnostic device) is not applicable or stated in this 510(k) summary for the DEFINE System.
Instead, the submission demonstrates compliance with:
- Safety standards: IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-2 (for RF surgical equipment), IEC 60601-1-6 (usability), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), IEC 62304 (software life cycle), ISO 14971 (risk management).
- Equivalence in intended use and technological characteristics to predicate devices.
The "performance" is primarily demonstrated through bench testing for electrical safety, EMD safety, RF output (IEC 60601-2-2), and software validation. These are conformity assessments to established standards rather than performance against a clinical acceptance threshold for diagnostic or therapeutic efficacy outcomes.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (as stated in submission) |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | The modified device was tested for compliance withIEC 60601-1. |
| Compliance with IEC 60601-1-2 (EMD Safety) | The modified device was tested for compliance with IEC 60601-1-2. |
| Compliance with IEC 60601-2-2 (RF Specific) | The modified device was tested for compliance with IEC 60601-2-2. |
| Compliance with IEC 62304 (Software) | Validation of the device software was performed in accordance with clause 14 of IEC 60601-1 (third edition) Software requirements, IEC to 62304:2006/A1:2016. |
| Biocompatibility (Cytotoxicity) Compliance with ISO 10993-5 | Compliance demonstrated (listed as a standard the device complies with). |
| Biocompatibility (Irritation/Sensitization) Compliance with ISO 10993-10 | Compliance demonstrated (listed as a standard the device complies with). |
| Risk Management Compliance with ISO 14971 | Compliance demonstrated (listed as a standard the device complies with). |
| Equivalence of RF Maximum Output Power (Cheek & Chin Applicators) | Predicate: 50 W; DEFINE System: idem (50 W). |
| Equivalence of Energy Output Levels (Cheek & Chin Applicators) | Predicate: Cheek Up to 60, Chin Up to 40; DEFINE System: idem. |
| Equivalence of Frequency (Cheek & Chin Applicators) | Predicate: 1 MHz; DEFINE System: idem. |
| Equivalence of RF Pulse Width (Cheek & Chin Applicators) | Predicate: 2 seconds; DEFINE System: idem. |
Note: The submission explicitly states "Clinical Performance Data: Not Applicable" (page 7 of 14). This signifies that the decision for substantial equivalence was based solely on non-clinical (bench) testing and comparison to predicate devices, without new human clinical studies for performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set data is provided or referenced, as the submission states "Clinical Performance Data: Not Applicable." The "test set" for non-clinical performance refers to the device and its components undergoing bench testing according to various standards. The document does not specify the number of units tested.
- Data Provenance: Not applicable for clinical data. For non-clinical data, it's typically performed by the manufacturer or a certified testing lab. The country of origin of the data is implied to be within controlled engineering/testing environments, likely at the manufacturer's location (Israel) or a contracted lab. The data is implicitly "prospective" in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There was no clinical test set for which ground truth needed to be established by experts.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. No clinical studies were conducted or referenced for this 510(k) submission. Therefore, no MRMC study, human reader improvement effect size, or AI assistance claims are present.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI or algorithm-only device in the context of diagnostic or interpretive performance. Its performance is tied to its physical mechanisms and safety parameters validated through bench testing, not an algorithm's standalone accuracy. Software validation (IEC 62304) ensures the software functions as intended and is safe, not that it performs a diagnostic or prescriptive task independently.
7. Type of Ground Truth Used
- For non-clinical testing: The "ground truth" is adherence to established engineering standards (e.g., IEC, ANSI, ISO). For example, electrical safety is "ground true" if the device passes the specified tests in IEC 60601-1.
- For clinical performance claims: Not applicable, as no clinical performance data was provided.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set in the typical sense (e.g., for image classification). The "software validation" mentioned relates to the software controlling the device's operation, not to a learned model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, for the same reasons as point 8.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2024
InMode Ltd. Ahava Stein Regulatory Consultant Tabor Building, Shaar Yokneam Yokneam, 2069200 Israel
Re: K242598
Trade/Device Name: DEFINE System (AG612444A) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, PBX, ISA, NUV Dated: October 16, 2024 Received: October 16, 2024
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 (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/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.
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"
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(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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). 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).
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Sincerely,
Digitally signed by Long H. Chen Long H. Chen-S -Date: 2024.11.14 10:05:21 -05'00'
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
DEFINE System (AG612444A)
Indications for Use (Describe)
The DEFINE System with the non-invasive applicators employs RF energy for various applications:
The DEFINE System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain. relief of muscle spasm. and for the temporary improvement of local blood circulation.
The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite.
The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed.
At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.
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
DEFINE DEVICE
510(k) Number K242598
Applicant Name:
Company
| Name: | InMode Ltd. |
|---|---|
| Tabor Building, Shaar Yokneam | |
| POB 44, Yokneam 2069200 | |
| Israel | |
| Tel: | +972-4-9097470 |
| Fax: | +972-4-9097471 |
| E-mail: | ahava@asteinrac.com |
Contact Person:
| Official Correspondent: | Ahava Stein |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd |
| Address: | 18 Hata'as Str., Suite 21Kfar Saba 4442520 Israel |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com | |
| Date Prepared: | October 14, 2024 |
| Trade Name: | DEFINE |
| Classification Name: | CFR Classification section 878.4400Product Codes GEI, PBX, ISA and NUV |
| Classification: | Class II Medical Device |
Predicate Device:
The DEFINE System is substantially equivalent to the following predicate devices:
| Predicate | Manufacturer | Device Predicate | 510(k) No. |
|---|---|---|---|
| Main Predicate | InMode Ltd. | EmFace Device withCheek & Chin Applicators | K191855 |
| SecondaryPredicates | InMode Ltd. | FORMA Applicator | K210492 |
| InMode Ltd. | MiniFX Applicator | K210492 | |
| InMode Ltd. | Morpheus8 Applicators | K210492 & K231790 |
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Device Description:
The DEFINE device is designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF energy is transmitted to the Applicators and delivered to the treatment area throughout the set of RF electrodes positioned on the treatment units. The invested RF energy is transformed into local heating of the treatment area. Local heating of the skin and underlying tissue layers temporarily ease the symptoms of muscle aches, pain & spasm. It also contributes to the temporary improvement of local blood circulation.
The DEFINE device platform comprises a AC/DC power supply unit, main controller, two RF generators, distributor card and user interface including a touch screen. The system platform contains four designated connectors for the following applicators:
- Cheek Applicator (hands-free) ●
- Chin Applicator (hands-free) ●
- FORMA Applicator ●
- MiniFX ●
- MORPHEUS8 Applicator with the resurfacing, 12 and 24 pin tip heads ●
The DEFINE device RF Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a "Start"/"Stop" button on the LCD screen or by a foot pedal. The DEFINE device incorporates a treatment deactivation button. Pressing the deactivation button by either the patient or caregiver would immediately halt the treatment and switch the device into a Pause mode until the operator re-enables it.
Intended Use/Indication for Use:
The DEFINE System with the non-invasive applicators employs RF energy for various applications:
The DEFINE System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, and for the temporary improvement of local blood circulation.
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DEFINE Device 510(k)
The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite.
The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.
Performance Standards:
The DEFINE device complies with the following FDA recognized consensus standards:
- o IEC 60601-1-2 Edition 4.1 2020-09 Consolidated Version - 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) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment Part 2-2: Particular ● requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- 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 o
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:
- The modified device was tested for compliance with the electrical safety standard IEC . 60601-1.
- The modified device was tested for compliance with the EMD safety standard IEC ● 60601-1-2.
- The modified device was tested for compliance with specific RF recognized consensus ● standard - IEC 60601-2-2.
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- Validation of the device software was performed in accordance with clause 14 of IEC ● 60601-1 (third edition) Software requirements, IEC to 62304:2006/A1:2016.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The DEFINE System is a modification of the EmFace System (a.k.a. Evoke System) previously cleared by the FDA (K191855), with the cheek and chin applicators. The EmFace device (K191855) is the main predicate device. Additionally, the DEFINE System supports the following FDA-cleared RF Applicators:
- o FORMA Applicator (K210492)
- MiniFX Applicator (K210492) ●
- Morpheus8 Applicators (K210492 and K231790) ●
Therefore, the FORMA Applicator (K210492), the MiniFX Applicator (K210492) and the Morpheus8 Applicators (K210492 and K231790) are the secondary predicate devices.
Table 1 presents the comparison of the DEFINE Device to the predicate EmFace device (K191855).
Table 2 presents the comparison of Cheek and Chin Applicators in the DEFINE device compared to those provided in the predicate EmFace device (K191855).
Comparison tables for the additional Applicators, including the FORMA Applicator, the MiniFX Applicator and the Morpheus8 Applicators are not provided as these Applicators are all identical to the secondary predicate FORMA Applicator (K210492), MiniFX Applicator (K210492) and Morpheus8 Applicators (K210492 and K231790) in intended use and all aspects of the technological characteristics. That is, absolutely no changes have been made to these applicators.
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Table 1: Comparison of the DEFINE Device to the predicate EmFace device (K191855
| EmFace Device (InMode Ltd.)Main Predicate Device (K191855) | DEFINE System (InMode Ltd.)Modified device | ||
|---|---|---|---|
| a) Device Classification and Clinical Characteristics | |||
| a) Product Code | PBX | GEI, PBX, ISA, NUV | |
| b) Class | Class II | idem | |
| c) Intended Use | See the Applicators Comparison Table (10.2.2) | idem | |
| d) Manufacturer | InMode Ltd. | idem | |
| e) Prescription or OTC | Prescription use only | idem | |
| f) Target Population | Adults requiring treatment as specified in the indications for use | idem | |
| g) Anatomical sites | Body parts requiring treatment as specified in the indications for use | idem | |
| h) Environment Used | Hospital or Clinic setting | idem | |
| i) Device Technological Characteristics | |||
| a) Device description / Design | The EmFace device with the Cheek and Chin Applicators is designed to deliver non-thermal RF energy to the skin and subdermal fat | The DEFINE System with all Applicators is designed to deliver non-thermal RF energy to the skin and subdermal fat. |
Page 5 of 11
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| Device components | Performance specifications | Physical specifications | Operating parameters | Transport & storage | |
|---|---|---|---|---|---|
| EmFace Device (InMode Ltd.)Main Predicate Device (K191855)The EmFace Device platform consists of the following components:• Console, including the following components:- AC/DC Power Supply Unit- Controller- Distributor Card- LCD touch screen color (10.1")- 2 RF Generators- 2 Applicator connectors (for Cheek and Chin Applicators)- Deactivation Safety Switch• Designated RF Applicators (see Table 10.2.2) | 100-240 VAC50-60 Hz4.0 A | Dimensions: 40.7 cm W x 40.9 cm D x 102.5 cm H[16.1" W x 16.1" D x 40.3" H]Weight: 20 Kg [44 lbs.] | Ambient Temperature Range: 15 – 35°C [59 – 95°F]Relative Humidity: 30% to 80%, non-condensingAtmospheric Pressure: 90 – 110 kPa | Ambient Temperature Range: -20 – 65°C [-4 – 149°F]Relative Humidity: 0% to 80%, non-condensingAtmospheric Pressure: 50 – 110 kPa | |
| DEFINE System (InMode Ltd.)Modified deviceThe Define System platform consists of the following components:• Console, including the following components:• AC/DC Power Supply Unit- Controller- Distributor Card- LCD touch screen color (12")- 2 RF Generators- 4 Applicator connectors (one for Cheek and one for Chin Applicators, one for Morpheus8 or MiniFX Applicators, and one for FORMA Applicator)- Deactivation Safety Switch• Designated RF Applicators (see Table 10.2.2) | idem | Dimensions: idemWeight: 33.0 Kg [72.753 lb] | idem | idem |
DEFINE Device 510(k)
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DEFINE Device 510(k)
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Page 8 of 11
| Chin Applicator in the DEFINE device compared to those provided in the predicate EmFace | |
|---|---|
| 100 100 | |
| 0 N1 | |
| Table 2 - Comparison of Cheek and | |
| - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -TT 4 0 4 0 4 0 4 0 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0device (K191855 | |
| THE A | |
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| EmFace Device Cheek & Chin Applicators(InMode Ltd.)Main Predicate Device (K191855) | DEFINE System Cheek & Chin Applicators(InMode Ltd.)Modified device | ||
|---|---|---|---|
| a) | Applicator cable length | 180 cm [71"] | 280 cm [100"] |
| c) | RF Maximum Output Power | 50 W | idem |
| d) | Energy Output Levels | Cheek Applicator: Up to 60 Energy LevelsChin Applicator: Up to 40 Energy Levels | Cheek Applicator: Up to 60 Energy LevelsChin Applicator: Up to 40 Energy Levels |
| e) | Frequency | 1 MHz | idem |
| f) | RF Pulse Width | 2 seconds | idem |
| g) | Number of electrodes | Cheek Applicators: 4 RF units, with 3 electrodes in each (total 12 electrodes on left cheek and 12 electrodes on right cheek)Chin Applicator: 3 RF units with 2 electrodes in each (total 9 electrodes) | Cheek Applicators: idemChin Applicator: 2 RF units with 3 electrodes in each (total 6 electrodes) |
| h) | Electrode dimensions | Thickness of side electrode: 4 mm;Thickness of middle electrode: 6 mm;Length of electrode: 21 mm;Centerline between electrodes: 9.5 mm | idem |
| i) | Temperature sensor | Thermistor embedded into the central electrode. | idem |
| j) | Applicator raw materials | ||
| a) | Applicator Housing | PC Makrolon 2458 | Tritan MXF 121 |
| b) | Cheek and Chin fixation mechanism | Adjustment straps and belts: JF-DG007- Cool Grey 11C90% Nylon and 10% Spandex Fabric with 1.2mm thickness | Fixture: Tritan MXF 121 |
| c) | RF/Pin electrodes | Gold coated stainless steel 304, insulated by Parylene C | idem |
Page 9 of 11
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| EmFace Device Cheek & Chin Applicators(InMode Ltd.)Main Predicate Device (K191855) | DEFINE System Cheek & Chin Applicators(InMode Ltd.)Modified device | |
|---|---|---|
| a) Sterilization and reprocessing | ||
| a) Sterilization | Not Applicable | idem |
| b) Reprocessing | Applicator handle is for multiple use | idem |
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Conclusions:
The DEFINE device has the same intended use and indication for use as the EmFace device with the Cheek and Chin Applicators (K191855) and the FORMA (K210492), MiniFX (K210492) and Morpheus8 (K210492 and 231790) Applicators. Furthermore, the technological characteristics are similar or even identical, including similar device components (i.e., main system platform containing the AC/DC power supply unit, main controller, two RF generators, distributor card and user interface including a touch screen), similar mechanism of action (heating skin and tissue layers using RF energy), similar treatment administration, similar energy regulation methods, biocompatibility of materials, validation of software component, and similar compliance with electrical, EMD and RF energy emitting device standards. The most important technological characteristic, i.e., using RF energy to deliver heat to the skin and tissue layers is the same in both devices.
The minor differences between the devices, mainly in the user interface to enable selecting the relevant Applicator, adding a temperature color scale to the temperatures and adding an indicator of the pressure for the Cheek Applicator contact with the skin, do not raise new types of questions about safety and effectiveness. Additional modifications to the Cheek and Chin Applicators included a more ergonomic design of positioning the applicators using a fixture rather than straps and belts, and modification of the patient contacting materials of the fixture (although the materials are still biocompatible). These modifications also do not raise new types of questions about safety and effectiveness
Furthermore, acceptable scientific methods were employed to evaluate the modified aspects of the device, including compliance with FDA recognized methods and standards to demonstrate RF safety and testing to validate the generated RF energy output in the DEFINE device is at least as safe and effective as the legally marketed, predicate EmFace device (K191855). Additionally, compliance with electrical and EMD safety standards, biocompatibility and validation of the device software have been provided in this 510(k) submission.
Consequently, the safety and effectiveness information provided in the 510(k) submission provides the supportive data necessary to demonstrate that the DEFINE device with the Cheek and Chin Applicators and the FORMA, MiniFX and Morpheus8 Applicators is substantially equivalent to the predicate EmFace device (K191855) and the FORMA (K210492), MiniFX (K210492) and Morpheus8 (K210492 and 231790) Applicators.
§ 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.