(245 days)
The DEKA Motus AX laser system is indicated for:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
The provided document is a 510(k) summary for the DEKA Motus AX medical laser system. The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.
Based on the content of this document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or reduction percentages common in clinical trials for new medical treatments and AI/ML devices). Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and ensuring safety and regulatory compliance.
The "device performance" reported is primarily in terms of technical specifications compared to the predicate device and conformance to electrical/safety standards.
| Feature / Criterion Type | DEKA Motus AX Performance (New Device) | Predicate Device (DEKA Synchro Repla: Y) | Acceptance (Implied) |
|---|---|---|---|
| Laser Type | Alexandrite | Alexandrite | Equivalent |
| Wavelength | 755 nm | 755 nm | Equivalent |
| Max Fluence | Range from 600 J/cm² (2.5mm hp) to 8 J/cm² (Moveõ hp) | Range from 600 J/cm² (2.5mm hp) to 14 J/cm² (24mm hp) | Comparable range, some differences in specific handpieces and max fluence for largest spot sizes, but considered substantially equivalent for indications. |
| Spot Sizes | 2.5 to 20mm | 2.5 to 24mm | Comparable (small difference in largest spot size) |
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms | Equivalent |
| Pulse Rep Rate | up to 10 Hz | up to 10 Hz | Equivalent |
| Skin Cooling System | Yes, integrated in Moveo handpiece, external optional for others | Yes, optional, integrated by Smartcooler handpiece or external | Similar functionality/availability |
| Indications for Use | Temporary hair reduction; Stable long-term or permanent hair reduction (6, 9, 12 months on all skin types incl. tanned); Treatment of benign pigmented lesions; Treatment of wrinkles; Photocoagulation of benign dermatological vascular lesions. | Identical to DEKA Motus AX (stated in text) | Equivalent |
| Compliance to Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1 | (Implied predicate also complies or was tested for relevant standards) | Met for DEKA Motus AX |
| Ex-vivo Performance | Produces comparable thermal energy distribution and adversely affected tissue region as predicate. | (N/A - used as comparison for new device) | Met for DEKA Motus AX |
| Biocompatibility | Performed on Moveo handpiece tip. | (N/A - specific to new device component) | Met for DEKA Motus AX |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Clinical Performance Data: None". This means there was no clinical test set (i.e., human subject data) used to demonstrate performance against specific clinical acceptance criteria in the context of an effectiveness study.
The non-clinical performance data included "ex-vivo performance data on three different tissue types". This refers to laboratory testing, not human patient data. The provenance of this ex-vivo data is not specified (e.g., country of origin). It would be considered prospective for the device under review, as these tests were conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical performance data was presented, there was no test set requiring multi-expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used for performance evaluation that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC comparative effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ex-vivo non-clinical performance data, the "ground truth" would be the measured thermal energy distribution and adversely affected tissue regions, as assessed by the scientific methods used in the laboratory setting. There is no mention of expert consensus, pathology, or outcomes data as ground truth for clinical performance, as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This is a hardware device (laser system), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2017
El.En. Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 50041 Calenzano (FI), Italy
Re: K162886
Trade/Device Name: DEKA Motus AX Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: May 15, 2017 Received: May 18, 2017
Dear Paolo Peruzzi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162886
Device Name DEKA Motus AX
Indications for Use (Describe)
The DEKA Motus AX laser system is indicated for:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin. Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary DEKA Motus AX
Submitter:
El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
June 19th, 2017
Device Trade Name:
DEKA Motus AX
Common Name:
Medical Laser system
Classification Name:
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX)
Classification Number:
21 CFR 878.4810
Predicate Devices:
DEKA Synchro Repla: Y family of laser systems (K150516).
Device Description:
The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.
Intended Use:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
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Treatment of wrinkles. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Substantial equivalence discussion:
The DEKA Motus AX is substantially equivalent to the 755nm laser source of the DEKA Synchro Repla: Y family of laser systems (K150516).
| Device TradeName | DEKA Motus AX | Predicate DeviceK150516DEKA Synchro Repla: Y family oflaser systems(755nm laser source) |
|---|---|---|
| Laser Type | Alexandrite | Alexandrite |
| Wavelength | 755 nm | 755 nm |
| Max Fluence | 2.5mm handpicece: 600J/cm25mm handpicece: 160J/cm27mm handpicece: 80J/cm210mm handpicece: 40J/cm212mm handpicece: 27J/cm214mm handpicece: 20J/cm215mm handpicece: 17J/cm216mm handpicece: 15J/cm218mm handpicece: 12J/cm220mm handpicece: 10J/cm2Mõveõ handpicece:8J/cm2 | 2.5mm handpicece: 600J/cm25mm handpicece: 160J/cm27mm handpicece: 80J/cm210mm handpicece: 40J/cm212mm handpicece: 27J/cm214mm handpicece: 20J/cm215mm handpicece: 17J/cm216mm handpicece: 15J/cm218mm handpicece: 12J/cm220mm handpicece: 10J/cm222mm handpicece: 16J/cm224mm handpicece: 14J/cm2 |
| Spot Sizes | 2.5 to 20mm | 2.5 to 24mm |
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms |
| Pulse Rep Rate | up to 10 Hz | up to 10 Hz |
| Skin CoolingSystem | Yes, integrated in the Moveohandpiece, external optional for theother handpieces | Yes, optional, integrated bySmartcooler handpiece or external. |
The DEKA Motus AX has the same indications for use as the above mentioned predicate device, with same principle of operation and essentially the same performances.
Clinical Performance Data:
None
Non-Clinical Performance Data:
The DEKA Motus AX was tested for standards conformance with the following standards:
IEC 60601-1- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
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IEC 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1- Safety of laser products – Part 1: Equipment classification and requirements.
Moreover, ex-vivo performance data on three different tissue types were submitted in order to show that DEKA Motus AX produces comparable thermal energy distribution and adversely affected tissue region as the predicate for the range of energy deposition parameters from the subject and predicate devices for the worst-case deposition time.
Finally, biocompatibility tests have been performed on the Moveo handpiece tip, which comes in contact with the patient.
Conclusion:
Based on the outcome of non-clinical performance data performed, we can conclude that the DEKA Motus AX laser system is substantially equivalent to the predicate device .
Additional Information:
None
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.