(29 days)
Ellipse Ydun system is intended to be used in dermatology, as tabled below:
- Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
Ellipse Ydun is a platform/console capable of driving the Ellipse Frax 1550 applicator, which is a 1550 nm Laser diode-based applicator cleared by FDA under K161162.
The Ydun system consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1550 applicator connects to the system and have built in Laser diodes emitting 1550 nm light in a fractionated pattern.
The provided text describes a 510(k) premarket notification for the Ellipse Ydun system, a laser surgical instrument. The document focuses on demonstrating substantial equivalence to a predicate device (Ellipse Nordlys with Frax 1550) rather than presenting a performance study with acceptance criteria for an AI/algorithm-driven device.
Therefore, the information required to populate a table of acceptance criteria and reported device performance (especially for an AI algorithm), details on test set provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in the provided text.
The document primarily outlines:
- Device Name: Ellipse Ydun
- Regulation Number: 21 CFR 878.4810 Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
- Regulatory Class: Class II
- Product Code: GEX
- Intended Use/Indications for Use: "Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures."
- Technological Comparison: The Ellipse Ydun is described as being "identical to the predicate device in that the Frax 1550 applicator/handpiece being used is the same as used by the predicate device and the Ellipse Ydun console driving the Frax 1550 is of the same technological design."
- Performance Standards: The device was tested according to and complies with various electrical safety, laser product, and quality management standards (e.g., US FDA 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC 60825-1, ISO13485).
Conclusion:
Based on the provided text, there is no information about an AI/algorithm-driven device, acceptance criteria or performance studies of the kind typically performed for software/AI-based medical devices. The submission is for a hardware device (laser instrument) seeking substantial equivalence based on its technological similarity to an existing predicate device and compliance with relevant safety and performance standards for hardware.
Therefore, I cannot fulfill the request for the table or other detailed information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm, as such information is not contained within this document.
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March 15, 2018
Ellipse A/S Ole Kofod QA/RA Manager Agern Alle 11 Horsholm, DK-2970 DK
Re: K180406
Trade/Device Name: Ellipse Ydun 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: February 9, 2018 Received: February 14, 2018
Dear Ole Kofod:
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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K180406 K18xxxx (TBD)
Device Name
Ellipse Ydun
Indications for Use (Describe)
Ellipse Y dun system is intended to be used in dermatology, as tabled below: · Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
| 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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FORM FDA 3881 (8/14)
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Special 510(k) Summary – K180406 – Section 3
Ellipse Ydun
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92.
Submitter Information:
| Date of the summary: | 15 March 2018 |
|---|---|
| Submitted by/manufacturer: | Ellipse A/S (Establishment Registration no. 3005112495)Agern Alle 112970 Hoersholm, DenmarkTel: + 45 4576 8808Fax: + 45 4517 6851 |
| Contact person: | Ole Kofod |
| Device Identification:Device Trade Name 1: | Ellipse Ydun (with Frax 1550 hand piece/applicator). |
| Device Model number 1: | 9SYS7852. |
| Common Name: | Intense Pulsed Light (IPL) & Laser. |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and indermatology (per 21 CFR Part 878.4810). |
| Device classification: | Class II (per 21 CFR 870.1250). |
| Product code: | GEX |
| Predicate Devices:Predicate device legally marketedto which Ellipse A/S claimssubstantial equivalence: | Ellipse Nordlys with Frax 1550 (K161162)Ellipse A/S Agern Alle 11DK-2970-Hørsholm, Denmark |
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Description of Ellipse Ydun with associated Frax 1550 applicator (hand piece):
Ellipse Ydun is a platform/console capable of driving the Ellipse Frax 1550 applicator, which is a 1550 nm Laser diode-based applicator cleared by FDA under K161162.
The Ydun system consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1550 applicator connects to the system and have built in Laser diodes emitting 1550 nm light in a fractionated pattern.
Intended Use/Indications for Use:
Ellipse Ydun system is intended to be used in dermatology, as tabled below:
- Y dun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as ● well as for skin resurfacing procedures.
Technological Comparison
Subject device, Ellipse Ydun, is identical to the predicate device in that the Frax 1550 applicator/handpiece being used is the same as used by the predicate device and the Ellipse Ydun console driving the Frax 1550 is of the same technological design.
Performance Standards:
The Ellipse Ydun Laser system has been tested according to and comply with:
- US FDA 21 CFR 1040.10 and 1040.11 for class IV Laser Products. ●
- IEC 60601-1 3rd edition, UL 60601-1 and CSA C22.2 No. 601.1. .
- IEC 60825-1 and IEC 60601-2-22. ●
- IEC 60601-1-2.
- Complies with the European Medical Device Directive 93/42/EEC (Annex II). ●
- Manufactured under ISO13485 Quality Management System certified by Presafe/DGM and QMI and also . complies with the US FDA 21CFR Part 820.
Substantial Equivalence conclusion:
The Ellipse Ydun system with Ellipse Frax 1550 applicator is substantially equivalent, in terms of technological characteristics, performance, intended use/indications for use, to the predicate device (K161162) listed on page 1 of this document.
The Ellipse Ydun system has been evaluated and compared to the above mentioned predicate system and applications, parameters, and intended use/indications for use, and have been judged to be substantially equivalent to the mentioned predicate device.
§ 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.