(174 days)
No
The description focuses on real-time impedance monitoring and adjusting RF energy based on that, which is a feedback loop mechanism, not necessarily AI/ML. There is no mention of learning, training data, or complex algorithms typically associated with AI/ML in the context of medical devices.
Yes
The device is intended for the percutaneous treatment of facial wrinkles, ablation and resurfacing of the skin, and non-invasive wrinkle treatment, all of which address medical conditions or provide therapeutic effects.
No
The device is intended for dermatological procedures involving electrocoagulation, hemostasis, ablation, resurfacing, and wrinkle treatment, which are therapeutic rather than diagnostic actions. Its functions involve delivering energy to tissue for treatment, not for identifying diseases or conditions.
No
The device description clearly outlines a system console with hardware components (CPU, power supply, RF pulse generator, I/O board, etc.) and physical applicators that deliver energy to the skin. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dermatological procedures, specifically electrocoagulation, hemostasis, ablation, resurfacing, and the treatment of facial wrinkles. These are all procedures performed directly on the patient's skin.
- Device Description: The device description details a system with applicators that deliver radiofrequency energy and infrared light to the skin. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such analysis.
- Performance Study: The performance study focuses on the clinical outcomes of the treatment (wrinkle improvement, patient satisfaction) rather than the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
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 Matrix Pro applicator is indicated for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV.
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
GEI
Device Description
Profound Matrix is a system that 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.
Console
The system console consists of a CPU, power supply, RF pulse generator, I/O board, splitter/distribution board and footswitch board. When the system is powered up, the user can select between user mode and service/maintenance mode. After selecting user mode and entering the required password, the user is requested to choose between the Matrix Pro, the Sublative RF or the Sublime applicators. Only one applicator can be used to treat a patient at any given time.
The user interfaces with the Profound Matrix System and applicators' settings through the 15″ touch screen. Each of the applicators have a finger trigger that can be used to activate the applicator or alternatively the end user can use the footswitch to activate the applicator.
Applicators
Matrix Pro
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 up to a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm.
The Matrix Pro applicator delivers the right amount of energy at the precise depth, every time. The technology of the Matrix Pro applicator combines adjustable depth, energy, and real time impedance monitoring for customizable and consistent results. The Profound Matrix system monitors tissue impedance across the 3 modalities, in real-time, while simultaneously adjusting RF energy pulse duration and power output. The result is an accurate dose of RF energy delivery with every treatment application for consistent treatment outcomes, independent of patient-to-patient, body location, skin hydration, and procedural-related impedance variations.
Sublative RF
The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface in a fractional manner via an array of multi-electrode pin tips, which results in heating of both the demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins while also delivering heat in a wide diffuse manner to the dermis.
Sublime
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)
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
A retrospective analysis of subject data was conducted to demonstrate the safety, efficacy, tolerability, and usability of the Matrix Pro Applicator for the treatment of wrinkles. The FUFT2002 source study, sponsored by Candela Medical, the manufacturer of the Profound Matrix System™, was a multi-site prospective clinical trial.
The retrospective analysis comprised data from 32 healthy subjects, aged 25-70 years, with Fitzpatrick Skin Types II-IV who received up to 3 full-face treatment for wrinkles with the Matrix Pro Applicator (27W) and returned for follow-ups 1- and 3- months after last treatment. A total of 92 treatments were conducted during the study, with treatments administered at depths ranging from 0.8 to 3.5 mm and 0.5 to 4.0 J pulse energy.
Primary efficacy endpoint was assessed by blinded evaluators comparing photographs taken at Baseline and at 3-month follow-up (3MFU) presented in randomized de-identified order. Treatment was considered a success if at least 2 of 3 blinded reviewers correctly identified the post-treatment photograph based on the appearance of wrinkles.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Retrospective analysis of subject data from a multi-site prospective clinical trial (FUFT2002).
Sample Size: 32 healthy subjects.
Key Results:
- Primary Efficacy Endpoint: Blinded reviewers correctly identified posttreatment photographs for 75% of subjects (24 of 32), surpassing the study's pre-determined success criteria of 70%.
- Post-hoc Assessment: 62.5% (20 of 32) of subjects were responders, defined as participants whose "after" photos were rated at least 1 point improved on the validated Fitzpatrick Wrinkle and Elastosis Scale (FWES) by at least two of three blinded reviewers.
- Mean Change in FWES: The mean change (improvement) in combined blinded evaluator FWES ratings from baseline to 3 Months Follow-Up assessment was found to be statistically significant (p
§ 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.
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July 1, 2024
Candela Corporation Rina Ordonez Sr. Regulatory Affairs Specialist 251 Locke Drive Marlborough, Massachusetts 01752
Re: K240070
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: January 9, 2024 Received: May 23, 2024
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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" (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).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.07.01 18:56:13 -04'00'
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
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Indications for Use
510(k) Number (if known) K240070
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 Matrix Pro applicator is indicated for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV.
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 62m.V/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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K240070 Profound Matrix System
This 510(k) Summary is being submitted in accordance with requirement 21CFR § 807.92.
1. General Information
January 9, 2024
Applicant Candela Corporation
251 Locke Drive Marlborough MA 01752 USA
Contact Person
Rina Ordonez Senior Regulatory Affairs Specialist Candela Corporation 251 Locke Dr. Marlborough, MA 01752 Office: 508-834-6072 Email: rinao@candelamedical.com
2. Device Information
Matrix™, Profound Matrix™ Proprietary Name/Trade Name: 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
3. Predicate Device
Primary Predicate: Lutronic Infini (K121481) Reference Predicate Device: Profound Matrix (K211217)
4. Device Description
Profound Matrix is a system that 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.
5
Console
The system console consists of a CPU, power supply, RF pulse generator, I/O board, splitter/distribution board and footswitch board. When the system is powered up, the user can select between user mode and service/maintenance mode. After selecting user mode and entering the required password, the user is requested to choose between the Matrix Pro, the Sublative RF or the Sublime applicators. Only one applicator can be used to treat a patient at any given time.
The user interfaces with the Profound Matrix System and applicators' settings through the 15″ touch screen. Each of the applicators have a finger trigger that can be used to activate the applicator or alternatively the end user can use the footswitch to activate the applicator.
Applicators
Matrix Pro
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 up to a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm.
The Matrix Pro applicator delivers the right amount of energy at the precise depth, every time. The technology of the Matrix Pro applicator combines adjustable depth, energy, and real time impedance monitoring for customizable and consistent results. The Profound Matrix system monitors tissue impedance across the 3 modalities, in real-time, while simultaneously adjusting RF energy pulse duration and power output. The result is an accurate dose of RF energy delivery with every treatment application for consistent treatment outcomes, independent of patient-to-patient, body location, skin hydration, and procedural-related impedance variations.
Sublative RF
The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface in a fractional manner viaan array of multi-electrode pin tips, which results in heating of both the demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins while also delivering heat in a wide diffuse manner to the dermis.
Sublime
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.
5. 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 Matrix Pro applicator is indicated for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV.
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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 higher energy levels greater than 100 ]/cm³, the Sublime applicator is limited to Fitzpatrick skin types I-IV.
6. New indication for use for the Matrix Pro
The Matrix Pro applicator is newly intended for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV. This new indication is supported by comparison of the subject device with the predicate and reference devices that demonstrate comparability in technical functionality, safety performance, and intended use (illustrated in the Table below), and through the provision of retrospective study clinical and safety data that supports the safety and efficacy of application of the subject device for the new intended use to the intended patient population.
| Type | Subject Device | Predicate Device | Reference Predicate Device |
|---|---|---|---|
| 510(k) | K240070 | K121481 | K211217 |
| Device Name | Matrix Pro - Profound Matrix | Infini RF system | Matrix Pro - Profound Matrix |
| Company Name | Candela Corporation | Lutronic Inc. | Candela Corporation |
| Product code | GEI-Electrosurgical, Cutting & | GEI-Electrosurgical, Cutting & | GEI-Electrosurgical, Cutting & |
| Coagulation & Accessories | Coagulation & Accessories | Coagulation & Accessories | |
| 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
Matrix Pro applicator is indicated for
the percutaneous treatment of facial
wrinkles in patients with Fitzpatrick
Skin Types I-IV.
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. | 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 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. |
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7. Intended Use / Indication For Use Comparison
The subject device, Matrix Pro, and its predicate device, Infini (K121481), have similar technical configurations and indications for use, both are intended to be used for not just general dermatological procedures for electrocoagulation and hemostasis but also for percutaneous facial wrinkles. Candela Corporation has performed clinical studies to support the wrinkles indications for use and the results of the studies can be found in the clinical section of this submission, demonstrating no new questions of safety or efficacy.
8. Technological Specifications Comparison
The subject device Matrix Pro applicator for Profound Matrix system shares with the predicate device Infini (K121481) the same underlying technology and presents similar intended use.
Both Matrix Pro and predicate devices use radiofrequency as their energy source with microneedles delivered to the skin. Both have the same main functional components consisting of a system console with a user interface.
The subject device is substantially equivalent to the predicate devices with respect to hardware and software, principle of operation and product design.
Any differences do not raise any new concerns for safety or efficacy. Matrix Pro has been tested and has completed a clinical study on the proposed indication that demonstrated the device's ability to meet the wrinkle endpoint.
9. Performance Data
The Profound Matrix has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards.
IEC 60601-1: Medical electrical equipment- Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility.
IEC 60101-2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
10. Clinical Performance
A retrospective analysis of subject data was conducted to demonstrate the safety, efficacy, tolerability, and usability of the Matrix Pro Applicator for the treatment of wrinkles. The FUFT2002 source study, sponsored by Candela Medical, the manufacturer of the Profound Matrix System™, was a multi-site prospective clinical trial.
The retrospective analysis comprised data from 32 healthy subjects, aged 25-70 years, with Fitzpatrick Skin Types II-IV who received up to 3 full-face treatment for wrinkles with the Matrix Pro Applicator (27W) and returned for follow-ups 1- and 3- months after last treatment. A total of 92 treatments were conducted during the study, with treatments administered at depths ranging from 0.8 to 3.5 mm and 0.5 to 4.0 J pulse energy.
8
Primary efficacy endpoint was assessed by blinded evaluators comparing photographs taken at Baseline and at 3-month follow-up (3MFU) presented in randomized de-identified order. Treatment was considered a success if at least 2 of 3 blinded reviewers correctly identified the post-treatment photograph based on the appearance of wrinkles. Blinded reviewers correctly identified posttreatment photographs for 75% of subjects (24 of 32), surpassing the study's pre-determined success criteria of 70%. Post-hoc assessment of the primary outcome was also performed defining an individual subject responder as a participant whose after photos were rated at least 1 point improved on the validated Fitzpatrick Wrinkle and Elastosis Scale (FWES) by at least two of three blinded reviewers. 62.5% (20 of 32) of subjects were responders under this criteria. Additionally, the mean change (improvement) in combined blinded evaluator FWES ratings from baseline to 3 Months Follow-Up assessment was found to be statistically significant (p