(95 days)
No
The device description focuses on mechanical components, adjustable settings (frequency, needle depth), and standard electrical power. There is no mention of data processing, algorithms, or learning capabilities.
Yes
The device is intended for the treatment of wrinkles and to improve the appearance of facial acne scars, which are therapeutic indications.
No
Explanation: The device is described as a microneedling device intended for treatment of wrinkles and acne scars. Its function is to create microscopic punctures in the skin for cosmetic improvement, not to diagnose any condition.
No
The device description explicitly details multiple hardware components including a handpiece, needle cartridge, battery, charger, and motor. It also describes mechanical actions like needle movement and penetration depth adjustment.
Based on the provided text, the Exceed Unlimited device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of wrinkles and acne scars on the face by creating microscopic punctures in the skin. This is a therapeutic/cosmetic procedure performed directly on the patient's skin.
- Device Description: The device is a microneedling device that physically interacts with the skin. It does not analyze biological samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples, detect markers of disease, or provide diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Exceed Unlimited does not fit this description.
N/A
Intended Use / Indications for Use
The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I. Il and/or III in the following facial areas: qlabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.
The device is a prescriptive device and complies with 21CFR 801.109.
Product codes (comma separated list FDA assigned to the subject device)
OAI
Device Description
The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles.
The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50-60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.
The frequency of the handpiece can be adjusted from 100-150Hz and is indicated on a display. The needle penetration is adjusted by the needle protrusion setting dial, which can be adjusted between 0.0 (min.) and 1.9 mm (max.).
The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneedles of 1.5 mm length (0.35 mm gauge) and an internal safety membrane. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face, specifically: glabellar frown lines, periorbital lines and cheek folds.
Indicated Patient Age Range
Adults aged 22 years or older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance tests were conducted in line with recognized standards in terms of general requirements, biocompatibility, electrical safety, and software.
Non-clinical performance data demonstrates that the device performs as intended under anticipated conditions of use.
The following performance characteristics are tested:
i. Accuracy of needle penetration depth and puncture rate in pig skin with high-speed camera measurement;
ii. Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane; and
iii. Identification of the maximum safe needle penetration depth for the device in pig skin with highspeed camera measurement.
Performance data supports the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 23, 2024
Mt.Derm GmbH Stefan Polland Regulatory Affairs Manager Blohmstr. 37-61 Berlin, 12307 Germany
Re: K233709
Trade/Device Name: Exceed Unlimited Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: OAI Dated: January 24, 2024 Received: January 24, 2024
Dear Stefan Polland:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Exceed Unlimited
Indications for Use (Describe)
The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I. Il and/or III in the following facial areas: qlabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
MT.DERM
510(k) Summary K233709
Executive Summary
| Submitter's Name: | MT.DERM GmbH |
|---|---|
| Submitter's Contact: | Stefan Polland |
| Submitter's Address: | Blohmstr. 37-61, 12307 Berlin, Germany |
| Submitter's Telefon: | +49 30 7676 220 171 |
| Device Trade Name: | Exceed Unlimited |
| Submition Date: | 24th Jan, 2024 |
| Submission update: | 16th Feb, 2024 |
1. Device Classification Information:
| Regulation
Number | Device
Classification
name | Device
Class | Product
Code | Generic description | Classification
Panel | Type |
|----------------------|----------------------------------------------|-----------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------|
| 21 CFR
878.4430 | Microneedling
device for
aesthetic use | Class 2 | QAI | 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. | General & Plastic
Surgery | Traditional
510 (k) |
2. Device Description
The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles.
The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50-60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.
The frequency of the handpiece can be adjusted from 100-150Hz and is indicated on a display. The needle penetration is adjusted by the needle protrusion setting dial, which can be adjusted between 0.0 (min.) and 1.9 mm (max.).
5
The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneedles of 1.5 mm length (0.35 mm gauge) and an internal safety membrane. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY.
3. Indications/Intended Use
The Exceed Unlimited is a microneedling device and accessories 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.
The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, III, III and IV in adults aged 22 years or older.
The device is a prescriptive device and complies with 21CFR 801.109.
4. Predicate Device
Exceed K182407
The Exceed Microneedling device is a microneedling device and accessories 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.
The Exceed Microneedling device is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, III and IV in adults aged 22 years or older.
Intended use applies exclusively to the following patient groups: Adult men and women aged 22 years or older who are in good health.
The device is a prescription device and complies with 21CFR 801.109.
6
5. Technological Characteristics
| Property | Exceed Unlimited | Exceed Microneedling
Device | Significant differences |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device
Manufacturer | MT.DERM GmbH
Blohmstr. 37 - 61,
12307 Berlin,
Germany | MT.DERM GmbH
Blohmstr. 37 – 61,
12307 Berlin,
Germany | Not applicable |
| Device Trade
Name | Exceed Unlimited device | Exceed microneedling device | Not applicable |
| 510(K) Number | | (A) K182407
(B) K180778 | Not applicable |
| Device
Classification
name | Microneedling device for
aesthetic use | Microneedling device for
aesthetic use | Identical |
| Device Product
Code | QAI | QAI | Identical |
| Device
Classification | Class II | Class II | Identical |
| Regulation
number | 21 CFR 878.4430 | 21 CFR 878.4430 | Identical |
| Use | Prescription | Prescription | Identical |
| Intended Location
of Use | Face | Face | Identical |
| Intended use and
Indications | The Exceed Unlimited device is
a microneedling device and
accessories 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.
The Exceed Unlimited device is
a microneedling device and
accessories intended to be used
as a treatment to improve the
appearance of facial acne scars
in Fitzpatrick skin types I, II, III
and IV in adults aged 22 years or
older. | K180778: The Exceed
Microneedling device is a
microneedling device and
accessories 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.
K182407: The Exceed
Microneedling device is a
microneedling device and
accessories intended to be used
as a treatment to improve the
appearance of facial acne scars
in Fitzpatrick skin types I, II, III
and IV in adults aged 22 years
or older. | Identical |
| Geometry | 6 needles, squared arrangement | 6 needles, squared arrangement | Identical |
| Property | Exceed Unlimited | Exceed Microneedling
Device | Significant differences |
| Needle protrusion
setting | 0 - 1.9 mm | 0 - 1.9 mm | Identical |
| Maximum needle
penetration
(maximum needle
length) | 1.5mm | 1.5 mm | Identical |
| Frequency | 100-150 Hz (±10%) | 100-150 Hz (±10%) | Identical |
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Image /page/7/Picture/0 description: The image shows the logo for MT.DERM. The logo is in white text on a red background. The text is sans-serif and appears to be slightly blurred.
6. Substantial Equivalency and Comparison of Technological Similarities & Differences
6.1. Key Similarities.
- i. The device classification (generic description) and basic technologies are equivalent in that both devices are micro needling systems containing >1 needle that mechanically punctures or injures the skin for aesthetic use.
- ii. Identical intended use.
- iii. The depth of penetration of the needles (needle length) is equivalent 1.5mm
- iv. Intended for prescription use.
- v. Location of use (Face)
- vi. Identical needle configuration
- vii. Identical needle protrusion setting
- viii.Identical Frequency
6.2. Differences.
Although the systems share the basic technology they do differ in two major areas:
- i. Power Supply - Exceed Microneedling device was supplied directly by a wall plug. Exceed Unlimited is supplied by rechargeable battery.
- ii. Control - Exceed Microneedling device was controlled by a separate control unit. Exceed Unlimited is directly controlled with the hand piece.
This difference has been addressed by the manufacturer through the applicable safety standards (General controls and mitigation measures).
Although there are differences between the proposed device, Exceed Unlimited, and predicate device, Exceed Microneedling Device (K182407), General controls of the FD&C Act and "Special controls" listed below demonstrate that the Exceed Unlimited device raises no new questions in relation to safety and efficacy compared to the predicate device.
8
Image /page/8/Picture/0 description: The image shows the logo for MT.DERM. The logo is white text on a red background. The text is in a sans-serif font and is centered on the image.
7. General controls and mitigation measures
To demonstrate safe and effective performance and support substantial equivalence has undergone a number of non-clinical performance tests in line with recognized standards in terms of general requirements, biocompatibility, electrical safety and software. The following non-clinical performance data is provided in support of the substantial equivalence determination.
7.1. Summary of Risk and mitigation measures
| Identified Risk to Health | Mitigation Measures | Evidence |
|---|---|---|
| Adverse tissue reaction | Biocompatibility evaluation | ISO 10993-5 Third edition 2009-06-01 |
| ISO 10993-7:2008 | ||
| ISO 10993-10: 2010 | ||
| ISO 10993-11:2017 | ||
| Labeling | ISO 15223-1 Fourth edition 2021-07 | |
| ISO 20417:2021, Corrected version 2021-12 | ||
| Sterilization validation | ISO 11135:2014 + Amd.1:2018 | |
| Cross contamination and | ||
| infection | Reprocessing validation | A cleaning validation was performed for reusable components of the device. (Reprocessing |
| Medical Devices in Health Care Settings: Validation Methods and Labeling) | ||
| Non-clinical performance testing | Non-clinical performance data demonstrates that the device performs as intended under | |
| anticipated conditions of use. | ||
| The following performance characteristics are tested | ||
| i. Accuracy of needle penetration depth and puncture rate in pig skin with high - | ||
| speed camera measurement; | ||
| ii. Safety features built into the device to protect against cross-contamination, | ||
| including fluid ingress protection due to a safety membrane; and | ||
| Identified Risk to Health | Mitigation Measures | Evidence |
| Shelf life testing | iii. Identification of the maximum safe needle penetration depth for the device in | |
| pig skin with highspeed camera measurement. | ||
| 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 | ||
| ISO 11607-1 Second edition 2019-02 | ||
| ISO 11607-2 Second edition 2019-02 | ||
| Labeling | Section 13 Proposed labeling | |
| ISO 15223-1 Fourth edition 2021-07 | ||
| ISO 20417:2021, Corrected version 2021-12 | ||
| Electrical shock or | ||
| Electromagnetic interference | ||
| with other devices | EMC testing and electrical | |
| safety testing | IEC 60601-1:2005/AMD2:2020 | |
| IEC 60601-1-2:2014/AMD1:2020 | ||
| IEC 60601-1-6:/AMD2:2020 | ||
| Labeling | ISO 15223-1 Fourth edition 2021-07 | |
| ISO 20417:2021, Corrected version 2021-12 | ||
| IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION | ||
| Non-clinical performance testing | Non-clinical performance data demonstrates that the device performs as intended under | |
| anticipated conditions of use. | ||
| The following performance characteristics are tested | ||
| i. Accuracy of needle penetration depth and puncture rate in pig skin with high - | ||
| speed camera measurement; | ||
| Identified Risk to Health | Mitigation Measures | Evidence |
| ii. | ||
| Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane; and | ||
| iii. | ||
| Identification of the maximum safe needle penetration depth for the device in pig skin with highspeed camera measurement. | ||
| Damage to underlying tissue including nerves and blood vessels, scarring and hyper and hypopigmentation. | ||
| Exceeding safe penetration depth | ||
| Mechanical failure | ||
| Software malfunction | Technological characteristics | Non-clinical performance data demonstrates that the device performs as intended under anticipated conditions of use. |
| The following performance characteristics are tested | ||
| Exceeding safe penetration depth | ||
| Mechanical failure | ||
| Software malfunction | i. | |
| Accuracy of needle penetration depth and puncture rate in pig skin with high - speed camera measurement; | ||
| ii. | ||
| Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane; and | ||
| iii. | ||
| Identification of the maximum safe needle penetration depth for the device in pig skin with highspeed camera measurement. | ||
| Shelf life testing | ISO 11607-1 Second edition 2019-02 | |
| ISO 11607-2 Second edition 2019-02 | ||
| Labeling | ISO 15223-1 Fourth edition 2021-07 | |
| ISO 20417:2021, Corrected version 2021-12 | ||
| Software verification, validation and hazard analysis | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION |
9
MT.DERM
Page 6 of 8
10
MT.DERM
11
8. Special Controls - Non clinical performance testing
In addition to the general standards and risk mitigation measures identified above, the Exceed Microneedling device has been subjected to the special controls outlined in 21 CFR 878.4430.
9. Clinical performance testing
Not applicable.
10. Statement of Substantial Equivalence:
513(i) of the FD&C Act (21 U.S.C. 360c(i) states that for substantial equivalence a proposed device is required to have the same intended use and similar technological characteristics as the predicate device. Where there are differences in technological characteristics, these can be negated by appropriate clinical or scientific data demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not raise any different questions of safety and effectiveness than the predicate device for the same intended use.
MT.DERM GmbH has demonstrated that the Exceed Unlimited device has the same generic classification (generic description) and basic technologies as the predicate device Exceed microneedling system (K182407). Both devices are micro needling systems containing >1 needle that mechanically punctures or injures the skin for aesthetic use. Both devices have used needle depths of up to 1.5mm in clinical investigations.
Where there are differences between the Exceed Unlimited device and the predicate MT.DERM GmbH has conducted substantial non-clinical performance testing applicable to those general and special controls deemed necessary by the agency for this product classification and has determined that the Exceed Unlimited device raises no new questions relating to safety or efficacy and therefore has demonstrated that the Exceed Unlimited device is substantially equivalent to the referenced predicate K182407.