The LipoAI is indicated for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.

Device Description

The LipoAl is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin. The DEKA LipoAl device consists of: An AC/DC power supply unit, CPU controller, LASER source, Cooling system, User interface with LCD touch screen, Beam delivery system. Laser activation is controlled by footswitch. Electrical specifications are: 200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max)

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI-driven diagnostic devices.

The document describes a 510(k) premarket notification for a medical laser device, DEKA LipoAI. The core of this submission is to demonstrate substantial equivalence to an existing predicate device (Lutronic AccuSculpt II Laser system), not to prove performance against specific acceptance criteria for an AI algorithm.

Here's a breakdown of why the requested information is absent and what is present:

No AI-driven diagnostic or analytical capabilities: The DEKA LipoAI is a "Laser Surgical Instrument" for physical procedures like surgical incision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis. It does not appear to have any AI components that perform diagnosis, image analysis, or provide analytical outputs requiring performance metrics like sensitivity, specificity, or AUC. The "AI" in "LipoAI" might refer to "Artificial Intelligence" in a product branding sense, but its function as described is that of a laser delivery system, not an intelligent analytical tool requiring performance criteria to classify medical conditions.
Focus on Substantial Equivalence: The document explicitly states the purpose is to "demonstrate substantial equivalence" to a predicate device. This process primarily involves comparing specifications, indications for use, and safety standards rather than proving novel performance capabilities of an AI system.
Non-Clinical Performance Data: The "Non-Clinical Performance Data" section discusses:
- Electrical safety and electromagnetic compatibility (EMC): Tested against standards like ANSI AAMI ES60601-1 and IEC 60601-1-2.
- Software Validation and Verification Testing: Conducted "as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" This likely refers to the software controlling the laser's operation, not an AI for diagnosis.
- Additional non-clinical testing: Against standards like IEC 60601-2-22 and IEC 60825-1 (laser safety standards).
  These are all engineering and safety compliance tests, not performance studies for an AI algorithm.
"Clinical Performance Data: None": This explicitly states that no clinical performance data was provided for this submission. This further confirms that no studies were conducted to assess the diagnostic or analytical performance of an AI component, as such studies would be considered clinical performance.

Therefore, I cannot provide a table of acceptance criteria or details about an AI performance study because the provided document does not indicate the device has AI capabilities that would require such performance evaluation in the context of diagnostic accuracy.

The information requested would typically be found in a submission for an AI/ML-driven diagnostic medical device. This document details a laser surgical instrument, where the "AI" likely does not translate to diagnostic or analytical artificial intelligence.

Summary

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October 21, 2021

EL.EN Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager VIA Baldanzese 17 Calenzano, Firenze 50041 Italy

Re: K212270

Trade/Device Name: DEKA LipoAI 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: July 15, 2021 Received: July 20, 2021

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/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.

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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 and Part 809: 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" (21 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 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.

Purva Pandya 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

Enclosure

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Indications for Use

510(k) Number (if known) K212270

Device Name DEKA LipoAI

Indications for Use (Describe)

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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510(k) Summary

DEKA LIPOAI

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:

September 17, 2021

Device Trade Name:

DEKA LIPOAI

Common Name:

Powered Laser Surgical Instrument

Classification Name:

Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology

Product Code:

GEX

Regulatory Class:

Class II

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Classification Number:

21 CFR 878.4810

Predicate Device:

Lutronic AccuSculpt II Laser system (K101573)

Device Description:

The LipoAl is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source.

The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin.

The DEKA LipoAl device consists of:

An AC/DC power supply unit
CPU controller
. LASER source
Cooling system
. User interface with LCD touch screen
. Beam delivery system

Laser activation is controlled by footswitch.

Electrical specifications are:

200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max)

Indications for Use:

The LipoAl is indicated for the surgical incision, excision, vaporization, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAl is further indicated for laser assisted lipolysis.

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Comparison with The Predicate Device:

The DEKA LIPOAI is substantially equivalent to the AccuSculpt II Laser system (K101573):

Device Trade	Proposed Device	Predicate Device	comment
Name	DEKA LipoAI	Lutronic AccuSculpt II(K101573)
Indications forUse	The LipoAl is indicated forthe surgical incision,excision, vaporization,ablation, and coagulation ofsoft tissue. All soft tissue isincluded, such as skin,cutaneous tissue,subcutaneous tissue,striated and smooth tissue,muscle, cartilage meniscus,mucous membrane, lymphvessels and nodes, organsand glands. The LipoAl isfurther indicated for laserassisted lipolysis.	The AccuSculpt II LaserSystem is indicated for thesurgical incision, excision,vaporization, ablation, andcoagulation of soft tissue.All soft tissue is included,such as skin, cutaneoustissue, subcutaneous tissue,striated and smooth tissue,muscle, cartilage meniscus,mucous membrane, lymphvessels and nodes, organsand glands. The AccuSculptII is further indicated forlaser assisted lipolysis.	Identical
Regulationnumber	21 CFR 878.4810 Lasersurgical instrument for usein general and plasticsurgery and in dermatology	21 CFR 878.4810 Lasersurgical instrument for usein general and plasticsurgery and in dermatology	Identical
Product Code	GEX	GEX	Identical
Laser type	• Pulsed Nd:YAG	• Pulsed Nd:YAG	Identical
Wavelength	1444 nm	1444 nm	Identical
Max Pulse Energy	300 mJ	300 mJ	Identical
Transmissionsystem	600 µm Optical fiber	600 µm Optical fiber	Identical
Pulse width	Up to 100 µs	Up to 100 µs	Identical
Device TradeName	Proposed Device	Predicate Device	comment
	DEKA LipoAI	Lutronic AccuSculpt II(K101573)
Pulse repetitionrate	5-40 Hz	5-40 Hz	Identical
Aiming beam	Red and Green visible laserdiode	Red visible laser diode	Difference does notaffect safety andeffectiveness of thedevice
Max Outputpower	12W	12 W	Identical

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Clinical Performance Data:

None

Non-Clinical Performance Data:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the LipoAl device, according to the following standards:

. ANSI AAMI ES60601-1Medical 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.

Software Validation and Verification Testing

Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Additional non-clinical testing conducted

Additional tests were conducted on the LipoAl device, according to the following standards:

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K212270

. 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:

On the basis of the comparison with the predicate device and on the non-clinical performance data , we can conclude that DEKA LIPOAI is as safe, as effective, and performs as well as the legally marketed predicate device (K101573).

Additional Information:

None.

Regulation Number and Section

§ 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.