(85 days)
Alexandrite 755nm laser source:
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).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (sun spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
The DEKA MOTUS A Y is a medical device equipped with two laser sources: 755nm and 1064mm. The laser sources deliver 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 text is a 510(k) premarket notification letter from the FDA regarding the DEKA MOTUS AY device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-driven medical device.
The document details the device's substantial equivalence to predicate devices based on technical specifications and indications for use, but it explicitly states under "Clinical Performance Data: None" and focuses on "Non-Clinical Performance Data" which are limited to conformance with electrical and laser safety standards.
Therefore, I cannot extract the information required to answer your questions as they relate to AI/ML device performance and validation.
Here's why the provided text isn't relevant to your request for AI/ML device validation specifics:
- Device Type: The DEKA MOTUS AY is a laser surgical instrument, not an AI/ML diagnostic or therapeutic device. Its performance is evaluated based on physical characteristics and safety standards, not on algorithms interpreting data or making predictions.
- "Acceptance Criteria" in this context: For this device, acceptance criteria would be technical specifications (e.g., wavelength, fluence, pulse duration within a certain range), safety standards compliance, and equivalence to legally marketed predicates. These are listed in tables comparing the device to its predicates.
- "Study that proves the device meets the acceptance criteria": For this device, the "proof" comes from non-clinical testing for compliance with electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and the fact that its specifications are substantially equivalent to already cleared devices. There's no AI algorithm to validate.
If you provide a document related to an AI/ML medical device submission, I would be able to answer your questions.
{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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2018
Elen Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese, 17 Calenzano, 50041 IT FI
Re: K181486
Trade/Device Name: DEKA MOTUS AY 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 31, 2018 Received: June 6, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K181486
Device Name DEKA MOTUS AY
| Indications for Use (Describe) | |
|---|---|
| Alexandrite 755nm laser source: |
Alexandrite 755nm laser source:
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).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (sun spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) Summary
DEKA Motus AY
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:
August 28, 2018
Device Trade Name:
DEKA MOTUS AY
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:
Primary predicate: Synchro Repla: Y family of laser systems (K150516). Reference predicate: DEKA Motus AX (K162886)
Device Description:
The DEKA MOTUS A Y is a medical device equipped with two laser sources: 755nm and 1064mm. The laser sources deliver 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:
Alexandrite 755nm laser source:
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
{4}------------------------------------------------
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).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Substantial equivalence discussion:
The DEKA MOTUS AY is substantially equivalent to the DEKA Synchro Repla:Y family of laser systems (K150516).
755 nm laser:
| Device Trade Name | Proposed 510(k) DeviceDEKA MOTUS AY | Predicate DeviceK162886DEKA Motus AX | Predicate DeviceK150516DEKA Synchro Repla: Yfamily of laser systems |
|---|---|---|---|
| Laser Type | Alexandrite | Alexandrite | Alexandrite |
| Wavelength (nm) | 755 nm | 755 nm | 755 nm |
| MAX Fluence (J/cm2) | 2-200 J/cm² | 2-600 J/cm² | 2-600 J/cm² |
| Handpiece Spot Sizes(diameter millimeter) | 2.5, 5, 7, 10, 12, 14, 15, 16,18, 20 mm | 2.5, 5, 7, 10, 12, 14, 15, 16,18, 20 mm | 2.5, 5, 7, 10, 12, 14, 15, 16,18, 20, 22, 24 mm |
| Pulse Duration(milliseconds) | 2 to 50 ms | 2 to 50 ms | 0.2 to 50 ms |
| Pulse Repetition Rate(Hz) | up to 10 Hz | up to 10 Hz | up to 10 Hz |
{5}------------------------------------------------
| Device Trade Name | Proposed 510(k) DeviceDEKA MOTUS AY | Predicate DeviceK162886DEKA Motus AX | Predicate DeviceK150516DEKA Synchro Repla: Yfamily of laser systems |
|---|---|---|---|
| Skin Cooling System | Yes(handpiece integrated andexternal) | Yes(handpiece integrated andexternal) | Yes(handpiece integrated andexternal) |
| Skin Coolingtemperature | 15°C | 15°C | 4-20°C |
1064 nm laser:
| Device Trade Name | Proposed 510(k) DeviceDEKA MOTUS AY | Predicate DeviceK150516DEKA Synchro Repla:Y family of lasersystems |
|---|---|---|
| Laser Type | Nd: YAG | Nd:YAG |
| Wavelength (nm) | 1064 nm | 1064 nm |
| MAX Fluence (J/cm2) | 2-600 J/cm² | 2-600 J/cm² |
| Handpiece Spot Sizes(diameter millimeter) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 , mm | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20, 22, 24mm |
| Pulse Duration(milliseconds) | 0.2 to 50 ms | 0.2 to 50 ms |
| Pulse Repetition Rate(Hz) | up to 10 Hz | up to 10 Hz |
| Skin Cooling System | Yes(handpiece integrated and external) | Yes(handpiece integrated and external) |
| Skin Coolingtemperature | 15°C | 4-20°C |
The DEKA MOTUS AY has the same indications for use as the above mentioned predicate devices, with same principle of operation and essentially the same performances.
Clinical Performance Data:
None
Non-Clinical Performance Data:
The DEKA MOTUS AY was tested for standards conformance with the following standards:
AAMI/ANSI ES60601-1- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
{6}------------------------------------------------
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.
Conclusion:
Based on the outcome of non-clinical performance data performed, we can conclude that the DEKA Motus AY laser system is substantially equivalent to the predicate devices .
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.