(311 days)
Not Found
No
The device description focuses on mechanical removal of skin tissue and control of needle depth and position. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the treatment of moderate and severe wrinkles in the mid and lower face, which is a medical condition or aesthetic concern that benefits from intervention.
No
The Cytrellis® Dermal Micro-Coring™ System is intended for the treatment of moderate and severe wrinkles by mechanically removing skin, not for diagnosing conditions.
No
The device description clearly outlines physical components like a console, handpiece, needles, and an LCD touch display, indicating it is a hardware-based medical device.
Based on the provided information, the Cytrellis® Dermal Micro-Coring™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of moderate and severe wrinkles in the mid and lower face. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device mechanically removes skin tissue to improve the appearance of wrinkles. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Anatomical Site: The device is applied directly to the skin of the face. IVDs typically involve testing samples taken from the body.
- Performance Studies: The studies focus on the effectiveness of the treatment in reducing wrinkles and the safety of the device during treatment. They do not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for IVDs.
In summary, the Cytrellis Dermal Micro-Coring System is a therapeutic device used for a cosmetic procedure, not a device used to perform diagnostic tests on samples outside the body.
N/A
Intended Use / Indications 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.
Product codes
QAI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mid and lower face
Indicated Patient Age Range
22 years or older
Intended User / Care Setting
medical professionals
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 blinded assessment by three (3) independent evaluators was performed. The evaluators assessed before and 90-day post treatment photos of the subject's cheek area for improvement using the Lemperle Wrinkle Severity Scale (LWSS).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 multicenter study was conducted at four (4) sites in the United States.
Fifty-one (51) subjects completed the study.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Mean change from baseline for the LWSS was 1.1 when the treatment was performed at up to 4mm.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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
3
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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4
CYTRELLİ S
| Submitter: | Cytrellis Biosystems,
Inc. 299C Washington
Street Woburn, MA
01801 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cronholm
President and CEO
Telephone: 857-317-5191
E-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 Microneedling
Device K180778 |
| Regulatory Class: | Class II |
5
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.
6
Image /page/6/Picture/0 description: The image shows the word "CYTRELLIS" in blue font. There is a line underneath the word. To the right of the word, there are four orange dots arranged in a square shape, and a circled R symbol.
| 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. |
7
Image /page/7/Picture/0 description: The image shows the word "CYTRELLIS" in blue font. There is a horizontal line underneath the word. To the right of the word, there is a symbol that looks like four red dots arranged in a square.
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, including
| needle length, geometry, maximum penetration depth, and puncture rate. | ||
|---|---|---|
| (2) Non-clinical performance data demonstrates that the device performs as intended | ||
| under anticipated conditions of use. The following performance characteristics have | ||
| been tested: | ||
| (i) | Accuracy of needle penetration depth | |
| and puncture rate | Accuracy of needle penetration depth and | |
| puncture rate was tested in a suitable skin | ||
| substrate model and measured using the | ||
| Keyence Laser System | ||
| (ii) | Safety features built into the device to | |
| protect against cross-contamination & | ||
| fluid ingress protection | The device design prevents cross | |
| contamination including fluid ingress | ||
| protection due to the needle cartridge design. | ||
| Design elements include RFID to prevent | ||
| needle cartridge re-use and tortuous path for | ||
| fluid ingress. Testing was performed under | ||
| worst case scenarios. | ||
| (iii) | Identification of the max safe needle | |
| penetration depth for the device & for | ||
| the labeled indications for use | Maximum safe needle penetration depth was | |
| identified in a suitable skin substrate model | ||
| and measured using the Keyence Laser | ||
| System. | ||
| (3) Performance data must demonstrate the | ||
| sterility of the patient-contacting | ||
| components of the device. | Performance data demonstrates the sterility of | |
| the patient-contacting components of the | ||
| device according to ISO 11137-1:2006, ISO | ||
| 11137-2:2013 and ISO/TS 13004:2013 | ||
| (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. | Performance data supports the shelf life of the | |
| device by demonstrating continued sterility, | ||
| package integrity, and device functionality | ||
| over the 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 | ||
| (5) Performance data must demonstrate the | ||
| electrical safety and electromagnetic | ||
| compatibility (EMC) of all electrical | ||
| components of the device. | Performance data demonstrates the electrical | |
| safety and electromagnetic compatibility | ||
| (EMC) of all electrical components of the | ||
| device according to IEC 60601-1:2012 3.1 | ||
| edition and IEC 60601-1-2:2014 |
8
Image /page/8/Picture/0 description: The image shows the word "CYTRELLIS" in blue font. There is a line underneath the word. To the right of the word is a symbol that looks like four red dots.
| (6) Software verification, validation, and
hazard analysis must be performed for all
software components of the device. | Software verification, validation, and hazard
analysis were performed for all software
components of the device according to in
accordance with FDA's Guidance for the
Content of Premarket Submissions for
Software Contained in Medical Devices |
|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (7) The patient-contacting components of the
device must be demonstrated to be
biocompatible. | The patient-contacting components of the
device were demonstrated to be biocompatible
including evaluation of cytotoxicity, irritation,
and sensitization, acute systemic toxicity and
material-mediated pyrogenicity and
hemocompatibility per ISO 10993-1 |
| (8) Performance data must validate the
cleaning and disinfection instructions for
reusable components of the device. | A cleaning and disinfection validation was
performed for reusable components of the
device per AAMI TIR30:2011/(R)2016 and
AAMI TIR12:2010 |
| (9) Labeling includes 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 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 |
9
Image /page/9/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 graphic of four red dots arranged in a square pattern. The font is a serif font and the word is in all capital letters.
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.
10
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.
11
Image /page/11/Picture/0 description: The image shows the word "CYTRELLIS" in blue font. There is a horizontal line underneath the word. Above the right side of the word are four orange dots arranged in a square. To the right of the word is the registered trademark symbol.
Technical Specifications Comparison:
| Characteristic | Subject of this
510(K)
510(K) Pending
Cytrellis Dermal
Micro-Coring
System | Predicate Device
K180778
Exceed
Microneedling
Device | Similarities and
significant
differences to the
predicate device |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Manufacturer | Cytrellis Biosystems,
Inc. | MT.DERM GmbH
Gustav-Krone-Str.
3,
14167 Berlin,
Germany | Not
Applicable |
| Device Trade Name | Cytrellis Dermal
Micro-Coring System | Exceed
Microneedling
device | Not Applicable |
| Product Code | QAI | QAI | Identical |
| Classification Name | Microneedling device
for aesthetic use | Microneedling
device for aesthetic
use | Identical |
| Device
Classification | Class II | Class II | Identical |
| Regulation Number | 21 CFR 878.4430 | 21 CFR 878.4430 | Identical |
| Use | Prescriptive | Prescriptive | Identical |
| Intended Location
of Use | Mid and Lower
Face | Face | Similar -
Both devices
are for the
treatment of
wrinkles |
| Characteristic | Subject of this
510(K)
510(K) Pending
Cytrellis Dermal
Micro-Coring
System | Predicate Device
K180778
Exceed
Microneedling
Device | Similarities and
significant
differences to the
predicate device |
| Intended Use and
Indications for Use | 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 Exceed is a
microneedling
device and
accessories is
intended for the
treatment of
wrinkles in
Fitzpatrick skin
types I, II and/or III
in the following
facial areas:
glabellar frown
lines, periorbital
lines and cheek
folds in adults aged
22 years or older. | Similar - Both devices
are used in aesthetic
procedures in
dermatology. Both
devices are for the
treatment of wrinkles.
The proposed
indication being sought
in this 510(K) is for
moderate and severe
cheek wrinkles with
Fitzpatrick skin types I
- IV. Clinical
performance data
provided demonstrates
that the Cytrellis
Dermal Micro- Coring
System is safe and
effective for the
indication and intended
use described. |
| Geometry | Single (1) needle or
three (3) needles
arranged in a straight
line. Needles are
ground to 10-degree
tip angle resulting in
two (2) cutting
services and two (2)
tips | 6 needles, squared
arrangement | Dissimilar - Clinical
and non-clinical
performance testing
demonstrates that the
Cytrellis Dermal
Micro-Coring System
does not pose any
undue or additional
risks and is effective |
| Characteristic | Subject of this
510(K)
510(K) Pending
Cytrellis Dermal
Micro-Coring
System | Predicate Device
K180778
Exceed
Microneedling
Device | Similarities and
significant
differences to the
predicate device |
| Max Needle length
used in clinical
study | Up to 5.0mm core
depth setting or
6mm needle tip
depth | 1.5mm | Dissimilar - Clinical
and non-clinical
performance testing
demonstrates that the
Cytrellis Dermal
Micro-Coring System
does not pose any
undue or additional
risks and is effective. |
| Characteristic | Subject of this
510(K)
510(K) Pending
Cytrellis Dermal
Micro-Coring
System | Predicate Device
K180778
Exceed
Microneedling
Device | Similarities and
significant differences
to the predicate device |
| Maximum needle
penetration
(maximum needle
length) | Up to 4.0mm core
depth setting or 5mm
needle tip depth | 1.5mm | Dissimilar - Clinical and
non-clinical
performance testing
demonstrates that the
Cytrellis Dermal Micro-
Coring System does not
pose any undue or
additional risks and is
effective. |
| Needle protrusion
setting | 0-4.0mm core
depth setting or 1-
5mm needle tip
depth | 0 - 1.9 mm | Dissimilar - Clinical and
non-clinical performance
testing demonstrates that
the Cytrellis Dermal
Micro-Coring System
does not pose any undue
or additional risks and is
effective. |
| Frequency | 8-12 Hz | 100-150 Hz
(±10%) | Dissimilar - Clinical and
non-clinical performance
testing demonstrates that
the Cytrellis Dermal
Micro-Coring System
does not pose any undue
or additional risks and is
effective. |
| Treatment Protocol | At least 2 but no more
than 3 treatments
spaced 4 weeks apart | 4 treatments spaced
4 weeks apart | Dissimilar - Clinical and
non-clinical performance
testing demonstrates that
the Cytrellis Dermal
Micro-Coring System
does not pose any undue
or additional risks and is
effective. |
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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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Image /page/15/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 symbol that looks like four red dots arranged in a square. The symbol is followed by the registered trademark symbol.
| 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 |
|---|---|
| ------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
results and the fundamental scientific technology.