(176 days)
The Fraxel II SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
This document is a 510(k) summary for the Fraxel II SR Laser System and Accessories, which is a medical device. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text, focusing on the requested acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or a table of device performance metrics that would be typically seen for software or AI-driven diagnostic devices (e.g., sensitivity, specificity, AUC). This device is a laser system for dermatological procedures, and the "performance" is described more qualitatively in terms of its intended clinical effects.
However, based on the nature of the submission, the implicit "acceptance criteria" for the FDA's 510(k) clearance are:
| Acceptance Criterion (Implicit) | Reported Device Performance (as described) |
|---|---|
| Substantial Equivalence in Indications for Use | "Substantial equivalence for the Fraxel II SR Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements." |
| Clinical Performance (Safety and Effectiveness) | "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the clinical performance of the Fraxel II SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This implies the device safely achieves its intended dermatological effects (coagulation of soft tissue, treatment of wrinkles, scars, pigmented lesions, skin resurfacing) without introducing new risks compared to predicates. |
| Technological Characteristics Equivalence | "Key technological characteristics of the Fraxel II SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel II SR Laser System as described in submission K060310 and the Fraxel SR Laser System as described in submission K053047." |
| No New Issues of Safety and Effectiveness Introduced | "Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." |
| FDA Clearance (Overall "Acceptance") | The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates all implicit acceptance criteria for 510(k) clearance were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies". However, it does not specify the sample size for these studies, nor does it explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "IDE Reliant studies" typically implies prospective clinical trials conducted under an Investigational Device Exemption (IDE), which are generally prospective. "Non-Significant Risk studies" would also typically involve prospective patient enrollment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical studies. Given this is a laser system and not an AI diagnostic tool, the "ground truth" would likely be clinical outcomes assessed by treating physicians/dermatologists, rather than interpretation by a panel of reviewers.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with AI assistance. This is expected as the device described is a laser system for treatment, not an AI diagnostic tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a "Laser System," not an "algorithm" or AI. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this medical device. The system is operated by a human.
7. The Type of Ground Truth Used
While not explicitly stated as "ground truth," for a therapeutic laser system, the "ground truth" of its efficacy would be based on clinical outcomes data from patients treated with the device. This would involve assessments of the reduction in wrinkles, improvement in scars, clearance of pigmented lesions, and overall skin resurfacing effects as observed and documented by clinicians, and potentially patient satisfaction. Safety would be assessed by tracking adverse events.
8. The Sample Size for the Training Set
The document refers to "Non-Significant Risk and IDE Reliant studies" for clinical analysis. For a physical device like a laser, this represents the clinical validation set, not a "training set" in the context of machine learning. The device itself (the laser system) is not an AI algorithm that "learns" from data in the way a diagnostic AI would. Therefore, the concept of a "training set sample size" as typically understood for AI/ML is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" and "ground truth for the training set" in the AI/ML sense is not applicable to this device. Clinical studies would establish the safety and efficacy of the device based on observed patient outcomes.
{0}------------------------------------------------
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Heather Tanner Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 641-5861 650 641-3461 fax htanner@reliant-tech.com
JAN 3 1 2007
NAME OF DEVICE
Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel II SR Laser System and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II
LEGALLY MARKETED PREDICATE DEVICES
Name: Fraxel II SR Laser System and Accessories 510(k) #: K060310
Name: Fraxel SR Laser System and Accessories 510(k) #: K050841
Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060
DEVICE DESCRIPTION
The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
{1}------------------------------------------------
062303
INDICATION FOR USE STATEMENT
The Fraxel II SR Laser System is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles:
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia:
Skin resurfacing procedures.
SUBSTANTIAL EQUIVALENCE COMPARISON
Indications for Use
Substantial equivalence for the Fraxel II SR Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements.
Clinical Performance Data
Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the clinical performance of the Fraxel II SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced.
Technological Characteristics
Key technological characteristics of the Fraxel II SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel II SR Laser System as described in submission K060310 and the Fraxel SR Laser System as described in submission K053047.
CONCLUSION
Based on the design, materials, function, intended use and clinical evaluation, the Fraxel II Laser System and Accessories is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. No changes are being made in the laser wavelength or operating principle. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reliant Technologies % Ms. Heather MacFalls 464 Ellis Street Mountain View, California 94043
JAN 3 1 2007
Re: K062303
Trade/Device Name: Fraxel II SR Laser System and Accessories 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: January 5, 2007 Received: January 5, 2007
Dear Ms. MacFalls:
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, TDA max 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 sectoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
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), 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. Malkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
cc: HFZ-401 DMC FZ-404 510(k) Staff
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): ├об2 30 3
Device Name: Fraxel II SR Laser System and accessories Indications For Use:
"The Fraxel II SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures."
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 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
510(k) Number_`K00302
§ 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.