(85 days)
No
The summary describes a computerized RF device for electrocoagulation and hemostasis, focusing on hardware components and basic monitoring of RF parameters. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.
No.
The device is intended for dermatological procedures for electrocoagulation and hemostasis, which are surgical functions, not therapeutic.
No
Explanation: The device description states its purpose is for "electrocoagulation and hemostasis" in dermatological procedures, which refers to treatment actions rather than diagnosis. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description explicitly details hardware components such as an AC/DC power supply unit, RF generator, controller, user interface (LCD touch screen), applicators, cable, and foot switch. It is a physical device that utilizes RF technology.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "dermatological procedures for electrocoagulation and hemostasis." This involves directly treating the patient's skin and tissues.
- Device Description: The device is described as an RF technology-based system that delivers energy to the skin via multi-electrode pins. This is a therapeutic device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to perform a procedure on the patient.
In Vitro Diagnostics (IVDs) are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.
Product codes
GEI
Device Description
The InMode System with the Morpheus8 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.
The device platform is basically constituted on the same system platform as FDA-Cleared InMode System with the Morpheus8 Applicators (K192695). The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.
The InMode System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus8 Applicator comprises handle and detachable, sterilized, disposable, single use 12, 24, 40 pin and T tip head accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body parts requiring treatment as specified in the indication for use
Indicated Patient Age Range
Adults requiring treatment as specified in the indication for use
Intended User / Care Setting
Hospital or Clinic setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical (Bench) Performance Data:
The performance and safety of the InMode System with the Morpheus8 Applicators treatment in dermatological procedures requiring electrocoagulation and hemostasis in deeper tissues of up to 5, 6 and 7 mm was evaluated in an ex-vivo tissue study. The study was conducted on a porcine animal model and included a single treatment of two different harvested porcine tissues: muscle and fat utilizing the InMode System with the Morpheus8 applicator 40 pin tip head. Treatment was followed by biopsy sampling of slices trimmed along the pin's penetration path and collection immediately stained by TTC staining to visualize the tissue coagulation necrosis pattern. The ex-vivo study results show that the Morpheus8 Applicators is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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.
July 2, 2020
InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba. Israel 4442520
Re: K200947/S001
Trade/Device Name: InMode System with the Morhpeus8 Applicators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 10, 2020 Received: June 12, 2020
Dear Amit Goren:
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.
1
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 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).
Sincerely.
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
2
Indications for Use
510(k) Number (if known) K200947
Device Name
InMode System with the Morpheus8 Applicators
Indications for Use (Describe)
The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62 m./pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| $\bigotimes$ Prescription Use (Part 21 CFR 801 Subpart D) | $\square$ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
INMODE SYSTEM WITH THE MORPHEUS8 APPLICATORS
510(k) Number K200947
Applicant Name:
| Company Name: | InMode MD Ltd. |
|---|---|
| Address: | Tabor Building, Shaar Yokneam |
| Yokneam 20692 | |
| Israel | |
| Tel: +972-4-9097470 | |
| Fax: +972-4-9097471 | |
| E-mail: amit@asteinrac.com |
Contact Person:
| Official Correspondent: | Amit Goren |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 44425 | |
| Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: amit@asteinrac.com | |
| Date Prepared: | July 02, 2020 |
| Trade Name: | InMode System with the Morpheus8 Applicators |
| Classification Name: | CFR Classification section 878.4400; (Product code GEI) |
| Classification: | Class II Medical Device |
Predicate Device:
The InMode System with the Morpheus8 Applicators is substantially equivalent to the following predicate device;
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| InMode Ltd. | InMode System with the Morpheus8 | |
| Applicators | K192695 |
4
Device Description:
The InMode System with the Morpheus8 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.
The device platform is basically constituted on the same system platform as FDA-Cleared InMode System with the Morpheus8 Applicators (K192695). The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.
The InMode System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus8 Applicator comprises handle and detachable, sterilized, disposable, single use 12, 24, 40 pin and T tip head accessory.
Following are the InMode System with the Morpheus8 Applicators specifications:
| RF Max Output Power: | 65 Watt |
|---|---|
| RF Output Frequency: | 1[MHz] |
| Dimension: | 46cm W x 46cm D x 100cm H |
| (18.2" W x 18.2" D x 40" H) | |
| Weight: | 30 Kg (70.4 lbs.) |
| Main Line Frequency (nominal): | 50-60 Hz |
| Input Voltage (nominal): | 100-240 VAC |
Intended Use/Indication for Use:
The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.
5
Performance Standards:
The InMode System with the Morpheus8 Applicators has been tested and complies with the following voluntary recognized standards:
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- 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.
- 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.
Non-Clinical (Bench) Performance Data:
The performance and safety of the InMode System with the Morpheus8 Applicators treatment in dermatological procedures requiring electrocoagulation and hemostasis in deeper tissues of up to 5, 6 and 7 mm was evaluated in an ex-vivo tissue study. The study was conducted on a porcine animal model and included a single treatment of two different harvested porcine tissues: muscle and fat utilizing the InMode System with the Morpheus8 applicator 40 pin tip head. Treatment was followed by biopsy sampling of slices trimmed along the pin's penetration path and collection immediately stained by TTC staining to visualize the tissue coagulation necrosis pattern. The ex-vivo study results show that the Morpheus8 Applicators is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis.
Animal Performance Data / Histology Data:
Not Applicable
Clinical Performance Data:
Not Applicable
6
Substantial Equivalence:
A comparison table is provided below comparing the intended use and basic technological characteristics of the subject device to the intended use and basic technological characteristics of the predicate device.
| Technological
Characteristic | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K200947
(Subject Device) | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K192695
(Predicate Device) |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,
Class | GEI
Class II | GEI
Class II |
| Indications for
Use | The InMode System with
the Morpheus8
Applicators is intended for
use in dermatological and
general surgical
procedures for
electrocoagulation and
hemostasis.
At higher energy levels
greater than 62 mJ/pin, use
of these Applicators is
limited to Skin Types I-IV. | The InMode System with
the Morpheus8
Applicators is intended
for use in dermatological
procedures for
electrocoagulation and
hemostasis.
At higher energy levels
greater than 62 mJ/pin,
use of these Applicators
is limited to Skin Types
I-IV. |
| Anatomical
Sites | Body parts requiring
treatment as specified in
the indication for use | idem |
| Target
Population | Adults requiring treatment
as specified in the
indication for use | idem |
| Environment
Used | Hospital or Clinic setting | idem |
| Energy Used /
Delivered | RF energy | idem |
| Design: | Fractional RF: Use of RF
energy delivered through a
matrix of multiple pin
electrodes allocated on the
applicator tip | idem |
| - Mechanism of
Action | Treatment is based on
fractional RF technology
for localized dermis and | idem |
| Technological
Characteristic | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K200947
(Subject Device) | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K192695
(Predicate Device) |
| | sub dermis coagulation
triggering slow collagen
regeneration and fibroblast
cells' proliferation. | |
| - Components | The InMode Morpheus8
Applicators are add-on
applicators to the FDA
cleared InMode System
(K192695).
The system consists of the
following components:
- Console, including a
power supply, RF
generator, controller, and
touch screen control and
display panel. - Applicator connected to
the console via a cable,
with tip including 12, 24,
40 & T tip heads. - Footswitch | idem |
| - System
Dimensions | 46cm W x 46cm D x
100cm H
[18.2" W x 18.2" D x
40" H] | idem |
| - Weight
Platform weight | 30 Kg (70.4 lbs.) | idem |
| Applicator
weight | Applicator - 0.4 Kg (0.88
lbs.)
Tip - 0.02 Kg | |
| Number of pins | 12, 24 and 40 pins | idem |
| Maximal
Treatment depth | 0.5mm (for T tip head)
4.0mm (for 12 pin tip
head)
7.0mm (for 24 and 40 pin
tip heads) | 0.5mm (for T tip head)
4.0mm (for 12 pin tip
head)
4.0mm (for 24 and 40 pin
tip heads) |
| Technological
Characteristic | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K200947
(Subject Device) | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K192695
(Predicate Device) |
| RF energy level | 5-30 (for 24 tip head up to
1 mm)
5-30 (for T tip head and
for 12 tip head)
5-60 (for 24 and 40 in the
range of 2-7mm) | 5-30 (for 24 tip head up
to 1 mm)
5-30 (for T tip head and
for 12 tip head up to 1
mm)
5-60 (for 12 tip head in
the range of 2-4mm)
5-60 (for 24 and 40 in the
range of 2-4mm) |
| Cable
Dimensions: | 270 cm | idem |
| Performance | Frequency: 1 MHz
Maximal RF output
power: 65W
Maximal pulse duration:
up to 74msec | idem |
| Standards Met | AAMI/ANSI ES 60601-1
IEC 60601-1-2
IEC 60601-2-2 | idem |
| Biocompatibility | All materials are
biocompatible | idem |
| Compatibility
with
Environment
and Other
Devices | InMode System with the
Morpheus8 Applicators is
compliant with the IEC
60601-1-2 (EMC Safety)
standard | idem |
| Sterility | The 12, 24, 40 and T tip
head are Gamma sterilized
and for single use.
The Morpheus8
Applicator handle is for
multiple use | idem |
| Technological
Characteristic | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K200947
(Subject Device) | InMode System with the
Morpheus8 Applicators
InMode Ltd.
K192695
(Predicate Device) |
| | 100-240 VAC 50-60 Hz
The InMode System with
the Morpheus8
Applicators is compliant
with the IEC 60601-1
standard. | |
| Mechanical
Safety | The InMode System with
the Morpheus8 Applicator
is compliant with the IEC
60601-1 standard. | idem |
| Chemical Safety | Not Applicable | Not Applicable |
| Thermal Safety | The InMode System with
the Morpheus8
Applicators is compliant
with the IEC 60601-1
standard. | idem |
| Radiation Safety | The InMode System with
the Morpheus8
Applicators is compliant
with the IEC 60601-1-2
(EMC Safety) standard. | idem |
7
8
9
The indications for use and technological characteristics of the InMode System with the Morpheus8 Applicators are substantially equivalent to the indications for use and technological characteristics of the FDA-Cleared InMode System with the Morpheus8 Applicators (K192695).
The design and components in the InMode System, including the console (with power supply, RF generator, controller and display panel) and the Applicator (with cable, connector to console, handle and tip) are similar to the design and components found in the predicate. The performance specifications (including RF frequency, pulse duration and RF energy per pin) of the subject device were shown to be identical and yielded the same RF energy per pin values to those of the predicate device. The safety features and compliance with safety standards in the InMode System with the Morpheus8 Applicators are identical to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also identical. Any minor differences in the technological characteristics do not raise new safety or effectiveness
10
concerns. Furthermore, the new InMode System with the Morpheus8 Applicators underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 and IEC 60601-2-2, comparative bench testing and ex-vivo tissue testing to evaluate and compare the fractional coagulation necrosis pattern of target tissues, formed by thermal effect of the InMode System with the Morpheus8 Applicators 24 and 40 pin tip heads in different tissue depths. These performance tests demonstrated that the minor differences in the device design and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the InMode System with the Morpheus8 Applicators are substantially equivalent to the predicate InMode System with the Morpheus8 Applicators, FDA-Cleared in 510(k) K192695, and therefore, may be legally marketed in the USA.