(311 days)
The Cytrellis® Dermal Micro-Coring™ System is intended for the treatment of moderate and severe wrinkles in the mid and lower face.
The Cytrellis Dermal Micro-Coring System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.
The Cytrellis Dermal Micro-Coring System removes unwanted skin by rapidly excising full thickness micro-columns of the dermal and epidermal tissue via specially designed hollow coring needles. The needles are controlled to precise coring depths and positions by the device console and handpiece. The system provides a range of skin removal percentages (treatment densities) and needle depths settings to customize the user needs that is controlled by the LCD touch display on the console. The treatment is applied in 1cm2 areas of the skin at a time by the handpiece, which has a vacuum assisted disposable in order to help with alignment between treatment areas. The Cytrellis Dermal Micro-Coring System mechanically removes full thickness sections of skin without evidence of scarring or need for surgical procedure. As much as 7.9% of the surface area of the skin is removed in columns that are the size of the inner diameter of the needle which is too small to cause visible scarring. The holes quickly close because of the natural elastin of the skin as they start to heal. This wound response, combined with the mechanical removal of the skin's surface area, leads to a reduction in the appearance of wrinkles.
Here's a breakdown of the acceptance criteria and study details for the Cytrellis Dermal Micro-Coring System, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Cytrellis Dermal Micro-Coring System are primarily focused on safety and effectiveness, demonstrated through non-clinical performance testing and a clinical study.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Result |
|---|---|---|
| Non-Clinical Performance Testing | ||
| Software | Documentation for moderate level of concern device in accordance with FDA Guidance. | Successfully submitted software documentation in accordance with FDA Guidance. (Page 6) |
| Electrical Safety | Meets relevant sections of IEC 60601-1. | Passed all relevant sections of IEC 60601-1. (Page 6) |
| Electromagnetic Interference (EMI) | Meets relevant sections (Radiated emissions, Conducted emissions, Harmonic emissions, Flicker emissions, Electrostatic discharge immunity test, radiated radio frequency immunity, Electrical fast transient/burst, lightning surge immunity, conducted RF immunity, electromagnetic field immunity, voltage dips and short interruptions, RFID compatibility, and power frequency magnetic field immunity test). | Successfully met all relevant sections to satisfy compliance. (Page 6) |
| Needle Characteristics | Identification of needle length, geometry, maximum penetration depth, and puncture rate. | Technical specifications and needle characteristics identified. (Page 7) |
| Accuracy of Needle Penetration Depth & Puncture Rate | Device performs as intended under anticipated conditions of use. | Accuracy of needle penetration depth and puncture rate tested in skin substrate model and measured using Keyence Laser System. (Page 7) |
| Safety Features (Cross-contamination, Fluid Ingress) | Device design prevents cross-contamination and fluid ingress (needle cartridge design, RFID, tortuous path). | Device design prevents cross-contamination and fluid ingress. Testing performed under worst-case scenarios. (Page 7) |
| Max Safe Needle Penetration Depth | Identification of max safe needle penetration depth for the device and labeled indications. | Maximum safe needle penetration depth identified in skin substrate model and measured using Keyence Laser System. (Page 7) |
| Sterility | Performance data demonstrates sterility of patient-contacting components according to ISO 11137-1:2006, ISO 11137-2:2013 and ISO/TS 13004:2013. | Performance data demonstrates sterility according to specified ISO standards. (Page 7) |
| Shelf Life | Performance data supports shelf life by demonstrating continued sterility, package integrity, and device functionality over intended shelf life according to ASTM F1980 -16, ISO 11607-1, ASTM F88-15, ASTM F1140 / F1140M-13, ASTM F2096-11, ASTM F1886 / F1886M-16. | Performance data supports shelf life according to specified ASTM and ISO standards. (Page 7) |
| Electrical Safety & EMC | Performance data demonstrates electrical safety and electromagnetic compatibility (EMC) of all electrical components according to IEC 60601-1:2012 3.1 edition and IEC 60601-1-2:2014. | Performance data demonstrates electrical safety and EMC according to specified IEC standards. (Page 7) |
| Software Verification, Validation, Hazard Analysis | Performed for all software components according to FDA Guidance. | Performed for all software components according to FDA Guidance. (Page 8) |
| Biocompatibility | Patient-contacting components demonstrated to be biocompatible (cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility per ISO 10993-1). | Demonstrated biocompatibility including evaluation of cytotoxicity, irritation, sensitization, acute systemic toxicity and material-mediated pyrogenicity and hemocompatibility per ISO 10993-1. (Page 8) |
| Cleaning & Disinfection Instructions | Validated for reusable components per AAMI TIR30:2011/(R)2016 and AAMI TIR12:2010. | Cleaning and disinfection validation performed for reusable components per AAMI TIR30:2011/(R)2016 and AAMI TIR12:2010. (Page 8) |
| Labeling (Device & Patient) | Includes required information on operation, technical parameters, reprocessing, disposal, shelf life, risks, benefits, and postoperative care. | Labeling includes all required information (as per sections 9 and 10 on page 8). |
| Clinical Study - Effectiveness | ||
| Reduction in Wrinkles | Mean change from baseline for the Lemperle Wrinkle Severity Scale (LWSS) is greater than 1.0. | Mean change from baseline for the LWSS was 1.3 [95% CI: 1.22, 1.42] when assessed at depth settings of up to 5mm. The lower limit of the 95% confidence interval is greater than 1.0, supporting the primary endpoint. When treatment was performed at up to 4mm, the LWSS change was 1.1. (Page 10) |
| Clinical Study - Safety | ||
| Adverse Events | No Serious Adverse Events; Anticipated Adverse Device Effects (ADEs) are mild to moderate and do not require intervention. | No Serious Adverse Events were reported. Nine (9) adverse events were reported in five (5) subjects, with four (4) considered ADEs (Black eye (bruising), cheek numbness, redness, track marks on cheek). All ADEs were classified as mild to moderate and did not require intervention, and were anticipated risks listed in labeling. (Page 10) |
Study Details for Clinical Evidence
Here are the details regarding the clinical study that proves the device meets the acceptance criteria for effectiveness and safety:
2. Sample Size and Data Provenance
- Sample Size for Test Set: Fifty-one (51) subjects completed the study.
- Data Provenance:
- Country of Origin: United States (multicenter study conducted at four (4) sites).
- Retrospective or Prospective: Prospective (subjects were treated over a period, and assessments were made at defined intervals post-treatment).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three (3) independent evaluators.
- Qualifications of Experts: The document states they were "blinded independent evaluators." While specific qualifications like "radiologist with 10 years of experience" are not provided, the context implies they are medical professionals qualified to assess wrinkle severity using the Lemperle Wrinkle Severity Scale (LWSS).
4. Adjudication Method for the Test Set
- The document implies that the assessment was performed by three independent evaluators, suggesting that their individual assessments contributed to the outcome. It does not explicitly state a specific adjudication method like "2+1" or "3+1" (e.g., if discrepancies were resolved by a tie-breaker or consensus). It reports a "mean change" based on their assessments, indicating all three evaluators' input was considered.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done comparing human readers with AI vs. without AI assistance.
- The study involved human evaluators assessing photographs to determine wrinkle improvement, but this was a measurement of the direct effect of the device on patients, not a study of AI assistance for human readers. The device itself is a physical microneedling system, not an AI diagnostic or assistance tool.
6. Standalone (Algorithm Only) Performance
- No standalone (algorithm-only) performance was done.
- As noted above, the Cytrellis Dermal Micro-Coring System is a physical medical device, not an AI algorithm. Its performance is measured by its direct effect on patients.
7. Type of Ground Truth Used
- Expert Consensus / Physician Reported Outcomes using a validated scale.
- The primary effectiveness endpoint was measured by improvement in wrinkles using the Lemperle Wrinkle Severity Scale (LWSS), assessed by three blinded independent evaluators from professional clinical portrait photographs.
- Safety ground truth was based on reported adverse events, classified by physicians as part of the clinical study.
8. Sample Size for the Training Set
- Not applicable / Not explicitly stated.
- This device is a physical medical device. The concept of a "training set" is typically associated with machine learning or AI models, which is not what this device is. The "training" for this device would refer to the development and engineering processes, which don't have a distinct "training set" like an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
- As explained above, there isn't a "ground truth for a training set" in the context of this physical device. The device's design and development would rely on engineering principles, preclinical testing (as outlined in section 1), and clinical studies for validation.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
July 12, 2022
Cytrellis Biosystems, Inc. Karen H. Cronholm President and CEO 299C Washington St Woburn, Massachusetts 01801
Re: K202517
Trade/Device Name: Cytrellis Dermal Micro-Coring System Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device for Aesthetic Use Regulatory Class: Class II Product Code: QAI
Dear Karen Cronholm:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 9, 2021. Specifically, FDA is updating this SE Letter for an omission of "22 years or older" in the Indications for Use Statement as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, long.chen@fda.hhs.gov.
Sincerely,
Colin K. Chen -S
for
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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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2021
Cytrellis Biosystems, Inc. Karen H. Cronholm President and CEO 299C Washington St Woburn, Massachusetts 01801
Re: K202517
Trade/Device Name: Cytrellis Dermal Micro-Coring System Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: June 9, 2021 Received: June 10, 2021
Dear Karen H. Cronholm:
We have reviewed vour 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/cdrl/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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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. Long H. Chen -S Chen -S Chen -S
Date: 2021.07.09 16:45:02 -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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202517
Device Name
Cytrellis Dermal Micro-Coring System
Indications for Use (Describe)
The Cytrellis Dermal Micro-Coring System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with 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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CYTRELLİ S
| Submitter: | Cytrellis Biosystems,Inc. 299C WashingtonStreet Woburn, MA01801 |
|---|---|
| Contact Person: | Karen CronholmPresident and CEOTelephone: 857-317-5191E-mail: kcronholm@cytrellis.com |
| Date Prepared: | July 9, 2021 |
| Device Trade Name: | Cytrellis® Dermal Micro-Coring™ System |
| Common Name: | Powered Microneedle Device |
| Classification Name: | Microneedling device for aesthetic use |
| Regulation Number: | 21 CFR 878.4430 (Product Code: QAI) |
| Predicate Device: | Exceed MicroneedlingDevice K180778 |
| Regulatory Class: | Class II |
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CYTRELLIS
Device Description:
The Cytrellis Dermal Micro-Coring System removes unwanted skin by rapidly excising full thickness micro-columns of the dermal and epidermal tissue via specially designed hollow coring needles. The needles are controlled to precise coring depths and positions by the device console and handpiece. The system provides a range of skin removal percentages (treatment densities) and needle depths settings to customize the user needs that is controlled by the LCD touch display on the console. The treatment is applied in 1cm2 areas of the skin at a time by the handpiece, which has a vacuum assisted disposable in order to help with alignment between treatment areas. The Cytrellis Dermal Micro-Coring System mechanically removes full thickness sections of skin without evidence of scarring or need for surgical procedure. As much as 7.9% of the surface area of the skin is removed in columns that are the size of the inner diameter of the needle which is too small to cause visible scarring. The holes quickly close because of the natural elastin of the skin as they start to heal. This wound response, combined with the mechanical removal of the skin's surface area, leads to a reduction in the appearance of wrinkles.
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| Statement of Intended Use: | The Cytrellis® Dermal Micro-Coring™ System is intended for the treatment of moderate and severe wrinkles in the mid and lower face. |
|---|---|
| Statement of Indication for Use: | The Cytrellis® Dermal Micro-Coring™ System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV |
| Summary of Non-Clinical Performance Testing: | The following performance and safety testing has confirmed the proposed device to be substantially equivalent to the predicate device: Software: documentation was prepared and submitted for a moderate level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices;Electrical Safety: the proposed Cytrellis Dermal Micro-Coring System has been tested and successfully passed all the relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety;Electromagnetic Interference: the proposed Cytrellis Dermal Micro-Coring System has been tested and successfully met all of the relevant sections (Radiated emissions, Conducted emissions, Harmonic emissions, Flicker emissions, Electrostatic discharge immunity test, radiated radio frequency immunity, Electrical fast transient/burst, lightning surge immunity, conducted RF immunity, electromagnetic field immunity, voltage dips and short interruptions, RFID compatibility, and power frequency magnetic field immunity test) to satisfy compliance. |
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To demonstrate safety and effectiveness and support substantial equivalence, the Cytrellis Dermal Micro-Coring System has undergone non-clinical performance testing in line with recognized standards.
| (1) The technical specifications and needle characteristics have been identified, includingneedle length, geometry, maximum penetration depth, and puncture rate. | ||
|---|---|---|
| (2) Non-clinical performance data demonstrates that the device performs as intendedunder anticipated conditions of use. The following performance characteristics havebeen tested: | ||
| (i) | Accuracy of needle penetration depthand puncture rate | Accuracy of needle penetration depth andpuncture rate was tested in a suitable skinsubstrate model and measured using theKeyence Laser System |
| (ii) | Safety features built into the device toprotect against cross-contamination &fluid ingress protection | The device design prevents crosscontamination including fluid ingressprotection due to the needle cartridge design.Design elements include RFID to preventneedle cartridge re-use and tortuous path forfluid ingress. Testing was performed underworst case scenarios. |
| (iii) | Identification of the max safe needlepenetration depth for the device & forthe labeled indications for use | Maximum safe needle penetration depth wasidentified in a suitable skin substrate modeland measured using the Keyence LaserSystem. |
| (3) Performance data must demonstrate thesterility of the patient-contactingcomponents of the device. | Performance data demonstrates the sterility ofthe patient-contacting components of thedevice according to ISO 11137-1:2006, ISO11137-2:2013 and ISO/TS 13004:2013 | |
| (4) Performance data must support the shelflife of the device by demonstratingcontinued sterility, package integrity, anddevice functionality over the intendedshelf life. | Performance data supports the shelf life of thedevice by demonstrating continued sterility,package integrity, and device functionalityover the intended shelf life according toASTM F1980 -16, ISO 11607-1, ASTM F88-15, ASTM F1140 / F1140M-13, ASTMF2096-11, ASTM F1886 / F1886M-16 | |
| (5) Performance data must demonstrate theelectrical safety and electromagneticcompatibility (EMC) of all electricalcomponents of the device. | Performance data demonstrates the electricalsafety and electromagnetic compatibility(EMC) of all electrical components of thedevice according to IEC 60601-1:2012 3.1edition and IEC 60601-1-2:2014 |
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| (6) Software verification, validation, andhazard analysis must be performed for allsoftware components of the device. | Software verification, validation, and hazardanalysis were performed for all softwarecomponents of the device according to inaccordance with FDA's Guidance for theContent of Premarket Submissions forSoftware Contained in Medical Devices |
|---|---|
| (7) The patient-contacting components of thedevice must be demonstrated to bebiocompatible. | The patient-contacting components of thedevice were demonstrated to be biocompatibleincluding evaluation of cytotoxicity, irritation,and sensitization, acute systemic toxicity andmaterial-mediated pyrogenicity andhemocompatibility per ISO 10993-1 |
| (8) Performance data must validate thecleaning and disinfection instructions forreusable components of the device. | A cleaning and disinfection validation wasperformed for reusable components of thedevice per AAMI TIR30:2011/(R)2016 andAAMI TIR12:2010 |
| (9) Labeling includes the following: | |
| (i) | Information on how to operate the device and its components and the typical course oftreatment; |
| (ii) | A summary of the device technical parameters, including needle length, needle geometry,maximum penetration depth, and puncture rate; |
| (iii) | Validated methods and instructions for reprocessing of any reusable components; |
| (iv) | Disposal instructions; and |
| (v) | A shelf life |
| (10) Patient labeling includes: | |
| (i) | Information on how the device operates and the typical course of treatment; |
| (ii) | The probable risks and benefits associated with use of the device; |
| (iii) | Postoperative care instructions |
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Results of Clinical Study:
A clinical study was conducted to support the safety and effectiveness of the Cytrellis Dermal Micro-Coring System for the treatment of moderate to severe cheek wrinkles in adults aged 22 years or older with Fitzpatrick skin types I-IV.
The objective of the study was to assess the effectiveness of the proposed device in reducing the signs of skin aging as measured by the improvement in wrinkles after at least two (2), but no more than three (3) standardized treatment sessions and to assess the safety of the proposed device as measured by the number of adverse events.
The multicenter study was conducted at four (4) sites in the United States. Subjects were treated at least two (2) times, but no more than (3) times, approximately 30 days apart, with the final assessment 90 days after the last treatment.
Professional clinical portrait photographs were taken of the subject at Day 0, Day 30, Day 60 and Day 90. Day 30, Dav 60 and Day 90 photos were taken for each treatment.*
Treatments were performed by licensed medical professionals.
Prior to treatment the subject was injected with local anesthetic, per the site's standard of care. The operator was instructed to use a skin removal (percent of skin removed per 1 cm2) of 6.7 or 7.9% for the face and submental areas and a skin removal percentage (needle density) of 6.7% for the perioral area. The operator started the treatment at a coredepth setting of 3mm but could increase or decrease the core-depth setting in increments of 0.5mm up to 5mm or down to 2.5mm, for a range of 2.5mm to 5mm to achieve maximum coring and ensure subject safety. Following the treatment, Aquaphor was applied to the treated areas.
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CYTRELLIS®
Demographics:
Fifty-one (51) subjects completed the study. The average age of the subjects was 62.9 years. The subject population was predominantly female (98%). The study included subjects with Fitzpatrick skin types I to IV.
Effectiveness - Physician Reported Outcomes:
A blinded assessment by three (3) independent evaluators was performed. The evaluators assessed before and 90-day post treatment* photographs of the subject's cheek area for improvement using the Lemperle Wrinkle Severity Scale (LWSS). When assessed at depth settings of up to 5mm, the mean change from baseline for the LWSS was 1.3 [95% CI: 1.22, 1.42]. The lower limit of the 95% confidence interval for the mean change is greater than 1.0, indicating that these data support the primary endpoint conclusion of 1 point or greater mean improvement. When the treatment was performed at up to 4mm, the LWSS change was 1.1.
Safety - Physician Reported Outcomes:
No Serious Adverse Events were reported. Nine (9) adverse events were reported in five (5) subjects. Of the nine, four (4) were considered Adverse Device Effects (ADEs). The ADEs were Black eye (bruising (1), cheek numbness (1), redness (1), and track marks on cheek (1). The ADEs were mild to moderate in severity and did not require intervention. All ADEs were anticipated risks of the device/treatment as listed in the device labeling.
*NOTE: Due to the COVID-19 pandemic subject photographs were taken at Day 150 or Day 180 per protocol amendment.
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Technical Specifications Comparison:
| Characteristic | Subject of this510(K)510(K) PendingCytrellis DermalMicro-CoringSystem | Predicate DeviceK180778ExceedMicroneedlingDevice | Similarities andsignificantdifferences to thepredicate device |
|---|---|---|---|
| DeviceManufacturer | Cytrellis Biosystems,Inc. | MT.DERM GmbHGustav-Krone-Str.3,14167 Berlin,Germany | NotApplicable |
| Device Trade Name | Cytrellis DermalMicro-Coring System | ExceedMicroneedlingdevice | Not Applicable |
| Product Code | QAI | QAI | Identical |
| Classification Name | Microneedling devicefor aesthetic use | Microneedlingdevice for aestheticuse | Identical |
| DeviceClassification | Class II | Class II | Identical |
| Regulation Number | 21 CFR 878.4430 | 21 CFR 878.4430 | Identical |
| Use | Prescriptive | Prescriptive | Identical |
| Intended Locationof Use | Mid and LowerFace | Face | Similar -Both devicesare for thetreatment ofwrinkles |
| Characteristic | Subject of this510(K)510(K) PendingCytrellis DermalMicro-CoringSystem | Predicate DeviceK180778ExceedMicroneedlingDevice | Similarities andsignificantdifferences to thepredicate device |
| Intended Use andIndications for Use | The Cytrellis®Dermal Micro-Coring™ System isintended for thetreatment ofmoderate and severewrinkles in the midand lower face.The Cytrellis DermalMicro-CoringSystem is indicatedfor use by medicalprofessionals for thetreatment ofmoderate and severewrinkles in the midand lower face inadults aged 22 yearsor older withFitzpatrick skin typesI-IV | The Exceed is amicroneedlingdevice andaccessories isintended for thetreatment ofwrinkles inFitzpatrick skintypes I, II and/or IIIin the followingfacial areas:glabellar frownlines, periorbitallines and cheekfolds in adults aged22 years or older. | Similar - Both devicesare used in aestheticprocedures indermatology. Bothdevices are for thetreatment of wrinkles.The proposedindication being soughtin this 510(K) is formoderate and severecheek wrinkles withFitzpatrick skin types I- IV. Clinicalperformance dataprovided demonstratesthat the CytrellisDermal Micro- CoringSystem is safe andeffective for theindication and intendeduse described. |
| Geometry | Single (1) needle orthree (3) needlesarranged in a straightline. Needles areground to 10-degreetip angle resulting intwo (2) cuttingservices and two (2)tips | 6 needles, squaredarrangement | Dissimilar - Clinicaland non-clinicalperformance testingdemonstrates that theCytrellis DermalMicro-Coring Systemdoes not pose anyundue or additionalrisks and is effective |
| Characteristic | Subject of this510(K)510(K) PendingCytrellis DermalMicro-CoringSystem | Predicate DeviceK180778ExceedMicroneedlingDevice | Similarities andsignificantdifferences to thepredicate device |
| Max Needle lengthused in clinicalstudy | Up to 5.0mm coredepth setting or6mm needle tipdepth | 1.5mm | Dissimilar - Clinicaland non-clinicalperformance testingdemonstrates that theCytrellis DermalMicro-Coring Systemdoes not pose anyundue or additionalrisks and is effective. |
| Characteristic | Subject of this510(K)510(K) PendingCytrellis DermalMicro-CoringSystem | Predicate DeviceK180778ExceedMicroneedlingDevice | Similarities andsignificant differencesto the predicate device |
| Maximum needlepenetration(maximum needlelength) | Up to 4.0mm coredepth setting or 5mmneedle tip depth | 1.5mm | Dissimilar - Clinical andnon-clinicalperformance testingdemonstrates that theCytrellis Dermal Micro-Coring System does notpose any undue oradditional risks and iseffective. |
| Needle protrusionsetting | 0-4.0mm coredepth setting or 1-5mm needle tipdepth | 0 - 1.9 mm | Dissimilar - Clinical andnon-clinical performancetesting demonstrates thatthe Cytrellis DermalMicro-Coring Systemdoes not pose any undueor additional risks and iseffective. |
| Frequency | 8-12 Hz | 100-150 Hz(±10%) | Dissimilar - Clinical andnon-clinical performancetesting demonstrates thatthe Cytrellis DermalMicro-Coring Systemdoes not pose any undueor additional risks and iseffective. |
| Treatment Protocol | At least 2 but no morethan 3 treatmentsspaced 4 weeks apart | 4 treatments spaced4 weeks apart | Dissimilar - Clinical andnon-clinical performancetesting demonstrates thatthe Cytrellis DermalMicro-Coring Systemdoes not pose any undueor additional risks and iseffective. |
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Image /page/12/Picture/0 description: The image shows the word "CYTRELLIS" in blue font with a line underneath it. To the right of the word is a symbol that looks like four red dots arranged in a square. The symbol is followed by the trademark symbol.
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Image /page/13/Picture/0 description: The image shows the word "CYTRELLIS" in blue font. There is a horizontal line under the word. To the right of the word, there are four red dots arranged in a square pattern.
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Image /page/14/Picture/0 description: The image shows the word "CYTRELLIS" in blue font with a horizontal line underneath. To the right of the word is a small design of four orange dots arranged in a diamond shape. The "S" in "CYTRELLIS" has a trademark symbol next to it.
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| Conclusion from Data: | Cytrellis Biosystems, Inc. has demonstrated that the proposed Cytrellis® Dermal Micro-Coring™ System is substantially equivalent to the predicate device based upon indications for use, design, test |
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results and the fundamental scientific technology.
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.