(51 days)
Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of:
- Skin Resurfacing .
- Wrinkles, Rhytides, and Furrows .
- Acne Scars .
The Ellipse Juvia system comprises the following major parts:
- A laser console containing a CO2 laser module capable of providing a laser beam having a . wavelength of 10,600 nm.
- A scanner that is intended to manipulate and place a pulsed beam received from the laser . console in a pre-specified pattern on the skin being treated.
- An optical fiber providing a beam path from the laser to the scanner. .
The Ellipse Juvia laser system received 510(k) clearance (K072023) based on substantial equivalence to predicate devices, not on a study demonstrating that it meets specific acceptance criteria. The submission focuses on comparing the new device's technical specifications and intended uses to those of already cleared devices to establish that the Ellipse Juvia does not raise new questions of safety or effectiveness.
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this 510(k submission, as it is not a requirement for substantial equivalence pathways where direct performance studies against pre-defined criteria might not be conducted.
However, based on the provided text, we can infer the "acceptance criteria" as substantial equivalence to the predicate devices and the "study" as a detailed comparison table of technical specifications and indications for use.
Here's an analysis based on what is provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Ellipse Juvia) |
|---|---|
| Indications for Use comparable to predicates: | Skin Resurfacing, Wrinkles, Rhytides, and Furrows, Acne Scars |
| Technology comparable to predicates: | CO2 laser module, scanner for pattern generation, fiber optic beam delivery system. |
| Wavelength identical to predicates: | 10,600nm |
| Power range comparable to predicates: | 0.11-20W |
| Minimum scanner spot size comparable to predicates: | Ø300µm (comparable or smaller than predicates) |
| Max power density comparable to predicates: | 28.6kW/cm2 (comparable to predicates) |
| Aiming beam specifications comparable to predicates: | 635nm, max 5mW |
| Scanning speed comparable to predicates: | 0.3-100 Hz |
| Beam activation method identical to predicates: | Foot switch |
| No new issues of safety or effectiveness: | Concluded that the device "should not raise any new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The submission does not describe a clinical study with a "test set" in the traditional sense of evaluating device performance on a sample of patients or images. The "test" here is a technical comparison against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert ground truth establishment for a test set is mentioned, as this was not a clinical performance study. The "truth" for substantial equivalence is based on the technical specifications and intended uses of legally marketed predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned, as there was no test set requiring expert review.
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
- No. This is a medical device for dermatological and plastic surgery procedures, specifically a laser system, not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant and not mentioned.
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. Standalone performance as typically described for AI algorithms is not relevant here. The "standalone" performance would be its physical output (wavelength, power, spot size), which is characterized by its technical specifications but not presented as a "study" in the provided document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the pre-existing FDA clearance of the predicate devices (Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and SLIM Evolution Family of CO2 Lasers). The equivalence claim is based on the comparison of specifications and indications to these already-cleared devices, implying that their safety and effectiveness are established.
8. The sample size for the training set
- Not applicable. There is no "training set" mentioned, as this is a medical device clearance based on substantial equivalence, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there's no ground truth establishment for it.
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Ellipse A/S
SEP 1 2 2007
Ellipse Juvia laser system
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92.
A. Contact information and device identification:
| Date of the summary: | 20 July 2007 |
|---|---|
| Submitted by/manufacturer: | Ellipse A/SAgern Alle 112970 Hoersholm, DenmarkTel: + 45 4576 8808Fax: + 45 4517 6851 |
| Contact person: | Ole Kofod |
| Device Trade Name: | Ellipse Juvia. |
| Device Model number: | 9EJU7465. |
| Common Name: | Laser treatment system. |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and indermatology (per 21 CFR Part 878.4810). |
| Device classification: | Class II. |
| Product code: | GEX |
| Predicate devices legallymarketed to which EllipseA/S claims equivalence: | • Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser andDelivery Device (K022060) manufactured by Lumenis, Inc., SantaClara, CA, USA.(Laser surgical instrument for use in general and plastic surgeryand in dermatology (per 21 CFR Part 878.4810)).• SLIM Evolution Family of CO2 Lasers and Delivery Device Ac-cessories (K063001) manufactured by Lasering S.r.l, Modena, It-aly.(Laser surgical instrument for use in general and plastic surgeryand in dermatology (per 21 CFR Part 878.4810)). |
B. Description of Ellipse Juvia system:
The Ellipse Juvia system comprises the following major parts:
- A laser console containing a CO2 laser module capable of providing a laser beam having a . wavelength of 10,600 nm.
- A scanner that is intended to manipulate and place a pulsed beam received from the laser . console in a pre-specified pattern on the skin being treated.
- An optical fiber providing a beam path from the laser to the scanner. .
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C. Intended Use of Ellipse Juvia system:
Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of:
- . Skin Resurfacing
- · Wrinkles, Rhytides, and Furrows
- Acne Scars
D. Comparison of Ellipse Juvia to predicate devices:
| Issue/data com-pared | Ellipse Juvia | SLIM(Lasering S.r.l) | Ultrapulse Encore(Lumenis) |
|---|---|---|---|
| FDA clearance /status | Being submitted (thissubmission) | K063001 | K022060 |
| Indications | Skin resurfacing,wrinkles, rhytids, andfurrows,acne scars | Skin resurfacing,treatment of furrows andwrinkles,acne scars,and others | Skin resurfacing,wrinkles, rhytids, and fur-rows,acne scars,and others |
| Technology | The system comprises:a) A laser console con-taining a CO2 lasermoduleb) A scanner for pro-ducing a pattern oflight spots on the skinc) a beam deliveringsystem connecting thelaser console and thescanner. | The system comprises:a) A laser console contain-ing a CO2 laser moduleb) A scanner for producinga pattern of light spots onthe skinc) a beam delivering sys-tem connecting the laserconsole and the scanner. | The system comprises:a) A laser console contain-ing a CO2 laser moduleb) A scanner for producinga pattern of light spots onthe skinc) a beam delivering sys-tem connecting the laserconsole and the scanner. |
| Length of beamdelivering system | 165cm | 130cm | 150 / 180 cm depending onmodel |
| Type of beam de-livering system | Fiber providing fullfreedom of movement | Articulated arm with 340°of freedom | Articulated arm with 360°of freedom |
| Wavelength | 10,600nm | 10,600nm | 10,600nm |
| Max power | 0.11-20W | 0.1-15W, 0.2-30W, 1-50Wdepending on the model | 1-60W |
| Minimum scannerspot size | Ø300µm | Ø400µm | Ø1300µm |
| Max power den-sity (computed asmax power di-vided by mini-mum scanner spotsize) | 20W / Ø300µm =28.6kW/cm2 | 15W / Ø400µm =15.0kW/cm230W / Ø400µm =30.0kW/cm250W / Ø400µm =50kW/cm2 | 60W/ Ø1300µm =6kW/cm2 |
| Aiming beam | 635nm, max 5mW | 635nm, max. 2mW | 635nm, max 5mW |
| Scanning speed(light spots on theskin per second) | 0.3-100 Hz | 1-10,000 Hz | 1-1,000 Hz |
| Time for a fullscan | In the range of 1 sec –Actual time is depend-ing on scan patternchosen | In the range of 1 sec – Ac-tual time is depending onscan pattern chosen | In the range of 1 sec – Ac-tual time is depending onscan pattern chosen |
| Beam activation | Foot switch | Foot switch | Foot switch |
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Conclusion:
Ellipse Juvia applications and indications are evaluated to be within the scope of the previously cleared devices. The same counts for the essential treatment parameters, the protective conditions for the skin during treatment, and the working conditions of the physician.
Based on this side-by-side comparison of the overall performance characteristics of the predicate devices under consideration Ellipse A/S concludes that no significant differences exist. The Ellipse Juvia should not raise any new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices.
| (Signature) | |
|---|---|
| Ole Kofod | |
| (Typed Name) | |
| 20-July-2007 | |
| (Date) |
(Premarket Notification 510(k) Number)
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ellipse A/S % Ole Kofod QA/RA Manager Agern Alle 11 DK-2970 Hørsholm Denmark
SEP 1 2 2007
Re: K072023 Trade/Device Name: Ellipse Juvia Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 31, 2007 Received: September 7, 2007
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 indicle 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 1 c. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, IDA 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 manufon wour not not hot 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); good manufacturing practice requirements as set
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Page 2 - Ole Kofod
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 100-1000.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to 100x) marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Notification
Device Name: Ellipse Juvia
Indications for Use:
Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of:
- Skin Resurfacing .
- Wrinkles, Rhytides, and Furrows .
- Acne Scars .
Concurrence of CDRH, Office valuation (ODF Prescription Use X Counter Use Division of General, Restoration Format 1-2-96) (Per 21CFR 801.109) and Neurological Devices 23 510(k) Number
§ 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.