(237 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Profound Matrix device, based on the provided text:
Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results for a novel device. As such, information regarding acceptance criteria for a new clinical performance study, multi-reader multi-case studies, and detailed ground truth establishment for a training set are largely not applicable or not provided in this context. The document explicitly states that "no clinical or animal studies were needed to support this 510(k) Premarket Notification."
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for a new clinical performance study with specific metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating that the device's technical characteristics and performance are comparable to the legally marketed predicate device, and it meets relevant safety and performance standards.
| Acceptance Criterion (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance (from Bench Testing) |
|---|---|
| Electrical Safety (IEC 60601-1) | Passed - Conducted testing and found to be acceptable. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Passed - Conducted testing and found to be acceptable. |
| High-Frequency Surgical Equipment Safety (IEC 60101-2-2) | Passed - Conducted testing and found to be acceptable. |
| Biocompatibility (ISO 10993) | Established based on predicate devices and results of ISO 10993 testing. |
| Software Verification & Validation (FDA Guidance) | Passed - Verification and validation testing conducted, results acceptable for software release, performed per FDA guidance. |
| Shelf-life and Transportation Testing | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Human Factors Summative Usability | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Thermal Testing (FDA Guidance for Electrosurgical Devices) | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Applicator Cleaning and Disinfecting Validation (FDA Guidance) | Performed. (Results are not explicitly detailed but are implied to be acceptable for substantial equivalence). |
| Ex-Vivo Thermal Damage Equivalence (Matrix Pro vs. Predicate) | Showed similar thermal effects (collagen denaturation, voids, and compressed fat cells) at similar depths and (for some settings) widths compared to the predicate (Infini). Noted that Matrix Pro has better energy control due to impedance calculation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the Ex-Vivo Thermal Damage Evaluation, the sample size was not explicitly specified numerically, but it involved "excised abdominal skin tissue." 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)."
- For other bench tests (electrical safety, EMC, software, etc.), the "sample size" refers to the device units tested, which is typically a smaller number to demonstrate compliance with engineering standards.
- No clinical test set was required or used for this 510(k) submission.
- Data Provenance:
- Ex-Vivo Thermal Damage Evaluation: The tissue was "ex-vivo, excised abdominal skin tissue." The country of origin is not specified, but it was likely laboratory bench testing.
- For other tests like electrical safety, EMC, and software, the data provenance would be internal laboratory testing by Candela Corporation.
- Retrospective or Prospective: All testing described is prospective bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided in this context. Since no clinical studies were performed, there was no need for experts to establish ground truth on patient data. The "ground truth" for the ex-vivo thermal damage evaluation would be the observed histological changes, interpreted by the researchers conducting the bench test.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided in this context. As there were no clinical studies and no expert interpretation of patient data for performance metrics, no adjudication method was mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The 510(k) summary explicitly states, "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."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, in the context of device function. The "performance" described pertains to the standalone device functionality and its components (applicators, software, electrical systems) rather than an AI algorithm. The Ex-Vivo Thermal Damage Evaluation and other bench tests evaluate the device's inherent performance. There is no mention of an AI algorithm in the traditional sense (e.g., for diagnosis or prediction) and therefore no standalone algorithm performance in that context.
7. The Type of Ground Truth Used
- For Ex-Vivo Thermal Damage Evaluation: Histological observation of "collagen denaturation consistent with tissue heating" and "voids consistent with broken fat cells membranes and a surrounding layer of compressed fat cells" were the "ground truth" for evaluating the thermal effects. This is a type of laboratory/experimental observation.
- For other bench tests: The "ground truth" is adherence to established engineering and safety standards (e.g., electrical parameters, software functionality).
8. The Sample Size for the Training Set
- Not Applicable. As no clinical or animal studies were performed and no machine learning algorithm for diagnostic or predictive purposes was described, there was no training set in the typical sense for a medical AI device. The device's "training" would be its design and engineering based on existing knowledge and predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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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,
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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
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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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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 andaccessories (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:
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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).
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| Predicate and Reference Devices | Reference Device | Reference Device | Reference Devices | |||||
|---|---|---|---|---|---|---|---|---|
| Specifications | Subject Device | Predicate Device | Specifications | Profound Matrix-Matrix Pro(Subject Device) | Infini Infini HandpieceK121481(Predicate Device) | Profound ProfoundDermal K161043(Reference Device #2) | ||
| Profound Matrix | InfiniRadiofrequencySystem (K121481) | eTwo(K141507) | Applicator Type | Short PulseMicroneedling | Short PulseMicroneedling | Long PulseMicroneedling | ||
| Indications for Use | The PROFOUNDMATRIX SYSTEM isIntended fordermatologicalprocedures, asfollows:The MATRIX PROapplicator isintended for use indermatologic,procedures forelectrocoagulationand hemostasis.The SUBLATIVE RFapplicator isindicated fordermatologicalproceduresrequiring ablationand resurfacing ofthe skin, and forthe treatment offacial wrinkles. Athigher energylevels greater than62 mJ/pin, theSublative RFapplicator islimited toFitzpatrick skintypes I-IV.The SUBLIMEapplicator isindicated for non-invasive wrinklestreatment At | The INFINIRadiofrequencySystem is intendedfor use indermatologic andgeneral surgicalprocedures forelectrocoagulationand hemostasis,and thepercutaneoustreatment of facialwrinkles. | The eTwo SkinTreatmentSystem isintended fordermatologicalprocedures.The SublativeRF applicator isindicated fordermatologicalproceduresrequiringablation andresurfacing ofthe skin, andfor thetreatment offacial wrinkles.At higherenergy levelsgreater than 62mJ/pin, theSublative RFapplicator islimited to skintypes I-IV.The Sublimeapplicator isindicated fornon-invasivewrinklestreatment. Athigher energylevels greaterthan 100J/cm3, theSublimeapplicator is | The ProfoundSystem isindicated for usein dermatologicand generalsurgicalprocedures forelectrocoagulationand hemostasis.Specifically, the25º Dermalhandpiece andcartridge are usedfor percutaneoustreatment of facialwrinkles, and the75º SubQhandpiece andcartridge are usedto improve theappearance ofcellulite inpatients withFitzpatrick skintypes I-III assupported bylong- term clinicaldata (6 months). | Applicator Dimensions | 14.4 x 14.3 cm / 5.7 x5.6" [W x H] | Unknown | 19.4 x 13.9 cm / 7.6 x5.5" |
| Specifications | Subject Device | Predicate Device | Reference Device | Reference Device | Energy Source | Matrix Pro: RadioFrequency | Infini handpiece: RadioFrequency | Profound DermalCartridge: RadioFrequency |
| Profound Matrix | InfiniRadiofrequencySystem (K121481) | eTwo(K141507) | Profound System(K161043) | RF Mode of operation | Bipolar | Bipolar | Bipolar | |
| higher energylevels greater than100 J/cm3, theSublime applicatoris limited toFitzpatrick skintypes I-IV | limited to skintypes I-IV. | RF Frequency | 1 MHz | 1 MHz | 460±5 kHz | |||
| Device Dimensions | 39.4 x 57.4 x 135.6cm | 36.2 x 40.9 x 171.3cm | 30 x 23 x 53 cm | 46.5x 44.5 x 125cm | Disposable Tip AreaCoverage & InjectionPattern | 1 cm² Square | 49 needle Tip1 cm²16 needle Tip 0.36 cm²Square | 1.4 cm x 0.16 cm Pseudo-Linear |
| Weight(Pounds, Kg) | 50, 22.5 | 61.7, 28 | 18.7, 8.5 | 55, 23 | RF Pulse duration | Up to 280 ms | 10 to 1000 ms | 3-5 seconds |
| Power Supply | Yes | Yes | Yes | Yes | # Of needles | 49 (7 x 7) | 49 (7 x 7) or 16 (4 x 4) | 10 (5 pairs of 2) |
| ElectricalRating | Single phase 100-240V, 3A,50/60Hz | Single phaseAC220-230V, 50-60HzPowerconsumption:500VA(Fuse: 250V/6.3A) | Single phase100-240 VAC,3A, 50-60Hz | Single phase 100-240 V, 2.5A,50-60Hz | # Of treatment levelsperinsertion | 1, 2 or 3 | 1 | 1 |
| User Interface | Graphics withtouchscreen | Graphics withtouchscreen | Graphics withtouchscreen | Graphics withtouchscreen | # Of treatment zonesperinsertion | 49, 98, or 147 | 49 | 5 |
| Applicators | Matrix Pro (RFmicroneedles)Sublative Sublime | RF microneedles | SublativeSublime | Dermal RFSubcutaneous RF | Maximum RF power | 50 W | 50 W | 15 W |
| Treatment Modes | Matrix Pro- Manual Sublative- Manual Sublime- Manual | Manual and Auto | Sublative –ManualSublime –Manual | Dermal – ManualSubcutaneous –Manual | Energy delivered pertreatmentlevel | 1 - 4 J | 25 mJ – 50 J1 – 20 Levels* | Unknown |
| RF Energy Activation | Fingerswitch orFootswitch | Fingerswitch orFootswitch | Fingerswitch | Fingerswitch | Energy delivered pertreatmentzone | 20 – 82 mJ | 0.51 mJ – 1.02 J | Unknown |
| Treatment Settings | Matrix Pro –needle depth andRF energySublative - RFenergy per pinSublime - RFpower density andIR fluence | Manual mode –needle depth, RFlevel (power), andRF pulseduration. Automode — Location(Lower faceSubmental, Neck,Forehead,Periorbital), Pass(1 to 3), Intensity(Low, Medium, | Sublative - RFenergy per pinSublime – RFpower densityand IR fluence | Dermal,Subcutaneous –Treatmenttemperature andtreatment time | Controlled energydelivered | Yes, Controlled bysampling impedance | NoNot controlled | NoNot controlled |
| Controlled thermal dose | No | No | Yes, PID temperaturecontrol 50-75°C ±10°Cwith treatment durationof 3-5 seconds | |||||
| RepetitionRate** | 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
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510(k) Summary – K211217
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510(k) Summary – K211217
Table 8-2: HANDPIECE AND CARTRIDGE LEVEL - Technical Comparison of Subject Device with Predicate and Reference Devices
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510(k) Summary – K211217
| Specifications | Profound Matrix-Matrix Pro(Subject Device) | Infini Infini HandpieceK121481(Predicate Device) | Profound ProfoundDermal K161043(Reference Device #2) | |
|---|---|---|---|---|
| Needle insertion angletotissue | 90° | 90° | 25° | |
| Insertion depth range | 0.8 - 3.5 mmSteps of 0.8 mm | 0.5 - 3.5 mmRecommended steps ofat least 0.5 mm | 2 mm | |
| Accuracy of insertiondepth | ±0.4 mm | Unknown | Unknown | |
| Needle Thickness /Diameter | 34 gauge160 μm | 32 gauge200 μm | 32 gauge200 μm | |
| Treatment Duration | Up to 4.5 sec | 10-400 ms (10 ms steps)400-1000 ms (50 mssteps) | 5 sec ±0.2 secincrements | |
| Rated Voltage | 275 Vrms | Unknown | 84 Vrms | |
| Mode of Operation | Microneedles areinserted into the dermiswhere they emit bipolarRF energy from theirelectrode needle tips,thermally damagingsurrounding tissue andstimulating atissue healing process. | Microneedles areinserted into the dermiswhere they emit bipolarRF energy from theirelectrode needle tips,thermally damagingsurrounding tissue andstimulating atissue healing process | Microneedles areinserted into the dermiswhere they emit bipolarRF energy from theirelectrode needle tips,thermally damagingsurrounding tissue andstimulating atissue 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
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| Specifications | Profound MatrixSublative RF(Subject device) | eTwo Skin Treatment SystemSublative RFK141507(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 Penetrationdepth | Up to 400 µm | Up to 400 µm |
| Disposable Treatment TipLifetime | 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 thedry skin's surface. The RF currentflows betweenthe rows of thepins, having the highest impact atthe electrode-skin contact pointswhere it creates spots ofdemarcated ablation andresurfacing of the skin (stratumcorneum, the deeper epidermisand superficial dermis) to achievewrinkle | During treatment, the multi-electrodepin array is placed on thedry skin's surface. The RF currentflows betweenthe rows of thepins, having the highest impact atthe electrode-skin contact pointswhere it creates spots ofdemarcated ablation andresurfacing of the skin (stratumcorneum, the deeper epidermisand superficial dermis) to achievewrinkle |
Table 8-3: Comparison of parameters for Profound Matrix System's Sublative RF applicator and eTwo System's Sublative applicator
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| Specifications | Profound MatrixSublime(Subject Device) | eTwo Skin Treatment SystemSublime (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.
§ 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.