(233 days)
The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.
The EXELO2 is a CO2 laser device designed for dermatological use. It produces a coherent monochromatic radiation at the wavelength of 1.6 microns. The system is composed of a base which encloses the power supply and control interface, an articulated mirror arm, and a scanner handpiece.
The provided text is a 510(k) summary for the EXELO2 Scanned CO2 Laser System for Dermatology. It describes the device, its specifications, indications for use, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" for the EXELO2 device's performance in terms of specific metrics like sensitivity, specificity, or accuracy. Instead, the study aims to demonstrate "substantial equivalence" to a predicate device, which is a regulatory standard rather than a specific performance metric.
The reported device performance is qualitative, focusing on histological findings.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K080915 Reliant Fraxel re:pair Carbon Dioxide Laser) | "Quantitative histology demonstrated substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 5 human subjects.
- Data Provenance: The study was conducted on "human subjects." The country of origin is not explicitly stated, but the contact information for Quantel USA (Bozeman, MT) suggests the study may have been conducted in the US. The study is prospective, as punch biopsies were taken at specific time points after exposure (10 min, 3 days, 14 days, 21 days, and 28 days).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish the ground truth for the histological analysis. It only states "Quantitative histology demonstrated substantial equivalence."
4. Adjudication Method for the Test Set
The adjudication method for the histological analysis is not specified in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The EXELO2 is a medical device (CO2 laser), not an AI-powered diagnostic or assistive tool, so this type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The EXELO2 is a CO2 laser device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used was quantitative histology. This means that tissue samples (punch biopsies) were analyzed to assess the effects of the laser treatment.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as the device is a laser system, not a machine learning model. There is no mention of any machine learning component requiring a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning algorithm, no ground truth needed to be established in this context.
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OCT 2 9 2009
Section 5
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 04-10-08 [21 CFR 807.92(a)(1)].
Contact Information [21 CFR 807.92(a)(1)] A.
Quantel USA
601 Haggerty Lane
Bozeman, MT 59715
Tel: 406-586-0131
Fax: 406-586-2924
Contact person: Michael Johnson M.D.
Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] B.
Trade Name: EXELO2 Scanned CO2 Laser System for Dermatology
Device Common Name: CO2 Laser
Classification Name: Laser Instrument, Surgical Powered (per 21 CFR 878.4810)
Product Code: ONG
Panel: Dermatology and Plastic Surgery
Device Classification: Class II
- Predicate Devices [21 CFR 807.92(a)(3)] C.
The EXELO2 device uses similar technology and has equivalent physical output characteristics as the following predicate devices:
K080915 Reliant Fraxel re:pair Carbon Dioxide Laser
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D. Device Description [21 CFR 807.92(a)(4)]
The EXELO2 is a CO2 laser device designed for dermatological use. It produces a coherent monochromatic radiation at the wavelength of 1.6 microns. The system is composed of a base which encloses the power supply and control interface, an articulated mirror arm, and a scanner handpiece.
E. Device Specifications [21 CFR 807.92(a)(6)]
The EXELO2 outputs a monochromatic laser beam of 1.6 micron wavelength with selectable pulse durations of between 2 and 8 milliseconds. The laser power is adjustable in the range of 1-30 Watts. The spot size is 250 microns. The aiming beam has a wavelength of 635 nanometers and a power of less than 1 milliWatt. The scanner covers areas adjustable between 1 and 4 centimeters and has a spot pitch of 0.25 to 3.50 millimeters.
F. Indications for Use [21 CFR 807.92(a)(5)]
The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.
. G. Performance Data [21 CFR 807.92(b)(2)]
The EXELO2 was tested on a series of 5 human subjects. Energy settings of 50mJ and 100mJ were used and punch biopsies were taken at 10 minutes, 3 days, 14 days, 21 days, and 28 days. Quantitative histology demonstrated substantial equivalence.
Conclusion [21 CFR 807.92(b)(3)] H.
Technologically, the EXELO2 was found to be substantially equivalent to the currently cleared K080915 Reliant Fraxel re:pair Carbon Dioxide Laser. The indications for use are similar to these previously cleared devices. The risks and benefits for the EXELO2 are argued to be comparable to the predicate devices. We believe that there are no new questions of safety or efficacy raised by the introduction of the EXELO2.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right resembles an abstract human figure with outstretched arms, possibly representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 2 9 2009
Quantel Derma GmbH % Quantel, USA Mr. Michael Johnson Medical Product Manager 601 Haggerty Lane Bozeman, Montana 59715
Re: K090639
Trade/Device Name: EXELO2 Scanned CO2 Laser System for Dermatology 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: ONG Dated: October 23, 2009 Received: October 27, 2009
Dear Mr. Johnson:
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 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 (reporting of medical
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Page 2 -- Mr. Michael Johnson
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4
pg 1 of 1
Indications for Use
510(k) Number (if known): K090639
Device Name: EXELO2
Indications for Use:
The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Af. Ogden formxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090639
§ 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.