Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical mechanisms of action (radiofrequency, microneedles, infrared light) and does not mention any computational or data-driven decision-making processes characteristic of AI/ML. The performance studies are bench and animal/clinical testing based on physical effects, not algorithmic performance.

Therapeutic

Yes.
The device is indicated for dermatological procedures, including electrocoagulation, hemostasis, ablation, resurfacing of the skin, and the treatment of facial wrinkles. These are all therapeutic applications.

Diagnostic

No

This device is intended for dermatological procedures involving electrocoagulation, hemostasis, ablation, resurfacing, and wrinkle treatment, which are therapeutic rather than diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly details hardware components, including applicators with microneedles, multi-electrode pin tips, and an infrared light source, which deliver energy to the skin. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Profound Matrix System Function: The Profound Matrix System is described as a device for dermatological procedures that uses radiofrequency and infrared energy to treat the skin directly. It performs procedures like electrocoagulation, hemostasis, ablation, resurfacing, and wrinkle treatment.
Lack of Specimen Analysis: The description does not mention the collection, preparation, or analysis of any specimens from the human body. The device interacts directly with the patient's skin.

Therefore, the Profound Matrix System falls under the category of a therapeutic or surgical device used for direct treatment of the patient, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows:

The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis.

The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV.

The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/ cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

The Profound Matrix System combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime.

The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm.

The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface via an array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins.

The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin, Facial (for wrinkles)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Bench testing was performed on ex-vivo, excised abdominal skin tissue in order to evaluate the treatment effects from the Matrix Pro applicator and the predicate device, the Infini applicator, and to compare the effects of the two devices. Delivered RF energies for the Matrix Pro and the Lutronic Infini were designed to be similar. The samples were treated with four RF energy levels (1), 2J, 3J and 4J) and included three treatment depths using two depth configurations (dense and spread).

Thermal effects from RF energy pulses were measured and found to be at the pulse depth setting for Matrix Pro (investigational device) and Lutronic Infini (primary predicate device). The thermal effects were found in similar depths following treatments with both devices. Similar widths (diameter of thermal impact) were measured following 1J Matrix Pro treatments and 3J and 4J Infini treatments. This may be explained by the lack of control of energy levels with the Infini, where the Matrix. Pro uses the impedance, calculated using the voltage and current during the procedure, to determine the pulse length. Thus, the device emits the precise amount of energy to the surrounding tissue that was selected by the end-user.

It was observed that the Lutronic Infini and the Matrix Pro produce similar thermal effects resulting from each device's bipolar RF microneedling: collagen denaturation consistent with tissue heating was observed in the dermis (i.e., the target tissue) voids consistent with broken fat cells membranes and a surrounding layer of compressed fat cells were observed in the fat layer.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121481

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K141507, K110672, K161043

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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.

December 16, 2021

Candela Corporation Rina Ordonez 251 Locke Dr Marlborough, Massachusetts 01752

Re: K211217

Trade/Device Name: Profound Matrix Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 19, 2021 Received: November 22, 2021

Dear Rina Ordonez:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,

1

including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations. please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website 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,

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) K211217

Device Name Profound Matrix

Indications for Use (Describe) The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows:

The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis.

The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV.

The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/ cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Executive Use (Part 91, 125) Private Pleasure	For-Hire, Commercial (Part 135, 121)
-----------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary — K211217 Profound Matrix System

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92

1. DATE PREPARED

April 21, 2021

2. SUBMITTER

Candela Corporation 251 Locke Drive Marlborough MA 01752 USA

3. OFFICIAL CORRESPONDENT

Rina Ordonez Senior Regulatory Affairs Specialist Candela Corporation 251 Locke Dr. Marlborough, MA 01752 Office: 508-834-6072 Email: rinao@candelamedical.com

4. DEVICE INFORMATION

Proprietary Name:	Profound Matrix™
Common/Usual Name:	Electrosurgical coagulation device and accessory
Classification Name:	Electrosurgical cutting and coagulation device and
accessories (21 CFR Part 878.4400)
Product Code:	GEI
Device Classification:	Class II

5. PREDICATE DEVICE

Primary Predicate: Lutronic Infini (K121481) Reference Devices: Syneron Medical Ltd eTwo Skin Treatment System (K141507, K110672), Syneron Candela Corporation Profound System (K161043)

6. INTENDED USE/INDICATION FOR USE

The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows:

4

510(k) Summary — K211217

The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis.

The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited toFitzpatrick Skin Types I-IV.

The SUBLIME applicator is indicated for non-invasive wrinkles treatment. At higher energy levels greater than 100 J/cm³, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

DEVICE DESCRIPTION 7.

The Profound Matrix System combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime.

The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm.

The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface viaan array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins.

The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

8. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics comparison between the Profound Matrix System and its predicates is done per applicator and system console, as each applicator incorporates different technology, and the console enables each technology.

The following table (Table 8-1) compares the key technological characteristics and features of the Profound Matrix System to the predicate device. The tables that follow compare the key technical characteristics and features of the different applicators with predicate and reference devices (Tables 8-2, 8-3, and 8-4).

5

Predicate and Reference Devices			Reference Device		Reference Devices
Specifications	Subject Device	Predicate Device		Specifications	Profound Matrix-
Matrix Pro
(Subject Device)	Infini Infini Handpiece
K121481
(Predicate Device)	Profound Profound
Dermal K161043
(Reference Device #2)
		Profound Matrix	Infini
Radiofrequency
System (K121481)	eTwo
(K141507)	Applicator Type	Short Pulse
Microneedling	Short Pulse
Microneedling	Long Pulse
Microneedling
Indications for Use	The PROFOUND
MATRIX SYSTEM is
Intended for
dermatological
procedures, as
follows:

The MATRIX PRO
applicator is
intended for use in
dermatologic,
procedures for
electrocoagulation
and hemostasis.

The SUBLATIVE RF
applicator is
indicated for
dermatological
procedures
requiring ablation
and resurfacing of
the skin, and for
the treatment of
facial wrinkles. At
higher energy
levels greater than
62 mJ/pin, the
Sublative RF
applicator is
limited to
Fitzpatrick skin
types I-IV.

The SUBLIME
applicator is
indicated for non-
invasive wrinkles
treatment At | The INFINI
Radiofrequency
System is intended
for use in
dermatologic and
general surgical
procedures for
electrocoagulation
and hemostasis,
and the
percutaneous
treatment of facial
wrinkles. | The eTwo Skin
Treatment
System is
intended for
dermatological
procedures.

The Sublative
RF applicator is
indicated for
dermatological
procedures
requiring
ablation and
resurfacing of
the skin, and
for the
treatment of
facial wrinkles.
At higher
energy levels
greater than 62
mJ/pin, the
Sublative RF
applicator is
limited to skin
types I-IV.
The Sublime
applicator is
indicated for
non-invasive
wrinkles
treatment. At
higher energy
levels greater
than 100
J/cm3, the
Sublime
applicator is | The Profound
System is
indicated for use
in dermatologic
and general
surgical
procedures for
electrocoagulation
and hemostasis.
Specifically, the
25º Dermal
handpiece and
cartridge are used
for percutaneous
treatment of facial
wrinkles, and the
75º SubQ
handpiece and
cartridge are used
to improve the
appearance of
cellulite in
patients with
Fitzpatrick skin
types I-III as
supported by
long- term clinical
data (6 months). | Applicator Dimensions | 14.4 x 14.3 cm / 5.7 x
5.6" [W x H] | Unknown | 19.4 x 13.9 cm / 7.6 x
5.5" |
| Specifications | Subject Device | Predicate Device | Reference Device | Reference Device | Energy Source | Matrix Pro: Radio
Frequency | Infini handpiece: Radio
Frequency | Profound Dermal
Cartridge: Radio
Frequency |
| | Profound Matrix | Infini
Radiofrequency
System (K121481) | eTwo
(K141507) | Profound System
(K161043) | RF Mode of operation | Bipolar | Bipolar | Bipolar |
| | higher energy
levels greater than
100 J/cm3, the
Sublime applicator
is limited to
Fitzpatrick skin
types I-IV | | limited to skin
types I-IV. | | RF Frequency | 1 MHz | 1 MHz | 460±5 kHz |
| Device Dimensions | 39.4 x 57.4 x 135.6
cm | 36.2 x 40.9 x 171.3
cm | 30 x 23 x 53 cm | 46.5x 44.5 x 125
cm | Disposable Tip Area
Coverage & Injection
Pattern | 1 cm² Square | 49 needle Tip
1 cm²

Manual Sublative
Manual Sublime
Manual | Manual and Auto | Sublative –
Manual
Sublime –
Manual | Dermal – Manual
Subcutaneous –
Manual | Energy delivered per
treatment
level | 1 - 4 J | 25 mJ – 50 J
1 – 20 Levels* | Unknown |
| RF Energy Activation | Fingerswitch or
Footswitch | Fingerswitch or
Footswitch | Fingerswitch | Fingerswitch | Energy delivered per
treatment
zone | 20 – 82 mJ | 0.51 mJ – 1.02 J | Unknown |
| Treatment Settings | Matrix Pro –
needle depth and
RF energy
Sublative - RF
energy per pin
Sublime - RF
power density and
IR fluence | Manual mode –
needle depth, RF
level (power), and
RF pulse
duration. Auto
mode — Location
(Lower face
Submental, Neck,
Forehead,
Periorbital), Pass
(1 to 3), Intensity
(Low, Medium, | Sublative - RF
energy per pin
Sublime – RF
power density
and IR fluence | Dermal,
Subcutaneous –
Treatment
temperature and
treatment time | Controlled energy
delivered | Yes, Controlled by
sampling impedance | No
Not controlled | No
Not controlled |
| Controlled thermal dose | No | No | Yes, PID temperature
control 50-75°C ±10°C
with treatment duration
of 3-5 seconds | | | | | |
| Repetition
Rate** | No existing setting | No existing setting | No existing setting | | | | | |
| Needle uncoated | 0.6 mm | 0.3 mm | 3 mm | | | | | |

Table 8-1: SYSTEM LEVEL - Technical Comparison of Subject System Device with Predicate and Reference Devices

6

510(k) Summary – K211217

7

510(k) Summary – K211217

Table 8-2: HANDPIECE AND CARTRIDGE LEVEL - Technical Comparison of Subject Device with Predicate and Reference Devices

8

510(k) Summary – K211217

| Specifications | Profound Matrix-
Matrix Pro
(Subject Device) | Infini Infini Handpiece
K121481
(Predicate Device) | Profound Profound
Dermal K161043
(Reference Device #2) | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Needle insertion angle
to
tissue | 90° | 90° | 25° | |
| | Insertion depth range | 0.8 - 3.5 mm
Steps of 0.8 mm | 0.5 - 3.5 mm
Recommended steps of
at least 0.5 mm | 2 mm |
| | Accuracy of insertion
depth | ±0.4 mm | Unknown | Unknown |
| Needle Thickness /
Diameter | | 34 gauge
160 μm | 32 gauge
200 μm | 32 gauge
200 μm |
| Treatment Duration | Up to 4.5 sec | 10-400 ms (10 ms steps)
400-1000 ms (50 ms
steps) | 5 sec ±0.2 sec
increments | |
| Rated Voltage | 275 Vrms | Unknown | 84 Vrms | |
| Mode of Operation | Microneedles are
inserted into the dermis
where they emit bipolar
RF energy from their
electrode needle tips,
thermally damaging
surrounding tissue and
stimulating a
tissue healing process. | Microneedles are
inserted into the dermis
where they emit bipolar
RF energy from their
electrode needle tips,
thermally damaging
surrounding tissue and
stimulating a
tissue healing process | Microneedles are
inserted into the dermis
where they emit bipolar
RF energy from their
electrode needle tips,
thermally damaging
surrounding tissue and
stimulating a
tissue healing process | |

*Level is defined by Intensity/Rate of Heating (Level 5 is equivalent to 9.58 W with a 300-ohm impedance) **Repetition Rate is defined as preset period between needle withdrawal and the next needle insertion

9

| Specifications | Profound Matrix
Sublative RF
(Subject device) | eTwo Skin Treatment System
Sublative RF
K141507
(Reference Device #1) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Energy Type | RF | RF |
| Applicator Dimensions | 15 x 16 cm / 5.9 x 6.3"
[W x H] | 15 x 16 cm / 5.9 x 6.3"
[W x H] |
| Applicator Weight | 0.5 kg. / 1.1 lbs. | 0.5 kg. / 1.1 lbs. |
| RF Frequency | 1 MHz | 1 MHz |
| Power Range | 14-55 W | 14-55 W |
| Treatment Area | 64 pin Tip 12 x 12 mm
-or-
44 pin Tip 3 x 11 mm | 64 pin Tip 12 x 12 mm
-or-
44 pin Tip 3 x 11 mm |
| Pulse Duration | Up to 500 ms | Up to 500 ms |
| Total RF Energy | Up to 100mJ/pin | Up to 100mJ/pin |
| Applicator Dimensions | 15 x 16 cm | 15 x 16 cm |
| Disposable Tip Matrix | 44 or 64 matrix pins | 44 or 64 matrix pins |
| RF Energy Penetration
depth | Up to 400 µm | Up to 400 µm |
| Disposable Treatment Tip
Lifetime | Up to 400 pulses | Up to 400 pulses |
| Rated Voltage | 275 Vrms | 275 Vrms |
| Mode of operation | During treatment, the multi-
electrodepin array is placed on the
dry skin's surface. The RF current
flows betweenthe rows of the
pins, having the highest impact at
the electrode-skin contact points
where it creates spots of
demarcated ablation and
resurfacing of the skin (stratum
corneum, the deeper epidermis
and superficial dermis) to achieve
wrinkle | During treatment, the multi-
electrodepin array is placed on the
dry skin's surface. The RF current
flows betweenthe rows of the
pins, having the highest impact at
the electrode-skin contact points
where it creates spots of
demarcated ablation and
resurfacing of the skin (stratum
corneum, the deeper epidermis
and superficial dermis) to achieve
wrinkle |

Table 8-3: Comparison of parameters for Profound Matrix System's Sublative RF applicator and eTwo System's Sublative applicator

10

| Specifications | Profound Matrix
Sublime
(Subject Device) | eTwo Skin Treatment System
Sublime (Refirme)
K141507 (Reference Device
#1) |
|-----------------------|------------------------------------------------|-------------------------------------------------------------------------------------|
| Energy Type | RF and IR | RF and IR |
| Applicator Dimensions | 20 x 20 cm / 7.8 x 7.8" | 20 x 20 cm / 7.8 x 7.8" |
| | [W x H] | [W x H] |
| Applicator Weight | 1.0 kg. / 2.2 lbs. | 1.0 kg. / 2.2 lbs. |
| Frequency | 1 MHz | 1 MHz |
| RF Power | 200 W (≤138.9 W/cm2) | 200 W (≤138.9 W/cm2) |
| | | |
| Treatment Area | 8 x 12 mm | 8 x 12 mm |
| Pulse Duration | Up to 200 ms | Up to 200 ms |
| Total RF Energy | Hz Mode: 50-200 J/cm3 | Hz Mode: 50-200 J/cm3 |
| | Hz Mode: 50-100 J/cm3 | Hz Mode: 50-100 J/cm3 |
| Wavelength Spectrum | 700 – 2000 nm | 700 - 2000 nm |
| Optical Energy: Power | 6 W/cm² ± 20% | 6 W/cm² ± 20% |
| Light Pulse Duration | Up to 250 ms | Up to 250 ms |
| Rated Voltage | 300 Vrms | 300 Vrms |
| Mode of operation | RF combined with light energy | RF combined with light energy |
| | heats the biological tissue in a | heats the biological tissue in a |
| | controlled fashion for non- | controlled fashion for non- |
| | ablative therapeutic effects | ablative therapeutic effects |
| | which trigger dermal tissue | which trigger dermal tissue |
| | remodeling for the treatment | remodeling for the treatment |
| | of wrinkles. The physician | of wrinkles. The physician |
| | adjusts the treatment | adjusts the treatment |
| | parameters for the patient's | parameters for the patient's |
| | treatment and the applicator is | treatment and the applicator is |
| | moved in a constant circular | moved in a constant circular |
| | pattern for a further decrease | pattern for a further decrease |
| | of any potential heating | of any potential heating |
| | damage to the skin. | damage to the skin. |

Table 8-4: Comparison of parameters for Profound Matrix System's Sublime RF applicator and eTwo System's Sublime applicator

9. PERFORMANCE DATA

The following performance data supports the substantial equivalence determination:

Electrical Safety and Electromagnetic Compatibility Standards

IEC 60601-1: Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance

IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirementsfor safety –

11

510(k) Summary - K211217

collateral standard: electromagnetic compatibility (EMC)- requirements and test

IEC 60101-2-2: Particular requirements for the basic safety and essentialperformance of high frequency surgical equipment and high frequency surgical accessories.

Biocompatibility

The biocompatibility of the Profound Matrix System's patient contacting componentshas been established based on the predicate devices and the results of ISO 10993 testing.

Software Verification & Validation

Software verification and validation testing was conducted, and results were found tobe acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for SoftwareContained in Medical Devices."

Bench Testing

Candela conducted additional bench testing, verification, and validation to assure that the Profound Matrix functions safely under the predefines specifications. Theadditional bench tests performed are as follows:

Shelf-life and transportation testing
Human factors summative usability
Thermal testing in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Electrosurgical Devicesfor General Surgery," (March 9, 2020).
. Applicator cleaning and disinfecting validation in accordance with FDA's "Guidance for Industry and FDA Staff: Reprocessing Medical Devices in HealthCare Settings: Validation Methods and Labeling

Ex-Vivo Thermal Damage Evaluation Summary

Bench testing was performed on ex-vivo, excised abdominal skin tissue in order to evaluate the treatment effects from the Matrix Pro applicator and the predicate device, the Infini applicator, and to compare the effects of the two devices. Delivered RF energies for the Matrix Pro and the Lutronic Infini were designed to be similar. The samples were treated with four RF energy levels (1), 2J, 3J and 4J) and included three treatment depths using two depth configurations (dense and spread).

Thermal effects from RF energy pulses were measured and found to be at the pulse depth setting for Matrix Pro (investigational device) and Lutronic Infini (primary predicate device). The thermal effects were found in similar depths following treatments with both devices. Similar widths (diameter of thermal impact) were measured following 1J Matrix Pro treatments and 3J and 4J Infini treatments. This may be explained by the lack of control

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510(k) Summary - K211217

of energy levels with the Infini, where the Matrix.

Pro uses the impedance, calculated using the voltage and current during the procedure, to determine the pulse length. Thus, the device emits the precise amount of energy to the surrounding tissue that was selected by the end-user.

It was observed that the Lutronic Infini and the Matrix Pro produce similar thermal effects resulting from each device's bipolar RF microneedling: collagen denaturation consistent with tissue heating was observed in the dermis (i.e., the target tissue) voids consistent with broken fat cells membranes and a surrounding layer of compressed fat cells were observed in the fat layer.

Animal and Clinical Testing

Based on the similarities of the device specifications, intended use, indications for use between the Profound Matrix and its predicate device, no clinical or animal studies were needed to support this 510(k) Premarket Notification.

10. STATEMENT OF SAFETY AND EFFECTIVENESS

The Profound Matrix shares a similar design and intended use to its predicate (K121481). Additionally, principles of operation, performance characteristics, technological characteristics are similar between the Profound Matrix System and its predicate devices. The results of verification and validation activities, i.e., testing to standards and performance testing of the devices, have demonstrated substantial equivalence of the Profound Matrix to its predicate devices. The minor differences in the Profound Matrix System do not raise new types of questions regarding safety andefficacy, and the data presented in this 510(k) Premarket Notification supports the contention that the device is substantially equivalent to the predicate device.