(92 days)
The Intended Use for Ellipse I2PL is:
Ellipse 12PL. is intended for use in dermatology.
- · Hair removal (permanent hair reduction).
- · Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness).
The Indications for Use for Ellipse I2PL are:
| Application | Treatment Variable | Fitzpatrick Skin Type | |||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| Hair RemovalHR ApplicatorHR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair RemovalHR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented LesionsAnd Benign Vascular Lesions | Pigmentation | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care andattention. | |||||||
| Key: ✓ Allowed; ⊖ Not Allowed |
Ellipse If PL is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair and for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores and diffuse redness in the area of dermatology.
The system consists of a console containing power unit and control electronics with control and display panel including software.
Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 555 nm - 950 nm.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Danish Dermatologic Development A/S (DDD) Ellipse I2PL dermatologic IPL system:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about specific study designs, sample sizes, ground truth establishment, and expert involvement are not explicitly present in this type of document. 510(k) clearances are often based on performance testing to ensure safety and functionality, and comparison to legally marketed predicate devices, rather than large-scale clinical trials proving efficacy against predefined acceptance criteria in the same way a PMA would require.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are not framed as specific performance thresholds that the device had to meet in independent clinical trials. Instead, the acceptance criteria are implicitly that the device's technical specifications and intended uses are substantially equivalent to legally marketed predicate devices. The "reported device performance" is essentially the device's capabilities and parameters, which are then compared to those of the predicate devices.
| Feature / Criterion (Implicit) | Ellipse I2PL Performance (Reported) | Corresponding Predicate Performance (for comparison) |
|---|---|---|
| Intended Use | Hair removal (permanent reduction) and treatment of benign pigmented and vascular lesions. | Matches or is a subset of predicate device intended uses (e.g., IPL™ Quantum, Skin Station™, EsteLux™). |
| Technology | Intense Pulsed Light (IPL) / broad spectrum light / touch screen operation. | Matches predicate devices (IPL™ Quantum, Skin Station™, EsteLux™). |
| Energy Spectrum | 555-950 nm | Predicates varied: 515-1200 nm (IPL™ Quantum), 400-1200 nm (Skin Station™), 470-1400 nm (EsteLux™). Ellipse I2PL's range falls within or overlaps these. |
| Energy Output/Setting | 0-21 J/cm² | Predicates varied: 15-45 J/cm² (IPL™ Quantum), 3-10 J/cm² (Skin Station™), 12-40 J/cm² (EsteLux™). Ellipse I2PL's range overlaps. |
| Pulse Duration | 5-55 mS | Predicates varied: 2-16 mS (to 48 mS triple pulsed) (IPL™ Quantum), 10 and 35 mS (Skin Station™), 10-100 mS (EsteLux™). Ellipse I2PL's range overlaps. |
| Applicator/Hand-piece Spot Size | 10 x 48 mm | Predicates varied: 8 x 34 mm (IPL™ Quantum), 22 x 55 mm and 35 x 12 mm (Skin Station™), various from 10x15mm to 16x46mm (EsteLux™). Ellipse I2PL's spot size is comparable to predicate devices. |
| Charge Time/Repetition Rate | 1.5-2.0 Sec. | Predicates: 2 Sec. (IPL™ Quantum), N/A (Skin Station™), 1 Sec. (EsteLux™). Ellipse I2PL's rate is comparable. |
| Cooling Method | Cooling handpiece by circulating water. | Predicates varied: Skin cooling components integrated in hand piece (IPL™ Quantum), N/A (Skin Station™), Skin cooling possible with Cool Roller™ (EsteLux™). Ellipse I2PL cooling method is similar or equivalent. |
| Patient Skin Types (Hair Removal) | Fitzpatrick Skin Types 1-5 (HR/HR-S applicators), 1-6 (HR-D applicator). | Implicitly equivalent to predicate devices' safe operating parameters. |
| Patient Skin Types (Pigmented/Vascular Lesions) | Fitzpatrick Skin Types 1-4. | Implicitly equivalent to predicate devices' safe operating parameters. |
The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which primarily relies on comparison and demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with specific performance endpoints. The conclusion explicitly states: "Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S believes that no significant differences exist. The Ellipse I-PL system should not raise new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. 510(k) submissions generally do not include detailed clinical study reports with patient sample sizes. The "test set" here refers to the parameters and specifications of the device being compared to predicates. Performance claims for the device would have been supported by internal testing and possibly limited clinical data, but the specifics are not in this summary.
- Data Provenance (country of origin, retrospective/prospective): Not specified in this 510(k) summary. Given the manufacturer is Danish, internal testing might have been done in Denmark or in collaboration with clinical sites.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- For a 510(k) based on substantial equivalence, ground truth for device performance is often established by engineering and medical professionals within the company and/or by referring to published literature and the established performance of the predicate devices. Clinical efficacy data, if used, would typically refer to assessments by qualified dermatologists or medical practitioners.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. This level of detail regarding clinical study methodology (like adjudication) is typically not found in a 510(k) summary unless a specific clinical study was a critical part of the equivalence claim, which is not the case here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the provided 510(k) summary does not indicate that an MRMC comparative effectiveness study was performed. The evaluation focuses on the device's technical specifications and intended use in comparison to predicate devices, not on human reader performance with or without AI assistance.
- Effect size of AI improvement: Not applicable, as no MRMC study with AI assistance is mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not explicitly stated in terms of a formal standalone clinical study report. The device itself (an IPL system) is a standalone technology, meaning it operates independently of "human-in-the-loop" performance in the context of an algorithm or AI. The performance of the device's energy output, pulse duration, and other physical parameters would have been characterized through engineering bench testing and system verification, which could be considered a form of standalone performance evaluation for the device's technical specifications.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the device's claims of safety and effectiveness in a 510(k) context is primarily established by:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices for similar indications.
- Technical Specifications: Engineering measurements and verification of the Ellipse I2PL's physical parameters (energy, wavelength, pulse duration) to ensure they are within safe and effective ranges comparable to predicates.
- Clinical Literature/Experience: General dermatologic understanding of IPL technology for hair removal and lesion treatment.
- If any minimal clinical data was included to support the claim, then patient outcomes (e.g., hair reduction, lesion clearance) would have been the ground truth, likely assessed by clinicians. However, no such data is detailed here.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an IPL system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physics of light-tissue interaction.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this type of medical device.
{0}------------------------------------------------
510(k) SUMMARY
Danish Dermatologic Development A/S (DDD) Ellipse I2PL dermatologic IPL 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: | 11 February 2005 |
|---|---|
| Submitted by/manufacturer: | Danish Dermatologic Development A/SAgern Alle 112970 Hoersholm, DenmarkTel: + 45 4576 8808Fax: + 4517 6851 |
| Contact person: | Ole Kofod |
| Device Trade Name: | Ellipse I2PL. |
| Device Model number: | 9ESL7228. |
| Common Name: | Intense Pulsed Light (IPL) 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 DDDclaims equivalence: | IPL™ Quantum (K024093; K020839) manufactured byLumenis Inc., 2400 Condensa Street, Santa Clara, CA 95051, USA.(Laser surgical instrument for use in general and plastic surgery andin dermatology (per 21 CFR Part 878.4810)).Skin Station™ (K030897) manufactured by Radiancy Inc., 40Ramland Road South, Suite 10, Orangeburg, New York 10962,USA.(Laser surgical instrument for use in general and plastic surgery andin dermatology (per 21 CFR Part 878.4810)).EsteLux™ (K020453) manufactured by Palomar MedicalTechnologies, Inc., 82 Cambridge Street, Burlington, MA 01803.(Laser surgical instrument for use in general and plastic surgery andin dermatology (per 21 CFR Part 878.4810)). |
{1}------------------------------------------------
<043255
B. Description of Ellipse I2PL:
Ellipse If PL is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair and for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores and diffuse redness in the area of dermatology.
The system consists of a console containing power unit and control electronics with control and display panel including software.
Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 555 nm - 950 nm.
C. Intended Use of Ellipse I-PL:
Ellipse I2PL is intended for use in dermatology.
- Hair removal (permanent hair reduction). .
- Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, . mottled pigmentation) and benign vascular lesions (diffuse redness). The Indications for Use for Ellipse I'PL are:
| Application | Treatment Variable | Fitzpatrick Skin Type | |||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| Hair RemovalHR ApplicatorHR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair RemovalHR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented LesionsAnd Benign Vascular Lesions | Pigmentation | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care and attention. | |||||||
| Key: ✓ Allowed; ⊖ Not Allowed |
D. Comparison of Ellipse I2PL to predicate devices:
| Ellipse I²PL | IPL™ Quantum | Skin Station™ | EsteLux™ | |
|---|---|---|---|---|
| 510(k) reference | Current submission | K024093; K020839 | K030897 | K020453 |
| Technology/Operation/Devicedescription | Intense Pulsed Light(IPL)/broad spectrumlight/touch screenoperation. | Intense Pulsed Light(IPL)/broad spectrumlight/touch screenoperation. | Intense Pulsed Light(IPL)/broadspectrum. Knoboperation. | Intense Pulsed Light(IPL)/broadspectrum. Knoboperation withdisplay. |
| Intended Use | Hair removal andthe treatment ofbenign pigmentedand vascular lesions | Hair removal,treatment of tattoos,benign pigmentedand benign vascularlesions | Hair removal andtreatment ofpigmented andvascular lesions | Hair reduction,treatment of facialand leg veins andvascular and benignpigmented lesions |
| Energy spectrum | 555-950 nm | 515-1200 nm * | 400-1200 nm | 470-1400 nm |
| Energy ouput/setting | 0-21 J/cm² | 15-45 J/cm² * | 3-10 J/cm² | 12-40 J/cm² |
| Pulse duration | 5-55 mS | 2-16 mS(to 48 mS triplepulsed). * | 10 and 35 mS | 10-100 mS |
{2}------------------------------------------------
人043255
| Ellipse I²PL | IPL™ Quantum | Skin Station™ | EsteLux™ | |
|---|---|---|---|---|
| 510(k) reference | Current submission | K024093; K020839 | K030897 | K020453 |
| Applicator/hand-piece spot size | 10 x 48 mm | 8 x 34 mm | 22 x 55 mm and35 x 12 mm | 16 x 46 mm, 12 x 28mm, 12 x 12 mm, 10x 15 mm |
| Charge time/repetion rate | 1.5-2.0 Sec. | 2 Sec. | N/A | 1 Sec. |
| Cooling method | Cooling handpiece bycirculating water. | Skin coolingcomponentsintegrated in handpiece. | N/A | Skin cooling possiblewith Cool Roller™ |
| Deviceclassification | II; 21 CFR 878.4810,GEX | II; 21 CFR 878.4810,GEX | II; 21 CFR 878.4810,GEX | II; 21 CFR 878.4810,GEX |
- See conclusion.
{3}------------------------------------------------
15 04 725
Conclusion:
IPI."M Quantum has a broader range of applications than Ellipse I PL. IPLTM Quantum may be updated with a Laser module for vascular treatment applications in addition to the IPL modules. Ellipse IPL does not employ a Laser module, only IPL, Ellipse I PL thus utilizes a
subset of the IPL TM Quantum applications.
SkinStation™ has identical range of applications as Ellipse I'PL, and the intended use and the performance is substantially equivalent.
EsteLux " has a broader range of applications than Ellipse I-PL, the intended use for Eilipse I2PL is covered by the EsteLux "M and the performance is substantially equivalent.
The systems and identical application modules utilized by IPL™ Quantum (Lumenis, Inc.), Skin Station™ (Radiancy Ltd.) , and EsteLux™ (Palomar) have been evaluated and compared to Ellipse I2PL. The Ellipse I-PL system, as far as these identical modules, applications and intended uses are concerned, are judged to be substantially equivalent to the IPL™ Quantum (predicate device cleared in K024093, K020839), SkinStation™ (predicate device cleared in K030897), and EsteLux™ (predicate device cleared in K991935, K984110).
Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S believes that no significant differences exist. The Ellipse I-PL system should not raise new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its wing.
Public Health Service
FEB 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ole Kofod OA/RA Manager, Operations Manager Danish Dermatologic Development A/S Agern Alle 11 DK-2970 Hoersholm Denmark
Re: K043255 Trade/Device Name: Ellipse I- PL. 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: November 19, 2004 Received: November 26, 2004
Dear Mr. 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 practice, labeling, and prohibitions against misbranding 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. 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); 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.
{5}------------------------------------------------
Page 2 - Mr. Ole Kofod
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 a legally 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), pleasc 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Rhodes
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
K043255 510(k) Number:
Ellipse I2PL Device Name:
Indications for Use:
The Intended Use for Ellipse I2PL is:
Ellipse 12PL. is intended for use in dermatology.
- · Hair removal (permanent hair reduction).
- · Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness).
The Indications for Use for Ellipse I2PL are:
| Application | Treatment Variable | Fitzpatrick Skin Type | |||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| Hair RemovalHR ApplicatorHR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair RemovalHR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented LesionsAnd Benign Vascular Lesions | Pigmentation | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care andattention. | |||||||
| Key: ✓ Allowed; ⊖ Not Allowed |
Prescription Use
AND/OR
(Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
WDC- 23663/0001 - 2063040 v3
510(k) Number K043255
§ 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.